SHANGHAI, China, April 1, 2026
Shanghai Henlius Biotech, Inc. announced that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for HLX319, a fixed-dose subcutaneous combination of pertuzumab and trastuzumab, marking a major milestone in advancing innovative biologics for HER2-positive breast cancer treatment. The approval enables clinical evaluation of a biosimilar-based, subcutaneous therapy designed to improve treatment efficiency and patient experience, reinforcing Henlius’ position in global oncology drug development.
NMPA IND Approval Advances Breast Cancer Innovation
The IND clearance from the NMPA allows Henlius to initiate clinical trials evaluating the safety, efficacy, and pharmacokinetics of HLX319, targeting patients with HER2-positive early, locally advanced, and metastatic breast cancer. This regulatory milestone reflects successful completion of preclinical studies and pharmaceutical comparability assessments, demonstrating that HLX319 is highly similar to the reference product Phesgo®. This approval highlights Henlius’ strong capabilities in biosimilar development and complex biologic formulations, enabling progression into clinical validation under strict regulatory and GxP frameworks.
Subcutaneous Combination Therapy Enhances Patient Experience
HLX319 introduces a novel fixed-dose subcutaneous formulation combining trastuzumab and pertuzumab, two established HER2-targeted therapies, into a single injection administered within minutes, eliminating the need for lengthy intravenous infusions. This approach significantly improves patient convenience, reduces hospital resource utilization, and enhances treatment accessibility, while maintaining comparable efficacy and safety profiles to existing intravenous regimens.
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The formulation incorporates recombinant human hyaluronidase (rHuPH20), enabling efficient drug absorption and delivery. This innovation addresses key clinical challenges in oncology treatment by simplifying administration and improving patient compliance, particularly in high-volume healthcare settings.
AI-Driven Platform Strengthens Biologic Development
A key differentiator of HLX319 is its integration of Henlius’ proprietary “mAb + enzyme” platform and AI-driven R&D technologies, including advanced computational modeling and mechanistic analysis. The company’s Henozye® hyaluronidase platform facilitates subcutaneous delivery of large-molecule biologics, enabling stable co-formulation of complex therapies. This platform supports enhanced drug dispersion, absorption, and formulation stability, significantly improving development efficiency compared to conventional methods. The use of AI-assisted drug development accelerates innovation while maintaining high standards in Chemistry, Manufacturing, and Controls (CMC), ensuring consistency, scalability, and regulatory compliance.
Strategic Expansion in Global Oncology Market
Breast cancer remains the most prevalent cancer among women worldwide, with HER2-positive cases accounting for approximately 15–20% of diagnoses, representing a significant global healthcare burden. Henlius has established a comprehensive oncology portfolio, including approved and investigational therapies across multiple markets, strengthening its global commercialization strategy.
The development of HLX319 reflects the company’s commitment to delivering high-quality, affordable biologics, particularly in emerging markets where access to advanced therapies remains limited. This IND approval positions Henlius to expand its leadership in biosimilars and innovative biologics, contributing to the evolution of precision oncology and patient-centric treatment solutions.
Source: Henlius press release
