Core Insights - Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖) announced that its HLX11 (biosimilar of pertuzumab, marketed as POHERDY in the U.S.) has received FDA approval for interchangeability with the original product PERJETA, making it the first and only biosimilar of PERJETA in the U.S. [1] - HLX11 is the first biosimilar of pertuzumab approved in the U.S. and the first interchangeable biosimilar for cancer treatment approved by the FDA [1] - The company has seven products approved for overseas markets, with four of them approved in the U.S. [1] Product and Market Details - HLX11 targets HER2 receptors and is indicated for metastatic breast cancer, early breast cancer, and adjuvant treatment for high-risk HER2-positive early breast cancer patients [1] - Organon, a New York Stock Exchange-listed company, will handle the commercialization of HLX11 outside of China, following a licensing and supply agreement signed in 2022 [1] Strategic Commitment - The CEO of Junshi Biosciences emphasized the achievement reflects the company's commitment to a sustainable global R&D system and a patient-centered approach, reinforcing its long-term commitment to global expansion [2] - The company aims to accelerate the delivery of quality biopharmaceuticals to benefit more patients worldwide and create greater value for human health [2]
复宏汉霖：生物类似药帕妥珠单抗在美获批上市 可覆盖原研产品所有适应症