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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 and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

SHANGHAI, China and REDWOOD CITY, Calif., July 6 (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 accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin [...]

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

SHANGHAI, China and REDWOOD CITY, Calif., Dec. 13 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced positive results of an interim analysis of overall survival from the pivotal study “CHOICE-01” (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus standard-of-care chemotherapy [...]

Junshi Biosciences Announces NMPA Accepted supplemental New Drug Application for Toripalimab in Combination with Chemotherapy as First-Line Treatment of Advanced NSCLC

SHANGHAI, China, Dec. 10 (Korea Bizwire) — 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 accepted the company’s supplemental New Drug Application (“sNDA”) for toripalimab in combination with chemotherapy as the [...]

Junshi Biosciences Announces Two Additional Indications for Toripalimab Included in China’s National Reimbursement Drug List

SHANGHAI, China, Dec. 3 (Korea Bizwire) — 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’s product toripalimab continues to be included in Category B in the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and [...]

Junshi Biosciences Announces Approval of Supplemental New Drug Application by NMPA for Toripalimab in Combination with Cisplatin and Gemcitabine as First-Line Treatment for Patients with Locally Recurrent or Metastatic Nasopharyngeal Carcinoma

SHANGHAI, China, Nov. 30 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the National Medical Products Administration (NMPA) of China has approved its supplemental New Drug Application (sNDA) for toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or [...]

Junshi Biosciences and Coherus Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer

SHANGHAI, China and REDWOOD CITY, Calif., Nov. 15 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug [...]

Junshi Biosciences and Coherus Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma

SHANGHAI, China and REDWOOD CITY, Calif., Nov. 1 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today that the United States Food and Drug Administration (“FDA”) has accepted for review the Biologics License Application (“BLA”) for toripalimab in combination with gemcitabine [...]

Junshi Biosciences and Coherus to Present Positive Progression Free Survival and Overall Survival Results from JUPITER-06, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma

SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 16 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced positive interim results from the pivotal study “JUPITER-06” (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line [...]

Junshi Biosciences and Coherus Announce Results from Phase 3 Study of Toripalimab Published in September Issue of Nature Medicine

SHANGHAI and REDWOOD CITY, Calif., Sept. 15 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced publication of a cover article in the September issue of Nature Medicine featuring clinical data from the pivotal study “JUPITER-02”, a randomized, double-blind, placebo-controlled Phase [...]