The First Non-Vaccine Investigational Product for Cervical HSIL Has Achieved Its Primary Endpoint

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SHANGHAI, Sept. 20, 2023 /PRNewswire/ -- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, has announced that the multinational Phase III clinical trial of APL-1702 (Cevira®), a novel, non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has met its primary endpoint. Based on the results, APL-1702 holds the potential to become the world's first non-vaccine product with verified clinical efficacy against cervical HSIL. The company will be in communication with regulatory authorities on new drug application and market approval in the coming months.

This study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and has enrolled 402 participants. The trial met its primary endpoint, together with a robust safety profile. Comprehensive data from this study will be presented at forthcoming academic conferences and published in scientific journals.

According to the Global Cancer Statistics 2020, there were 604,127 new cases of cervical cancer in women, with 341,831 deaths worldwide, making it the fourth most prevalent malignancy among females. In China, cervical cancer stands as the second most common malignancy among women.

The leading cause of cervical cancer is persistent HPV infection, which can result in precancerous cervical lesions. An alarming 20 percent of HSIL cases may progress to invasive cervical cancer within a decade. 1 According to Frost & Sullivan, the number of HSIL patients is projected to reach 16.6 million globally by 2030, with 2.2 million in China alone. With increasing adoption of cervical cytology screening, more individuals with precancerous cervical conditions are being identified at earlier stages, and this trend is expected to persist.

Local operation as the traditional treatment of cervical HSIL often come with potential adverse reactions such as cervical bleeding, infections, and cervical insufficiency. Cervical insufficiency can lead to a range of reproductive issues, including premature delivery, miscarriage, and higher rates of cesarean sections. There has been no non-vaccine product approved for the treatment of precancerous cervical lesions with proven clinical efficacy in a Phase III trial. APL-1702 is a pioneering photodynamic drug-device combination product. As a novel and non-invasive therapy, APL-1702 offers a straightforward and patient-friendly procedure that doesn't disrupt daily life. The combination aims to spare HSIL patients the pain and side effects often associated with surgical procedures, with a particular focus on preserving the fertility of women of child-bearing age.

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "This milestone marks a significant leap forward in the management of HSIL, with the potential to transform care in this domain. Moreover, tackling precancerous cervical conditions is pivotal for early prevention of cervical cancer and is an integral part of the three-tier cancer prevention system. Asieris Pharmaceuticals is committed to playing an active role in advancing China's Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy China 2030, aligning our efforts with the WHO's global strategy to accelerate the elimination of cervical cancer."

1. Expert Committee of Colposcopy and Cervical Pathology Branch (CSCCP) of Chinese Eugenics Association. Expert consensus on cervical cancer screening and abnormal management in China (II). Chinese Journal of Obstetrics and Gynecology, 2017, 18(3):286-288.

About APL-1702(Cevira®)

APL-1702(Cevira®) is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira® holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira® in July 2019. Cevira® is a registered trademark of Photocure ASA, based in Oslo, Norway.

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 other related diseases. 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, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.

Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

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