On November 17th, Shanghai Fuhong Hanlin Biotechnology Co., Ltd. (hereinafter referred to as "Fuhong Hanlin") announced that its HLX11 (Pertuzumab, US trade name: POHERDY) ®） Approved by the US Food and Drug Administration (FDA), it can be used interchangeably with the original product PERJETA (pertuzumab), becoming the first and only PERJETA biosimilar drug in the United States, covering all indications approved for the original product in the United States. As of now, 7 products of Fosun Pharma have been approved for overseas market, including 4 products approved for market in the United States.

The reporter also learned from Fosun Pharma that this is the first pertuzumab biosimilar drug in the United States and the first FDA approved interchangeable biosimilar drug for the treatment of cancer. HLX11 has also submitted listing applications and been accepted in China, Europe, and Canada. Partoluzumab is a monoclonal antibody against HER2 receptor, which is applicable to metastatic breast cancer, early breast cancer, and adjuvant treatment of HER2 positive early breast cancer patients with high risk of recurrence. Organon, a company listed on the New York Stock Exchange, will be responsible for the subsequent commercialization work. In 2022, Fosun Pharma signed a licensing and supply agreement with Organon, granting them exclusive commercial rights to multiple biosimilars, including POHERDY, in global regions outside of China.

Dr. Zhu Jun, Executive Director and CEO of Fosun Pharma, stated that this achievement demonstrates our core ability to build a sustainable global research and development system with rigorous scientific and regulatory standards, and also confirms Fosun Pharma's commitment to the core concept of "patient-centered" and its long-term commitment to promoting globalization strategy; We will accelerate the promotion of high-quality biopharmaceuticals to benefit more patients worldwide and create greater value for human health.