• Bevacizumab Injection officially approved by Indonesia's National Agency of Drug and Food Control (BPOM), following Nigeria, Pakistan, and Colombia – accelerating global commercialization
• Approval in ASEAN's largest pharma market strengthens BioDlink's position as a global supplier of antibody/XDC therapies via international GMP standards and commercial capabilities

SUZHOU, China, Aug. 21, 2025 /PRNewswire/ --  announced that its Bevacizumab Injection has obtained marketing authorization from Indonesia's National Agency of Drug and Food Control (BPOM). This marks BioDlink's fourth international approval within two months – following Nigeria, Pakistan, and Colombia – signaling accelerated BioDlink's global expansion into a sustained commercialization phase.

Strategic Significance of Indonesian Approval
Indonesia, the world's fourth-most populous nation, reports over 400,000 new cancer cases annually (WHO). Yet biologics accessibility remains below 15%. As ASEAN's largest pharmaceutical market and regulatory hub, this approval expedites regional market access across Southeast Asia. BioDlink's cost-effective bevacizumab, manufactured in China in compliance with international GMP standards, is helping to address critical treatment gaps for patients in Indonesia.

Global Standards, Proven Quality & Compliance
BPOM's rigorous review process, fully aligned with PIC/S international standards, reinforces the clinical value of bevacizumab while reaffirming BioDlink's world-class quality systems. Our manufacturing facility is GMP-certified across multiple regions—including China, Brazil, Egypt, Indonesia, Colombia, Argentina, and Pakistan—and recognized by Japan's PMDA. This comprehensive accreditation ensures end-to-end compliance for antibodies, ADCs/XDCs, and biosimilar products.

This approval has proven BioDlink's mature global commercialization capabilities:

• Manufacturing Scale: Four commercial-scale manufacturing lines at the Suzhou site ensure a reliable global supply of antibodies, ADCs/XDCs, and biosimilars.
• Regulatory Excellence: BPOM's PIC/S-aligned approval stands as a global benchmark, underscoring the strength of BioDlink's quality systems.
• Strategic Momentum: Successive approvals across four markets are driving accelerated expansion in Southeast Asia and Latin America.

Dr. Jun Liu, Chief Executive Officer and Executive Director of BioDlink, stated:
"These consecutive approvals demonstrate the strength of our quality systems and commercial execution. With Indonesia as a key ASEAN hub, and in close partnership with Kexing Biopharm, we are shifting from single-market breakthroughs to regional impact —expanding access, diversifying growth, and delivering affordable, high-quality therapies worldwide."

About BioDlink

BioDlink, a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biologics, is committed to being the trusted partner of choice for biopharmaceutical innovators worldwide. Leveraging our advanced one-base integrated platform, BioDlink delivers end-to-end CDMO services for protein-based therapeutics (such as mAb, BsAb), biosimilar, and bioconjugated drugs (such as XDCs/ADCs) from early-stage research through to commercial-scale manufacturing.

BioDlink operates large-scale biopharmaceutical manufacturing facilities compliant with GMP standards and adheres to international quality management systems aligned with regulatory requirements in the US, the EU, and China. With our cutting-edge technology platforms and expert teams, BioDlink facilitates accelerated development timelines, with clients spanning Europe, the Americas, Asia, and several key emerging markets.

BioDlink operates with a clear service philosophy: "Quality-Driven, Innovation-Enabled, Growth-Shared," and has assembled an experienced and forward-thinking team. Committed to rigorous quality and compliance, the company nurtures a collaborative ecosystem that empowers its partners and delivers shared success. For more information, please visit:  

- BioDlink's bevacizumab injection secures marketing authorization in Colombia and Pakistan following its recent approval in Nigeria, marking key regulatory milestones in high-need emerging markets.

- GMP certification in Brazil, Colombia, and Argentina spans the top three most populous countries in South America, collectively representing 71.4% of the continent's population.

- Backed by a globally recognized quality system and a strong track record in monoclonal antibody, ADC/XDC, biosimilar development and manufacturing, BioDlink, in partnership with Kexing BioPharm is fast-tracking access to high-quality oncology biosimilars in underserved regions.

SUZHOU, China, Aug. 13, 2025 /PRNewswire/ -- announced that its self-developed bevacizumab injection biosimilar has received marketing approval from Colombia's National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan's Drug Regulatory Authority of Pakistan (DRAP). This development underscores its mission to improve access to critical cancer therapies worldwide.

Following GMP certification in China, Colombia, Brazil, Argentina, Egypt, Indonesia and Pakistan, Kexing BioPharm, the global licensee for bevacizumab injection in emerging markets, has initiated regulatory filings in 35 countries in close collaboration with BioDlink. GMP certification in Brazil, Colombia and Argentina covers the top three most populous countries in South America, representing 71.4% of the continent's population ^[1].

BioDlink's manufacturing facilities span 50,000 square meters and have passed antibody drug and ADC EU-QP inspection (including zero-defect) five times in the past four years. BioDlink's global-quality system is robust, delivering over 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including Europe and the U.S.

Meeting unmet needs in public health

Colombia and Pakistan are key pharmaceutical markets in South America and South Asia respectively. Both nations see a trend toward an increase in the incidence of colorectal cancer. The launch of bevacizumab injection seeks to lower the cost of treatment for both public health systems and patients, while maintaining rigorous global quality standards.

Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is widely used in the treatment of various cancers, including metastatic colorectal cancer (mCRC) and metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). According to industry estimates, bevacizumab injection achieved global sales of USD 8.5 billion in 2023^[2]. 

