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. ...
Junshi Biosciences Receives Orphan Medicinal Product Designation from the European Committee for Toripalimab in Treatment of Nasopharyngeal Carcinoma
July 21, 2022 07:00 ET
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Junshi Biosciences
--6th Orphan Drug Designation granted to toripalimab in the US and EU SHANGHAI, China, July 21, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE:...
Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
July 06, 2022 08:00 ET
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Junshi Biosciences
- FDA has set a target action date of December 23, 2022 for the toripalimab BLA - - Toripalimab will be the first and only immuno-oncology agent for NPC in U.S., if approved - SHANGHAI, China and...
Junshi Biosciences Highlights Pipeline Advances in Immuno-Oncology Through Nearly 40 Data Presentations of Icatolimab and Toripalimab at ASCO 2022
June 06, 2022 20:13 ET
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Junshi Biosciences
--Favorable preliminary safety and efficacy data for anti-BTLA monoclonal antibody, icatolimab, for the treatment of lymphoma and solid tumors --Toripalimab continues to demonstrate synergy as...
VV116 Versus PAXLOVID Phase III Registrational Trial for Early Treatment of Mild to Moderate COVID-19 in High Risk Patients Reaches Primary Endpoint
May 24, 2022 23:22 ET
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Junshi Biosciences
--the study reached its primary endpoint(VV116 was statistically superior) and secondary efficacy endpoint --VV116 has a favorable safety profile and fewer adverse events than PAXLOVID SHANGHAI,...