Shanghai, China, May 12th, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, announced that the New Drug Application (NDA) for product APL-1702 (Hexaminolevulinate Hydrochloride Ointment Photodynamic Therapy System) has been accepted by the National Medical Products Administration (NMPA) Center for Drug Evaluation （CDE） for the treatment of histologically confirmed cervical high-grade squamous intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding carcinoma in situ. The acceptance number is (JXHS2400035).
APL-1702 is a first-in-class, non-surgical treatment for cervical HSIL with its efficacy proven in a randomized, double-blind, controlled international phase III trial. It heralds a potential paradigm shift in the treatment of precancerous cervical lesions, with the clinical focus moving from excision to long-term disease management. Emphasis lies in optimizing the delicate balance between treatment risks and benefits, striving to minimize or delay invasive procedures while effectively reversing the progression of the disease.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, stated, “Currently, there is no permanent solution for HSIL. Even after surgical treatment, there is still a risk of persistent lesions or recurrence, with the subsequent risk of cervical cancer remaining higher than in the general female population (the risk of developing invasive cancer within 10 years is five times higher than in ordinary women). Patients must continue to be followed up for at least 25 years after surgical treatment. Consequently, the development of non-surgical approaches that preserve the intact cervix and avoid or delay cervical trauma are highly significant for the long-term management of patients with pre-cancerous cervical lesions. This NMPA CDE acknowledgement brings us one step closer to delivering a new treatment option for patients, actively advancing the ‘Accelerated Elimination of Cervical Cancer Action Plan (2023-2030)’ and contributing to the early realization of the Healthy China strategy.”
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.