"Cancer incidence is rising sharply, especially colorectal cancer^[3], which has seen a global increase in early-onset cases in middle- and low?income countries," said Dr. Jun Liu, CEO and Executive Director of BioDlink. "With our partnership with Kexing Biopharm, we are committed to serving South American and other emerging markets and combat colorectal and lung cancers, the top two leading causes of cancer-related deaths worldwide ^[4]."

Since BioDlink signed an international commercialization agreement with Kexing BioPharm in early 2022, both parties have achieved an efficient closed-loop "R&D-manufacturing-access" model. BioDlink focuses on ensuring international manufacturing and supply chain robustness, while Kexing BioPharm leverages its global channels to drive localized market access efficiently.

BioDlink and Kexing BioPharm share an operational philosophy of "leading with quality and building on compliance" to focus on emerging markets such as South America, South Asia, Southeast Asia and Africa. Both companies look forward to deepening their global collaboration to fulfill a shared mission of advancing global healthcare.

About BioDlink

BioDlink, a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biologics, is committed to being the trusted partner of choice for biopharmaceutical innovators worldwide. Leveraging our advanced one-base integrated platform, BioDlink delivers end-to-end CDMO services for protein-based therapeutics (such as mAb, BsAb), biosimilar, and bioconjugated drugs (such as XDCs/ADCs) from early-stage research through to commercial-scale manufacturing.

BioDlink operates large-scale biopharmaceutical manufacturing facilities compliant with GMP standards and adheres to international quality management systems aligned with regulatory requirements in the US, the EU, and China. With our cutting-edge technology platforms and expert teams, BioDlink facilitates accelerated development timelines, with clients spanning Europe, the Americas, Asia, and several key emerging markets.

BioDlink operates with a clear service philosophy: "Quality-Driven, Innovation-Enabled, Growth-Shared," and has assembled an experienced and forward-thinking team. Committed to rigorous quality and compliance, the company nurtures a collaborative ecosystem that empowers its partners and delivers shared success. For more information, please visit:

About Kexing Biopharm Co., Ltd.

Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the integration of R&D, production and sales of recombinant protein drugs and microecological preparations. It focuses on antiviral, tumor and immune, blood, digestion, degenerative diseases and other therapeutic fields, builds cutting-edge biotechnology platforms such as new protein, new antibody, nucleic acid drugs, and adheres to the platform driven development model of "innovation+internationalization", At the same time, it explores the extensive application of biotechnology in the field of general health, actively cultivates and incubates new industries, the world's leading industrial platforms such as animal vaccines and synthetic organisms have been distributed, and is committed to becoming a leader in high-quality biopharmaceutics and serving global patients.

Reference:

[1] Top three most populous countries in South America.

[2] Bevacizumab injection achieved global sales of USD 8.5 billion in 2023.

[3] Cancer incidence is rising sharply, especially colorectal cancer

[4] Combat colorectal and lung cancers, the top two leading causes of cancer-related deaths worldwide

• BioDlink's Bevacizumab Injection has been granted marketing authorization by Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC), following GMP certifications in Brazil (a PIC/S member), Colombia, Egypt, Indonesia, and Argentina—further strengthening its global presence by opening access to the African market.
• Backed by a global recognized quality system and proven track record in antibody drug/XDC manufacturing and commercialization, BioDlink has strengthened its foothold in Latin America and beyond.
• BioDlink will accelerate the approval and market launch process of bevacizumab in emerging markets with Kexing Biopharm to fulfill the mission of safeguarding human health.

SUZHOU, China, June 16, 2025 /PRNewswire/ --  announced that its self-developed Bevacizumab Injection (Pusintin^®) has received marketing approval from National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria. This significant milestone accelerates BioDlink's global expansion efforts, and reaffirms its R&D and commercialization strength in biosimilar—offering a high-value, accessible treatment option for cancer patients worldwide.

Leveraging synergies with Kexing BioPharm, the global licensee for Pusintin^® in emerging markets, Pusintin^® has initiated regulatory filings in 35 countries. The approval in Nigeria not only marks the implementation of its global strategy but also signifies officially opening the door to the African market, bringing more affordable treatment alternatives to Nigerian patients.

ADDRESSING AFRICA'S GROWING HEALTHCARE NEEDS

Africa, with a population exceeding 1.5 billion (World Bank, 2024), faces increasing medical demand. Nigeria, as the "most populous country in Africa" (~220 million people), possesses both massive healthcare challenge and a major growth opportunity. According to the World Health Organization (WHO), Nigeria reports over 120,000 new cancer cases annually, growing at a rate of 5% per year—amid limited access to high-quality therapies. Pusintin^®'s approval meets this urgent medical need while serves as a model for expansion into other emerging-market.

INTERNATIONALLY RECOGNIZED MANUFACTURING & QUALITY EXCELLENCE

The approval has validated Pusintin^®'s compliance complies with international standards for R&D, manufacturing, and quality system. BioDlink's production facilities have already passed GMP inspections in China, Japan, Brazil, Colombia, Egypt, Indonesia, and Argentina and also passed antibody drug and ADC EU QP inspection 4 times in past two years. BioDlink's global-quality system ensures robust commercial supply, delivering more than 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including European and the U.S. in the past 3 years.

This millstone marks the beginning of BioDlink's international commercial rollout, injecting new momentum into its revenue diversification strategy and reinforcing its capabilities in global biosimilar commercialization.

BioDlink operates a large-scale, GMP-compliant biologics manufacturing facility, featuring four commercial lines with five drug substance production centers (including non-toxic conjugated drug substance units) and four drug production centers. Its world-class facilities and stringent quality system deliver reliable global supply for monoclonal antibodies (mAbs), bispecific antibodies, XDCs, and other biologics at global standards.

