(China, March 3, 2026) Asarum Pharmaceuticals (stock code: 688176.SH), a global innovative pharmaceutical company focusing on urogenital tumors and women's health, announced that its core product APL-1702 (trade name: Cevira®, generic name: Hexyl valerate hydrochloride ointment for cervical photodynamic therapy) has received a Drug Registration Certificate issued by the National Medical Products Administration of China, officially approving its market launch. 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 treatment area and redefining a potentially huge blue ocean 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 high-grade squamous intraepithelial lesions (CIN2) diagnosed by histopathology in my country exceeds 700,000, of which approximately 60% are CIN2. It is projected that the incidence, screening rate, and diagnosis rate will continue to increase over the next 10 years, indicating a significant unmet clinical need. In recent years, global treatment guidelines have shown a trend of shifting from "aggressive surgical treatment" to a more individualized and conservative "observation and management" model.

Given the current lack of other approved non-invasive treatments, this product is expected to reshape the treatment landscape in this field, which has long relied on destructive invasive or minimally invasive treatments such as surgery. It aims to shift from a "one-size-fits-all" approach to a "preferred non-invasive" treatment path, providing a breakthrough solution to the current clinical treatment dilemma.

This approval is based on the international multicenter Phase III clinical trial of Civita®, which included more than 20% European patients. The relevant research results were officially published in the Cell Press journal *Med* in December 2025 by Academician Lang Jinghe and Academician Zhu Lan of Peking Union Medical College Hospital and Professor Peter Hillemanns of Hannover Medical School, Germany. They were also presented orally at the 2024 European Organ Infection and Tumor Research Organization Congress (EUROGIN), the 2024 American Society of Gynecologic Oncology (SGO) Annual Meeting, and the 2024 Photodynamic Therapy & Photodiagnosis Update Conference. Furthermore, they were presented at the 27th National Congress of Clinical Oncology and the 2024 CSCO Annual Meeting, the 2024 International Congress on Papillomavirus, and the 2025 37th International Congress of Public Health (IPVC) with basic research experts and domestic and international clinical experts.

Data showed that Civita® significantly improved response rates and histopathological downgrade rates. In high-grade squamous intraepithelial lesions (CIN2), the response rate was 49.6% in the CIN2 treatment group and 22.6% in the placebo group (P=0.0003). In the CIN2 treatment group, 57.5% of patients showed histopathological transformation to normal tissue or low-grade squamous intraepithelial lesions (LSIL) at 6 months after the first treatment, compared to 30.6% in the placebo group (p=0.0009). This means that with only 1-2 treatments, nearly 60% of patients can avoid surgical resection. Furthermore, HPV clearance in the treatment group showed a significant decreasing trend, with approximately 60% of baseline HPV cleared at 12 months.

As a photodynamic therapy product integrating medication and device, Civita® is administered by gynecologists in outpatient settings without anesthesia, reducing single treatment time to less than 10 minutes. Patients can immediately resume normal work and life after placement, without waiting in the hospital, and can remove the device themselves after treatment. This "short outpatient placement + home treatment" model greatly improves medical efficiency and treatment accessibility, making it suitable for promotion in primary healthcare institutions. It helps to bridge the "last mile" of cervical cancer screening, diagnosis, and treatment, and is of great significance to achieving the global strategic goal of eliminating cervical cancer. Simultaneously, Civita® employs an innovative cold light source design, controlling the tissue temperature in the treatment area below 42°C. Clinical data shows that 97% of patients reported no pain in the cervical treatment area⁴ and no record of cervical structural damage, avoiding tissue thermal damage that may be caused by traditional photodynamic therapy, reducing local irritation, and improving treatment comfort.

Professor Wei Lihui, Chairperson of the Colposcopy and Cervical Pathology Branch of the Chinese Society for Eugenics Science (CSCCP), Honorary Chairperson of the Department of Obstetrics and Gynecology at Peking University, and Professor at Peking University People's Hospital, stated: "The successful approval of Cevita® is undoubtedly a breakthrough in the field of gynecological cervical disease diagnosis and treatment in my country. For the first time, it provides a proactive intervention plan that combines positivity and safety for the conservative treatment of precancerous cervical lesions. This not only provides clinicians with a new and better option for diagnosis and treatment decisions, but also represents a crucial step forward in practicing the concept of precision medicine and balancing disease treatment with patients' fertility needs. It is particularly worth mentioning that the clinical application of Cevita® after its approval is expected to reshape the long-standing treatment pattern in this field, which has been dominated by surgical and other destructive invasive or minimally invasive treatments, and realize a shift from a 'one-size-fits-all' approach to a 'preferred non-invasive' treatment path."

Professor Di Wen, President of the Obstetrics and Gynecology Branch of the Chinese Medical Doctor Association, Vice Chairman of the Obstetrics and Gynecology Branch of the Chinese Medical Association, and Professor at Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, pointed out: "The approval of Cevita® marks China's achievement of an internationally leading level in the field of non-invasive gynecological treatment. It provides clinicians with an effective tool for 'proactive intervention.' This outpatient, short-term non-invasive treatment model not only greatly protects the fertility potential of women of childbearing age but also significantly reduces surgical trauma and psychological burden on patients, embodying the 'patient-centered' treatment philosophy. Its approval will have a positive impact on the entire prevention and treatment strategy for gynecological tumors."

Professor Chen Fei, Chief Physician of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital and the principal investigator in China for the international multicenter Phase III clinical trial of Cervita®, stated: "Cervita® has unique advantages in treatment, including precise targeted removal of lesions, HPV (human papillomavirus) immune clearance, and preservation of fertility. In particular, its non-invasive treatment characteristics can preserve the integrity of the cervical anatomy and physiological function to the greatest extent, allowing nearly 60% of patients to delay or avoid surgery, providing a better option for patients with precancerous cervical lesions to effectively control the lesions and preserve fertility."

Based on the outstanding potential for HPV clearance demonstrated in the international multicenter Phase III clinical trial of Cevita®, and the potential for a huge unmet clinical need, the company has initiated the exploration of indications for HPV clearance.

In the international market, the marketing authorization application for Cervita® was successfully accepted by the European Medicines Agency in February of this year. The company has reached an agreement with the FDA on another Phase III clinical trial design to support the US launch of Cervita®. The company is currently actively seeking overseas commercialization partners.

Dr. Pan Ke, Founder, Chairman and CEO of Asco Pharmaceuticals, stated, “The approval of Cevita® is a milestone in Asco Pharmaceuticals’ history. We have always adhered to the corporate mission of ‘patient-centered and clinically valuable,’ focusing on a development strategy centered on women’s health and major diseases of the genitourinary system. We have launched a comprehensive commercialization effort 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 global development and commercial collaboration of this product, and promote the development of photodynamic therapy and other technology platforms and pipeline products. The successful approval of Cevita® marks a new stage of development for Asco, and we are confident in creating long-term, sustainable value for our investors.”

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