Photocure Partner Asieris Announces NDA Acceptance for Cevira in China

Photocure ASA, a company focused on bladder cancer treatments, has revealed a significant step forward for one of its licensed products. Partner Asieris Pharmaceuticals has announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Cevira® (APL-1702, Hexaminolevulinate Hydrochloride Ointment Photodynamic Therapy System). This acceptance by the NMPA is a key step towards potentially gaining market authorization in China for this innovative product.

Cevira is a photodynamic drug-device combination designed for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL). This product represents a critical advancement in treating pre-cervical cancer conditions without resorting to surgical methods. Asieris Pharmaceuticals holds the license for Cevira from Photocure, and this collaboration has been crucial in progressing the drug through various stages of development.

Dan Schneider, President and CEO of Photocure, expressed his satisfaction with the ongoing progress. He highlighted the importance of Cevira as a non-invasive treatment alternative that avoids the complications often associated with surgical interventions. Schneider also commended Asieris for their effective execution of programs licensed from Photocure and looked forward to more updates on Cevira's regulatory journey, as well as Asieris' NDA for Hexvix in China.

Asieris' media release underscores the significance of APL-1702, noting that it is the first non-surgical treatment for cervical HSIL with proven efficacy from an international phase III trial. This product could shift the treatment paradigm for precancerous cervical lesions by focusing on long-term disease management rather than immediate surgical excision. The goal is to find an optimal balance between the risks and benefits of treatment, aiming to minimize or postpone invasive procedures while effectively managing disease progression.

Cevira leverages the principles of photodynamic therapy, using a photosensitizer activated by light to achieve therapeutic effects. It is designed for patients over 18 years of age, excluding those with carcinoma in situ. The product has successfully completed Phase I and Phase II trials under Photocure’s development and achieved its primary endpoint in a Phase III clinical trial initiated by Asieris in November 2020.

Photocure ASA, known as The Bladder Cancer Company, is renowned for its transformative solutions that improve the lives of bladder cancer patients. Their technology, which makes cancer cells visible under a specific type of light, has led to better health outcomes globally. The company is headquartered in Oslo, Norway, and its shares are publicly traded on the Oslo Stock Exchange.

Asieris Pharmaceuticals, established in March 2010, is a global biopharmaceutical company dedicated to discovering and commercializing innovative drugs for genitourinary tumors and other related diseases. The partnership between Photocure and Asieris has been fruitful, with both companies working together to bring advanced treatments to market.

This development marks a pivotal moment in the journey of Cevira, bringing hope for a safer, non-surgical option for treating high-grade squamous intraepithelial lesions. The acceptance of the NDA by the NMPA is a significant milestone, potentially paving the way for Cevira's availability in China, thereby expanding treatment options for patients with pre-cervical cancer conditions.