SUSTAINING GLOBAL MOMENTUM

BioDlink will continue collaborating with Kexing BioPharm to accelerate Pusintin^®'s approval in Southeast Asia and Latin America. Driven by a committed to innovation, quality, and global compliance, BioDlink will continue accelerating its expansion in overseas and emerging markets—bringing life-changing therapies to more patients worldwide.

About BioDlink Biopharm Co., Ltd.

BioDlink was established in 2010, and has a large-scale commercial GMP production base for biological drugs, a total manufacturing capacity exceeding 20,000 liters. Guided by its "Empowering Innovation with Quality to Grow Together" mission, BioDlink is dedicated to advancing global healthcare through excellence in biosimilars.

The company has built integrated platforms for biosimilars and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.

BioDlink's quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. In addition, the company has already passed nearly 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.

Contact information
PR name: Fiona Wu
E-mail:  

• Global Milestone: GMP certification from Argentina, marking a key step in its global expansion and regulatory recognition.
• Scalable, Trustworthy Solutions: With advanced manufacturing capabilities, BioDlink deliver Pusintin® (bevacizumab) injection that are not only consistent and cost-effective, but a superior choice for markets seeking dependable therapeutic alternatives.
• Client-Centric Expansion: Strengthened partnership with Kexing Biopharm enables improved access to essential oncology treatments in the Latin American market.

SUZHOU, China, June 5, 2025 /PRNewswire/ -- has been granted GMP certification by National Administration of Drugs, Food and Medical Technology (ANMAT) of Argentina. This achievement adds to BioDlink's expanding portfolio of international GMP approvals, following recent certifications in Brazil, Indonesia, Egypt, and Colombia.

The GMP inspection, conducted by ANMAT, focused on commercial manufacturing facility in Suzhou, China, where biosimilar products are produced—including  Pusintin® (bevacizumab) injection. It is a broad-spectrum anti-VEGF monoclonal antibody treating metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). Kexing BioPharm, the global licensee for Pusintin® in emerging markets, collaborated closely with BioDlink to support this AVMAT inspection.

This inspection represents BioDlink's facilities and processes were found to be in full compliance with the stringent GMP standards set by ANMAT. BioDlink's Suzhou facility, which spans 50,000 square meters, is now certified by regulatory authorities in multiple countries. Currently, this site operates with a combined bioreactor capacity of 20,000 liters for antibody drug substance, integrating advanced perfusion fed-batch technology, to enable efficient and cost-effective antibody production. With an annual capacity of 300,000 liters of antibody drug substance, BioDlink is well-equipped to support the growing demand for mAb, BsAb, Antibody-drug Conjugate and biosimilar manufacturing in global markets.

According to a report by MarketsandMarkets，the Rest of Latin America (RoLA) accounted for 59.3% of the Latin American market in 2023. Most pharmaceutical and biopharmaceutical companies in the region prefer to conduct clinical trials in Argentina. So, it is another breakthrough for Pusintin® in the South American market, following the GMP certificates obtained in Colombia and Brazil. Argentina's GDP in 2023 was 646.075 billion US dollars, making it the third-largest economy in Latin America. According to global customs data statistics, in 2023, the import value of pharmaceuticals from around the world in the Latin American market increased by 12.68% year-on-year, with China being the second largest source of imports. Argentina is one of the top ten popular destinations for Chinese pharmaceutical enterprises to export to Latin America.

Dr. Jun Liu, CEO, and Executive Director of BioDlink commented "This GMP certification from Argentina is a significant step in our global expansion strategy, underscoring BioDlink's proven capabilities in reliable, scalable and affordable biosimilars, especially antibody drugs, on a global scale. Our partnership with Kexing Biopharm is better positioned to serve the Latin American market and contribute to improving access to essential oncology treatments."

Dr. Kelvin Shao, Vice President of Kexing BioPharm added "As one of the key partners of us, BioDlink's outstanding industrialization capabilities and superior product quality provide guarantee for overseas quality certification of Pusintin®. With the joint efforts of both sides, Pusintin® (bevacizumab) injection has successively received good news of the approval of GMP overseas, and we hope to help improve the accessibility of biosimilars and benefiting more patients furthermore."

About BioDlink Biopharm Co., Ltd.

BioDlink was established in 2010, and has a large-scale commercial GMP production base for biological drugs, a total manufacturing capacity exceeding 20,000 liters. Guided by its "Empowering Innovation with Quality to Grow Together" mission, BioDlink is dedicated to advancing global healthcare through excellence in biosimilars.

The company has built integrated platforms for biosimilars and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.

BioDlink's quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. In addition, the company has already passed nearly 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.

About Kexing Biopharm Co., Ltd.

Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the integration of R&D, production and sales of recombinant protein drugs and microecological preparations. It focuses on antiviral, tumor and immune, blood, digestion, degenerative diseases and other therapeutic fields, builds cutting-edge biotechnology platforms such as new protein, new antibody, nucleic acid drugs, and adheres to the platform driven development model of "innovation + internationalization", At the same time, it explores the extensive application of biotechnology in the field of general health, actively cultivates and incubates new industries, and is committed to becoming a leader in high-quality biopharmaceutics and serving global patients.

