Press release - Oslo, Norway, March 3, 2026: 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 (https://classic.clinicaltrials.gov/ct2/show/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: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: ed@photocure.com
Priyam Shah
Vice President Investor Relations
Tel : +17176815072
Email: priyam.shah@photocure.com
Media enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no