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July 06, 2022 08:00 ET | Source: Junshi Biosciences

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

- 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...
June 06, 2022 20:13 ET | Source: Junshi Biosciences

Junshi Biosciences Highlights Pipeline Advances in Immuno-Oncology Through Nearly 40 Data Presentations of Icatolimab and Toripalimab at ASCO 2022

--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...
May 24, 2022 23:22 ET | Source: Junshi Biosciences

VV116 Versus PAXLOVID Phase III Registrational Trial for Early Treatment of Mild to Moderate COVID-19 in High Risk Patients Reaches Primary Endpoint

--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,...
May 16, 2022 09:07 ET | Source: Junshi Biosciences

Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Paclitaxel and Cisplatin in First-Line Treatment of Advanced or Distant Metastatic Esophageal Squamous Cell Carcinoma

SHANGHAI, China, May 16, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
May 02, 2022 07:18 ET | Source: Junshi Biosciences

Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA

– The CRL requests a quality process change Junshi Biosciences and Coherus believe is readily addressable – – BLA resubmission anticipated by mid-summer 2022 with expected six month FDA review...
April 14, 2022 08:34 ET | Source: Junshi Biosciences

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, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences,...
April 08, 2022 20:25 ET | Source: Junshi Biosciences

Junshi Biosciences and Coherus Present Results of Phase 3 Study of Toripalimab in First Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma at 2022 AACR Annual Meeting

SHANGHAI, China, and REDWOOD CITY, Calif., April 09, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc....
April 03, 2022 07:48 ET | Source: Junshi Biosciences

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

SHANGHAI, China, April 03, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
March 31, 2022 11:32 ET | Source: Junshi Biosciences

Junshi Biosciences Announces Full Year 2021 Financial Results and Provides Corporate Updates

-Tackling the COVID-19 pandemic challenge with multi-pronged strategies - Pipeline progressed and expanded substantially SHANGHAI, China, March 31, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi...
March 16, 2022 06:30 ET | Source: Junshi Biosciences

Junshi Biosciences Announces First Patient Dosed in China in Phase III Clinical Trial of VV116 in Treatment of Moderate to Severe COVID-19

SHANGHAI, China, March 16, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...

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