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Investegate |Junshi Biosciences Announcements | Junshi Biosciences: Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma

Investegate announcements from Junshi Biosciences, Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma ....

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Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation. ....

United States , San Francisco , Patricia Keegan , Junshi Bioscience , Eli Lilly , Mcdavid Stilwell , Junshi Biosciences , Coherus Biosciences , Zhi Li , Sheryl Seapy , Institute Of Microbiology Chinese Academy Science , Exchange Commission On , Ir Team , Coherus Biosciences Inc , Drug Administration , Genentech Inc , Exchange Commission , National Reimbursement Drug List , National Medical Products Administration , Abbvie Inc , Pr Team , Shanghai Junshi Biosciences Co Ltd , United States Food , Breakthrough Therapy Designation , Breakthrough Therapy , Chief Medical Officer ,

Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma | Comunicados | Edición USA

Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma | Comunicados | Edición USA
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United States , San Francisco , Patricia Keegan , Junshi Bioscience , Eli Lilly , Mcdavid Stilwell , Junshi Biosciences , Coherus Biosciences , Zhi Li , Sheryl Seapy , Institute Of Microbiology Chinese Academy Science , Exchange Commission On , Ir Team , Coherus Biosciences Inc , Drug Administration , Genentech Inc , Exchange Commission , National Reimbursement Drug List , National Medical Products Administration , Abbvie Inc , Pr Team , Shanghai Junshi Biosciences Co Ltd , Therapy Designation Granted , Line Treatment , United States Food , Breakthrough Therapy Designation ,

Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma - Press Release

SHANGHAI, China, July 30, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for toripalimab in combination with platinum-containing chemotherapy as the first-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is the fifth NDA submitted for toripalimab in China.
The supplemental NDA is based on the JUPITER-06 study (Clinicaltrials.gov identifier: NCT03829969), which is a randomized, double-blind, placebo-controlled Phase III clinical study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. A total of 514 patients were enrolled. The co-primary endpoints were progression-free survival (PFS) as assessed by the Bli ....

United States , San Francisco , Ruihua Xu , Patricia Keegan , Junshi Biosciences , Zhi Li , Eli Lilly , Institute Of Microbiology Chinese Academy Science , Ir Team , Drug Administration , Data Monitoring Committee , Sun Yat Sen University Cancer Center , National Reimbursement Drug List , National Medical Products Administration , Pr Team , New Drug Application , Sun Yat Sen University Cancer , Blinded Independent Review Committee , Independent Data Monitoring Committee , For Global , Chief Medical Officer , National Reimbursement Drug , Breakthrough Therapy Designation , Chinese Society , Clinical Oncology , Neck Tumors ,

Junshi Biosciences Announces Acceptance by NMPA of

Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma
July 29, 2021 20:40 ET
| Source:
Junshi Biosciences
Junshi Biosciences
Shanghai, CHINA
SHANGHAI, China, July 30, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for toripalimab in combination with platinum-containing chemotherapy as the first-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is the fifth NDA submitted for toripalimab in China. ....

United States , San Francisco , Ruihua Xu , Patricia Keegan , Junshi Biosciences , Eli Lilly , Institute Of Microbiology Chinese Academy Science , Ir Team , Drug Administration , Data Monitoring Committee , Sun Yat Sen University Cancer Center , National Reimbursement Drug List , National Medical Products Administration , Pr Team , New Drug Application , Sun Yat Sen University Cancer , Blinded Independent Review Committee , Independent Data Monitoring Committee , For Global , Chief Medical Officer , National Reimbursement Drug , Breakthrough Therapy Designation , Chinese Society , Clinical Oncology , Neck Tumors , Urothelial Carcinoma ,