SKB BIO Receives NMPA Approval for Clinical Trial of Novel Dual-Load ADC Drug

Stock News07-27

SKB BIO (06990) has announced that it has received a clinical trial notification letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), approving the Investigational New Drug (IND) application for its novel dual-load antibody-drug conjugate (ADC), SKB565, for the treatment of advanced solid tumors.

This marks the first clinical-stage dual-load ADC developed by the company. Leveraging its technological expertise and platform advantages in the ADC field, SKB BIO has established a pipeline of innovative molecules that combine high-value targets with differentiated design and global potential.

Building on this foundation, the company is further expanding its "ADC+Immuno-Oncology (IO)" strategy. This includes, on one hand, exploring high-quality combination therapies, such as various ongoing clinical regimens combining ADCs with PD-(L)1 monoclonal antibodies, as well as the combination of its PD-1/VEGF bispecific antibody SKB118 with its proprietary ADC assets. On the other hand, it advances an integrated R&D approach by incorporating functional elements with synergistic mechanisms into a single ADC molecule.

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