Asieris: CEVIRA Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions
Asieris: CEVIRA Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions |
| [03-March-2026] |
OSLO, Norway, March 3, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its core product APL-1702 (trade name: CEVIRA®), has received the Drug Registration Certificate from China's National Medical Products Administration (NMPA), enabling commercial launch in China. Cevira (APL-1702) is a photodynamic drug-device combination product in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL), licensed to Asieris by Photocure. With Cevira's regulatory approval in China, Photocure is eligible for a milestone payment with further sales milestones based on future revenue. The announcement from Asieris states: "As the world's first non-surgical, non-invasive therapy for patients with cervical intraepithelial neoplasia grade 2 (CIN2), APL-1702 is expected to fill a critical clinical gap in this therapeutic area and redefine a massive, previously underserved market for non-invasive cervical disease treatment. In the absence of other approved non-invasive treatment options, APL-1702 has the potential to reshape a treatment landscape long dominated by surgical and other invasive or minimally invasive interventions. It will enable a shift from a "one-size-fits-all" approach toward one that prioritizes non-invasive therapy, offering a breakthrough solution to current clinical challenges." "This regulatory milestone is a substantial achievement for a non-surgical organ-sparing treatment option which addresses an important unmet medical need," said Anders Neijber, Photocure's Chief Medical Officer Read Asieris' full media release here: https://asieris.com/asieris-cevira-approved-in-china-as-first-in-class-non-invasive-therapy-for-cervical-precancerous-lesions/ Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. About Cevira® Cevira® (APL-1702) is a photodynamic drug-device combination product in development. Based on the principles of photodynamic therapy, the Cevira product aims to use a photosensitizer in combination with light activation to produce a therapeutic effect as a non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding carcinoma in situ. For international markets, the marketing authorization application (MAA) for Cevira was accepted for review by the European Medicines Agency (EMA) in February this year. The company has also reached an agreement with the U.S. FDA on the design of a separate Phase III trial to support Cevira's potential U.S. approval. About Photocure ASA 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/news About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. For more information, please contact: This information was brought to you by Cision http://news.cision.com The following files are available for download:
SOURCE Photocure | ||
Company Codes: Bloomberg:PHO@NO,ISIN:NO0010000045,Oslo:PHO,RICS:PHO.OL,Stockholm:PHOO,Stuttgart:PHS |
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