Sichuan Kelun Pharmaceutical Co.,Ltd. (SZ: 002422) has announced that its controlling subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., received a clinical trial approval notice from the National Medical Products Administration's Center for Drug Evaluation for its new dual-load antibody-drug conjugate (ADC) drug, SKB565, for the treatment of advanced solid tumors.

This marks the first dual-load ADC candidate from Kelun-Biotech to enter the clinical stage. Leveraging its deep technical expertise and platform advantages in ADC development, the company has built a pipeline of innovative molecules featuring high-value targets, differentiated designs, and global potential.

Building on this foundation, Kelun-Biotech is expanding its "ADC + tumor immunology" strategy. This includes a dual focus on exploring high-quality combination therapies, such as ongoing clinical trials combining various ADCs with PD-(L)1 monoclonal antibodies, as well as the PD-1/VEGF bispecific antibody SKB118 with its proprietary ADC assets. The strategy also involves advancing integrated research to incorporate functional elements with synergistic mechanisms into a single ADC molecule.

SKB565 is a core representative of Kelun-Biotech's "ADC+IO" integrated development strategy, developed using the company's proprietary OptiDC platform. The drug features an innovative dual-load design, allowing it to deliver both a toxin and an immunomodulator—two agents with synergistic mechanisms of action—directly to tumor tissue.

Compared to traditional ADCs carrying only a toxin, SKB565 possesses a dual anti-tumor mechanism. It precisely kills tumor cells while simultaneously activating the immune system within the tumor microenvironment to mount an anti-tumor immune response, aiming for stronger and more durable tumor suppression.

In preclinical studies, SKB565 demonstrated excellent anti-tumor activity and a favorable safety profile, providing strong support for its promising therapeutic potential in subsequent clinical development.