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Junshi Biosciences Reports the NMPA Acceptance of sNDA for Toripalimab + Axitinib as 1L Treatment of Unresectable or Metastatic Renal Cell Carcinoma

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Junshi Biosciences Reports the NMPA Acceptance of sNDA for Toripalimab + Axitinib as 1L Treatment of Unresectable or Metastatic Renal Cell Carcinoma

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  • The sNDA was based on the P-III study (RENOTORCH) evaluating toripalimab + axitinib vs sunitinib monotx. in a ratio (1:1) in 421 patients. The study was jointly led by principal investigators Professor Jun GUO of the Peking University Cancer Hospital and Professor Yiran HUANG of Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
  • The interim analysis results showed a reduction in the risk of disease progression or death while improving 2EPs i.e., ORR. The safety profile was consistent with known risks with no new safety signals
  • Additionally, the company will collaborate with regulatory authorities to provide more effective and accessible treatment options to Chinese patients

Ref: Globe Newswire Image: Junshi

Related News:- Junshi Biosciences Reports the NMPA Acceptance of sNDA of Toripalimab for Advanced Triple-Negative Breast Cancer

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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