Contact information

PR name: Fiona Wu

E-mail:

• International recognition of quality system with GMP-compliance in the key markets of Brazil, Indonesia, Egypt, Colombia and Argentina
• Passed its first-ever on-site PIC/S audit, reinforcing its strong commitment to stringent international regulatory standards
• Demonstrated BioDlink's capability to develop and deliver globally trusted biosimilars, especially antibody drugs, with proven consistency and reliability

SUZHOU, China, May 21, 2025 /PRNewswire/ --  has achieved a significant milestone in regulatory compliance after successfully passing an on-site GMP inspection conducted by Brazil's National Health Surveillance Agency (ANVISA), a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme). This is the first time BioDlink's production site and quality systems have passed an official on-site GMP audit by a PIC/S member country which is a milestone certification for the internationalization of BioDlink's quality system.

This inspection focused on the company's commercial production site in Suzhou and specifically reviewed the manufacturing of its Pusintin^® (bevacizumab) injection, a broad-spectrum anti-VEGF monoclonal antibody treating metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). Kexing BioPharm, the global licensee for Pusintin^® in emerging markets, worked closely with BioDlink to support this ANVISA inspection.

This inspection was conducted according to the rigorous guidelines of PIC/S and Brazil's national GMP regulations, laying a strong foundation for expanding Pusintin^®, an antibody developed and manufactured by BioDlink, worldwide. Over one week, ANVISA inspectors thoroughly examined the BioDlink site's manufacturing, quality testing, storage, utility systems, and overall quality management, providing a top rating with full approval and no observations.

BioDlink's Suzhou facility—now certified by regulatory authorities in five countries, such as Brazil, Indonesia, Egypt, Colombia and Argentina—spans 50,000 square meters and integrates perfusion fed-batch technology, streamlining antibody production and reducing costs. With four complete production lines, and an annual capacity of 300,000 liters of antibody drug substance, this site supports scalable and regulatory-compliant Pusintin^® production for global markets.

As of recent estimates, the Indonesian pharmaceutical market is valued at around USD 10–12 billion, and growing at a CAGR of 10-12% ^【1】, making it the largest in Southeast Asia. With Indonesia already issuing a PIC/S-based GMP certification to BioDlink's Suzhou site, the company is well-positioned to serve Southeast Asian and Indonesian pharmaceutical demand. With lung cancer ^【2】 being a leading cause of death in Indonesia in the past decade, further Pusintin^® rollout aligns with Indonesia's increasing investments in oncology care and biosimilar integration.

"Clearing our first on-site GMP audit by a PIC/S member signals more than compliance—it demonstrates BioDlink's capability to develop and deliver globally trusted biosimilars, especially antibodies, with quality and consistency," said Dr. Jun Liu, CEO and Executive Director of BioDlink. "With Pusintin^® and our strong strategic alliance with Kexing Biopharm, we have initiated overseas registration for Pusintin^® in over 30 countries and regions, aiming to make high-quality oncology biologics more affordable and accessible across Latin America, Southeast Asia, and the Middle East."

" Since 2022, our partnership with BioDlink has given us the confidence that we are delivering exceptional levels of technical rigor and reliability in manufacturing—crucial for the complex CMC development and manufacturing of biosimilar drugs, which usually are much more challenging.  This GMP certification from Brazil, one of the key markets, is a powerful validation of our collaboration's ongoing global expansion strategy," said Dr. Kelvin Shao, Vice President of Kexing BioPharm. "We are truly proud to celebrate this achievement together with our partners, as we continue working side by side to bring global standards, and affordable oncology treatments where they're needed most to make biosimilars more accessible worldwide."

About PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. is an international cooperation platform that comprises coming from all over the world (Europe, Africa, America, Asia and Australasia). It leads the international development, implementation, and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products.

Learn more：

About BioDlink Biopharm Co., Ltd.

BioDlink was established in 2010, and has a large-scale commercial GMP production base for biological drugs, a total manufacturing capacity exceeding 20,000 liters. Guided by its "Empowering Innovation with Quality to Grow Together" mission, BioDlink is dedicated to advancing global healthcare through excellence in biosimilars.

The company has built integrated platforms for biosimilars and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.

BioDlink's quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. In addition, the company has already passed nearly 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.

About Kexing Biopharm Co., Ltd.

Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the integration of R&D, production and sales of recombinant protein drugs and microecological preparations. It focuses on antiviral, tumor and immune, blood, digestion, degenerative diseases and other therapeutic fields, builds cutting-edge biotechnology platforms such as new protein, new antibody, nucleic acid drugs, and adheres to the platform driven development model of "innovation+internationalization", At the same time, it explores the extensive application of biotechnology in the field of general health, actively cultivates and incubates new industries, the world's leading industrial platforms such as animal vaccines and synthetic organisms have been distributed, and is committed to becoming a leader in high-quality biopharmaceutics and serving global patients.

Contact information

PR name: Fiona Wu
E-mail:

• BioDlink congratulates Junshi Biosciences on receiving IND approval from China's NMPA for JS212, the company's first bispecific ADC.
• JS212 combines dual-targeting antibody technology with a cytotoxic payload, representing a next-generation therapeutic.
• BioDlink provided end-to-end development and manufacturing support, showcasing its industry-leading ADC capabilities.
• Approval marks a key milestone in the development of next-generation antibody-drug conjugates.

SUZHOU, China, May 8, 2025 /PRNewswire/ -- , a leading global CDMO, proudly congratulates its partner Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of China to initiate clinical trials for the JS212 injection — Junshi Biosciences' first bispecific antibody-drug conjugate (ADC).

JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 — two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.

Dr. Jun Liu, CEO and Executive Director of BioDlink, stated: "As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in ADC research, development and manufacturing. The IND approval of JS212 — a technically demanding bispecific ADC —­ highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We're honored to support the advancement of this important program."

Dr. Jing Tong, Deputy Director of Junshi Biosciences' Innovation Research Institute, shared: "We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future."

