Shanghai, China, January 16, 2025 – 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, announces that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application of APL-2302(ASN-3186 Capsule)for the treatment of advanced solid tumor.
APL-2302 is a novel USP1 inhibitor with completely independent intellectual property rights, which plays its anti-tumor role through a “synthetic lethality” mechanism. The results of the non-clinical pharmacodynamics (PD) studies show that APL-2302 is an active USP1 inhibitor. Monotherapy and combination therapy of APL-2302 showed excellent tumor suppression efficacy in vitro and in vivo. It is expected to provide a new treatment option for patients with advanced solid tumors, including breast cancer, ovarian cancer, prostate cancer, and other specific solid tumors with certain biomarkers (such as BRCA mutation).
This is a Phase I/IIa, open-label, multi-center, dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of ASN-3186 in patients with advanced solid tumors. APL-2302 IND was approved by the U.S. Food and Drug Administration (FDA) in October 2024.
Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals,stated, “We are delighted that APL-2302 IND has received approval from the NMPA. We will conduct clinical trials in China targeting late-stage solid tumors. APL-2302 has demonstrated promising activity in preclinical studies, and we look forward to further evaluating its potential in clinical research projects. We are committed to advancing the clinical development of this candidate drug, aiming to benefit more patients with this USP1 inhibitor.”
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.