CEVIRA Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions

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/

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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.

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:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]

Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: [email protected]

Priyam Shah
Vice President Investor Relations
Tel : +17176815072
Email: [email protected]

Media enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/photocure/r/asieris–cevira-approved-in-china-as-first-in-class-non-invasive-therapy-for-cervical-precancerous-l,c4315843

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