Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed biosimilar POHERDY? (HLX11) for specific indications in HER2-positive metastatic breast cancer [2][6]. Product Information - HLX11 is a biosimilar of Pertuzumab, with a specification of 420mg/14mL (30mg/mL) for intravenous injection [2]. - The approved indications include treatment in combination with Trastuzumab and Docetaxel for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [2]. - It is also indicated for use in early breast cancer as part of a comprehensive treatment plan for HER2-positive locally advanced, inflammatory, or early breast cancer patients [2]. Regulatory Progress - HLX11's registration progress includes: - Acceptance of the marketing authorization application by the National Medical Products Administration of China in December 2024 [3]. - Acceptance of the marketing authorization application by the European Medicines Agency in March 2025 [3]. - Acceptance of the new drug submission by Health Canada in May 2025 [3]. Financial Investment - As of October 2025, the cumulative R&D investment for HLX11 is approximately RMB 225 million (unaudited) [4]. Market Potential - According to IQVIA MIDAS data, the global sales of Pertuzumab products are projected to be approximately $3.304 billion in 2024 [5]. Strategic Impact - The approval of POHERDY? marks the fourth product approved for Fuhong Hanlin in the U.S., enhancing the company's international market presence [6]. - Commercial rights for HLX11 outside of mainland China and Hong Kong, Macau, and Taiwan were granted to Organon LLC in June 2022, allowing Fuhong Hanlin to benefit from sales milestones and royalties following the U.S. approval [6].