IBD98-M, an anti-inflammatory drug for the treatment of Inflammatory Bowel Disease (IBD), submitted an application for Phase II clinical trial to the NMPA on February 17, 2023, and received notification of approval to conduct the Phase II clinical trial on May 19, 2023.

IBD98-M is a new dosage form for the development of combination drugs for the treatment of inflammatory bowel disease, with prolonged release effect and wound-adhesion properties in pellet made by multi-layer coating pellet technology (MLCP), containing Mesalamine and hyaluronic acid as the active ingredients.

This clinical trial, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial of IBD98-M prolonged-released capsule will be treated in patients with mild to moderate Ulcerative Colitis. The trial is planned to be conducted in China and is expected to be completed between 2023/6 and 2026/6 (3 years), although the actual completion time will be adjusted based on patient status.

Holy Stone Healthcare and Gongwin Biopharm (stock code: 6617) will collaborate on conducting IBD98-M Phase II Clinical Trial in China. Both parties will invest funds and manpower in this case. The remarkable experience of Gongwin Biopharm in conducting clinical trials in China, as well as its vast networks will benefit the planning and conducting of future clinical trials. In addition, both parties will cultivate the licensing opportunities in the China market to create a new era and share the profits.