Core Viewpoint - Fuhong Hanlin's biosimilar drug POHERDY has received FDA approval, making it the first interchangeable biosimilar of PERJETA in the U.S. market, covering all indications approved for the original product [1] Group 1: Company Developments - Fuhong Hanlin's stock price increased by 4.58%, reaching HKD 67.40, with a trading volume of HKD 40.6885 million [1] - The FDA approval allows POHERDY to be used interchangeably with the original PERJETA, marking a significant milestone for the company [1] - POHERDY is the first biosimilar of pertuzumab approved in the U.S. and the first interchangeable biosimilar for cancer treatment [1] Group 2: Market Position - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]

Core Viewpoint - Fuhong Hanlin (02696) shares rose over 4% following the FDA approval of its biosimilar drug POHERDY, making it the first interchangeable biosimilar of PERJETA in the U.S. market [1] Company Summary - Fuhong Hanlin's stock increased by 4.11%, reaching HKD 67.1, with a trading volume of HKD 31.4021 million [1] - The FDA approved POHERDY, a biosimilar of pertuzumab, allowing it to be used interchangeably with the original product PERJETA, covering all indications previously approved for the original drug in the U.S. [1] - POHERDY is noted as the first biosimilar of pertuzumab in the U.S. and the first interchangeable biosimilar approved for cancer treatment by the FDA [1] - Fuhong Hanlin has submitted applications for HLX11 in China, Europe, and Canada, which have been accepted for review [1] - The company has a total of seven products approved for sale overseas, with four of those approved in the U.S. [1]