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Asieris Received China NMPA’s Approval to Start a Global Phase III Clinical Trial for APL-1702 to Treat Cervical Precancerous Lesions (HSIL)

时间:2020-07-08

Shanghai China, July 8, 2020 – Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, announced today it has received Clinical Trial Approval (CTA) from China’s National Medical Products Administration (NMPA) for the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira®), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL).


“Receiving the CTA from NMPA for APL-1702 is a significant milestone for the company as it builds and expands its capabilities in the genitourinary disease area,” commented Dr. John Zhuang, Asieris’ Chief Operation Officer and APL-1702’s project leader. “APL-1702 has the potential to be the first non-surgical treatment product for cervical precancerous lesions in the world. Female patients of childbearing age have strong desires for a non-surgical treatment that preserves the cervical function, and APL-1702 holds the potential of fulfilling this significant unmet medical need, thereby bringing substantial relief to these patients.”


In addition to China, Asieris has concurrently initiated this global pivotal trial in the United States, Germany, Romania, Hungary, Russia, Ukraine and other European countries. Data from this trial will support the market approval applications in China, the United States, the European Union, and other countries.


About Cervical Dysplasia
High grade cervical squamous intraepithelial lesion (HSIL) is a precancerous condition caused by a persistent HPV infection, a highly prevalent sexually transmitted disease. Each year there are approximately 10 million cases with high grade disease and over 50 thousands new cases of cervical cancer worldwide. In China, approximately 2% of the female population develop HSIL each year.
Currently surgical excisions, primarily LEEP/LLETZ and CKC, are the most common treatment options. However, these surgical treatment methods may cause adverse reactions, including bleeding, infection, and damages to the cervix, which may subsequently lead to  adverse effects on the reproductive function (such as premature birth, abortion).

About APL-1702 (Cevira®)
Cevira® is a photodynamic drug-device combination product. Based on the principle of photodynamic therapy, a photosensitizer is combined with light activation of specific wavelength to produce therapeutic effects. APL-1702 is intended for patients of 18 years and older with high-grade cervical dysplasia (HSIL), including all HPV subtype strains.
Cevira® is easily placed on the cervix by a gynecologist and removed by the patient at the end of treatment, with no disruption to her normal daily activities during treatment. Only one or two treatments are needed. This breakthrough treatment would provide a new option to both Chinese and overseas patients, allowing them to avoid the pain and adverse reactions associated with surgical procedure, especially avoid the impact of surgery on reproduction.
APL-1702 has received the Fierce Innovation Awards – Life Sciences Edition 2019 in the category of Medical Device Innovation. No non-surgical treatment product has been approved for treating HSIL disease in any country to date.

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