China gives nod to Asieris/Photocure’s Cevira as first non-surgical therapy for cervical lesions

Cevira (APL-1702), a photodynamic drug-device combination developed by Norway-based Photocure ASA and licensed to China-based Asieris Pharmaceuticals, has won market approval from China’s National Medical Products Administration (NMPA), clearing the product for commercial launch. The approval covers the non-surgical treatment of cervical intraepithelial neoplasia grade 2 (CIN2), a form of high-grade squamous intraepithelial lesion (HSIL) driven by persistent human papillomavirus infection. No pharmacological therapy had previously been approved for this indication in any major regulatory jurisdiction, making Cevira the first non-invasive cervical therapy to reach the market for cervical precancerous lesions treatment.

Cevira is indicated for patients aged 18 years and above with CIN2, excluding carcinoma in situ. The product combines a hexaminolevulinate-based photosensitizer with an integrated intravaginal LED light source. Once administered, the photosensitizer is preferentially taken up by dysplastic cervical epithelial cells, where light activation generates reactive oxygen species that destroy the abnormal tissue while sparing surrounding healthy stroma.

The NMPA approval enables Asieris Pharmaceuticals to proceed with commercial distribution in China, and will trigger a milestone payment to Photocure. Photocure and Asieris partnered on the molecule under a 2019 deal, with Asieris taking global rights in return for USD 5 million upfront and committing to up to USD 36 million in milestone payments on a first approval in the US and EU, and a further USD 14 million if Cevira is awarded a second indication in China, the US, and EU.

The approval rests on data from a randomized, double-blind, placebo-controlled Phase III trial (NCT04484415) conducted across multiple sites in China. The study enrolled 402 patients with histologically confirmed CIN2/3 and used histological regression to CIN1 or lower at six months as its primary endpoint. Asieris and Photocure announced that the trial met this endpoint with statistical significance in September 2023. Earlier Phase II results had suggested a response rate of approximately 50% for Cevira compared with roughly 30% for placebo, though the Phase III figures have not been formally disclosed.

The approval arrives in a treatment landscape that has been defined entirely by surgical and ablative procedures. Loop electrosurgical excision, cold knife conization, cryotherapy, and laser ablation have constituted the standard of care for decades. These interventions carry risks including cervical stenosis, hemorrhage, and adverse effects on subsequent pregnancies, concerns that weigh particularly on women of reproductive age.

The absence of any approved pharmacological alternative has long been recognized as a gap in cervical disease management, and the development pipeline reflects this. Inovio Pharmaceuticals was developing VGX-3100, a DNA-based therapeutic vaccine targeting HPV-16/18 E6 and E7 oncoproteins. However, Inovio ceased further development of VGX-3100 for cervical HSIL in the US in August 2023 after Phase III data prompted the FDA to require additional biomarker validation. Other investigational agents include GX-188E from Genexine, as well as a broader wave of therapeutic HPV vaccines and immune-modulating approaches designed to stimulate T-cell–mediated clearance of HPV-infected cells and reverse premalignant lesions.

Cevira’s photodynamic mechanism is distinct from these immunotherapeutic approaches in that it directly ablates dysplastic tissue rather than relying on immune-mediated lesion regression, though it requires clinical administration via its proprietary device. For markets outside China, the European Medicines Agency accepted Cevira’s marketing authorization application for review in February 2026, and Photocure has reached agreement with the US FDA on the design of a separate Phase III trial to support a potential US filing.