Asieris' CEVIRA® Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions
Asieris' CEVIRA® Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions |
| [03-March-2026] |
SHANGHAI, March 3, 2026 /PRNewswire/ -- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women's health, announced today that its core product APL-1702 (trade name: CEVIRA®, Hexaminolevulinate Hydrochloride Ointment Photodynamic Therapy System), has received the Drug Registration Certificate from China's National Medical Products Administration (NMPA) for its commercial launch. As the world's first non-surgical, non-invasive therapy for patients with cervical intraepithelial neoplasia grade 2 (CIN2)[1], CEVIRA® is expected to fill a critical clinical gap in this therapeutic area and redefine a massive, previously underserved market for non-invasive cervical disease treatment. Cervical cancer remains a major global health threat to women. According to market research released in 2023, more than 700,000 patients in China were diagnosed, based on histopathological confirmation, with cervical high-grade squamous intraepithelial lesion, of whom approximately 60% were classified as CIN2. Over the next decade, disease prevalence, screening rates and confirmed diagnoses are expected to rise[2-3], indicating substantial unmet clinical need. In recent years, global clinical guidelines have increasingly moved away from a proactive reliance on surgical intervention towards a more personalized, conservative paradigm centered on active surveillance and management. In the absence of other approved non-invasive treatment options, CEVIRA® has the potential to reshape a treatment landscape long dominated by surgical and other invasive or minimally invasive interventions. It will enable a shift from a "one-size-fits-all" approach toward one that prioritizes non-invasive therapy, offering a breakthrough solution to current clinical challenges. The approval was supported by results from CEVIRA®'s international, multicenter Phase III clinical trial, which enrolled a patient population that included more than 20% participants from Europe. The pivotal study results were formally published in December 2025 in Med[4], a Cell Press journal. The study was led by Academicians Lang Jinghe and Zhu Lan from Peking Union Medical College Hospital, with Professor Peter Hillemanns from Hannover Medical School serving as a senior author.The findings were published in Med, a Cell Press journal, by Academicians Lang Jinghe and Zhu Lan with Peking Union Medical College Hospital, and were also presented as oral presentations at major international scientific meetings, including the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference and the Society of Gynecologic Oncology (SGO) Annual Meeting. In addition, the clinical data were disseminated through invited oral presentations at several major international conferences, including the European Research Organization on Genital Infection and Neoplasia (EUROGIN) 2024, the Society of Gynecologic Oncology (SGO) Annual Meeting 2024, and the Photodynamic Therapy & Photodiagnosis Update 2024. Further academic exchanges and scientific discussion with basic researchers and clinical specialists from China and abroad took place at the 27th National Clinical Oncology Conference & 2024 CSCO Annual Meeting, the International Papillomavirus Conference (IPVC) 2024, and the 37th Public Health Symposium 2025. The results showed that CEVIRA® significantly improves both response rates and histopathological regression. In patients with CIN2, the response rate in the CEVIRA® group was 49.6%, compared with 22.6% in the placebo group (p=0.0003). Moreover, 57.5.0% of patients in the CEVIRA® group achieved histopathological regression to normal histology or low-grade squamous intraepithelial lesions (LSIL) histology at six months after the first treatment, compared with 30.6% in the placebo group (p=0.0009). These findings indicate that after only one to two treatment courses, nearly 60% of patients may avoid surgical excision.[4] In addition, the CEVIRA® group demonstrated a significant improvement in HPV clearance rates, with approximately 60% of baseline HPV infections cleared at 12 months.