SIMCERE PHARMA (02096) announced that its self-developed bispecific antibody-drug conjugate (BsADC) candidate, SIM0610, has received clinical trial approval from China's National Medical Products Administration (NMPA). The drug is intended for trials targeting patients with locally advanced or metastatic solid tumors.

SIM0610 is a BsADC that simultaneously targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET). It induces tumor cell apoptosis by internalizing and releasing a topoisomerase I inhibitor (TOP1i). Both EGFR and cMET are abnormally activated in various solid tumors, including non-small cell lung cancer (NSCLC), with cMET activation being a key mechanism of resistance to EGFR tyrosine kinase inhibitors (EGFR-TKIs).

By leveraging dual-target synergy, SIM0610 is expected to enhance antitumor activity and overcome drug resistance. Preclinical studies have demonstrated its significant antitumor efficacy across multiple tumor models.

As an innovation-driven pharmaceutical company, SIMCERE PHARMA operates the "National Key Laboratory of Neuroscience and Oncology Drug Development." It focuses on neuroscience, oncology, autoimmune diseases, and anti-infectives while proactively exploring future therapeutic areas with high unmet clinical needs, aligning with its mission of "Innovating for Patients." The company drives growth through both in-house R&D and collaborative innovation, maintaining strategic partnerships with multiple biotech firms and academic institutions.