Gelonghui, May 12 | Yahong Pharmaceutical (688176.SH) announced that the company recently received the “Notice of Acceptance” approved and issued by the National Drug Administration (NMPA). The company's product APL-1702 (generic name: aminonovalerate ointment photodynamic therapy system) is intended to treat high-grade cervical squamous intraepithelial lesion (HSIL) patients aged 18 and above to eliminate cancer in situ (HSIL). accepted.
APL-1702 is defined by the attributes of the State Drug Administration as a drug-based pharmaceutical combination product. Among them, the pharmaceutical part is aminohexyl hydrochloride ointment, and the device part is a vaginal cervical photodynamic therapy lamp. APL-1702 is a drug combination photodynamic therapy product as a potential topical nonsurgical treatment for patients with high-grade cervical squamous intraepithelial disease (HSIL).
The APL-1702 phase III clinical trial is a prospective, randomized, double-blind, placebo-controlled international multicenter phase III clinical trial (hereinafter referred to as “this study”) to evaluate the efficacy and safety of APL-1702 on high-grade cervical squamous intraepithelial lesion (HSIL). Academician Lang Jinghe from Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences was the main researcher. 402 eligible patients from China, Germany, the Netherlands and other countries were randomized and enrolled in this study. The completed statistical analysis results showed that the study had reached the main efficacy end point and was safe.