The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast cancer, marking a significant step in the development of novel therapies for this patient population.
KL-A167: A Promising Category 1 Biologic
KL-A167 is an in-house developed Category 1 biologic that has garnered an investment of RMB 26 million in its development to date. Preclinical studies have demonstrated the molecule’s clear anti-tumor effects in multiple solid tumors, including colorectal cancer and non-small cell lung cancer. The drug primarily binds to PD-L1 on the surface of tumor cells, alleviating the inhibition of tumor cell immune function, activating immune function, and killing tumor cells.
SKB264: An Antibody Drug Conjugate (ADC) Targeting TROP2
SKB264 is an antibody drug conjugate (ADC) that targets TROP2. Sichuan Kelun-Biotech out-licensed this drug to US major Merck in a significant USD 1.4 billion deal in May 2022. The potential of SKB264, combined with KL-A167, offers a new approach to treating HR+/HER2 breast cancer, highlighting the company’s commitment to advancing innovative cancer therapies.-Fineline Info & Tech
