Shanghai Henlius Biotech Secures NMPA Approval for Phase 2/3 Trials of HLX22 and HLX87 in HER2-Positive Breast Cancer

Shanghai Henlius Biotech Inc. announced that the National Medical Products Administration has approved applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (antibody-drug conjugate targeting HER2) for the first-line treatment and neoadjuvant treatment of HER2-positive breast cancer. As of the announcement date, no similar combination has been approved for marketing globally. The approval marks a significant step forward in the company's oncology pipeline, but Henlius cautioned that successful development and commercialization of HLX22 and HLX87 cannot be guaranteed.

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