Breaking News: Asieris Clears Major Hurdle for Innovative Ulcerative Colitis Drug!

SHANGHAI, Aug. 30, 2023 /PRNewswire/ — Get ready for a groundbreaking stride in the realm of medical progress as Asieris Pharmaceuticals (688176), a global biopharma pioneer, propels innovation to new heights. Focusing on pioneering drugs for genitourinary tumors and related diseases, Asieris announces a resounding triumph: the National Medical Products Administration (NMPA) has granted Investigational Drug (IND) approval for its revolutionary oral drug, APL-1401.

This remarkable achievement follows the green light from the U.S. Food and Drug Administration (FDA), marking a double victory for Asieris.

APL-1401 holds transformative potential as it targets moderately-to-severely active ulcerative colitis (UC), a chronic inflammatory bowel disease that impacts countless lives. The stage is set for a randomized, double-blind Phase Ib study that will uncover the safety, tolerability, pharmacokinetics, and early efficacy of APL-1401. This study holds the promise of reshaping the landscape of UC treatment.

The journey of UC, marked by inflammation and continuous bowel damage, leads to heightened risks of surgeries, hospitalizations, and even colorectal cancer. With a mission to enhance the quality of life, induce and maintain clinical remission, and minimize cancer risks, APL-1401 emerges as a beacon of hope. Asieris’ commitment to addressing unmet medical needs is evident as it leads the charge in exploring new avenues for UC treatment.

Dr. Linda Wu, Chief Development Officer of Asieris, voices her excitement: “Receiving NMPA’s IND approval for APL-1401 is a triumph that ignites a new era for UC treatment. It’s not just a milestone; it’s a promise of a brighter future for ulcerative colitis patients in China. This achievement elevates our expertise and technological capabilities in gastrointestinal diseases. With unwavering dedication, we’re gearing up for clinical trials in China, eager to expand the array of advanced medication choices for patients.”

As the curtains rise on this transformative chapter, Asieris Pharmaceuticals takes its place at the forefront of medical innovation, rewriting the story of hope, progress, and a commitment to improving lives.”

Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Disease-a-Month. 2019; 11: 53.

Yan Pengguang, Li Jingnan. Standard Diagnosis and Treatment of Ulcerative Colitis. Chinese Journal of Internal Medicine, 2021, 60(6):4.

About Asieris

Step into the world of medical breakthroughs with Asieris Pharmaceuticals (688176.SH), a dynamic force in the biopharma arena since its inception in March 2010. Fuelled by a relentless passion for improving human health while upholding patient dignity, we’re rewriting the script on genitourinary tumor treatments and related diseases.

Picture a future where innovation knows no bounds, where patient well-being is paramount, and where global leadership is defined by the fusion of research, manufacturing, and commercial excellence. Asieris is charting a course to become that very beacon of transformation, offering unparalleled integrated solutions that transcend borders, connecting patients across China and beyond.

At the heart of our journey lies a steadfast commitment to research and development. With a proprietary R&D platform and cutting-edge technologies, we’re breaking new ground in exploring mechanisms of action, screening and evaluating drug candidates with unrivaled efficiency. Our quest is clear: to launch pioneering drugs that fill the gaps in patient care, carving a path towards unmet clinical needs.

But that’s not all – we’re rewriting the rules for genitourinary diseases. Through strategic partnerships and in-house expertise, we’re crafting a pipeline that anticipates tomorrow’s challenges today. By embracing the latest technologies and therapeutics, we’re pioneering a future that’s not just promising but transformative. We’re not just thinking about today; we’re shaping the tomorrows of diagnosis and treatment, weaving together an extraordinary portfolio that spans the spectrum.

Asieris Pharmaceuticals: where innovation, compassion, and patient empowerment converge to usher in a brighter, healthier future for all.

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