Sino Biopharmaceutical Limited (SBP Group) has obtained clinical-trial clearance from China’s National Medical Products Administration for LM-364 “Nectin-4TME ADC,” a self-developed, Category 1 oncology asset targeting advanced solid tumours. The candidate had previously received Investigational New Drug approval from the U.S. Food and Drug Administration in April 2026 and has already entered clinical testing in Australia, underscoring the company’s accelerated global development strategy.

LM-364 is engineered by LaNova Medicines, SBP Group’s wholly owned subsidiary, using a proprietary tumour-microenvironment (TME)–responsive antibody–drug conjugate platform. The molecule targets Nectin-4, a clinically validated antigen highly expressed in malignancies such as urothelial carcinoma, triple-negative breast cancer, cervical cancer, non-small cell lung cancer, and head-and-neck squamous cell carcinoma. Traditional Nectin-4 ADCs often generate dose-limiting toxicities—namely skin rash and neurotoxicity—due to binding in normal tissues; LM-364 aims to overcome these limitations by activating high-affinity binding selectively within the TME, thereby concentrating cytotoxic effects at the tumour site while limiting systemic exposure.

Preclinical data unveiled at the American Association for Cancer Research Annual Meeting in April 2026 demonstrated: • Potent, selective cytotoxicity and significant by-stander effects under TME-mimicking conditions. • Robust in-vivo efficacy with tumour growth inhibition of 119.10 % in triple-negative breast cancer, 107.46 % in urothelial carcinoma, 168.79 % in cervical cancer, and 86.73 % in esophageal cancer across multiple PDX models. • Favourable safety profile, showing a highest non-severely toxic dose of 60 mg/kg in rhesus monkey seven-week repeat-dose studies.

With regulatory approvals secured in China, the United States and Australia, SBP Group plans to initiate a multi-region Phase I study to assess safety, tolerability, pharmacokinetics and preliminary efficacy of LM-364 as both monotherapy and in combination regimens for patients with advanced solid tumours. Subsequent efforts will focus on determining the recommended dose for future clinical development.