BioDlink is committed to becoming a trusted CDMO biologics partner. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.

With a comprehensive ADC platform supported by key R&D technologies, BioDlink enables efficient, centralized production of antibody intermediates, drug substances, and finished products. This setup accelerates timelines and reduces tech transfer costs. At the same time, BioDlink's quality system is built according to international standards and has passed GMP audits in multiple countries, which can empower global customers.

About BioDlink Biopharm Co., Ltd.

With over 10 years of experience in antibody and ADC drug development, BioDlink offers full-service CDMO solutions for biologic drugs — from early-stage R&D through to commercial production.

The company has built integrated platforms for biologics and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.

BioDlink's quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. The company has successfully supported over 100 projects with development, clinical filings, and manufacturing services. In addition, the company has already passed near 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.

Guided by its "Empowering Innovation with Quality to Grow Together" mission, BioDlink is dedicated to enabling partners and advancing global healthcare through excellence in biologics.

About Shanghai Junshi Biosciences Co., Ltd.

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company's products have received approvals in China and international markets, one of which is toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of "providing patients with world-class, trustworthy, affordable, and innovative drugs," Junshi Biosciences is "In China, For Global." At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.).

Pursuant to EudraLex Volume 4 regulations (EU Good Manufacturing Practice, "EU GMP") and the guiding principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), this EU QP audit involved a comprehensive and in-depth audit mainly focused on the production quality of monoclonal antibody ("mAb") drug substances, ADC drug substances and ADC drug products of TAA013. The audit covered manufacturing management system, quality management system, plant facilities and equipment management system, validation and computerized system, data integrity verification and management, material management system, product testing and release management and other aspects, thereby further affirming that the Group's commercial production base possesses EU GMP-compliant quality systems and production capacity. This indicates that the Group's commercial production and quality management systems for mAb drug substances and ADC drugs have been recognized by an international professional institution, laying a solid foundation for the high-quality commercialization of TAA013 and the Group's international development.

ABOUT TOT BIOPHARM'S ADC ONE-STOP INDUSTRIALIZATION PLATFORM

Located at the Group's headquarters in Suzhou Industrial Park, TOT BIOPHARM's ADC one-stop industrialization platform possesses core research and development technology advantages. It is equipped with a full range of capabilities from drug development to commercial production, which can realize the one-stop commercial production of antibodies and ADC drug substances and drug products, as well as flexible and diverse production capacity to meet the needs of different production scales for small trials, pilot tests and commercialization.

In recent years, TOT BIOPHARM has accelerated its strategic adjustment, strengthened its competitive advantage in the antibody conjugated drugs (ADCs) field, and facilitated the construction of an industry-leading ADC one-stop commercialization platform. The company has made every effort to expand its one-stop innovative drug CDMO business, achieving breakthrough results and an ever-growing business scale, which has already become a new engine for corporate growth.

The net proceeds from the Subscriptions have amounted to HK$470 million (approximately RMB 400 million), which will improve corporate liquidity, expand the capital base, optimize the capital structure, and provide support for corporate long-term growth. The company intends to apply the proceeds to: further expand CDMO business and strengthen project cooperation with domestic and foreign pharmaceutical companies; promote the continuous construction of global R&D centers, improving ADC commercialization capacities, thereby improving product cost-effectiveness; complete the phase III clinical trial of TAA013 and etc.; carry out production and marketing of Pusintin®, Tazian®, and Megaxia®, etc.

Mr. Fu Shan, Chairman of TOT BIOPHARM, Managing Partner, Global Co-CEO and Asia CEO of Vivo Capital LLC, highlighted: "This transaction is another major milestone of TOT BIOPHARM , which symbolizes its clear strategic planning and business performance have been highly recognized by shareholders. Over the past years, the management team of the company has always concentrated on the advantages of core competencies, optimized resource allocation, and built a differentiated pathway to create a domestically leading and internationally competitive ADC platform. They have also actively expanded CDMO business and established a commercialization platform with great competitive edges and industrial value, showing strong potential and sustainability, which gains shareholders and the board of directors'  confidence in the company's future development."

Dr. Liu Jun, CEO of TOT BIOPHARM, expressed, "It is a great honor to gain the strong support and recognition of our two major shareholders, Vivo Capital and Centerlab, during the critical period of us re-setting corporate priorities on commercialization and strategic adjustment with ADC as the core. By far, our strategic transformation and up-gradation to ADC CDMO have yielded remarkable results. This capital increase will further enhance our capital strength and provide financial support for corporate sustainability. In the upcoming days, we will continue to take efforts to optimize capital structure, establish a diversified and sustainable business model, as well as to enhance the comprehensive strength of process development, accelerate the ADC commercialization process, and create a new engine for CDMO business growth, thereby strengthening the corporate earning capacity, and creating bountiful returns for shareholders and investors."

About Vivo Suzhou Fund and Other Funds Managed by Vivo Capital LLC

Vivo Suzhou Fund is a limited partnership established in the PRC managed by Vivo Equity Investment Management (Shanghai) Co., Ltd., a private equity fund manager registered with the Asset Management Association of China which is directly wholly-owned and controlled by Vivo Capital LLC. Vivo VIII Funds, which are also funds managed by Vivo Capital LLC, have been shareholders of the Company since December 2015. Vivo Capital LLC's predecessor was founded in the United States in 1996. Vivo Capital LLC was incorporated in the State of California of the United States in 2005, and is an investment adviser registered with the United States Securities and Exchange Commission. Spanning private equity, public equity and venture capital, it is a global healthcare investment firm that focuses on finding and building value in healthcare companies in the United States and Greater China. It invests in both public and private healthcare companies through funds managed by it or its affiliate, including Vivo Suzhou Fund and Vivo VIII Funds, among others. In terms of assets under management (AUM), as of 31 December 2021, Vivo Capital LLC managed over US$6.4 billion in client assets on a discretionary basis.

