Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under the brand name Dupert, for the treatment of adult patients with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC). The drug is indicated for second-line use in patients who have previously undergone at least one systemic treatment.
Fulzerasib, a small-molecule KRAS G12C inhibitor, marks the first of its kind to enter the Chinese market. Innovent secured exclusive development and commercialization rights for Greater China through a lucrative USD 312 million deal with GenFleet in September 2021. The drug’s mechanism involves the irreversible covalent modification of the cysteine residues of the KRAS G12C protein mutant. This action inhibits the GTP/GDP exchange mediated by the protein, downregulating the activation level of the KRAS protein and, in turn, suppressing downstream signaling pathways. The drug’s anti-tumor effects are achieved through the induction of tumor cell apoptosis and cell cycle arrest.
The NMPA’s approval was contingent upon the outcomes of a single-arm regulatory Phase II study in China, which aimed to evaluate the safety, tolerability, and efficacy of fulzerasib as a monotherapy for KRAS G12C mutant advanced NSCLC patients who had failed or were intolerant to standard treatments. The study reported an overall good tolerability profile for fulzerasib. As of the data cutoff on December 13, 2023, the analysis included 116 NSCLC subjects. The confirmed objective response rate (cORR), as evaluated by the Independent Imaging Review Committee (IRRC), stood at 49.1%, with a disease control rate (DCR) of 90.5%. The median duration of remission (DoR) had not been reached at the time of analysis. The median progression-free survival (PFS) was recorded at 9.7 months, and the median overall survival (OS) remains pending.- Flcube.com
