By Fineline Cube 
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for A400 (also known as EP0031). The application targets adult patients with RET‑fusion positive locally advanced or metastatic non‑small‑cell lung cancer (NSCLC).
What Is A400/EP0031?
- Next‑Generation RET Inhibitor – A highly selective oral agent that blocks oncogenic RET signaling in NSCLC, medullary thyroid cancer (MTC), and other solid tumors harboring RET alterations.
- Clinical Profile – In March 2021, Kelun‑Biotech granted Ellipses Pharma Limited an exclusive license to develop, manufacture, and commercialize EP0031 outside Greater China and select Asian markets.
Regulatory Milestone
- NDA Acceptance – The CDE’s endorsement follows positive data from the two pivotal Phase 2 cohorts (KL400‑I/II‑01) of the study.
- Cohort Outcomes – Cohort 1 (first‑line) and Cohort 2 (second‑line+) evaluated 90 mg QD dosing in treatment‑naïve and pre‑treated RET‑fusion positive NSCLC patients, respectively.
- Efficacy & Safety – Both cohorts met primary endpoints, demonstrating robust activity even in patients with prior immunotherapy or brain metastases, while maintaining an encouraging and manageable safety profile.
Market Implications
- Competitive Positioning – A400/EP0031 offers a differentiated, highly selective therapeutic option in the rapidly expanding RET‑targeted oncology segment.
- Global Reach – With Ellipses holding rights outside China, the drug is poised for accelerated international commercialization, potentially capturing a significant share of the $10‑$15 billion RET‑inhibitor market.
- Strategic Value for Kelun‑Biotech – The NDA acceptance strengthens the company’s portfolio and signals growth potential for future solid‑tumor indications.
Key Takeaways
- NMPA endorsement of A400/EP0031 validates strong Phase 2 data and positions the drug for first‑in‑class approval in China.
- International partnership with Ellipses expands the commercial footprint beyond Greater China.
- Positive safety profile in heavily pre‑treated populations enhances the drug’s appeal to clinicians and payers alike.-Fineline Info & Tech