Chinese companies Innovent Biologics (HKEX: 01801) and GenFleet have recently secured approval from China’s National Medical Products Administration (NMPA) for Dupert (fulzerasib), the country’s first KRAS G12C inhibitor for advanced non-small cell lung cancer (NSCLC) in adults who have undergone prior systemic therapy.
This breakthrough therapy addresses a challenging mutation, offering a critical new treatment option for patients with limited alternatives, says pharma analytics firm GlobalData.
Innovent and GenFleet Therapeutics entered into an exclusive license agreement in September 2021 for the development and commercialization of fulzerasib in China, with option-in rights for markets outside the country. Fulzerasib, in combination with cetuximab, is currently in Phase II trials for NSCLC in Europe in collaboration with Germany’s Merck KGaA (MRK: DE). Fulzerasib is also in clinical development for colorectal cancer (CRC). It is in Phase III trials in China and the US for CRC.
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