Kelun-Biotech's Next-Generation RET Inhibitor A400/EP0031 Receives NDA Acceptance in China for NSCLC Treatment
- Sichuan Kelun-Biotech announced that China's NMPA accepted its New Drug Application for A400/EP0031, a next-generation selective RET inhibitor for treating RET-fusion positive non-small cell lung cancer.
- The acceptance is based on positive Phase 2 results from the KL400-I/II-01 study, which demonstrated favorable efficacy in both treatment-naïve and pretreated NSCLC patients, including those with brain metastases.
- A400/EP0031 previously received FDA Fast Track designation in March 2024 and is being developed globally through a partnership with Ellipses Pharma for markets outside Greater China.
- The drug addresses an unmet medical need for RET-fusion positive NSCLC patients, who represent 1.4% to 2.5% of Chinese NSCLC cases and derive limited benefit from conventional treatments.
Ellipses Pharma
Posted 9/30/2022
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/1/2021