First International Shipment of HANSIZHUANG Launched
SHANGHAI, Jan. 25, 2024 /PRNewswire/ -- On January 25, a truck carrying anti-PD-1 mAb Zerpidio? (serplulimab, Chinese trade name: HANSIZHUANG) slowly left Henlius' Songjiang First Plant. These products, bearing Henlius' mission of benefiting patients worldwide with high-quality biopharmaceuticals...
First International Shipment of HANSIZHUANG
SHANGHAI, Jan. 25, 2024 /PRNewswire/ -- On January 25, a truck carrying HANSIZHUANG Zerpidio? (anti-PD-1 monoclonal antibody, Chinese trade name: HANSIZHUANG) slowly left Henlius' Songjiang First Plant. These products, bearing Henlius' mission of "benefiting patients worldwide with high-quality ...
HANSIZHUANG Sets Sail in Indonesia Market
* The 1st China anti-PD-1 monoclonal antibody successfully approved in Southeast Asia - * The 1st overseas approval of?HANSIZHUANG, highlighting another major milestone of Henlius' global strategy after HANQUYOU - * Along with?KGbio and other partners to develop and launch HANSIZHUANG in ov...
The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of non-squamous NSCLC Accepted by the NMPA
SHANGHAI, Dec. 12, 2023 /PRNewswire/ -- Shanghai?Henlius Biotech, Inc. (2696.HK) announced that the NDA for new indication of HANSIZHUANG, serplulimab, an innovative anti-PD-1 mAb independently developed by the company, in combination with chemotherapy as a first-line treatment for patients with...
Henlius Reported Financial Results for the First Three Quarters of 2023: Total Revenue Exceeded RMB3.9 billion, Profitability Further Improved
SHANGHAI, Nov. 15, 2023 /PRNewswire/ --?Henlius(2696.HK)announced its financial results and business update for the first three quarters of 2023. As of September 30, 2023, Henlius generated a total revenue of RMB3.9278 billion, rising by 84.0% YoY, and a profit totaledRMB407.8 million, attributed ...
Henlius Announces NMPA Approvals of Two ADC Candidates for IND
SHANGHAI, Oct. 27, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696. HK) announced that?the investigational new drug (IND) applications of HLX42 for Injection, a novel EGFR-targeting antibody-drug conjugate (ADC) as well as HLX43, a novel PD-L1-targeting ADC, have been approved by the Na...
Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India
* The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India? * Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commerc...
Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India
* The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India * Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commerci...
First Patient Dosed for MRCT Phase 3 Study on First-Line LS-SCLC of Henlius Anti-PD-1 mAb Serplulimab in Europe
SHANGHAI, Oct. 25, 2023 /PRNewswire/ --?Shanghai?Henlius Biotech, Inc. (2696.HK) announced that the first patient inEurope has been dosed in the international multi-centre phase 3 clinical trial (NCT05353257) of the company's self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination ...
Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC
SHANGHAI, Sept. 25, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696. HK) announced that?the new drug application (NDA) for new indication of HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, in combination with drugs...
Henlius Expands Collaboration with KGbio to Develop, Commercialize and Supply Henlius' novel anti-PD-1 mAb HANSIZHUANG in MENA
* HANSIZHUANG's coverage footprint includes 22 emerging market countries acrossSoutheast Asia and MENA – * KGbio to develop and commercialise HANSIZHUANG in 12 MENA countries; Henlius to receiveUS$7 million upfront payment plus royalties and up to US$8 million in regulatory milestone payments...
Henlius 2023 H1 Results: Achieved record profits and RMB2.5 billion revenues, opening a new chapter of high-quality growth
SHANGHAI, Aug. 25, 2023 /PRNewswire/ --?Henlius (2696.HK) announced its 2023 interim results.?In the first half of 2023, Henlius reported a boost in operating profits ofRMB240.0 million and revenues of RMB2.5005 billion, up by 93.9% YoY, driven by growth in core oncology products.?HANQUYOU (trast...
HANQUYOU Marks 3rd Anniversary with Brilliant Achievements
* HANQUYOU?is the China-developed biosimilar with the most?marketing approvals, covering?41 countries and regions * The launch of HANQUYOU?kicks off the competition between Chinese pharmaceutical companies and the world's bio-pharmaceutical companies in biosimilar monoclonal antibodies * He...
HANQUYOU Marks 3rd Anniversary with Brilliant Achievements
* HANQUYOU?is the China-developed biosimilar with the most?marketing approvals, covering?41 countries and regions * The launch of HANQUYOU?kicks off the competition between Chinese pharmaceutical companies and the world's bio-pharmaceutical companies in biosimilar monoclonal antibodies * He...
Henlius Forecasts Profit in 1H 2023
Spurring a Seamless R&D, Manufacturing, and Commercialisation Positive Cycle SHANGHAI, July 3, 2023 /PRNewswire/ -- Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited comprehensive management accounts for the six months endedJune 30, 2023, ...
Henlius Forecasts Profit in 1H 2023
Spurring a Seamless R&D, Manufacturing, and Commercialisation Positive Cycle SHANGHAI, July 3, 2023 /PRNewswire/ --?Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited comprehensive management accounts for the six months endedJune 30, 2023, ...
Henlius Achieved Steep Revenue Growth in Q1 2023, Core Products Sales Surged
SHANGHAI, April 17, 2023 /PRNewswire/ -- As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with 5 products launched inChina. Leveraging the differentiated competitive edges of its pr...
Henlius 2022 Annual Results: Significant Achievements in Commercialisation, Surged to RMB3.2 Billion in Revenues
SHANGHAI, April 1, 2023 /PRNewswire/ --?Henlius (2696.HK) announced its 2022 annual results. In 2022, Henlius' revenue reached aboutRMB3.2147 billion, representing an increase of 91.1% YoY, primarily due to sales revenue and licensing revenue generated by the successive commercialisation of vario...
EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)
* HANSIZHUANG (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC) * The EC and the FDA previously granted Orphan Drug Designations (ODDs) for HANSIZHUANG in SCLC * HANSIZHUANG is approved in China for microsatellite instability-high (MSI-H)...
Henlius Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02
* The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in the U.S. - * HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name inEurope: Zercepac?; trade names in Australia: Tuzucip? and Trastucip?) has been approved in more than 3...