News Release

Asieris’ Multinational Phase III Clinical Trial for the Non-Surgical Treatment of HSIL Has Completed Enrollment

Shanghai, China, 9 August 2022 – Asieris Pharmaceuticals, a global biopharmaceutical company specializing in the discovery and development of innovative drugs for the treatment of genitourinary tumors and other major diseases, announced that its multinational Phase III Clinical Trial of Cevira®(APRICITY), a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has successfully completed enrollment.

APRICITY is a multicenter, prospective, double-blind, randomized, and placebo controlled Phase III study to evaluate the safety and efficacy of the integrated drug-and-light delivery device Cevira® for the treatment of HSIL. The clinical trial was conducted concurrently at 65 sites in 8 countries including China, Germany, Hungary and and the Netherlands. A total of 402 subjects were enrolled.

Cervical cancer is the fourth-most common cancer in women worldwide.1 In 2020, 604,000 new cases and 342,000 deaths worldwide were attributed to cervical cancer.1,2 According to Frost & Sullivan, there is a huge portion of the global population, about 3.5 million people, who may have cervical precancerous lesions. With wider use of cervical cytology and HPV screening, more cervical lesions will be detected in the precancerous stage, and the number of diagnosed patients is expected to continue to rise in the future.

Conventional surgical treatment may cause adverse reactions noticeably bleeding, infection, and organic injury of the cervix, which may lead to a series of reproductive dysfunctions such as premature delivery and miscarriage. Currently, no non-surgical approach has been approved for the treatment of precancerous cervical lesions. 

Cevira® is a breakthrough photodynamic drug-device combination product, based on the accumulation of a photosensitizer in the target cells. Upon illumination, it generates reactive oxygen species that eradicate the diseased cells by inducing apoptosis and necrosis. As a novel, non-invasive, outpatient therapy, the treatment process of Cevira®  is easy to operate. Data from Phase I and II clinical trials of Cevira® have shown promising safety and efficacy results. Cevira® is expected to serve the high unmet medical need for non-surgical and safe treatment option for patients with HSIL, especially for young women of reproductive ages.

“We sincerely thank all the participating patients, investigators and their supporting staff. We have successfully completed the trial enrollment ahead of schedule despite the COVID-19 pandemic and rising international tensions,” said Dr. John Zhuang, Chief Operation Officer at Asieris. “We will continue progressing  our clinical trial and bring this potential novel therapy to patients with cervical precancerous lesions globally.”

1. Cervical cancer. Available from: https://www.who.int/health-topics/cervical-cancer

2. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49.

About Cevira®

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 innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. 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 medical 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.