* World's first anti-PD-1 mAb for the first-line treatment of SCLC * Making a new record with the median OS of 15.8 months in an international, multi-center, phase 3 clinical trial * Granted orphan drug designations by the FDA and the EC, paving the way for international commercialization SH...
PRINCETON, N.J., Jan. 7, 2023 /PRNewswire/ -- Fosun Pharma (600196.SH, 02196.HK) has recently entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) serplulimab inth...
SHANGHAI, Nov. 30, 2022 /PRNewswire/ --?Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient was dosed in NCT05468489, a bridging head-to-head trial inthe United States comparing HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently develo...
SHANGHAI, Nov. 1, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic?name: serplulimab injection), in combination with carboplatin and albumin-bound paclitaxel for the first-lin...
* ASTRUM-005 is the first study to demonstrate that PD-1 inhibitors plus chemotherapy can improve survival for patients with ES-SCLC. * In ASTRUM-005, serplulimab combined with chemotherapy achieved by far the longest OS in first-line immunotherapy for ES-SCLC. Compared with chemotherapy, the...
SHANGHAI, Aug. 18, 2022 /PRNewswire/ --?Henlius (2696.HK) announced its 2022 interim results. 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, 1 in ...
SHANGHAI, July 26, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner Cipla Limited ("Cipla") has received the relevant registration certificates from the Therapeutic Goods Administration ofAustralia ("TGA") for the approval of Henlius' sel...
* Palleon and Henlius to co-develop Bifunctional HER2-Sialidase and a second bifunctional sialidase to be jointly designed - * Henlius received exclusive license for two products in China (including Hong Kong, Macau, and Taiwan); Palleon retains all other global rights - * Palleon receives u...
SHANGHAI, June 6, 2022 ?/PRNewswire/ --?Shanghai Henlius Biotech, Inc. (2696.HK) announced that an international randomized phase 3 study (ASTRUM-005) of HANSIZHUANG (serplulimab), an anti-PD-1 mAb independently developed by Henlius, as first-line treatment for extensive-stage small-cell lung can...
SHANGHAI, April 11, 2022 /PRNewswire/ --?Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of HANSIZHUANG (serplulimab), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with chemotherapy for the first-line tr...
SHANGHAI, April 7, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). This is the first such d...
SHANGHAI, March 25, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA)for the treatment of adult ...
SHANGHAI, March 17, 2022 /PRNewswire/ -- Henlius (2696.HK) announced its annual results for the year endedDecember 31st, 2021, sharing the company's recent noteworthy progress and achievements. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, afford...
SHANGHAI, March 16, 2022 /PRNewswire/ -- Henlius (2696.HK) announced its annual results for the year endedDecember 31st, 2021, sharing the company's recent noteworthy progress and achievements. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, afford...
* The ASTRUM-005 states that serplulimab combined with carboplatin-etoposide prolonged median OS in both the overall population and the Asian subgroup, the median overall survival (OS) in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, reducing risk of death by 38%...
SHANGHAI, Dec. 8, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first interim analysis met the primary study endpoint of the overall survival (OS) of the Phase 3 clinical study (NCT04063163) of its innovative PD-1 inhibitor serplulimab in combination with chemot...
SHANGHAI, Dec. 4, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). It is indicated for the treatment of meta...
SHANGHAI, Nov. 25, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the filing of a clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients with locally advanced or metastatic solid tumours has been approved by the ...
SHANGHAI, Sept. 18, 2021 /PRNewswire/ -- The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) will be held online and in-person from 25th to 29th September 2021. In this meeting, Henlius will release 4 study results of 2 products to be commercialized, the novel anti-PD-1 mAb ser...
SHANGHAI, Sept. 17, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of Serplulimab Injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with carboplatin and albumin-bound ...