Sichuan Kelun Pharmaceutical (002422.SZ): Clinical trial application for new drug SKB571 approved.

Sichuan Kelun Pharmaceutical (002422.SZ) has announced that its subsidiary Sichuan Kelun BoTai Biopharmaceutical Co., Ltd. ("Kelun BoTai") has recently received a clinical trial notification for the new drug SKB571, which it developed, from the National Medical Products Administration's Drug Evaluation Center on November 15, 2024. SKB571 is a novel bispecific ADC drug aimed at treating various solid tumors such as lung cancer and gastrointestinal tumors. Through scientific target selection and differential bispecific molecule design, SKB571 enhances tumor targeting, overcomes tumor heterogeneity, and improves efficacy. With the use of the OptiDCTM platform's highly hydrophilic toxin-linker strategy, SKB571 has shown consistent DAR values and favorable pharmacokinetic properties in vivo. Preclinical studies have demonstrated that SKB571 has shown good anti-tumor effects and safety in various human tumor xenograft models and in crab-eating macaques. In the third quarter of 2024, Kelun BoTai received notice from MSD (Merck & Co., Inc. in Rahway, New Jersey, USA) regarding the exercise of exclusive rights for SKB571. Kelun BoTai has received $37.5 million from MSD for exercising this exclusive right, and upon reaching certain development and sales milestones, will be entitled to additional milestone payments and tiered royalties based on net sales of SKB571 after commercialization. Kelun BoTai will retain the rights to develop, use, manufacture, and commercialize SKB571 in mainland China, Hong Kong, and Macau.