Shanghai, China, and London, United Kingdom, October 7, 2026
Asieris Pharmaceuticals (688176.SH), a global biopharmaceutical company focused on genitourinary cancers and women’s health, has entered into an exclusive licensing agreement with Theramex for CEVIRA® (APL-1702), an investigational-internationally licensed photodynamic drug-device combination product designed to treat cervical precancerous lesions associated with human papillomavirus (HPV) without surgery. The agreement covers Europe, Australia, New Zealand and Turkey, while Asieris retains rights to the product in the rest of the world. The transaction has a potential total value of more than US$250 million, including upfront and regulatory milestone payments, additional commercial milestones and tiered royalties. The agreement remains subject to certain conditions, including arrangements relating to product supply, manufacturing-site audits, alignment with the upstream licensing agreement and clarification with the European Commission regarding the device’s clinical value assessment. The collaboration is intended to support the further development, regulatory progress and potential commercialization of CEVIRA® across key international markets, expanding access to innovative women’s healthcare solutions if the relevant requirements are met.
CEVIRA® Offers a Non-Surgical Approach to Cervical Lesions
CEVIRA® (APL-1702) combines local drug delivery with controlled light activation through an integrated intravaginal device. It is being developed as a non-surgical treatment for cervical precancerous lesions associated with HPV, including cervical intraepithelial neoplasia (CIN). Unlike conventional surgical approaches that remove affected cervical tissue, CEVIRA® is designed to provide a localized treatment option that may help preserve cervical tissue in appropriately selected patients. The product is intended for administration by a healthcare professional in an office-based setting, with the device subsequently removed at home by the patient according to the intended treatment procedure. By combining a pharmaceutical component with a light-based treatment mechanism, the technology represents a drug-device approach to addressing an important need in gynecological care. Cervical precancerous lesions can require monitoring or intervention depending on their severity and individual clinical circumstances. A non-surgical option could potentially broaden treatment choices for eligible women, although its suitability, benefits and limitations must be assessed through applicable clinical and regulatory standards. CEVIRA® is positioned as a potential first-in-class innovation in this therapeutic area, with the licensing agreement creating an opportunity to advance its development and commercialization beyond China.
$250 Million Licensing Deal Expands Global Market Reach
Under the agreement, Theramex is expected to receive exclusive commercialization rights for CEVIRA® across Europe, Australia, New Zealand and Turkey, subject to the agreement’s conditions. Asieris will retain rights in other territories, allowing the company to continue pursuing its broader international strategy. The financial terms include a US$15 million upfront payment and US$11 million in near-term regulatory milestone payments, alongside additional commercial milestone payments and tiered royalties. The potential total deal value exceeds US$250 million, although the full amount depends on the achievement of specified milestones and other contractual conditions. The upfront payment is subject to several requirements, including execution of a supply agreement, successful audits of CEVIRA® manufacturing sites, alignment of the new agreement with the upstream licensing agreement and clarification with the European Commission regarding the device’s clinical value assessment. These provisions are important because manufacturing readiness, regulatory expectations and clinical-value considerations can influence the timing of commercialization in international markets. For Asieris, the agreement provides a route to leverage Theramex’s established focus on women’s health and its international commercial presence. For Theramex, the partnership offers an opportunity to expand its portfolio with a novel treatment approach for cervical precancerous lesions.
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China Approval Supports CEVIRA® Development Strategy
In March 2026, CEVIRA® received approval from China’s National Medical Products Administration (NMPA) as a non-invasive therapy for cervical precancerous lesions, according to Asieris. This regulatory milestone provides an important foundation for the product’s development strategy, while approvals and commercialization in Europe, Australia, New Zealand and Turkey will depend on the applicable requirements in each jurisdiction. Asieris Pharmaceuticals, founded in 2010, develops innovative therapies and technologies for genitourinary cancers and women’s health through internal research and development and strategic collaborations. Theramex, headquartered in London, focuses on women’s health, with products spanning contraception, fertility, menopause, osteoporosis and uterine health, and operates across more than 50 countries through direct operations and partners. The companies’ collaboration combines Asieris’s product-development capabilities with Theramex’s women’s-health expertise to pursue the potential of CEVIRA® in additional markets. The agreement marks a significant commercial development for a non-surgical cervical precancer treatment, while further regulatory, manufacturing and market-access requirements remain important steps toward wider availability.
Source: Asieris Pharmaceuticals press release
