Innovent’s IBI351 Receives the NMPA’s Breakthrough Therapy Designation for Advanced Colorectal Carcinoma
- The NMPA has granted Breakthrough Therapy Designation for IBI351 (GFH925) to treat previously treated advanced CRC patients with KRASG12C mutation
- The BTD was based on the pooled analysis from ongoing 2 clinical trials evaluating IBI351 monotx. in 54 CRC patients which showed the favorable safety, tolerability & promising antitumor activity of IBI351 monotx. & the results will be published at ASCO 2023
- IBI351 also received the BTD from the NMPA for advanced NSCLC harboring KRASG12C mutation who have received 1 systemic therapy. Innovent & GenFleet collaborated in Sept 2021 for IBI351 in China (incl. mainland China, Hong Kong, Macau &Taiwan) with additional option-in rights for development & commercialization globally
Ref: PRNewswire | Image: Innovent
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