Shanghai, China, January 22, 2026 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announces that it has received approval from a Human Research Ethics Committee in Australia and has completed clinical trial notification with the Therapeutic Goods Administration to initiate a Phase I clinical study of its internally developed drug candidate, APL-2401 (also known as ASN-8639 tablets), in patients with FGFR2/3-driven advanced solid tumors. This marks the second regulatory clearance for APL-2401’s clinical development, following its Investigational New Drug (IND) approval by China’s National Medical Products Administration (NMPA) earlier. The Company plans to actively advance the international multi-center clinical development of this product.
APL-2401 is a highly selective dual-target small-molecule inhibitor of Fibroblast Growth Factor Receptor 2/3 (FGFR2/3), independently developed by the Company. It is expected to offer a novel therapeutic option for patients with advanced solid tumors, such as urothelial carcinoma, cholangiocarcinoma, endometrial cancer, gastric cancer, breast cancer, ovarian cancer, non-small cell lung cancer, and other specific solid tumors.
Using Company‘s TAIDD platform and multi-structural simulation of drug targets , Asieris’ research team discovered hit compounds. Further optimization on the selective binding to FGFR2/3 led to the identification of the final preclinical candidate compound APL-2401. APL-2401 is a highly selective small-molecule inhibitor of FGFR2/3 with a non-covalent binding mode. Compared with current selective inhibitors of FGFR2 or FGFR3, APL-2401 demonstrated superior dual kinase inhibitory activity, tumor cell-killing effects, and modulation of the tumor microenvironment. Compared with pan-FGFR inhibitors, APL-2401 significantly reduced FGFR1- and FGFR4-related toxicities. Preclinical studies showed that APL-2401 exhibited robust efficacy and a wider safety window across multiple models with FGFR2/3 genetic mutations, amplifications, or overexpression. Compared with existing agents in the same class, APL-2401 demonstrated potential best-in-class advantages in potency, selectivity, safety, and drug properties. It is expected to become a blockbuster product in the field of FGFR2/3-targeted therapy.
Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals, stated, “The successive clinical trial approvals for APL-2401 from the NMPA in China and the regulatory authority in Australia mark the accelerated advancement of its global synchronized development. With its potential best-in-class profile, this candidate drug aims to address the unmet clinical needs in FGFR2/3-driven tumors. We are committed to actively advancing its international multi-center clinical studies to bring new hope to patients worldwide.”
It was successfully accepted into the “30-working-day review and approval pathway” specified in the Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs (No. 86, 2025) issued by the National Medical Products Administration (NMPA) on September 12, 2025, and received approval in just 22 working days，making it one of the first in the country to be approved under this new policy.Following approval, the first patient was successfully dosed in China within just 15 working days.
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.