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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 [...]

TopAlliance Appoints Virginia Ellen Maher, MD, as Vice President of Medical Sciences

SHANGHAI, China, Nov. 1 (Korea Bizwire) — TopAlliance Biosciences, a wholly own subsidiary of Junshi Biosciences (HKEX: 1877; SSE: 688180) today announced the appointment of Dr. Virginia Ellen Maher as VP of Medical Sciences, reporting to the company’s Chief Medical Officer Dr. Patricia Keegan. In her new role, she will lead or support the company’s [...]

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 Announces Expansion of Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Post-Exposure Prophylaxis for COVID-19

SHANGHAI, China, Sept. 19 (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 United States Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for etesevimab (JS016/LY-CoV016) 1,400 mg and bamlanivimab (LY-CoV555) 700 [...]

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 [...]

Positive Interim Results of CHOICE-01 Study Evaluating Junshi Biosciences and Coherus’ Toripalimab for First Line Treatment of Non-Small Cell Lung Cancer Presented at World Conference on Lung Cancer

SHANGHAI, China and REDWOOD CITY, Calif., Sept. 14 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (Nasdaq: CHRS) announced the presentation today of positive interim results from the pivotal study “CHOICE-01” (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as [...]

Junshi Biosciences and Coherus Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

SHANGHAI, China and REDWOOD CITY, Calif., Sept. 1 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today the completion of the rolling submission of the Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for toripalimab in combination [...]

Junshi Biosciences Announces 2021 Interim Financial Results and Provides Corporate Updates

SHANGHAI, China, Aug. 31 (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 its financial results for the six months ended June 30, 2021 and provided corporate updates. First Half 2021 Financial Highlights Total revenue reached RMB 2,114 million [...]

Distribution of Etesevimab/JS016 in the US Reopened

SHANGHAI, China, Aug. 29 (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 United States Food and Drug Administration (the “FDA”), alongside the Office of the Assistant Secretary for Preparedness and Response, has resumed the shipment [...]