About Centerlab

Centerlab was incorporated in Taiwan in 1959 and its shares were listed on the Taipei Exchange in 2003 (stock code: 4123). It is Taiwan's largest manufacturer of oral liquid pharmaceuticals, with a market share of about 70%. Its products are mainly oral solutions, including syrups, suspensions, emulsions and other dosage forms. It also engages in new drug research and development, active pharmaceutical ingredients, minimally invasive medical devices and other businesses through investments in other corporations. In recent years, Centerlab is known as the "Biotech Industrial Bank" in Taiwan for its track record of incubating or investing in various biotech and related companies listed or to be listed on the Stock Exchange or the Taipei Exchange (including the Company) and fostering their growth and development. As of 31 December 2021, Centerlab had total assets of NT$30.4 billion (equivalent to approximately US$1.1 billion).

About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)

TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumor drugs and therapies, striving to build a leading oncology treatments brand worthy of the trust of patients and their family members, and medical professionals.

The Company has set up an internationally competitive innovative drugs commercial production base equipped with including antibody drug substance and formulation production facility, as well as an integrated ADC commercial production facility capable of putting out both ADC drug substance and freeze-dried formulation. By the first half of 2022, the production capacity for biological drugs of the base is expected to reach approximately 20,000 liters, realizing quality commercial production of innovative drugs.

Given its competitiveness in R&D and production, TOT BIOPHARM has strategic partners in domestic and overseas pharmaceutical corporations to provide one-stop CDMO services from develop and manufacture. Upholding its "facilitating innovation and mutual growth with a focus on quality" service concept, the Company is committed to hastening development and production of chemical drugs and biological drugs, especially ADC drugs, and to empowering its partners to the ultimate end of benefiting patients.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to TOT BIOPHARM, are intended to identify certain of such forward-looking statements. TOT BIOPHARM does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of TOT BIOPHARM with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond TOT BIOPHARM's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, TOT BIOPHARM's competitive environment and political, economic, legal and social conditions.

TOT BIOPHARM, the Directors and the employees of TOT BIOPHARM assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF) which can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing angiogenesis and inducing degeneration of existing blood vessels, and inhibit tumor growth. As a broad-spectrum anti-tumor drug, bevacizumab injection has become a globally recommended standard therapy in the treatment guidelines for a variety of malignant tumors, which had abundant real-world evidence of its efficacy and safety since its entry into the market in 2004. Bevacizumab injection has currently been included in the National Medical Insurance Directory. According to the Frost & Sullivan Report, bevacizumab's market share in China will increase to RMB 6.4 billion in 2023 and RMB 9.9 billion in 2030.

Pusintin® is a biosimilar to bevacizumab injection sold under the trade name of Avastin® in China. TOT BIOPHARM strictly followed the NMPA's "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars" and has taken rigorous and comprehensive head-to-head comparisons between Pusintin® and the reference bevacizumab. The results from pharmaceutical studies, non-clinical studies, and clinical studies proved that Pusintin® has similar PK characteristics with the originator drug and presents clinically equivalent with highly similarity in safety and immunogenicity.

Bevacizumab has been approved for 8 indications globally, and 6 indications in China, including mCRC, NSCLC, glioblastoma multiforme (GBM), and for the treatment of hepatocellular carcinoma (HCC), ovarian cancer, and cervical cancer. According to the "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars", Pusintin® will be eligible for application by way of extrapolation for use in all indications of Avastin® approved in China.

TOT BIOPHARM has established large-scale commercial production base in Suzhou Industrial Park that meets international standards, covering an area of 50,000 square meters with a capacity of monoclonal antibodies reaches 20,000L until the first half of 2022. Pusintin® adopts the self-developed Perfusion-batch mixed culture technology (PB-Hybrid® Technology) for commercial production. This technology has been verified in the production of Phase III clinical drugs, which can simplify the process and shorten the production cycle, reduce production costs, and greatly improve the cost advantage of Pusintin®.

Dr. Liu Jun, CEO of TOT BIOPHARM, said, "We are very pleased for the Pusintin® 's marketing approval of NMPA, which can provide high-quality and affordable treatment options for more cancer patients. This is really a key milestone for TOT BIOPHARM. Meanwhile, it has once again verified the superiority of our one-stop innovative drug R&D and production platform. By virtue of our highly competitive commercial production platform and technology platform, we will constantly accelerate the implementation of innovative achievements and improve the availability of medicines, and let the achievements of national medicine benefit more patients."

About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)

TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumor drugs and therapies, striving to build a leading oncology treatments brand worthy of the trust of patients and their family members, and medical professionals.

The Company has set up an internationally competitive innovative drugs commercial production base equipped with including antibody drug substance and formulation production facility, as well as an integrated ADC commercial production facility capable of putting out both ADC drug substance and freeze-dried formulation. By the first half of 2022, the production capacity for biological drugs of the base is expected to reach approximately 20,000 liters, realizing quality commercial production of innovative drugs.

Given its competitiveness in R&D and production, TOT BIOPHARM has developed many series and varieties of oncology drugs, forming a high standard and comprehensive pharmaceutical product chain. In addition to innovating in developing its own drugs, it also has strategic partners in domestic and overseas pharmaceutical corporations to provide one-stop CDMO services from R&D, crafts development, clinical trials, registration and application to commercial production. Upholding its "facilitating innovation and mutual growth with a focus on quality" service concept, the Company is committed to hastening development and production of chemical drugs and biological drugs, especially ADC drugs, and to empowering its partners to the ultimate end of benefiting patients.

