SIMCERE PHARMA (02096)SIM0613 (LRRC15 antibody drug conjugate) has obtained the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration.

Simcere Pharma (02096) announced that its independently developed antibody-drug conjugate (ADC) targeting LRRC15, injectable SIM0613, has received the drug clinical trial approval notification issued by the National Medical Products Administration (NMPA) of China, intending to conduct clinical trials for late-stage solid tumors. SIM0613 is a novel ADC targeting the protein 15 (LRRC15) which is rich in leucine-rich repeat sequences. LRRC15 is highly expressed on the surface of fibroblasts in various solid tumors and tumor-related cells, but is rarely expressed in normal cells. After binding to the LRRC15 protein, SIM0613 enters tumor cells through endocytosis and releases a cytotoxic payload, effectively killing tumor cells with minimal impact on normal cells. SIM0613 is specially designed to better penetrate the tumor interior, killing tumor cells and tumor-related fibroblasts, showing significant tumor regression effects in various preclinical models. In December 2025, Simcere's subsidiary, Jiangsu Sunstrong Pharmaceuticals Co., Ltd. (Sunstrong), signed an exclusive licensing agreement with Ipsen Pharma SAS. (Euronext stock code: IPN; ADR trading code: IPSEY) (Ipsen). Under the agreement, Sunstrong is entitled to receive up to $1.06 billion, including upfront payments, as well as research and development, regulatory, and commercial milestone payments, and tiered royalties on sales. After completing the technology transfer process, Ipsen will have manufacturing rights and will take responsibility for all activities outside the Greater China region, including Phase I preparation activities and the submission of new drug clinical trial applications. Simcere Pharma is an innovative and research-driven pharmaceutical company with a National Key Laboratory for Neurological and Oncology Drug Development. The company focuses on neuroscience, anti-tumor, autoimmune, and anti-infection fields, while actively laying out future disease areas with significant clinical needs in accordance with its mission of "being born for patients". The company drives innovation through independent research and collaborative partnerships with innovative companies and research institutes.