News Release

Asieris to publish the study protocol of Cevira® as a novel treatment in patients with high grade squamous intraepithelial lesion (HSIL) on BMJ Open

Shanghai, China, 9 June 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 the publication in BMJ Open of the APRICITY study protocol. APRICITY is a multicentre, prospective, double-blind, randomised controlled Phase III study further evaluating the efficacy and safety of the integrated drug-and light-delivery device Cevira® in the treatment of high grade squamous intraepithelial lesion (HSIL).

Cervical cancer is the fourth most common cancer in women worldwide1. In 2020, 604,000 new cases and 342,000 deaths worldwide were attributed to cervical cancer.1,2 Current treatments of HSIL of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality.

As a novel, non-invasive outpatient therapy, Cevira® holds the potential to serve the high unmet medical need for non-surgical, safe treatment options for patients with HSIL, especially for young women of reproductive age.

The clinical trial is being conducted simultaneously in China and Europe which was approved by the National Medical Products Administration (NMPA) in July 2020, and the world’s first patient was dosed in November of the same year.

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.