Sichuan Kelun Pharmaceutical (002422.SZ): New drug SKB535 clinical trial application approved

Sichuan Kelun Pharmaceutical (002422.SZ) announced that its controlled subsidiary Sichuan Kelun Botai Biopharmaceutical Co., Ltd. ("Kelun Botai") recently received a clinical trial notification letter from the National Medical Products Administration (NMPA) Drug Evaluation Center on November 15, 2024, approving the clinical trial application for its innovative drug SKB535. According to the NMPA official website, SKB535 is the first optimized innovative drug clinical trial evaluation and approval pilot project approved by NMPA, with a evaluation and approval time of 21 days. It is said that SKB535 is a new ADC drug developed by Kelun Botai using the OptiDCTM platform technology based on the biological characteristics of the target, with independent intellectual property rights, showing good efficacy and safety profile in preclinical studies and intended for the treatment of late-stage solid tumors. Kelun Botai has signed a license and cooperation agreement with Merck (the business name of Merck & Co., Inc. based in Roewe City, New Jersey, United States) for the development of SKB535 for cancer therapy. After reaching specific development and sales milestones, Kelun Botai will be entitled to receive further milestone payments and tiered royalties based on net sales of SKB535 commercialization.