Simcere Pharmaceutical Group Limited (Simcere Pharma) announced that China’s National Medical Products Administration has granted Clinical Trial Approval for SIM0613, an independently developed LRRC15-targeting antibody-drug conjugate intended for advanced solid tumours. The green light allows the company to initiate clinical studies on the injectable candidate.

SIM0613 binds to leucine-rich repeat-containing protein 15, which shows high expression in multiple tumour types and cancer-associated fibroblasts but limited presence in normal cells. Once internalised, the ADC releases a cytotoxic payload designed to kill cancer cells while sparing healthy tissue. Pre-clinical models demonstrated deep tumour penetration and robust tumour regression, according to the company.

Development of SIM0613 is supported by a December 2025 licensing agreement between Simcere subsidiary Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd. and Ipsen Pharma SAS. The deal is valued at up to US$1.06 billion in upfront, development, regulatory and commercial milestone payments, alongside tiered royalties on future sales. Ipsen holds manufacturing rights following technology transfer and will manage all activities—including IND and Clinical Trial submissions—outside Greater China.

Simcere Pharma positions itself as an innovation-focused pharmaceutical group with an emphasis on neuroscience, oncology, autoimmune and anti-infective therapeutics. The company operates a State Key Laboratory of Neurology and Oncology Drug Development and maintains collaborative relationships with multiple domestic and international research organisations.