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亚虹医药就创新产品APL-1702递交发补材料 以期尽快获批上市
Core Insights - Yahui Pharmaceutical (688176) is accelerating the review process for its product APL-1702, a photodynamic therapy system for treating high-grade squamous intraepithelial lesions (HSIL), aiming for swift market approval [1] - The company reported a revenue of 202 million yuan in 2024, achieving its commercial operation breakeven target, and a 151.24% year-on-year revenue growth in Q1 2025 [2] - APL-2501, an antibody-drug conjugate for treating various advanced tumors, is progressing well, with plans to complete CMC and GLP toxicology studies in 2025 [2] - APL-2302, a novel oral small molecule inhibitor targeting USP1, has received approval for clinical trials in the US and China, with the first patient enrolled in March 2025 [3] Group 1 - APL-1702 is the first product to show positive results in international Phase III trials for HSIL, with a target population of approximately 2.1 million patients in China [1] - The company is conducting systematic research on market accessibility and payment assurance, and is advocating for policies to support cervical cancer prevention [1] Group 2 - The company has exceeded its initial revenue target for 2024, achieving 202 million yuan, and reported a significant increase in Q1 2025 revenue [2] - APL-2501 has shown superior characteristics compared to competitors, with plans for further development and clinical trial submissions in 2026 [2] Group 3 - APL-2302 is designed to induce synthetic lethality in tumors by inhibiting USP1, with ongoing clinical trials expected to advance in 2025 [3] - The company has received regulatory approvals for APL-2302 trials in both the US and China, indicating strong progress in its clinical development pipeline [3]