(China, March 3, 2026) Yanhong Pharmaceutical (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on urogenital tumors and women's health, announced that its core product APL-1702 (brand name: CEVIRA®/希维她®, generic name: Hematoporphyrin Monomethyl Ether Hydrochloride Ointment Cervical Photodynamic Therapy System) has been approved for marketing by the National Medical Products Administration of China (NMPA) with the issuance of the Drug Registration Certificate. This product is the world's first non-surgical, non-invasive treatment for patients with cervical intraepithelial neoplasia grade 2 (CIN2), filling a clinical gap in this therapeutic area and redefining a vast untapped market for non-invasive treatments.
Currently, cervical cancer remains a major threat to women's health worldwide. According to a 2023 market survey, the number of patients with histopathologically confirmed high-grade squamous intraepithelial lesions (HSIL) in China exceeds 700,000, with approximately 60% being CIN2. The prevalence, screening rate, and diagnosis rate are expected to continue rising over the next decade, creating a significant unmet clinical need. In recent years, global clinical guidelines have shifted from an "aggressive surgical treatment" approach to a more individualized, conservative "observation and management" model.
In the absence of other approved non-invasive treatment options, this product is poised to reshape the long-standing treatment landscape dominated by surgical or other destructive invasive/minimally invasive procedures, transitioning from a "one-size-fits-all" approach to a "prefer non-invasive" pathway. It provides a breakthrough solution to current clinical challenges.
The approval is based on the international multicenter Phase III clinical study of CEVIRA®, which included over 20% European patients. The study results were officially published in Med, a journal under Cell Press, in December 2025 by Academician Lang Jinghe and Academician Zhu Lan from Peking Union Medical College Hospital, along with Professor Peter Hillemanns from Hannover Medical School in Germany. The findings were also presented as oral reports at the 2024 EUROGIN Congress, the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting, and the 2024 Photodynamic Therapy & Photodiagnosis Update Conference. Additionally, academic exchanges were conducted with basic research experts and domestic/foreign clinical specialists at the 27th National Clinical Oncology Congress & 2024 CSCO Annual Meeting, the 2024 International Papillomavirus Conference, and the 37th IPVC Symposium in 2025.
Data show that CEVIRA® significantly improves response rates and histopathological downgrading rates. Among CIN2 patients with HSIL, the response rate was 49.6% in the treatment group versus 22.6% in the placebo group (P=0.0003). At 6 months post-first treatment, 57.5% of CIN2 patients in the treatment group showed histopathological results of normal tissue or low-grade squamous intraepithelial lesion (LSIL), compared to 30.6% in the placebo group (P=0.0009). This means nearly 60% of patients can avoid surgical excision after just 1–2 treatments. Furthermore, HPV clearance in the treatment group showed a significant downward trend, with nearly 60% of baseline HPV cleared at 12 months.
As a photodynamic therapy product integrating drug and device, CEVIRA® is administered by gynecologists in outpatient settings without anesthesia, reducing single-visit time to under 10 minutes. Patients can resume normal work and life immediately after placement, without hospital waiting, and remove the device themselves post-treatment. This "short outpatient placement + home-based treatment" model greatly enhances medical efficiency and accessibility, making it suitable for promotion in primary healthcare institutions. It helps bridge the "last mile" in the cervical cancer screening-diagnosis-treatment continuum, holding significant importance for achieving the global goal of eliminating cervical cancer. Additionally, CEVIRA® uses an innovative cold light source design, keeping the temperature of the treated tissue below 42°C. Clinical data show 97% of patients reported no pain in the cervical treatment area, with no records of cervical structural damage, avoiding thermal injury common in traditional photodynamic therapy, reducing local irritation, and improving treatment comfort.
Professor Wei Lihui, Director of the Colposcopy and Cervical Pathology Branch of the Chinese Society of Eugenics, Honorary Director of the Department of Obstetrics and Gynecology at Peking University, and Professor at Peking University People's Hospital, stated: "The successful approval of CEVIRA® marks a breakthrough in China's diagnosis and treatment of cervical diseases. For the first time, it provides an active intervention option for conservative treatment of precancerous cervical lesions that balances efficacy and safety. This not only offers clinicians a new, superior choice but also represents a critical step forward in practicing precision medicine and balancing disease treatment with fertility preservation. Notably, CEVIRA®'s clinical application could reshape the long-standing dominance of surgical or other destructive invasive/minimally invasive treatments, transitioning from 'one-size-fits-all' to 'prefer non-invasive' pathways."
Professor Di Wen, President of the Obstetrics and Gynecology Branch of the Chinese Medical Doctor Association and Vice Chairman of the Obstetrics and Gynecology Branch of the Chinese Medical Association, affiliated with Renji Hospital of Shanghai Jiao Tong University School of Medicine, noted: "CEVIRA®'s approval signifies China's attainment of international leadership in gynecological non-invasive treatment. It provides clinicians with an effective 'active intervention' tool. This outpatient, short-duration non-invasive treatment model not only protects the fertility potential of women of childbearing age but also significantly reduces surgical trauma and psychological burden, embodying a 'patient-centered' philosophy. Its approval will positively impact the prevention and treatment strategies for gynecological tumors."
Professor Chen Fei, Chief Physician in the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital and Principal Investigator of the Chinese cohort in CEVIRA®'s international multicenter Phase III trial, emphasized: "CEVIRA® offers unique advantages in precise targeted lesion clearance, HPV immune clearance, and fertility preservation. Its non-invasive nature maximizes the integrity of cervical anatomical structure and physiological function, allowing nearly 60% of patients to delay or avoid surgery, providing a superior option for controlling lesions and preserving fertility in precancerous cervical lesion patients."
Based on the outstanding HPV clearance potential demonstrated in CEVIRA®'s international multicenter Phase III trial and the substantial unmet clinical demand, the company has initiated exploration of indications for HPV clearance.
Internationally, CEVIRA®'s marketing authorization application was accepted by the European Medicines Agency (EMA) in February this year. The company has reached agreement with the U.S. FDA on the design of another Phase III trial to support CEVIRA®'s U.S. launch. Currently, the company is actively seeking overseas commercialization partners.
Dr. Pan Ke, Founder, Chairman, and CEO of Yanhong Pharmaceutical, remarked: "CEVIRA®'s approval is a milestone in Yanhong Pharmaceutical's history. We have always adhered to our corporate mission of 'patient-centricity and clinical value orientation,' focusing on women's health and major urogenital diseases. We have launched comprehensive commercialization efforts to ensure this disruptive innovation benefits Chinese patients with precancerous cervical lesions as soon as possible. Meanwhile, we will accelerate global development, commercial partnerships, and the advancement of photodynamic drug-device combination technologies and other platform pipelines. CEVIRA®'s success marks Yanhong's entry into a new development stage, and we are confident in creating long-term, sustainable value for investors."
