SIMCERE PHARMA (02096.HK): SIM0613 (LRRC15 ADC) Receives NMPA Clinical Trial Approval

NewTimeSpace News: Simcere Pharmaceutical Group Limited (02096.HK) released a voluntary announcement on May 6, 2026, disclosing that SIM0613 has received clinical trial approval from the NMPA.

SIM0613 is a novel ADC targeting Leucine-Rich Repeat Containing 15 (LRRC15). LRRC15 is highly expressed on the surface of various solid tumors and cancer-associated fibroblasts, but rarely expressed in normal cells. After binding to LRRC15 protein, SIM0613 is endocytosed into tumor cells and releases cytotoxic payloads to kill tumor cells while having minimal impact on normal cells. Specifically designed to better penetrate tumor tissue, the drug can kill both tumor cells and cancer-associated fibroblasts, and has demonstrated significant tumor regression effects in multiple preclinical in vivo models.

In December 2025, Simcere Zaiming, a subsidiary of the Group, entered into an exclusive license agreement with Ipsen Pharma SAS. Under the terms of the agreement, Simcere Zaiming is entitled to receive a total payment of up to USD 1.06 billion, including an upfront payment and development, regulatory and commercial milestone payments, plus tiered sales royalties. Ipsen will be responsible for all activities outside the Greater China region.

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