May 6, 2026, Simcere Zaiming announces today that SIM0613 for Injection, an LRRC15-targeting antibody-drug conjugate (ADC) independently developed by the company, has received the Clinical Trial Approval issued by the National Medical Products Administration (NMPA) of China, and is intended for commencing clinical trial for advanced solid tumors.
SIM0613 targets the leucine-rich repeat-containing 15 (LRRC15), a protein highly expressed in various tumor types and cancer-associated fibroblasts but with limited expression on normal cells. Upon binding to the LRRC15 protein, SIM0613 is internalized where the cytotoxic payload is released, killing the cancer cells and therefore sparing healthy cells. SIM0613 is specifically engineered for deep tumor penetration，killing cancer cells and cancer-associated fibroblast cells, resulting in robust tumor regressions in multiple in vivo preclinical models.
In December 2025, Simcere Zaiming entered into an exclusive licensing agreement with Ipsen Pharma SAS. Under the terms of the License Agreement, Ipsen holds the exclusive global rights, outside of Greater China, for development, manufacturing and commercialization of SIM0613. Pursuant to the License Agreement, Simcere Zaiming is eligible to receive up to US$1,060 million comprising a US$45 million upfront payment, and development, regulatory and commercial milestone payments. Simcere Zaiming is also eligible for tiered royalties on sales, contingent upon successful development and regulatory approvals.
About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (2096.HK). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking 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. pr@zaiming.com