Asieris Pharmaceuticals (SHA: 688176) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for APL-1702 (CEVIRA), a world‑first photodynamic therapy (PDT) for the treatment of cervical high‑grade squamous intraepithelial lesions (HSIL). The innovative product combines hexyl aminolevulinate hydrochloride ointment with a single‑use intravaginal cold light source, offering a non‑surgical alternative to conventional excisional procedures.
Regulatory Milestone
Item
Detail
Company
Asieris Pharmaceuticals (SHA: 688176)
Product
APL-1702 (CEVIRA)
Drug Class
Photodynamic therapy (PDT) – world‑first for cervical HSIL
Local drug delivery + intravaginal cold light source
Prior Submission
NMPA NDA submitted May 2024 (China)
Clinical Evidence – International Phase III
Parameter
Detail
Study Design
International multi‑center Phase III
European Participation
> 20% of participants enrolled from Europe
Primary Support
EMA MAA based on Phase III data
Treatment Modality
Non‑surgical PDT vs. conventional excision (LEEP/cone biopsy)
Clinical Value
Cervical‑sparing alternative for women of childbearing age
Strategic Implications
Cervical HSIL Unmet Need: HSIL (CIN 2/3) affects millions of women globally; standard LEEP/cone biopsy carries cervical incompetence risks affecting future pregnancy outcomes—APL-1702 offers fertility‑preserving alternative.
Photodynamic Innovation: As the world‑first PDT for cervical HSIL, APL-1702 establishes a new therapeutic class, potentially expanding to other HPV‑related precancerous conditions (vulvar, anal HSIL).
Dual Regulatory Strategy:NMPA NDA (May 2024) + EMA MAA (Feb 2026) demonstrates Asieris’ global ambitions and China‑first innovation model with international validation.
European Market Access: EMA acceptance positions APL-1702 for EU‑wide approval, addressing significant demand for non‑invasive cervical disease management in European screening programs.
Market Context
Factor
Impact
Cervical HSIL Incidence
~ 500,000+ cases annually in EU; current standard of care invasive with fertility concerns
PDT Market Expansion
Photodynamic therapy established in dermatology/oncology; cervical application represents novel expansion
Asieris Differentiation
First‑mover in cervical PDT; potential for orphan‑like positioning given lack of alternatives
Reimbursement Pathway
Non‑surgical approach may qualify for premium pricing vs. LEEP; cost‑effectiveness data critical for NICE/EMA assessment
Forward‑Looking Statements This brief contains forward‑looking statements regarding EMA review timelines, approval expectations, and global commercialization potential for APL-1702. Actual results may differ due to risks including regulatory review outcomes, manufacturing scalability for device‑drug combination, and physician adoption of non‑surgical HSIL management.-Fineline Info & Tech
By Fineline Cube