Core Viewpoint - The company has received FDA approval for its biosimilar drug POHERDY® (HLX11), which is a significant milestone for its international market presence and product recognition [1][2][3] Group 1: FDA Approval - The FDA approved the biologics license application (BLA) for POHERDY® (HLX11) for intravenous use, with indications for treating HER2-positive metastatic breast cancer (MBC) in adults who have not previously received anti-HER2 treatment or chemotherapy [1] - The approval is based on comprehensive reviews of comparative studies demonstrating the similarity in quality, safety, and efficacy between HLX11 and its reference drug, Perjeta® [2] Group 2: Market Potential - HLX11 is projected to generate approximately $3.304 billion in global sales in 2024, indicating a strong market potential for the product [3] - Following the approval of POHERDY®, the company has a total of seven products approved for overseas markets, with four of those in the United States, enhancing its international market strategy [3] Group 3: Collaboration and Future Plans - The company has entered into an exclusive licensing agreement with Organon LLC for the commercialization of HLX11 outside of China and Hong Kong, Taiwan [3] - The company plans to advance local commercialization efforts in collaboration with Organon LLC once conditions are favorable [3]