Photocure ASA (OSE:PHO) announced that its partner Asieris Pharmaceuticals has received regulatory approval in China for Cevira (APL-1702), the world's first non-invasive therapy for cervical precancerous lesions.
Cevira is a drug-device combination based on photodynamic therapy, designed to treat high-grade squamous intraepithelial lesions (HSIL) without surgery. The approval by China's National Medical Products Administration (NMPA) enables commercial launch in the country.
The therapy is expected to fill a critical gap in women's health, offering a non-surgical option in a field long dominated by invasive procedures. Photocure, which licensed Cevira to Asieris in 2019, is eligible for milestone payments and future sales-based royalties.
Cevira achieved its primary endpoint in a Phase 3 trial in 2023, and regulatory filings are also underway in Europe, with discussions ongoing with the U.S. FDA for a separate Phase 3 study.
Photocure's CMO Anders Neijber described the approval as "a substantial achievement for a non-surgical organ sparing treatment option which addresses an important unmet medical need,".
PHO.OL has traded between NOK 47.60 and NOK 79.80 over the past year. The stock is currently trading at NOK 75.00, up 17%.
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