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HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots:China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapyNDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…
June 5, 2025

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New Drug Designations - November 2023
INSIGHTS+

New Drug Designations – November 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…
December 27, 2023

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Insights+ Key Biosimilars Events of August 2019
INSIGHTS+

Insights+ Key Biosimilars Events of August 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space…
September 9, 2019

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