Core Viewpoint - Fuhong Hanlin (02696) saw a stock price increase of over 3%, currently trading at 67.2 HKD, with a transaction volume of 3.9331 million HKD, following the FDA approval of its biosimilar drug POHERDY, which can be used interchangeably with the original product PERJETA [1] Group 1: FDA Approval and Market Impact - Fuhong Hanlin and Organon announced that the injection of patuzumab (POHERDY) received FDA approval, making it the first and only biosimilar of PERJETA in the U.S. market, covering all indications approved for PERJETA [1] - The approval is expected to enhance Fuhong Hanlin's market position and potentially increase revenue streams from the U.S. market [1] Group 2: Additional Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulizumab injection (H drug), is proposed to be included in the breakthrough therapy designation for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, marking its first potential recognition [1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally, indicating significant advancements in Fuhong Hanlin's product pipeline [1]

Core Viewpoint - Fuhong Hanlin (02696) saw a stock price increase of over 3%, currently trading at 67.2 HKD, following the FDA approval of its biosimilar drug POHERDY, which can be used interchangeably with the original product PERJETA, making it the first and only biosimilar of PERJETA in the U.S. market [1][1][1] Group 1: FDA Approval and Market Impact - Fuhong Hanlin and Organon announced that the injection of patuzumab (POHERDY) received FDA approval, allowing it to be used interchangeably with the original product PERJETA [1][1] - POHERDY is now the first and only biosimilar of PERJETA approved in the U.S., covering all indications for which PERJETA has been approved [1][1] Group 2: Additional Developments - On November 12, the CDE announced that Fuhong Hanlin's PD-1 antibody drug, Surulitin (H drug), is proposed to be included in the breakthrough therapy designation for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1][1] - The H drug is noted as the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer globally [1][1]