Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential approval.
CFT8919: A Promising BiDAC Degrader for EGFR L858R Tumors
CFT8919 is an orally bioavailable BiDAC degrader specifically designed to target EGFR L858R mutations, which are common in solid tumors. The drug has shown promising activity and selectivity against solid tumors carrying EGFR L858R mutations, indicating its potential as a targeted therapy for these cancers.
Exclusive Licensing Agreement and Global Reach
In May of this year, Betta Pharma entered into an exclusive licensing agreement with US-based C4 Therapeutics Inc. (NASDAQ: CCCC), securing exclusive development and commercialization rights to CFT8919 in Greater China, including Hong Kong SAR, Macau SAR, and Taiwan. This partnership underscores the global interest in CFT8919 and its potential impact on the treatment of EGFR L858R-driven non-small cell lung cancer (NSCLC).
Pre-Clinical Data and Potential Applications
Pre-clinical studies have demonstrated CFT8919’s activity in both in vivo and in vitro models of EGFR L858R-driven NSCLC. The drug targets a broad range of drug-resistant mutations and has shown intracranial activity, suggesting its potential to prevent or treat brain metastasis in patients with EGFR L858R-positive tumors.-Fineline Info & Tech
