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)
December 25, 2022 08:16 ET
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Junshi Biosciences
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA - - Junshi Biosciences and Coherus are actively engaged in ongoing discussions...
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
December 10, 2022 18:30 ET
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Junshi Biosciences
-- Preliminary study results show that tifcemalimab is well-tolerated at all administered doses. The observed clinical activity of tifcemalimab in combination with toripalimab in lymphoma patients...
Junshi Biosciences Announces Submission of a Marketing Authorization Application for Toripalimab to the UK Medicines and Healthcare Products Regulatory Agency
November 24, 2022 07:30 ET
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Junshi Biosciences
SHANGHAI, China, Nov. 24, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
Junshi Biosciences Announces Approval of Supplemental Application for Additional Indications of Adalimumab Injection
November 22, 2022 01:13 ET
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Junshi Biosciences
SHANGHAI, China, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
Junshi Biosciences Announces Submission of a Marketing Authorization Application to the European Medicines Agency for Toripalimab
November 14, 2022 19:00 ET
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Junshi Biosciences
--The MAA was submitted in the EU for toripalimab seeking indications for the 1st line treatment of NPC and the 1st line treatment of ESCC -- The global commercialization plan for toripalimab has...
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
October 12, 2022 08:37 ET
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Junshi Biosciences
SHANGHAI, China and REDWOOD CITY, Calif., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc....
Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small Cell Lung Cancer
September 20, 2022 10:24 ET
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Junshi Biosciences
SHANGHAI, China, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
Junshi Biosciences Announces 2022 Interim Financial Results and Provides Corporate Updates
August 31, 2022 01:47 ET
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Junshi Biosciences
-- Clinical trials of core drug candidates are progressing steadily with the debut of the company’s FIH asset -- Toripalimab’s sales performance is consistently improving; the US BLA is under review ...
Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for JS110 (XPO1 inhibitor)
August 25, 2022 22:44 ET
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Junshi Biosciences
SHANGHAI, China, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
Junshi Biosciences Announces Acceptance of Supplemental Application for Additional Indications of Adalimumab Injection
August 17, 2022 21:21 ET
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Junshi Biosciences
-- Additional indications: treatment for Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis and pediatric Crohn’s disease SHANGHAI, China, Aug. ...