Asieris: Cevira Endorsed with Level 1A Evidence in Expert Consensus
Oslo, Norway, March 25, 2026: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that Cevira was included in the joint expert consensus of four prestigious medical societies in China. This new expert consensus on photodynamic therapy (PDT) for cervical squamous intraepithelial lesions (SIL) recommends Cevira® with class 1A evidence establishing a new benchmark for non-invasive treatment of cervical precancerous lesions.
Asieris’ media release states that the release of this consensus marks a significant step toward the standardized and evidence-based application of PDT in the management of cervical precancerous lesions in China:
“The consensus draws on the latest domestic and international clinical evidence, offering a systematic review and recommendations for the use of PDT in SIL. This consensus follows the internationally recognized grading of recommendations, assessment, development, and evaluation (GRADE) methodology. It integrates expert consensus and the clinical practice in China, classifying the research evidence based on bias risk, inconsistency, indirectness, imprecision, and publication bias. The evidence levels are categorized as 1A, 1B, 2A, 2B, and 3. Notably, it affirms that Cevira® (Hexaminolevulinate Hydrochloride Ointment Photodynamic Therapy System) holds Level 1A evidence for the treatment of patients with cervical intraepithelial neoplasia grade 2 (CIN2). The highest tier of evidence – typically derived from rigorous meta-analyses or large-scale randomized controlled trials, with expert consensus exceeding 80% – underscores Cevira’s proven efficacy and safety and lays a solid academic foundation for its broader clinical adoption. With the publication of this consensus, clinicians now have clear guidance to treatment strategies for cervical precancerous lesions.”
Cevira (APL-1702) is a photodynamic drug-device combination product for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL), licensed to Asieris by Photocure. Earlier this month Cevira received regulatory approval in China.
Read the full media release here: https://asieris.com/cevira-endorsed-with-level-1a-evidence-in-expert-consensus-establishing-a-new-benchmark-for-non-invasive-treatment-of-cervical-precancerous-lesions/
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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.
Photocure developed Cevira through Phase I and Phase II trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III clinical trial for APL-1702 (Cevira) which achieved its primary endpoint in September 2023, Clinical trial number: NCT04484415.
In February 2026, the marketing authorization application (MAA) for Cevira was accepted for review by the European Medicines Agency (EMA). In March 2026, Asieris received the Drug Registration Certificate from China’s National Medical Products Administration (NMPA), enabling commercial launch in China. 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:
Dan Schneider
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Photocure ASA
Email: ds@photocure.com
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Photocure ASA
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Priyam Shah
Vice President Investor Relations
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Email: priyam.shah@photocure.com
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Corporate Communications (Norway)
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