PR:
IR:

HONG KONG and SUZHOU, China, Aug. 13, 2021 /PRNewswire/ -- TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Group"; stock code: 1875.HK), a biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its unaudited interim results for the six months ended 30 June 2021.

KEY MILESTONES IN 2021 1H

In the first half of 2021, on the back of by national policies and driven by innovative R&D, the oncology drug market in China boomed and continued to gather growth momentum. The Group continued to implement its strategic plans drawing on its own strengths and competitive advantages, striving to become a leading player in the domestic ADC market. The Group speeded up R&D of ADC drugs and industrial planning and grasped market opportunities, enabling it to achieve breakthroughs in the realm of innovative drug CDMO/CMO.

Approval for Two Products Launching in the Market:

• TOZ309 (temozolomide capsules) was approved for launch in China by the NMPA in May 2021. It is a first-line medication for newly diagnosed and recurrent glioma as well as recurrent anaplastic astrocytoma. TOZ309 is the first self-developed chemical drug of TOT BIOPHARM. Together with other pharmaceutical companies in China to hasten market penetration of the product. It will at the same time prepare for renewal of the fourth round of drugs for centralized procurement in China in 2022.
• TOM218 (Megaxia® - megestrol acetate oral suspension) is imported by the Group, it owns the exclusive agency of the drug in mainland China, Hong Kong and Macau. The drug can alleviate the cachexia status of AIDS and cancer patients, including loss of appetite and body weight, and nausea and vomiting that sometimes occur. Compared to the solid dosage forms, oral suspensions can reduce the discomfort of patients in swallowing. Megaxia® had been approved for sale in the United States in 2014 and is the first high concentration megestrol acetate oral suspension approved for sale in China.

Major milestones of key products in clinical trial

• Core product TAB008 – Application for Marketing Approval Submitted and Being Processed: TAB008 is a bevacizumab biosimilar self-developed by TOT BIOPHARM for treating malignant tumors including advanced, metastatic and recurrent NSCLC and metastatic colorectal cancer. The new drug application (NDA) of TAB008 was filed in September 2020 and currently being processed by NMPA, which completed an on-site inspection and GMP-compliance inspection in January 2021. the Group expects to receive approval for marketing of the drug by end of 2021. As bevacizumab covers a number of cancers common in China, market demand would be huge.
• TAA013 – Smooth Progress of Phase III Clinical Trial: TAA013 is an ADC candidate containing trastuzumab and an emtansine derivative (Trastuzumab-MCC-DM1) for treating advance-stage or metastatic HER2+ breast cancer which could not be cured by trastuzumab and be surgically removed. In July 2020, the drug was given to the first patient in the Phase III clinical trial. To date, over 70 clinical research centers in the country are involved in the Phase III clinical trials making satisfactory progress.

Key milestones of commercial production planning

• In the first half of 2021, TOT BIOPHARM actively deployed for ADC pilot production and commercial production. It has put together highly competitive GMP-compliant pilot production facilities for mAb and ADC liquid formulation and drug substance, including the OEB-5 potency-level freeze-dried powder/liquid injection formulation (Capacity of ADC drug substance: 1g~300g/batch; Capacity of ADC formulation line: 500~5,000 vials/batch) and a GMP-compliant ADC commercial production workshop (Capacity of ADC drug substance: 1,000g~3,000g/batch; Capacity of ADC formulation line: 10,000~15,000 vials/batch).

Prominent Competitiveness of ADC Drugs

TOT BIOPHARM possesses core conjugation process technologies, a complete ADC analysis technology platform and independent analysis capabilities in respect of ADC critical metric attributes. Accordingly, we have achieved technical breakthroughs in the regulation of glycoforms, enabling precise control of the composition of each glycoform. It attributes to ensure the successful development of ADC processes and produce high quality of products.

TOT BIOPHARM has established an expert team for the R&D of conjugation process technologies of ADCs and an analysis team for complex ADC molecule structure. Boasting their extensive practical experience, successful exemplary cases and their comprehensive experience ranging from R&D, process development, clinical trials, registration and filing for approval to commercial production, and our products are at the leading position among ADCs in China.

CDMO/CMO BUSINESS ACHIEVES LEAPFROG BREAKTHROUGH

Devised One-stop Innovative Drug CDMO Solution

Despite the intense competition in the biomedical sector, TOT BIOPHARM has been able to effectively seize market opportunities and by giving full play to its open technological platform and commercial production capability, it has speeded up development of its "one-stop, localized" CDMO/CMO business, particularly in the ADC sector. It is able to capture first opportunities in the market and secure cooperation opportunities.

• TOT BIOPHARM owns core conjugation process technologies and has the ability to scale up technologies. With that advantage and capable of independent analysis of ADC critical metric attributes, the Group can guarantee the high quality of its product R&D work.
• It possesses "perfusion-batch hybrid technology" that can support commercial production of mAb drugs, including scaling up production from 25L to 2,000L directly, helping simplify the production process and shorten the production cycle, in turn enhance markedly the economic return of commercial CDMO/CMO projects.
• Priding long-term trusting relationship with partners, the Group took on various new CDMO/CMO projects in the first half of 2021, and saw substantial increase in terms of number of partners and business scale with the relevant revenue recording a substantial year-on-year growth of 330%.
• Being able to complete all the stages from R&D to putting out the end products in one plant and one place within the same production base at its Suzhou headquarter, TOT BIOPHARM managed to reduce much of the risks and difficulties in management, transportation and technological from outsourcing different procedures to different suppliers.

