Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. The combination therapy was previously awarded priority review status and breakthrough therapy designation by the NMPA.
Sintilimab: A PD-1 Inhibitor Approved for Multiple Indications in China
Sintilimab, a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company (NYSE: LLY), works by binding to PD-1 molecules on the surface of T-cells, blocking the PD-1/PD-L1 pathway, and reactivating T-cells to kill cancer cells. In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications, making it a significant player in the country’s immuno-oncology landscape.
Fruquintinib: A Selective Inhibitor of VEGF Receptors
Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2, and -3). Takeda holds the rights to market fruquintinib outside of China under the trade name Fruzqala, while Eli Lilly co-markets the drug with HutchMed in China under the brand name Elunate. The drug was approved to treat previously treated metastatic colorectal cancer (CRC) in the US in November 2023 and is also registered in the European Union (EU), Switzerland, Canada, Japan, the UK, Argentina, Australia, and Singapore.-Fineline Info & Tech
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