Simcere Pharmaceutical (02096.HK) Announces NMPA Approval for Phase I Clinical Trial of SIM0613, a Novel LRRC15-Targeting Antibody-Drug Conjugate for Advanced Solid Tumors

Zhitong Finance APP reported that Simcere (02096) announced its independently developed antibody-drug conjugate (ADC) injection, SIM0613, targeting LRRC15, has received the clinical trial approval notice issued by the National Medical Products Administration (NMPA) of China. The company plans to conduct clinical trials for advanced solid tumors.

SIM0613 is a novel ADC targeting leucine-rich repeat-containing protein 15 (LRRC15). LRRC15 is highly expressed on the surface of various solid tumors and tumor-associated fibroblasts but is minimally expressed in normal cells. After SIM0613 binds to the LRRC15 protein, it enters tumor cells via endocytosis and releases a cytotoxic payload, thereby killing tumor cells while having minimal impact on normal cells. SIM0613 has been specially designed to better penetrate tumor interiors, killing both tumor cells and tumor-associated fibroblasts, and has demonstrated significant tumor regression effects in various preclinical in vivo models.

In December 2025, ZAIMING, a subsidiary of our group, entered into an exclusive licensing agreement (the "Agreement") with Ipsen Pharma SAS (Euronext: IPN; ADR: IPSEY) ("Ipsen"). Under the terms of the Agreement, ZAIMING is entitled to receive up to US$1.06 billion, including an upfront payment, as well as payments related to R&D, regulatory and commercial milestones. Additionally, ZAIMING will be eligible to receive tiered royalties on net sales. After completing the technology transfer process, Ipsen will hold the production rights and assume responsibility for all activities outside of Greater China, including Phase I preparatory activities and the submission of new drug clinical trial applications.

Our company is an innovation- and R&D-driven pharmaceutical enterprise, and our group has established the "National Key Laboratory for Neuroscience and Oncology Drug Development in China." Our group focuses on the fields of neuroscience, oncology, autoimmune diseases, and anti-infectives, while proactively making forward-looking investments in disease areas with significant future clinical needs, fulfilling our corporate mission of "Born for Patients." Our company drives progress through both independent research and collaborative innovation, establishing strategic partnerships with multiple innovative enterprises and research institutions.