Strengthened Cooperation and Exchange

TOT BIOPHARM cherishes its long-term relationship and various kinds of cooperation with diverse partners and aiming to enhance core competitiveness of CDMO services.

• On 19 July, TOT BIOPHARM and BrightGene Bio-Medical Technology Co., Ltd. (688166.SH) became strategic cooperation partners, which has seen its one-stop for ADC drug CDMO service platform strengthen in favor of R&D and commercialization of innovative drugs. Pursuant to the agreement, the two parties will work together to provide clients with services starting with development of production craftsmanship, moving on to scaling up production and eventually GMP-compliant production. The cooperation realized seamless connection of industrial chains, removing the risks from cross-regional regulation, and is a marriage of strengths in terms of technologies and resources, allowing further upgrade of the CDMO service platform for ADC drugs to provide one-stop solutions to innovative drug corporations to help them reduce R&D risks and make commercialization more efficient.

CORE BUSINESS ADVANTAGES

TOT BIOPHARM has developed three core business advantages, providing a solid foundation for development of and cooperation in relation to innovative drugs.

• Three Technology Platforms and Comprehensive Industrial Value Chain

TOT BIOPHARM has three integrated technology platforms and a proven international quality Management and Registration System and registration team, plus a comprehensive industrial value chain that covers from R&D, process development, clinical trials, registration and filing to commercial production, giving it a solid foundation to speed up R&D, lay out international market presence and for its for its CDMO/CMO business.

• A Packed Product Pipeline with Huge Market Potential

At present, the Group has 12 drug candidates in the pipeline, including monoclonal antibody drugs such as TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and ADCs such as TAA013 (anti-HER2 ADC), for indications involving various high incidence cancers, such as non-small-cell lung cancer, breast cancer, gastric cancer, cerebral gliomas cancer and cervical cancer.

• Rare Capability of Commercially Producing mAb and ADC

Agreeing with the industrial upgrade of the Company and to meet market demand, the Group kicked off effort to expand production capacity in 2021, continuing to bolster the commercial production capacity of its antibody drugs and ADC products to prepare for the continuous expansion of the CDMO/CMO business. According to our strategic plan, we will keep on expanding our production capacity of mAb drugs to more than 16,000L.

Future Development

Dr. Liu Jun, Chief Executive Officer, Chief Science Officer and Executive Director of TOT BIOPHARM, said, "We expect TAB008, our first biological drug, to be approved for launch to market in 2021, hence we will corporate with sizable pharmaceutical plants to roll out our marketing plan. At the same time, we will push forward clinical procedures of ADC TAA013 to enrich the ADC product pipeline. With biological drug CDMO business in China at large booming, leverage on our advantage of "one-base" CDMO/CMO value chain, we will allocate our resources to optimize CDMO business in ADC field, strengthen our brand image as well as consolidate our market position.

"Looking ahead, we believe the competitive advantages of TOT BIOPHARM will become more and more obvious. We will keep presenting employees with ample room for development, and to our partners, with the best strategic solutions, and for shareholders, create value."

FINANCIAL HIGHLIGHTS (as at 30 June 2021)

Hong Kong Financial Reporting Standards Measures:

• Revenue was RMB23.132 million, representing a year-on-year growth of 78% thanks to the Group's proactive expansion of CDMO/CMO business heeding market changes, with relevant revenue up year-on-year growth by a substantial 330%.
• R&D expenses were RMB88.749 million, representing a year-on-year decrease of 11%, mainly attributable to the completion of Phase III clinical trials for the TAB008 project in the second half of 2020, which resulted in a year-on-year decrease in costs of clinical trials, also, R&D work completed for the TOZ309 project, there was a significant reduction of relevant expenses on R&D consumables.
• Selling expenses were RMB11.202 million, representing a year-on-year decrease of 18%, mainly attributable to the Company's sales strategy adjustments, resulting in reduction of relevant costs and expenses.
• General and administrative expenses were RMB26.823 million, representing a year-on-year increase of 11%, mainly attributable to the increase in operating and management expenses related to related to employee, administration and taxation, etc..
• The above mentioned all in account, net loss of the Group for the first half of 2021 reached RMB115.005 million, representing a year-on-year decrease of 11%.

About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)

TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumor drugs and therapies, striving to build a leading brand of oncology treatments worthy of the trust of patients and their families, and medical professionals.

The Company has in place three major integrated technology platforms. They are:

Therapeutic Monoclonal Antibody and ADC Technology Platform: it integrates research and development (R&D) and production capacities for antibody-based drugs and ADC, with the designed production capacity of the commercialization base of biological drugs reaching 16,000L to accommodate high-quality commercialization of drug candidates;

Gene Engineering Based Therapeutics Technology Platform: it integrates anti-tumor immunotherapy, gene therapy and viral therapy and pursues R&D and production of tumor-targeted oncolytic virus products;

Innovative Drug Delivery Technology Platform: a comprehensive platform for the process development and commercial production of high intensity and frequency of drug injections. It adopts a production design with aseptic lyophilization and aseptic filling to satisfy the GMP production requirement of active level lyophilized powder and water needle

Using these platforms, the Company has studied and developed various anti-tumor drug series and genres, and has formed a high quality and comprehensive drug product chain. Currently, the Company has 12 drugs under research and development. On top of developing innovative proprietary drugs, the Company also draws on its own industry value chain to build a complete industry chain platform that supports operations from R&D and clinical development to production and marketing. By adopting an open platform business model, it is able to cooperate with biomedical enterprises and third parties at different stages along its industry value chain.