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Junshi Biosciences Announces Acceptance of the New Drug Application for JS002 (anti-PCSK9 mAb)

>SHANGHAI, China, April 25, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced the acceptance of the new drug application for the company’s recombinant humanized anti-PCSK9 monoclonal antibody (product code: JS002) by the National Medical Products Administration (“NMPA”).

Junshi Biosciences Announces Toripalimab plus Chemotherapy Significantly Improved Event-free Survival (EFS) versus Chemotherapy as Perioperative Treatment for Resectable Stage III Non-small Cell Lung Cancer (NSCLC) in Phase 3 Neotorch Study

>SHANGHAI, China, April 21, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced that positive interim event-free survival (EFS) results from the Neotorch study were presented at the ASCO April Plenary Series.

Junshi Biosciences Announces Phase 3 Clinical Study of Senaparib for Advanced Ovarian Cancer Maintenance Treatment Following First-line Therapy Met Primary Endpoint

>SHANGHAI, China, April 11, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“FLAMES Study”, NCT04169997) investigating the poly (ADP-ribose) polymerase (“PARP”) inhibitor, senaparib (product code: JS109/IMP4297), had finished its pre-specified interim analysis. Senaparib was jointly developed by Junshi Biosciences and IMPACT Therapeutics, Inc. (“IMPACT Therapeutics”), as a maintenance treatment following first-line platinum-based chemotherapy in patients with International Federation of Gynecology and Obstetrics (“FIGO”) stage III/IV ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer who achieved a complete response or partial response. The Independent Data Monitoring Committee (the “IDMC”) concluded that the primary endpoint had met the pre-defined efficacy boundary. Junshi Biosciences and IMPACT Therapeutics will communicate with regulatory authorities regarding a new drug application for the drug in the near future.

Junshi Biosciences Announces Approval for Marketing of VV116 in China

>SHANGHAI, China, January 30, 2023 (GLOBE NEWSWIRE) – Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the National Medical Products Administration (the “NMPA”) has conducted urgent review and approval under Special Examination and Approval of Drugs, and conditionally approved for marketing Deuremidevir Hydrobromide Tablets (project code: JT001/VV116, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”).