Asieris Announces First Patient Enrollment in the Global Phase III Clinical Trial for APL-1702

Shanghai China, November 12, 2020 – Asieris Pharmaceuticals is a China-based biotech company with global aspirations to discover, develop, and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases. They announced today that the first patient was enrolled in and administered the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira®). This drug and clinical trial are being developed for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL).

HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease infections and over 50,000 new cases of cervical cancer worldwide. In China, approximately 2% of women 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 risks including bleeding, infection, and/or damage to the cervix. These methods also may increase reproductive function risks of premature birth or a terminated pregnancy. There is a high unmet need in women of childbearing age for treatment that can preserve their complete cervical function.

“APL-1702 provides a novel treatment option for HSIL patients, minimizing pain and side effects of surgical approaches. We firmly believe it is a breakthrough therapy with potential to be the first non-surgical treatment for cervical pre-cancerous lesions in the world,” commented Dr. John Zhuang, Asieris’ Chief Operation Officer and APL-1702’s project leader. “Asieris will always focus on genitourinary tumors and related diseases, fulfill significant unmet medical needs, thereby bringing substantial relief to the patients.”

APL-1702 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 in any other country to date.

In addition to China, Asieris has applied to concurrently initiate this global clinical trial in other European countries including Germany, Romania, Hungary, Russia, and Ukraine. Data from this trial will support the market approval applications in China, the European Union, and other countries.

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 wavelengths to produce therapeutic effects. APL-1702 is intended for patients 18 years and older with high-grade squamous intraepithelial lesions (HSIL), including all HPV sub-types. Cevira® is easily placed on the cervix by a gynecologist and removed by the patient at the end of treatment, with no disruption to 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 minimize the pain and risks associated with surgical procedures, especially to eliminate the impact of surgery on reproduction.

About Asieris Pharmaceuticals

Asieris Pharmaceuticals was founded inside the ‘China Medical City’ located in the city of Taizhou, Jiangsu Province, PRC, in March 2010. Asieris is determined to become a leading pharmaceutical company driven by innovative technologies and products that focus on genitourinary tumors and related diseases. The company and its professional teams are located in Shanghai, Beijing, Taizhou, and the US, with their research and development center in Jinqiao District, Shanghai. Asieris adheres to the growth model of proprietary R&D supplemented by in-licensing, to rapidly establish leadership in their focused fields with in-depth strategic plans. We create global values with our first-in-class innovative drugs with breakthrough potentials. Meanwhile, we have unique R&D platforms for anti-tumor and anti-microbial resistance drugs. In addition, we in-license late-development stage marketed products for the Chinese market to enhance our pipeline and to quickly establish our leadership position in the domestic market.