#China #Chengdu #Kelun-Biotech #A400/EP0031 #RET Inhibitor

Kelun-Biotech's Promising New Drug Application

In September 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced significant progress in its oncology drug development efforts. The company revealed that the National Medical Products Administration (NMPA) of China accepted for review their New Drug Application (NDA) for A400/EP0031, a novel selective RET inhibitor. This promising compound is specifically designed to treat adults who have RET-fusion positive non-small cell lung cancer (NSCLC), a challenging and often treatment-resistant cancer.

Overview of A400/EP0031

A400/EP0031 is a small molecule designed as a next-generation RET kinase inhibitor. This drug has been evaluated through two pivotal Phase 2 cohorts in the KL400-I/II-01 clinical study. The cohorts focused on advanced stages of RET-fusion positive NSCLC, specifically assessing both treatment-naïve patients and those previously treated. The results from this study indicate that A400/EP0031 can be taken orally at a daily dose of 90 mg, marking a significant advancement in treatment options for this patient population.

Kelun-Biotech's studies have shown that A400/EP0031 achieves robust efficacy in treating patients who have previously undergone therapies such as immunotherapy or have developed brain metastases. Additionally, the safety profile of A400/EP0031 is reported to be manageable and encouraging, suggesting minimal adverse effects compared to existing treatments.

The Need for Targeted Therapies

RET-fusion positive NSCLC is characterized by genetic alterations that contribute to the growth of tumors. The occurrence of RET gene fusions in Chinese NSCLC patients is relatively rare but significant, ranging from 1.4% to 2.5%. Traditional therapies often yield limited results for these patients, underscoring the critical need for innovative treatment solutions tailored to their unique conditions. As the landscape of cancer treatment evolves, the emergence of selective inhibitors like A400/EP0031 holds promise for addressing the limitations of current therapies.

Dr. Michael Ge, CEO of Kelun-Biotech, expressed optimism about the results of the clinical studies. He emphasized that A400/EP0031 not only demonstrates potential efficacy but also positions the company strategically in the realm of targeted therapies for solid tumors.

Collaborations and Future Developments

In addition to its ongoing studies, Kelun-Biotech has partnered with Ellipses Pharma Limited, a U.K.-based oncology drug developer, to extend the reach of A400/EP0031 beyond Greater China and select Asian markets. This collaboration aims to develop, manufacture, and commercialize the drug internationally under its code EP0031.

Moreover, A400/EP0031 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), a critical step that acknowledges the drug's potential to provide significant clinical value. The FDA clearance for Phase 2 development indicates strong future prospects for A400/EP0031 across multiple global markets including the U.S., U.K., and Europe.

Conclusion

As Kelun-Biotech continues its journey towards innovative cancer therapies, A400/EP0031 stands out as a key player in the treatment of RET-fusion positive non-small cell lung cancer. The acceptance of its NDA by the NMPA marks a significant milestone not only for Kelun-Biotech but also for patients who have long awaited advancements in their treatment options. With ongoing studies and global collaborations, the future looks promising for this cutting-edge therapy.

For more detailed information, please visit Kelun-Biotech's official website.