SKB BIO-B (06990): The clinical trial application for the new drug SKB535 has been approved by the National Medical Products Administration.

SKB BIO-B(06990) announced that the company has received a clinical trial notification letter for the innovative drug SKB535 that it developed, approved by the National Medical Products Administration (NMPA) Drug Evaluation Center on November 15, 2024. According to the NMPA official website, SKB535 is the first optimized innovative drug clinical trial evaluation and approval pilot project approved by the NMPA, with a review and approval time of 21 days. SKB535 is a new ADC drug developed by the company using the OptiDCTM platform technology based on the biological characteristics of the target, with independent intellectual property rights. It has shown good efficacy and safety in preclinical studies, and is intended for the treatment of advanced solid tumors. The company has signed a development and cooperation agreement with Merck (Merck & Co., Inc., based in Kenilworth, New Jersey, USA) for the development of SKB535 for cancer treatment. Upon reaching specific development and sales milestones, the company will be entitled to receive further milestone payments and tiered royalties based on net sales of SKB535 after commercialization.