Asieris Received China NMPA's Approval to Start a Global Phase III Clinical Trial for APL-1702 to Treat Cervical Precancerous Lesions (HSIL)

July 7,2020

Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, announced today it has received Clinical Trial Approval (CTA) from China's National Medical Products Administration (NMPA) for the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira^®), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).

"Receiving the CTA from NMPA for APL-1702 is a significant milestone for the company as it builds and expands its capabilities in the genitourinary disease area," commented Dr. John Zhuang, Asieris' Chief Operation Officer and APL-1702's project leader. "APL-1702 has the potential to be the first non-surgical treatment product for cervical precancerous lesions in the world. Female patients of childbearing age have strong desires for a non-surgical treatment that preserves the cervical function, and APL-1702 holds the potential of fulfilling this significant unmet medical need, thereby bringing substantial relief to these patients."

In addition to China, Asieris has concurrently initiated this global multi-centered Phase III clinical trial in the United States, Germany, Romania, Hungary, Russia, and Ukraine. Data from this trial will support the market approval applications in China, the United States, the European Union, and other countries.