Asieris Launches CEVIRA, World's First Non-Invasive Treatment for Precancerous Cervical Lesions
核心洞察
Asieris Pharmaceuticals (搜索) launched CEVIRA®, the world's first non-surgical, non-invasive treatment for precancerous cervical lesions, following regulatory approval in China in March 2026.
The product achieved its first shipment in June 2026, with the world's first prescription issued in Beijing and adoption across over 150 hospitals nationwide within months.
CEVIRA® received a Level 1A evidence recommendation for treating cervical intraepithelial neoplasia (搜索) grade 2 (CIN2) in the 2026 CSCCP photodynamic therapy consensus.
Asieris Pharmaceuticals (搜索) has launched CEVIRA®, the world's first non-surgical, non-invasive treatment for precancerous cervical lesions, marking a significant clinical milestone in women's health. The product received regulatory approval in China in March 2026, filling what the company describes as a critical clinical gap in this therapeutic area, and achieved its first shipment just three months later in June 2026.
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals (搜索), said: "In the first half of 2026, Asieris achieved multiple milestones in both commercialization and innovation pipelines. We delivered sustained sales growth and significant pipeline progress. Most excitingly, our core product CEVIRA®—the world's first non-invasive treatment for precancerous cervical lesions—was successfully launched in China with a strong commercial start, marking the company's official entry into a phase of accelerated delivery of innovation outcomes and further solidifying the foundation for our transition from Biotech to Biopharma."
Commercial Launch and Early Adoption
The commercial rollout of CEVIRA® proceeded rapidly following approval. The world's first prescription was issued in Beijing on the same day as the first shipment, which the company attributes to cross-functional collaboration efficiency and commercial supply capabilities. Within 10 days of the initial launch, first prescriptions were rolled out across 70 hospitals in 30 cities nationwide, supported by an exclusive online launch on JD Health. To date, the product has been adopted in over 150 hospitals across the country.
To support the launch, Asieris has established a comprehensive omnichannel commercial presence centered on public hospitals, building a specialized promotion team of more than 100 professionals focused on physician education and clinical evidence dissemination for photodynamic therapy in cervical high-grade squamous intraepithelial lesions (HSIL). This team spans medical affairs, marketing, and sales, and is complemented by a full commercial support structure encompassing government affairs and market access, sales excellence operations, commercial operations, supply chain, and compliance.
Clinical Evidence and Guideline Recognition
On the academic front, the company is prioritizing post-marketing studies to strengthen clinical data, continuously publishing multidimensional subgroup analysis results in domestic and international journals and at major congresses. Two Chinese consensus documents were released in the first half of 2026. Notably, in the 2026 updated photodynamic therapy consensus issued by the Chinese Society for Colposcopy and Cervical Pathology (CSCCP), CEVIRA® is recommended, with Level 1A evidence, for the treatment of cervical intraepithelial neoplasia (搜索) grade 2 (CIN2).
During the 19th International Federation for Cervical Pathology and Colposcopy (IFCPC) Congress in June 2026, the company initiated an international expert consensus meeting on the standardized application of local photodynamic therapy (PDT) for precancerous cervical lesions, helping to shape global treatment guidelines.
Accessibility and Fertility-Focused Initiatives
To address accessibility and financial burden, Asieris has conducted and published disease burden and pharmacoeconomic studies, and released a Fertility-Friendly Blue Book in July 2026. Together with the China Women's Development Foundation, the company launched the "Fertility-Friendly Cervical Health Care" public benefit program, aimed at reducing unnecessary cervical excision procedures through the establishment of fertility-friendly cervical clinics. Following a kickoff meeting in Beijing at the end of 2025, the program has rolled out exchange activities and public education campaigns across multiple provinces.
International Expansion and Pipeline Progress
CEVIRA® has made positive progress in international market development, with its Marketing Authorization Application (MAA) successfully accepted for review by the European Medicines Agency (搜索) (EMA). The company is actively establishing commercial partnerships in Europe, emerging markets, and Belt and Road countries and regions.
Beyond CEVIRA®, Asieris reported progress across its broader pipeline. In urologic oncology, the Phase I clinical trial of APL-2401 (搜索) (FGFR2/3 (搜索) inhibitor) completed enrollment of its first patient in January 2026, with preliminary safety characteristics and efficacy signals observed. APLD-2304, the world's first portable single-use blue-light flexible cystoscope, obtained EU CE certification in August 2026. In breast cancer and gynecologic oncology, APL-2501 (搜索) (CLDN6/9 (搜索)-ADC) received FDA and NMPA approval to initiate clinical trials in August 2026, with plans to start a Phase I monotherapy dose-escalation study by year-end enrolling patients with advanced solid tumors including ovarian cancer and non-small cell lung cancer.
Financial Performance
During the reporting period, Asieris recorded operating revenue of RMB 155 million, up 19.28% year over year. The company's breast cancer products Ouyoubi® and Ounalin®, together with kidney cancer product Dipaite®, continued to drive growth through academic engagement and channel expansion, laying a foundation for the sales of CEVIRA®.