On August 4, 2025 Asieris Pharmaceuticals (Stock Code: 688176.SH) reported 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 (Press release, Asieris Pharmaceuticals, AUG 4, 2025, View Source [SID1234654734]). The company will maintain proactive communication with the Center for Drug Evaluation (CDE) to expedite the New Drug Application (NDA) review process.

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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.