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Sandoz Acquires CIMERLI® Business from Coherus, Further Building Biosimilar and Ophthalmology Leadership in US Market

CIMERLI®*, a ranibizumab biosimilar, is interchangeable with LUCENTIS®** (ranibizumab injection) for all approved indications Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients Basel, March 4, 2024 (Korea Bizwire) – Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI®* [...]

Junshi Biosciences and Coherus Announce Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Clinical Trial Evaluating Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma

SHANGHAI, China and REDWOOD CITY, Calif., Feb. 15 (Korea Biziwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) today announced positive results of a final analysis of overall survival (“OS”) from the pivotal study JUPITER-02 (NCT03581786), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab [...]

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 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 [...]

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 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 Expand Immuno-Oncology Collaboration to Include TIGIT-Targeted Antibody

SHANGHAI, China, and REDWOOD CITY, Calif., Jan. 10 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) today announced that Coherus has initiated the process to exercise its option to license JS006, Junshi Biosciences’ TIGIT-targeted antibody, in the United States and Canada, expanding the companies’ 2021 immuno-oncology [...]

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 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 [...]