PR Newswire - Asieris Pharmaceuticals Enters an Exclusive Licensing Agreement with Theramex for CEVIRA® subject to certain conditions, Advancing the Global Development and Commercialization of a Non-Surgical Treatment for Cervical Precancerous Lesions in Europe

• Agreement is expected to grant Theramex exclusive rights to CEVIRA^® in Europe, Australia, New Zealand and Turkey, while Asieris retains rights for the rest of the world.
• 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 a few conditions, which include the signing of a supply agreement, successful audits of CEVIRA^® manufacturing sites, streamlining this agreement with the upstream licensing agreement, and a clarification with the European Commission around the clinical value assessment of the CEVIRA^® device.

SHANGHAI and LONDON, Oct. 7, 2026 /PRNewswire/ -- Asieris Pharmaceuticals (688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative therapies for the treatment of genitourinary tumors and gynecological diseases, and Theramex, a global specialty pharmaceutical company dedicated to women and their health, today announced that they have entered into an exclusive licensing agreement for CEVIRA^® (APL-1702) covering all countries in Europe, as well as Australia, New Zealand and Turkey. 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 a few conditions, which include the signing of a supply agreement, successful audits of CEVIRA^® manufacturing sites, streamlining this agreement with the upstream licensing agreement, and a clarification with the 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.

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 patient's dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus.

Through internal 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 of products spanning from disease diagnosis to treatment within its focused therapeutic areas.

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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding potential development, regulatory approval, commercialization 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.