SIMCERE PHARMA's ADC Candidate SIM0613 Receives Chinese Regulatory Nod for Clinical Trials

Stock News
May 06

SIMCERE PHARMA (02096) announced that its internally developed antibody-drug conjugate (ADC) targeting LRRC15, SIM0613 for injection, has received a drug clinical trial approval notice from China's National Medical Products Administration (NMPA). The approval allows for the initiation of clinical trials in patients with advanced solid tumors. SIM0613 is a novel ADC designed to target Leucine-Rich Repeat-Containing Protein 15 (LRRC15). LRRC15 is highly expressed on the surface of various solid tumors and cancer-associated fibroblasts but is rarely found on normal cells. After binding to the LRRC15 protein, SIM0613 is internalized into tumor cells, where it releases its cytotoxic payload, leading to tumor cell death while minimizing impact on healthy cells. SIM0613 is specially engineered to enhance penetration into tumor tissues, effectively killing both tumor cells and cancer-associated fibroblasts. It has demonstrated significant tumor regression in multiple preclinical in vivo models. In December 2025, the group's subsidiary, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd. (Simcere Zaiming), entered into an exclusive licensing agreement with Ipsen Pharma SAS (Euronext: IPN; ADR: IPSEY). Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06 billion, including an upfront payment, as well as development, regulatory, and commercial milestone payments, in addition to tiered sales royalties. Following the completion of the technology transfer process, Ipsen will hold manufacturing rights and will assume responsibility for all activities outside Greater China, including preparatory work for Phase I trials and the submission of new drug clinical trial applications. The company is an innovation and R&D-driven pharmaceutical enterprise and has established the "National Key Laboratory for Neuroscience and Oncology Drug Research." The group focuses on the fields of neuroscience, oncology, autoimmune diseases, and anti-infectives, while proactively exploring future disease areas with significant clinical needs, in line with its mission of "Born for Patients." The company drives growth through both in-house R&D and collaborative innovation, having established strategic partnerships with numerous innovative companies and academic research institutions.

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