Junshi Biosciences Announces 2022 Interim Financial Results and Provides Corporate Updates
31 août 2022 01h47 HE
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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)
25 août 2022 22h44 HE
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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
17 août 2022 21h21 HE
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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
21 juil. 2022 07h00 HE
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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
06 juil. 2022 08h00 HE
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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
06 juin 2022 20h13 HE
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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
24 mai 2022 23h22 HE
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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,...
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
16 mai 2022 09h07 HE
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Junshi Biosciences
SHANGHAI, China, May 16, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...
Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA
02 mai 2022 07h18 HE
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Junshi Biosciences
– 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...
Junshi Biosciences and Coherus Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States
14 avr. 2022 08h34 HE
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Junshi Biosciences
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,...