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Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody

SHANGHAI, China, Aug. 27, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization

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Junshi Biosciences Announces Acceptance by NMPA of

SHANGHAI, China, Aug. 27, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company...

Guangzhou , Guangdong , China , Beijing , Maryland , United-states , Shanghai , Suzhou , Jiangsu , San-francisco , California , Chinese

Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody | Comunicados | Edición USA

Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody | Comunicados | Edición USA
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Guangzhou , Guangdong , China , Beijing , Maryland , United-states , Shanghai , Suzhou , Jiangsu , San-francisco , California , Chinese

Investegate |Junshi Biosciences Announcements | Junshi Biosciences: Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody

Investegate announcements from Junshi Biosciences, Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody

Guangzhou , Guangdong , China , Beijing , Maryland , United-states , Shanghai , Suzhou , Jiangsu , San-francisco , California , Chinese

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.

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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

Guangzhou , Guangdong , China , Shanghai , United-states , Suzhou , Jiangsu , Beijing , Maryland , Canada , San-francisco , California

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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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.

Guangzhou , Guangdong , China , Shanghai , United-states , Suzhou , Jiangsu , Beijing , Maryland , San-francisco , California , Chinese

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.

Guangzhou , Guangdong , China , Shanghai , United-states , Suzhou , Jiangsu , Beijing , Maryland , San-francisco , California , Chinese

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 the Blinded Independent Review Committee (BICR) and overall survival (OS). Secondary endpoints included the PFS assessed by investigator, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety. Based on the results of the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the co-primary endpoints of PFS and OS have crossed the prespecified efficacy boundaries and that toripalimab combined with standard chemotherapy as the first-line treatment significantly prolonged the PFS and OS of patients with advanced or metastatic ESCC, compared with placebo combined with standard chemotherapy. Data from the JUPITER-06 study will soon be presented at the 2021 ESMO Annual Meeting.

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