RE:G12D/G12V KRAS mutation in PC & CRC patients respond to PelaNovember 24, 2023 - China's Innovent Biologics files first NDA for a KRAS G12C inhibitor with China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and is anticipated to benefit more lung cancer patients harbouring KRAS G12C mutation after approval.
Innovent is also exploring the potential of IBI351 in combination therapy for previously-untreated advanced NSCLC patients with KRAS G12C mutation. Two Phase 1b studies of IBI351, in combination with cetuximab (ERBITUX®, EGFR inhibitor) and sintilimab (TYVYT®, PD-1 inhibitor) respectively, are currently ongoing.
Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules ), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection).
Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners.
https://www.biospace.com/article/releases/china-s-first-nda-for-a-kras-g12c-inhibitor-innovent-announces-the-national-medical-products-administration-of-china-has-accepted-and-granted-priority-review-designation-to-the-new-drug-application-for-ibi351/