Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a market filing for its HLX11, a biosimilar version of Perjeta (pertuzumab). The company is seeking regulatory approval for the drug’s use in combination with trastuzumab and chemotherapy as an adjuvant treatment for HER2 positive early breast cancer patients at high risk of recurrence. Additionally, it is intended for use in combination with trastuzumab and docetaxel for HER2 positive, metastatic, or unresectable locally recurrent breast cancer patients who have not previously received anti-HER2 treatment or chemotherapy for metastatic breast cancer.
HLX11 Development and Clinical Progress
HLX11 is an in-house developed recombinant anti-HER2 domain II humanized monoclonal antibody (mAb). The drug completed a Phase I study in Hong Kong in November 2021, marking a significant step in its clinical development. Further, the global, multi-center Phase III study for HLX11 as a neoadjuvant therapy for HER2 positive, HR negative early or locally advanced breast cancer successfully met its primary endpoint in September of this year, demonstrating the potential efficacy and safety profile of the drug.
Implications for Breast Cancer Treatment
The acceptance of HLX11 for review by the CDE is a crucial milestone for Henlius Biotech as it moves towards providing patients with HER2 positive breast cancer more treatment options. If approved, HLX11 has the potential to improve outcomes for patients with high-risk early breast cancer and those with metastatic disease, contributing to the company’s mission to enhance access to innovative oncology therapies.-Fineline Info & Tech
