Shanghai, China, August 1, 2025 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced that its oral drug APL-1401 has demonstrated positive preliminary results in a Phase Ib clinical trial for the treatment of moderately-to-severely active ulcerative colitis (UC).
APL-1401 is a potent and selective dopamine β-hydroxylase (DBH) inhibitor. It is an innovative oral drug independently researched and developed by the company, featuring a novel mechanism of action for the treatment of UC. Currently, there is no cure for UC. The development of APL-1401 is expected to provide a new therapeutic option for UC patients. With no other competing drugs targeting the same mechanism globally, APL-1401 possesses first-in-class (FIC) potential.
UC is a chronic idiopathic inflammatory bowel disease (IBD) of the colon that causes superficial mucosal inflammation. Globally, approximately 5 million patients suffer from UC, with about 49% experiencing moderate-to-severe symptoms. This drives increasing demand for biological agents and targeted therapies. As of 2023, the global prevalence of UC continues to show a persistent upward trend1-3. According to Mordor Intelligence’s global UC market research, the market is projected to reach USD 10.56 billion in 2025 and increase to USD 13.21 billion by 2030, representing a Compound Annual Growth Rate (CAGR) of approximately 4.6%4.
The inflammatory nature of UC can lead to persistent intestinal damage, increasing the risks of hospitalization, surgery, and colorectal cancer. Currently, there is no cure for UC, and the efficacy and safety of existing therapies leave room for further improvement. There remains a significant unmet medical need, necessitating novel mechanism-based treatments.
The company conducted this study as a Phase Ib randomized, double-blind trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patients with moderately-to-severely active UC. The dose escalation phase has been completed, demonstrating a favorable safety profile. Positive efficacy signals were observed within the short treatment period of only four weeks. Based on these positive results, the company plans to further evaluate the efficacy of this potential first-in-class therapy over a 12-week treatment period in a larger cohort of patients with moderately-to-severely active UC. This will provide more comprehensive supportive data for subsequent clinical studies, with the aim of offering patients a new treatment choice in the future.
Ms. Joanna Zhang, Chief Medical Officer of Asieris Pharmaceuticals, stated, “We are very pleased that APL-1401 has demonstrated positive preliminary results in this Phase Ib clinical trial for UC. These results provide strong support for the further development of this product. We hope that APL-1401 will offer a novel and effective treatment option for ulcerative colitis patients worldwide.”
References：
- Ng SC, Shi HY, Hamidi N, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2018;390(10114):2769-2778.
- Kaplan GG, Windsor JW. The four epidemiological stages in the global evolution of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2021;18(1):56–66.
- Alatab S, Sepanlou SG, Ikuta KS, et al. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet Gastroenterology & Hepatology. 2020;5(1):17–30.
- Ulcerative Colitis Market Size, Trends, Share & Growth Drivers 2030
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, 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.