On June 3, Simcere Zaiming announced that SIM0613 initiated a Phase I clinical trial, with the first patient enrolled in China on June 2, 2026. SIM0613 is a novel anti-LRRC15 antibody-drug conjugate (ADC) developed by the company.
This multicenter, open-label Phase I study is designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary anti-tumor efficacy of SIM0613 in patients with advanced solid tumors.
SIM0613 is a novel ADC targeting LRRC15, a protein highly expressed in multiple solid tumors and cancer-associated fibroblasts (CAFs), and closely associated with tumor invasion, metastasis, and the immunosuppressive tumor microenvironment. Optimized with enhanced tumor penetration capability, SIM0613 is designed to eliminate both tumor cells and tumor-associated fibroblasts, and has demonstrated significant anti-tumor activity across multiple preclinical in vivo models.
In December 2025, Ipsen entered into an exclusive licensing agreement with Simcere Zaiming for SIM0613. Under the agreement, Ipsen obtained exclusive worldwide rights outside Greater China for the development, manufacturing, and commercialization of SIM0613. Simcere Zaiming is eligible to receive up to US$1.06 billion in potential payments and retains clinical development and commercialization rights in China.
About Simcere Zaiming
Simcere Zaiming is an oncology-focused bipharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere Zaiming dedicated to developing ground breaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu, COSELA, Enweida, Endostar, and Enlituo. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners.