Asieris: Cevira (APL-1702) NDA Advances to Second Round of Technical Review

04 Aug 2025 14:39 CEST

Press release - Oslo, Norway, August 4, 2025: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) communicated today that its photodynamic drug-device combination
product candidate Cevira (APL-1702), has advanced to the second round of
technical review.

The company will maintain proactive communicationwith the Center for Drug
Evaluation (CDE) to expedite the New Drug Application (NDA) review process.
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.

Read Asieris' full media release here: https://asieris.com/asieris-apl-1702-nda
-advances-to-second-round-of-technical
-review/ (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fasie
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For more information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Email: ds@photocure.com

Erik Dahl

CFO

Photocure ASA

Tel: +47 45055000

Email: ed@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no

Note to editors:

All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
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Photocure does not take any responsibility for accessing such information which
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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.
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 (https://classic.clinicaltrials.gov/ct2/show/NCT04484415).

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.

More information:
Access the news on Oslo Bors NewsWeb site

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