SIMBAY News | Lingshi Zhiyuan's First-in-Class TCR-TCE Drug ES502 Targeting RAS G12V Receives NMPA Clinical Trial Approval in China

Shanghai, October 14, 2026 — Shanghai Lingshi Zhiyuan Biotechnology Co., Ltd., a portfolio company of SIMBAY, announced that its ES502 injection has received implicit clinical trial approval from China's National Medical Products Administration (NMPA). The investigational drug targets advanced solid tumors harboring the RAS G12V mutation. The approval marks a significant milestone for the company, which secured an Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) on March 12, 2026, achieving dual regulatory green lights in both China and the United States.

ES502 is a first-in-class T cell receptor–T cell engager (TCR-TCE) therapeutic designed to target the RAS G12V mutation. The drug's core mechanism involves activating T cells to specifically recognize and destroy tumor cells carrying the RAS G12V mutation. Compared with small-molecule RAS inhibitors, ES502 offers greater tumor specificity and a wider therapeutic window. Its distinct mechanism of action is also positioned to help overcome tumor drug resistance — a persistent challenge in oncology treatment.

The development of ES502 is underpinned by two proprietary technology platforms. The first is a peptide-human leukocyte antigen (pHLA) target discovery platform, which the company says addresses a core bottleneck in TCR drug development by enabling the isolation and validation of disease-associated pHLA targets from patient samples. The second is a soluble TCR engineering platform, built on years of protein engineering expertise, which the company says can achieve million-fold improvements in binding affinity and drug-like properties — a critical factor in translating TCR therapeutics from the laboratory to commercial viability.

Beyond oncology, the company is positioning its TCR drug pipeline for expansion into infectious diseases and autoimmune disorders. The rationale: many diseases are closely linked to the HLA system, and the ability to discover disease-relevant pHLA targets and engineer soluble TCR drugs could open new therapeutic frontiers across multiple indications.

Shanghai Lingshi Zhiyuan Biotechnology is an innovative Chinese biopharmaceutical company focused on the discovery, development, and commercialization of T cell receptor therapies to address unmet clinical needs in oncology, infectious diseases, and autoimmune conditions.

The company is incubated at SIMBAY, a medical innovation hub located in the Waigaoqiao Bonded Zone in the heart of Shanghai's Pudong Free Trade Zone. SIMBAY leverages the zone's unique "free trade plus bonded" economic model and integrates a full spectrum of biopharmaceutical services — including CRO, CDMO, and EHS capabilities — along with access to prominent investment institutions, to support the translation of medical technologies from bench to market.