科伦博泰与默沙东(美国新泽西州罗威市默克公司的商号)签订了开发SKB535用于癌症治疗的许可与合作协议。待达到特定开发及销售里程碑后，科伦博泰将有权收取进一步里程碑付款及SKB535商业化后按净销售额计算的分级特许权使用费。Sichuan Kelun Pharmaceutical (002422.SZ) announced that the company recently learned that its holding subsidiary Sichuan Kelun Botai Biomedical Co., Ltd. has received the clinical trial notification letter for the clinical trial application of its developed innovative drug SKB535 from the National Medical Products Administration (NMPA) on November 15, 2024.
According to the Smart Finance APP, Sichuan Kelun Pharmaceutical (002422.SZ) announced that the company recently learned that its holding subsidiary Sichuan Kelun Botai Biomedical Co., Ltd. has received the clinical trial notification letter for the clinical trial application of its developed innovative drug SKB535 from the National Medical Products Administration (NMPA) on November 15, 2024. According to the NMPA official website, SKB535 is the first pilot project approved by NMPA for the optimized innovative drug clinical trial review, with a review and approval time of 21 days.
It is reported that SKB535 is a new ADC drug developed by Kelun Botai based on the biological characteristics of the target, using OptiDCTM platform technology, which has shown good efficacy and safety margins in preclinical studies, and is intended for the treatment of advanced solid tumors.
Kelun Botai has signed a licensing and cooperation agreement with Merck (the business name of Merck & Co., Inc., based in Rahway, New Jersey, USA) for the development of SKB535 for cancer treatment. After reaching specific development and sales milestones, Kelun Botai will have the right to receive further milestone payments and a tiered royalty based on net sales after the commercialization of SKB535.
