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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 ,

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

(1)
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 ....

United States , 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 , Urothelial Carcinoma ,

Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for .
Junshi BiosciencesJuly 30, 2021 GMT
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 , 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 ,

Investegate |Junshi Biosciences Announcements | Junshi Biosciences: NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines of Prior Systemic Therapy

2
indication approved for Toripalimab in China
SHANGHAI, China, Feb. 22, 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 granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. This is the first approval of immune checkpoint blockade therapy in NPC in the world and the second approved indication for toripalimab in China. In December 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of unresectable or metastatic melanoma. ....

United States , San Francisco , Ruihua Xu , Patricia Keegan , Junshi Biosciences , Eli Lilly , Institute Of Microbiology Chinese Academy Science , Guidelines Of Chinese Society Clinical Oncology , Ir Team , World Health Organization , Drug Administration , Sun Yat Sen University Cancer Center , National Reimbursement Drug List , National Medical Products Administration , Pr Team , Metastatic Nasopharyngeal Carcinoma , Least Two Lines , Prior Systemic , Sun Yat Sen University Cancer , Chief Medical Officer , For Global , Chinese Society , Clinical Oncology , Breakthrough Therapy Designation , National Reimbursement Drug , Drug Designations ,