Asieris Pharmaceuticals (Stock Code: 688176.SH) announced that its photodynamic drug-device combination product APL-1702, for the non-surgical treatment of cervical High-Grade Squamous Intraepithelial Lesion (HSIL), has advanced to the second round of technical review. The company will maintain proactive communication with the Center for Drug Evaluation (CDE) to expedite the New Drug Application (NDA) review process.
Cervical cancer is a highly preventable disease with a well-established cause. In 2020, the World Health Organization (WHO) launched its Global Strategy to Accelerate the Elimination of Cervical Cancer, through adoption of a resolution by 194 countries, including China. To advance the Healthy China 2030 initiative, and support the WHO’s Cervical Cancer Elimination Initiative, the Chinese government has issued key policies, including the Healthy China Initiative: Implementation Plan for Cancer Prevention and Control and the Action Plan for Accelerating Elimination of Cervical Cancer (2023-2030). At a recent press briefing on “Accelerating Elimination of Cervical Cancer,” the National Health Commission revealed that the risk of cervical cancer is rising in China, particularly among younger women, signaling that there is still much to be done in the fight to control and prevent this disease.
The main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years. According to Frost Sullivan analysis, it is projected that by 2030, the number of HSIL patients worldwide and in China will reach 16.6 million and 2.2 million, respectively. With the increasing popularity of dual-cancer screening and cervical cytology tests, more and more patients with cervical precancerous lesions are being detected at early stages before cancer develops, and it is expected that the number of patients will continue to increase.
APL-1702 is a groundbreaking product that combines innovative, clinical, and social value. As a first-in-class treatment to be debuted in China, backed by proven efficacy in an international phase III trial, it is poised to become the world’s first non-invasive therapy for HSIL. Clinically, APL-1702 is set to redefine the treatment paradigm of precancerous cervical lesions, moving beyond the one-size-fits-all approach of cervical resection. It aims to reverse disease progression while preserving the cervix, avoiding damage from resection, and supporting long-term management and recurrence prevention. From a societal perspective, managing HSIL patient is a crucial step in the “early diagnosis and early treatment” of cervical cancer. APL-1702 combines the value of early cervical cancer intervention and the promotion of a fertility-friendly society, and it is expected to contribute to the success of the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030) and the Healthy China Initiative.
The company will continue to prioritize APL-1702 and its photodynamic drug-device combination platform, in a bid to build a comprehensive, tiered gynecological portfolio. This strategy will center on product iteration and indication expansion, while leveraging synergies across the pipeline to drive broader growth.
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 women’s health. 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.