Asieris Pharmaceuticals has announced its set-up of the Women's Health Business Unit for commercialization. This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health. The new business unit will center around core asset APL-1702, a potentially first-in-class non-surgical treatment of cervical high-grade squamous intraepithelial lesions.

Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health. APL-1702, a photodynamic drug-device combination developed for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has demonstrated positive results in the global international multi-center phase III clinical trial, and the complete data will be released at EUROGIN in March 2024. APL-1702 is on track to become the world's first product with proven efficacy in the non-surgical treatment of HSIL.

The company is proactively preparing for New Drug Application (NDA) procedures. Local operation as the traditional treatment of cervical HSIL often comes with potential adverse reactions such as cervical bleeding, infections, and cervical insufficiency. Cervical insufficiency can lead to a range of reproductive issues, including premature delivery, miscarriage, and higher rates of cesarean sections.

To date, there has been no non-surgical product approved for the treatment of precancerous cervical lesions with proven clinical efficacy in a phase III trial. Given the psychological challenges faced by cancer patients and the inherent risks associated with surgical interventions, there is a significant and unmet clinical need for non-surgical treatments for precancerous cervical lesions. To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.

In addition to making strides in women's health, the Oncology Business Unit, led by Mr. Xinming Jiang, Senior Vice President, has embarked on its commercialization journey. Notably, the kidney cancer treatment, Dipaite, and the breast cancer product, Ouyoubi, have been successfully launched. During the clinical development phase, Asieris Pharmaceuticals has built a strong portfolio in the field of urological tumors, unveiling a series of positive results.

A notable development is the positive interim analysis results from the phase II clinical trial for its oral drug APL-1202 in combination with PD-1 inhibitor tislelizumab, as a neoadjuvant therapy in muscle-invasive bladder cancer (MIBC). These results will be released in the Rapid Oral Abstract session at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium 2024. Furthermore, the phase III clinical trial of APL-1706, another drug for bladder cancer diagnosis and management, has met its primary endpoint.

The new drug application has been accepted by the National Medical Products Administration (NMPA). APL-1202 is currently involved in two concurrent phase III/pivotal clinical trials. The first, a pivotal clinical trial, is studying the use of APL-1202 in combination with infusion chemotherapy for the treatment of relapses in intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) patients who have undergone chemotherapy.

The second phase III clinical trial is investigating the use of APL-1202 as a monotherapy in previously untreated patients with intermediate-risk NMIBC.