Shanghai, China, August 13, 2026 – Asieris Pharmaceuticals (688176.SH), a leading global biopharmaceutical company dedicated to advancing innovative therapies for genitourinary tumors and women health with significant unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of APL‑2501 (CLDN6/9-ADC), a novel asset independently developed by its controlling subsidiary, for the treatment of advanced solid tumors.
APL-2501 is an anti CLDN6/9 ADC independently developed by Asieris, which features a proprietary hydrophilic linker and a topoisomerase inhibitor payload. It is expected to be indicated for a range of advanced solid tumors, including ovarian cancer, non‑small cell lung cancer, endometrial cancer, and gastric cancer.
Preclinical data for APL 2501 and the associated novel linker platform were selected for poster presentations at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025). APL-2501 utilizes a high affinity monoclonal antibody targeting CLDN6/9, coupled with a purpose designed linker that enhances hydrophilicity while enabling homogeneous conjugation at a drug-to-antibody ratio(DAR) of 8. These attributes confer excellent stability on the ADC molecule, reduce nonspecific cellular uptake, broaden the therapeutic window, and are expected to further improve efficacy. Compared with similar products under development, APL-2501 offers broader target coverage together with superior binding affinity, internalization efficiency, cytotoxic activity, and molecular stability. These characteristics support its strong clinical differentiation and may translate into a wider therapeutic window, more durable anti-tumor activity, and broader patient population.
The target expression profile of APL 2501 is distinct from that of existing ADC antigens, which may provide clinical benefits to patients who do not respond to current ADC therapies. It is designed for patients with advanced tumors who are refractory or relapsed to conventional treatment, and also holds potential for clinical development expansion from late line to second line or even first line therapy.
Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals, stated, “We are pleased that the IND for APL 2501 has been approved by the FDA. The preclinical data for APL 2501 are encouraging, and we are eagerly looking forward to the clinical data for this candidate drug, further demonstrating its efficacy and safety. To address real-world clinical treatment needs, we aim to bring meaningful benefits to more patients as early as possible.”
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.
Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.