Portfolio News

December 23, 2025 – Simcere Zaiming, an oncology-focused bipharmaceutical company and a subsidiary of Simcere Pharmaceutical Group (2096.HK)announced that its bispecific antibody-drug conjugate (BsADC) candidate SIM0610 has received an approval from the National Medical Products Administration (NMPA) to enter clinical trials. The study will focus on patients with locally advanced or metastatic solid tumors.

SIM0610 is a BsADC that simultaneously targets the epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET). It consists of a humanized anti-EGFR/cMET bispecific antibody linked via a cleavable hydrophilic linker to a topoisomerase I inhibitor (TOP1i). The mechanism of action involves the bispecific antibody binding to EGFR and/or cMET on the surface of tumor cells, followed by internalization and release of TOP1i, which induces DNA damage and tumor cell apoptosis.

The EGFR and cMET signaling pathways are frequently co-expressed or abnormally activated in various solid tumors, such as non-small cell lung cancer (NSCLC). Notably, cMET pathway activation, particularly through amplification or overexpression, is a key mechanism of resistance to EGFR tyrosine kinase inhibitors (TKIs) in NSCLC. By simultaneously inhibiting both targets, SIM0610 aims to enhance antitumor activity, overcome drug resistance, and improve treatment specificity through its favorable plasma stability and hydrophilicity.

Preclinical data demonstrate that SIM0610 exhibits potent proliferation-inhibiting activity against multiple tumor cell lines. It also suppresses the growth of EGFR/cMET double-negative tumor cells via a bystander effect. In in vivo pharmacodynamic models of NSCLC and colon cancer, SIM0610 has shown significant antitumor efficacy, suggesting its potential as a novel and effective treatment option for patients with locally advanced or metastatic solid tumors positive for EGFR and/or cMET expression.