Fosun Pharma Receives NMPA Approval for Phase 1 Trial of HLX319 Biosimilar for Breast Cancer Treatment
Key Insights
Fosun Pharma has received approval from China's National Medical Products Administration (NMPA) for Phase 1 clinical trials of HLX319 (search), a biosimilar injection of pertuzumab-trastuzumab for subcutaneous administration.
HLX319 (search) contains active ingredients trastuzumab and pertuzumab, along with a proprietary hyaluronidase excipient (HLXTEHAase02) developed by Fosun Pharma to enable subcutaneous delivery.
The biosimilar is intended for both adjuvant/neoadjuvant treatment of early-stage breast cancer and treatment of metastatic breast cancer.
Fosun Pharma has secured regulatory approval from China's National Medical Products Administration (NMPA) to proceed with Phase 1 clinical trials of HLX319 (search), an independently developed biosimilar injection of pertuzumab-trastuzumab designed for subcutaneous administration. The Hong Kong-listed pharmaceutical company announced it plans to conduct the clinical trials in China once conditions are met.
Novel Formulation Strategy
HLX319 (search) represents a biosimilar approach to the established pertuzumab-trastuzumab combination therapy, formulated specifically for subcutaneous injection. The drug consists of the active ingredients trastuzumab and pertuzumab, combined with HLXTEHAase02, a novel recombinant human hyaluronidase that Fosun Pharma developed independently as an excipient.
The inclusion of the proprietary hyaluronidase enzyme is designed to facilitate subcutaneous delivery of the dual antibody combination, potentially offering patients a more convenient administration route compared to traditional intravenous formulations.
Therapeutic Applications
According to the company's announcement, HLX319 (search) is intended for multiple therapeutic applications in breast cancer treatment. The biosimilar is being developed for adjuvant and neoadjuvant treatment of early-stage breast cancer, as well as for the treatment of metastatic breast cancer.
This broad therapeutic scope positions HLX319 (search) to potentially address various stages of HER2 (search)-positive breast cancer, from early intervention strategies to advanced disease management.
Development Milestone
The NMPA approval for Phase 1 clinical trials represents a significant regulatory milestone for Fosun Pharma's biosimilar development program. The approval allows the company to begin human testing of HLX319 (search)'s safety profile and pharmacokinetic properties in the Chinese market.
Fosun Pharma's stock responded positively to the announcement, with shares rising 8.817% following the regulatory approval news, reflecting investor confidence in the company's biosimilar development capabilities and the commercial potential of HLX319 (search) in the Chinese oncology market.