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VV116 Versus PAXLOVID Phase III Registrational Trial for Early Treatment of Mild to Moderate COVID-19 in High Risk Patients Reaches Primary Endpoint

SHANGHAI, China, May 25 (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 Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 (JT001) and nirmatrelvir/ritonavir (“PAXLOVID”) in the [...]

Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Paclitaxel and Cisplatin in First-Line Treatment of Advanced or Distant Metastatic Esophageal Squamous Cell Carcinoma

SHANGHAI, China, May 16 (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 China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination [...]

Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA

SHANGHAI, China, and REDWOOD CITY, Calif., May 2 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the U.S. Food and Drug Administration (“FDA”, “the Agency”) has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for toripalimab in combination with gemcitabine and [...]

Junshi Biosciences and Coherus Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States

SHANGHAI, China and REDWOOD CITY, Calif., April 14 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) for toripalimab, a PD-1 inhibitor, for the treatment of small cell lung [...]

Junshi Biosciences and Coherus Present Results of Phase 3 Study of Toripalimab in First Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma at 2022 AACR Annual Meeting

SHANGHAI, China, and REDWOOD CITY, Calif., April 9 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced the results of the prespecified final progression-free survival (“PFS”) analysis and the interim overall survival (“OS”) analysis of the JUPITER-02 study (NCT03581786), a pivotal Phase 3 trial in [...]

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

SHANGHAI, China, April 3 (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 announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal [...]

Junshi Biosciences Announces Full Year 2021 Financial Results and Provides Corporate Updates

SHANGHAI, China, March 31 (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 announced financial results for the full year 2021 and provided corporate updates. Full Year 2020 Financial Highlights Total revenue reached RMB [...]

Junshi Biosciences Announces First Patient Dosed in China in Phase III Clinical Trial of VV116 in Treatment of Moderate to Severe COVID-19

SHANGHAI, China, March 16 (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 first patient was dosed in its Phase III trial of VV116 for the treatment of moderate to severe [...]

Junshi Biosciences and Coherus Announce Presentation 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, at March ASCO Plenary Series

SHANGHAI, China and REDWOOD CITY, Calif., March 15 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus” ), today announced the presentation of positive results and biomarker analysis from the pivotal study “CHOICE-01” (clinicaltrials.gov identifier# NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as [...]

Junshi Biosciences and Coherus Announce Positive Results from Phase 3 Esophageal Cancer Study of Toripalimab Published in Cancer Cell

SHANGHAI, China and REDWOOD CITY, Calif., March 4 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. today announced the online publication in Cancer Cell of Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): a multi-center randomized phase 3 trial. The manuscript publication was accompanied by a Cancer [...]