[4] As a photodynamic drug-device combination product, CEVIRA® is administered by gynecologists in a routine outpatient visit without anesthesia, with the entire procedure taking less than 10 minutes. Patients can return to normal work and daily life immediately after placement, without waiting in hospital, and remove the device themselves once treatment is complete. This care model — brief outpatient placement with treatment completed at home — has the potential to materially improve healthcare efficiency and broaden access to treatment. It also makes CEVIRA® well suited for use in primary care settings, helping bridge the "last mile" between screening, diagnosis, and treatment, and supporting global efforts to eliminate cervical cancer. Additionally, CEVIRA® incorporates an innovative cold light source technology that enhances treatment comfort by maintaining tissue temperature at the treatment site below 42°C, Clinical data indicate that 97% of patients reported no pain in the cervical treatment area[4], with no observed cervical structural damage, thereby avoiding the risk of thermal injury associated with conventional photodynamic therapy, minimizing local irritation, and significantly improving overall patient tolerability. Wei Lihui, Chair of the Chinese Society for Colposcopy and Cervical Pathology (CSCCP), Honorary Director of the Department of Obstetrics and Gynecology at Peking University, and Professor at Peking University People's Hospital, said, "The approval of CEVIRA® represents a breakthrough in the diagnosis and treatment of cervical diseases in China. It is the first time that an active intervention combining both efficacy and safety has become available for the conservative management of cervical precancerous lesions. This provides clinicians with a new and superior option for clinical decision-making and marks a critical step forward in advancing precision medicine while balancing disease control with patients' fertility preservation needs. Notably, the post-approval clinical use of CEVIRA® is expected to reshape a treatment paradigm that has long relied on surgical and other invasive or minimally invasive approaches, enabling a shift from a 'one-size-fits-all' strategy toward a preference for optimized non-invasive treatment pathways." Di Wen, Chair of the Chinese Obstetricians and Gynecologists Association and Vice Chair of the Chinese Society of Obstetrics and Gynecology, and Professor at Renji Hospital, Shanghai Jiao Tong University School of Medicine, said, "The approval of CEVIRA® positions China at the global forefront of non-invasive gynecological therapies. It offers clinicians an effective option for proactive intervention. This outpatient, short-course, non-invasive treatment not only helps preserve the reproductive potential of women of childbearing age, but also substantially reduces surgical trauma and psychological burden. By embodying a truly patient-centered approach, its approval is expected to positively shape strategies for the prevention and management in gynecologic oncology." Professor Chen Fei, Chief Physician of Obstetrics and Gynecology at Peking Union Medical College Hospital and the China principal investigator of the international multicenter Phase III clinical study of CEVIRA®, said, "CEVIRA® offers distinct clinical advantages, including targeted lesion elimination, HPV clearance, and preservation of reproductive function. In particular, as a non-invasive therapy, it maximally preserves the anatomical structure and physiological integrity of the cervix, enabling nearly 60% of patients to delay or avoid surgery and providing patients with cervical precancerous lesions with a superior treatment option that effectively controls disease while maintaining fertility." Building on the HPV clearance potential observed in the international, multicenter Phase III trial and the substantial unmet clinical need, the company is advancing research towards an HPV clearance indication for CEVIRA®. For international markets, the marketing authorization application (MAA) for CEVIRA® was accepted for review by the European Medicines Agency (EMA) in February this year. The company has also reached an agreement with the U.S. FDA on the design of a separate Phase III trial to support CEVIRA®'s potential U.S. approval. Meanwhile, Asieris is actively seeking overseas commercialization partners. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "The approval of CEVIRA represents a major milestone in our journey. Guided by our corporate mission of being patient-centric and driven by clinical value, we have maintained a strategic focus on women's health and major diseases of the genitourinary system. We have initiated a comprehensive commercialization plan to ensure that this disruptive innovation benefits Chinese patients with cervical precancerous lesions as soon as possible. At the same time, we will accelerate the product's global development and commercialization partnerships, while continuing to strengthen our photodynamic drug-device combination and other technology platforms, as well as the development of our pipeline assets. This approval opens an exciting new chapter for Asieris, and we are confident to deliver long-term, sustainable value to our investors."
About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and women's health. We strive to improve human health to preserve patient's dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus. Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.
SOURCE Asieris | ||||||
Company Codes: Shanghai:688176 |
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