亚虹医药APL-1702产品进入第二轮技术审评阶段

Core Insights - Jiangsu Yahon Pharmaceutical Technology Co., Ltd. announced that the National Medical Products Administration (NMPA) has initiated the second round of technical review for its photodynamic therapy product APL-1702, aimed at treating high-grade squamous intraepithelial lesions (HSIL) [1][2] - APL-1702 is the first HSIL treatment product to achieve positive results in international multi-center Phase III clinical trials, positioning it as a potential non-surgical treatment option in a market dominated by traditional surgical methods [2] Company Updates - The company is actively communicating with the CDE to expedite the new drug approval process for APL-1702, which has received an acceptance notice for its application to treat patients aged 18 and older with confirmed HSIL [1] - APL-1702 is a photodynamic treatment system using a specific formulation (Ammonium Pentanoate Hexyl Ester) and is intended for patients excluding those with in situ carcinoma [1] Industry Context - Traditional treatment methods for cervical precancerous lesions primarily involve surgical procedures such as Loop Electrosurgical Excision Procedure (LEEP) and Cold Knife Cone Excision (CKC), with no non-surgical treatment products currently available on the market [2] - The introduction of APL-1702 could represent a significant advancement in the treatment landscape for HSIL, offering a non-invasive alternative validated by international clinical trials [2]