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Junshi Biosciences Announces Acceptance of NDA for VV116 in China

SHANGHAI, China, Jan. 17 (Korea Bizwire) — 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 new drug application (“NDA”) for Deuremidevir Hydrobromide Tablets (project code: JT001/VV116, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 drug, [...]

Junshi Biosciences Announces Toripalimab as Perioperative Treatment for Operable NSCLC Patients Met Primary Endpoint in Phase 3 Clinical Study

SHANGHAI, China, Jan. 18 (Korea Bizwire) — 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 a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“Neotorch”, NCT04158440) of the company’s anti-PD-1 monoclonal antibody, toripalimab, in [...]

Junshi Biosciences Announces NEJM Publication of Results of Phase 3 Study of VV116 Versus PAXLOVID for Adults at High Risk for Progression to Severe COVID-19

SHANGHAI, China, Dec. 29 (Korea Bizwire) — 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 announces the online publication in New England Journal (NEJM) of the Phase 3 trial (NCT05341609) comparing the efficacy and safety of VV116 (JT001) and [...]

Junshi Biosciences and Hikma Sign Exclusive Licensing Agreement for Cancer Treatment Drug Toripalimab for the Middle East and North Africa Region

SHANGHAI, China, Dec. 26 (Korea Bizwire) — 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 announces a new exclusive licensing and commercialization agreement with Hikma Pharmaceuticals PLC (Hikma), a multinational pharmaceutical company, for toripalimab in the [...]

Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

SHANGHAI, China and REDWOOD CITY, Calif., Dec. 25 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application [...]

$Junshi Biosciences Announces Updated Clinical data from Phase I study of anti-BTLA antibody Tifcemalimab in Treatment of Relapsed/Refractory Lymphomas at 64th ASH Annual Meeting$

Junshi Biosciences Announces Updated Clinical data from Phase I study of anti-BTLA antibody Tifcemalimab in Treatment of Relapsed/Refractory Lymphomas at 64th ASH Annual Meeting

SHANGHAI, China, Dec. 10 (Korea Bizwire) — 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 updated preliminary data from a Phase I study of tifcemalimab as a single agent or in combination with [...]

Junshi Biosciences Announces Submission of a Marketing Authorization Application for Toripalimab to the UK Medicines and Healthcare Products Regulatory Agency

SHANGHAI, China, Nov. 24 (Korea Bizwire) — 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 company has submitted a marketing authorization application (“MAA”) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency [...]

Junshi Biosciences Announces Approval of Supplemental Application for Additional Indications of Adalimumab Injection

SHANGHAI, China, Nov. 22 (Korea Bizwire) — 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 supplemental application for additional indications of adalimumab injection (project code: UBP1211, trade name: 君邁康®) for the treatment of [...]

Junshi Biosciences Announces Submission of a Marketing Authorization Application to the European Medicines Agency for Toripalimab

SHANGHAI, China, Nov. 15 (Korea Bizwire) — 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 company has submitted a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for toripalimab. The indications [...]

Junshi Biosciences and Coherus Announce Publication of Positive Results from CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer, in the Journal of Clinical Oncology

SHANGHAI, China and REDWOOD CITY, Calif., Oct. 12 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) today announced the publication of toripalimab plus chemotherapy for patients with treatment-naïve advanced non-small cell lung cancer: a multi-center randomized phase 3 trial (CHOICE-01) in the Journal of Clinical Oncology. Toripalimab [...]