SKB BIO-B(06990): SKB571 new drug clinical trial application approved by the National Medical Products Administration.

SKB BIO-B (06990) announced that on November 15, 2024, the company received a clinical trial notification letter approved by the National Medical Products Administration Drug Evaluation Center for the company's new drug SKB571. SKB571 is a novel bispecific ADC targeted at a variety of solid tumors such as lung cancer and digestive tract tumors. Through scientific target selection and differentiated bispecific molecule design, it enhances tumor targeting and helps overcome tumor heterogeneity, improving efficacy. With the high hydrophilic toxin-linker strategy on the OptiDC platform, this asset has a uniform DAR value and demonstrates good in vivo pharmacokinetic properties. Preclinical studies have shown promising anti-tumor effects and safety in various human tumor xenograft models and cynomolgus monkeys. In the third quarter of 2024, the company was informed by MSD (Merck & Co., Inc., in Kenilworth, New Jersey, USA) about exercising its exclusive option for SKB571. The company has received $37.5 million payment from MSD for exercising this exclusive option and will be entitled to further milestone payments and tiered royalties based on net sales after reaching specific development and sales milestones for SKB571. The company will retain the rights to develop, use, manufacture, and commercialize SKB571 in mainland China, Hong Kong, and Macao.