On 27 February 2026, Shanghai Henlius Biotech, Inc. (Stock code: 2696) announced that HLX11, its proposed Perjeta (pertuzumab) biosimilar, received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The recommendation covers use in combination with trastuzumab and chemotherapy for specified HER2-positive breast cancer treatments. Following this opinion, the European Commission is expected to reach a final decision within two to three months, and any approval would apply across all European Union Member States as well as Iceland, Liechtenstein, and Norway.

HLX11 underwent analytical similarity studies, pharmacokinetic comparison, and clinical evaluations, demonstrating a high degree of similarity in quality, safety, and efficacy to the reference drug. The data released also noted that the production lines related to HLX11 had met European GMP standards. According to IQVIA MIDAS, pertuzumab products had global sales of US$3.30 billion in 2024.

HLX11 has been pursued on multiple regulatory fronts. Its new drug application was accepted by China’s National Medical Products Administration in December 2024, followed by the marketing authorisation application acceptance by the EMA in March 2025 and a new drug submission acceptance by Health Canada in May 2025. In November 2025, the United States Food and Drug Administration approved HLX11 through a biologics license application, indicating growing international recognition of the biosimilar’s potential.