Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that it has signed a conditional exclusive license agreement with Theramex HQ UK Limited, granting Theramex exclusive rights to APL‑1702 (CEVIRA®), a first‑in‑class photodynamic therapy product for the treatment of cervical high‑grade squamous intraepithelial lesions (HSIL), across Europe, Australia, New Zealand, and Turkey. The transaction is valued at over US$250 million in total potential payments, including a US$15 million upfront payment, US$11 million in near‑term registration milestones, commercialization milestone payments, and tiered royalties on net sales.
Deal Structure
| Item | Detail |
|---|---|
| Licensor | Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) |
| Licensee | Theramex HQ UK Limited |
| Product | APL‑1702 (brand name: CEVIRA® / 希维她®) |
| Licensed Territory | European countries, Australia, New Zealand, Turkey |
| Retained Territory | All other global regions retained by Asieris (including China) |
| Upfront Payment | US$15 million (subject to conditions precedent) |
| Near‑Term Milestones | US$11 million (registration milestones) |
| Total Deal Value | >US$250 million (including commercial milestones + tiered royalties) |
| Approval Date | 2 October 2026 (Board of Directors) |
Conditions Precedent to Upfront Payment
The upfront payment is contingent upon satisfaction of the following conditions:
- Execution of a supply agreement
- Successful audit of the CEVIRA® manufacturing facility
- Alignment and consistency with upstream license agreements
- Clarification and confirmation with the European Commission regarding the clinical value assessment of the CEVIRA® device
Drug Profile & Mechanism of Action
- Product: CEVIRA® (APL‑1702), comprising hexyl aminolevulinate hydrochloride ointment and a disposable cervical photodynamic treatment lamp — a fully integrated, single‑use photodynamic therapy system.
- Innovation: First‑in‑class globally — combines innovative topical drug delivery with an integrated vaginal cold‑light source, representing a breakthrough in non‑invasive cervical lesion treatment.
- Mechanism: Photodynamic therapy achieves precise, targeted clearance of cervical lesions while simultaneously promoting HPV (human papillomavirus) immune clearance.
- Key Clinical Advantages:
- Targeted lesion eradication with high precision
- HPV immune clearance — addresses the root viral etiology, not just the lesion
- Fertility preservation — non‑invasive approach maximally preserves cervical anatomical structure and physiological function
- Non‑invasive treatment — avoids surgical excision (LEEP/conization), offering a superior option for women seeking to retain reproductive capacity
- Intellectual Property: Proprietary product developed by Asieris Pharmaceuticals with global IP coverage.
Regulatory Status
| Market | Status | Detail |
|---|---|---|
| China (NMPA) | Approved | March 2026 — approved for histologically confirmed CIN2 in patients aged ≥18 years (excluding cervical invasive carcinoma and adenocarcinoma in situ) |
| Europe (EMA) | Under Review | Marketing Authorization Application (MAA) for HSIL accepted by the European Medicines Agency in February 2026 |
Licensee Profile – Theramex
Theramex is a London‑headquartered, global specialty pharmaceutical company focused on women’s health across all life stages. Its portfolio spans contraception, fertility, menopause management, osteoporosis, and uterine health. The company operates in over 50 countries through a combination of direct operations and strategic partnerships. Theramex is not a related party of Asieris Pharmaceuticals.
Market Impact & Outlook
- European HSIL Opportunity: Cervical HSIL/CIN2 represents a significant unmet need in Europe, where current standard‑of‑care relies heavily on surgical excision (LEEP/conization), which carries risks of cervical incompetence and adverse pregnancy outcomes. A non‑invasive, fertility‑sparing photodynamic therapy could reshape treatment algorithms across the EU.
- First‑Mover Advantage: CEVIRA® is the first photodynamic therapy product of its kind globally, with no direct competitor offering an integrated drug‑device system for cervical lesion treatment.
- Dual‑Market Commercialization: With NMPA approval already secured in China and an EMA MAA under review, Asieris is pursuing a parallel commercialization strategy — retaining full rights in China (where it will commercialize independently) while leveraging Theramex’s established women’s health infrastructure across 50+ countries for the licensed territories.
- Deal Economics: The >US$250 million total deal value underscores the commercial potential of CEVIRA® and represents a significant monetization event for Asieris, with the US$15 million upfront providing near‑term non‑dilutive capital to fund ongoing global development.
- Strategic Fit for Theramex: CEVIRA® aligns directly with Theramex’s core competency in women’s health and fills a whitespace in its portfolio — a novel, non‑surgical cervical treatment that complements its existing uterine health franchise.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, clinical development plans, commercialization expectations, and deal economics for CEVIRA® (APL‑1702). Actual results may differ materially due to risks including the satisfaction of conditions precedent to the upfront payment, EMA review outcomes, manufacturing readiness, market access and reimbursement negotiations, competitive dynamics, and the inherent uncertainties of pharmaceutical commercialization. APL‑1702 may not receive marketing approval in all licensed territories. Investors are advised to exercise caution.-Fineline Info & Tech
