Photocure ASA

Regulatory Filings • Jul 8, 2020

Photocure's partner Asieris Received China NMPA's Approval to Start a Global Phase III Clinical Trial for APL-1702 (Cevira)

Shanghai China, July 8, 2020 – AsierisPharmaceuticals (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'sNational Medical ProductsAdministration (NMPA) for the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira®), which isbeing developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).

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

Please read the full release here.

About Photocure

Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com