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亚虹医药(688176.SH):APL-1202临床试验申请获得国家药品监督管理局批准

Yahong Pharmaceutical (688176.SH): APL-1202 clinical trial application has been approved by the National Medical Products Administration.

Gelonghui Finance ·  Jun 24 18:24

On June 24th, Gelonghui | Ya Hong Pharmaceutical (688176.SH) announced that recently, Jiangsu Ya Hong Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "the Company") received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA), and the company's APL-1202 clinical trial application for treating Free-living Amoebae (FLA) infections has been approved.

This study is a multicenter, single-arm Phase II clinical trial to evaluate the efficacy and safety of APL-1202 in the treatment of Free-living Amoebae (FLA) infections. There is no formal treatment guideline or expert consensus for FLA infections worldwide, especially for FLA-caused brain infections, which have a very low incidence rate but a high mortality rate of up to 90%. Currently, the potential effective treatment options are summarized based on a few case reports, without a standard treatment plan. In view of the fact that there are no domestically approved drugs for this indication and no standard treatment plan, and following the value concept of "Improving human health and making life more dignified" to fulfill social responsibility, the company plans to ensure domestic clinical supply of free-living amoeba infection cases through this study. The company currently has no further development plan for APL-1202 in this indication.

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