Theramex Enters an Exclusive Licensing Agreement with Asieris for CEVIRA

ANNOUNCEMENT FOR EUROPEAN FINANCIAL AND PHARMACEUTICAL TRADE MEDIA ONLY.

Theramex Enters an Exclusive Licensing Agreement with Asieris for CEVIRA^® (hexaminolevulinate hydrochloride photodynamic therapy system, APL-1702) subject to certain conditions, a Potential First-in-Class Non-Surgical Treatment for Cervical Precancerous Lesions in Europe

Agreement is expected to strengthen Theramex's women's health pipeline and expands its presence in gynaecology with a differentiated, late-stage investigational for Europe drug-device combination product

APL-1702 is approved in China and it is designed as an in-office, non-surgical treatment option for women with CIN2 cervical lesions associated with human papillomavirus (HPV) with potential cost saving for European healthcare systems

LONDON, UK and SHANGHAI, China - Oct 7. 2026 - Theramex, a global specialty pharmaceutical company dedicated to women and their health, and Asieris Pharmaceuticals, a global innovative biopharmaceutical company focused on genitourinary tumours and women's health, today announced that they have entered into an exclusive licensing agreement for APL-1702 covering all countries in Europe, as well as Australia, New Zealand and Turkey, subject to certain conditions. Asieris retains the rights for the rest of the world.

APL-1702 is a photodynamic drug-device combination product being developed as a non-surgical treatment for cervical precancerous lesions associated with HPV, including cervical intraepithelial neoplasia. The product is designed to be administered by a healthcare professional in an office-based setting and may provide a local treatment option for appropriate women who would otherwise be considered for surgical procedures. By offering a non-surgical approach designed to preserve cervical tissues, APL-1702 has the potential to address a highly unmet clinical need for non-surgical treatments globally.

The deal includes 15 million US dollars of upfront payment and a total of 11 million dollars of near-term regulatory milestone payments，and commercial milestone payments as well as tiered royalties. The total deal value is in excess of 250 million US dollars.

The upfront payment is subject to certain conditions, which include signing of a supply agreement, successful audits of CEVIRA^® manufacturing sites, streamlining this agreement with the upstream agreement, and a clarification with European Commission around the clinical value assessment of the CEVIRA^® device.

In March 2026, Asieris announced that CEVIRA^® had received approval from China's National Medical Products Administration as a first-in-class non-invasive therapy for cervical precancerous lesions.

About CEVIRA^®

CEVIRA^® (APL-1702) is a photodynamic drug-device combination product being developed for the non-surgical treatment of cervical precancerous lesions associated with HPV. The product combines local drug delivery with controlled light activation in a fully integrated intravaginal device intended for administration by a healthcare professional and removal at home by the patient. CEVIRA^® is a registered trademark of Photocure ASA.

About Theramex

Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women through each stage of her life by providing a broad portfolio of products across contraception, fertility, menopause, osteoporosis and uterine health. Headquartered in London, Theramex operates in more than 50 countries through a combination of direct presence and trusted partners.

About Asieris Pharmaceuticals

Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative therapies for the treatment of genitourinary tumors and women's health. We strive to improve human health to preserve patients' dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus.

Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding potential development, regulatory approval, commercialisation and market potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties, including regulatory review, clinical development outcomes, manufacturing readiness, market access, reimbursement and commercial adoption. Actual results may differ materially from those expressed or implied. APL-1702 may not be approved or available in all countries, and product information may vary by jurisdiction. Nothing in this press release should be construed as medical advice or as a recommendation for the use of any product.

Media Contacts

TheramexMedia [email protected]

Asieris PharmaceuticalsMedia [email protected]