Icotinib complete maintenance period clinical data released for the first time, highlighting the commercialization potential in the field of freehold immunity for CSPC New Shine (01952)

At the 20th European Crohn's and Colitis Organization Conference (ECCO 2025) that ended on February 22nd, YunDing XinYao (01952) announced the innovative therapy - Velsipity (Vedolizumab) for moderate to severe active ulcerative colitis (UC) for the first time in Asia. The complete maintenance period data of the Phase III clinical trial was revealed, showing significant clinical and statistical improvements and good safety profile. This further confirms the drug's advantage as an innovative therapy for treating moderate to severe active ulcerative colitis, bringing hope to many patients. It is known that with the prolongation of the disease, the disability rate and the incidence of colorectal cancer in patients with ulcerative colitis continue to rise. By 2030, the number of ulcerative colitis patients in China is expected to double compared to 2019, reaching approximately 1 million people. The study results announced this time provide strong evidence to support the broader clinical application of Vedolizumab. Vedolizumab is the only advanced therapy for ulcerative colitis in the Asian population with moderate to severe active ulcerative colitis who have completed key randomized controlled trials. "As the only drug confirmed to be effective for isolated proctitis in the global Phase III ELEVATE clinical trial, Vedolizumab in the Phase III clinical trial in multiple centers in Asia for treating moderate to severe active ulcerative colitis achieved positive results in both the induction and maintenance periods. We look forward to Vedolizumab benefiting more patients with ulcerative colitis in the future," said Professor Wu Kaichun, head investigator of the Vedolizumab Asia-Pacific clinical trial, Executive Director of the World Gastroenterology Organization, Executive Director and Secretary-General of the Asian Pacific Association for Digestive Disease, Deputy Director of the Digestive Disease Branch of the Chinese Medical Association, and Professor at the Fourth Military Medical University Attached Xijing Hospital of the People's Liberation Army. Professor Wu Kaichun further explained: "Vedolizumab, a new generation of selective S1P modulator, has shown rapid efficacy through an oral, once-daily treatment regimen, achieving clinical remission, and demonstrating a positive effect on deep healing, significantly increasing the proportion of patients with normal endoscopic recovery and mucosal healing, helping patients achieve standardization sooner." Data confirm that after 40 weeks of maintenance treatment, the Vedolizumab group showed significant clinical and endoscopic benefits. Vedolizumab showed strong therapeutic effects in multiple endpoints, including mucosal healing, endoscopic normalization, and histological improvement. In 2024, Vedolizumab was commercialized in Singapore and Macau, and its new drug listing application has been officially accepted in mainland China and Hong Kong. In December of the same year, Vedolizumab was officially included in the list of urgently needed drugs and medical devices in the Guangdong-Hong Kong-Macao Greater Bay Area, and after the first prescription was issued in Foshan, Guangdong Province, it has accelerated the landing in 45 medical institutions designated by the "Hong Kong-Macao Medical Device Platform", achieving full coverage in 9 cities in the Greater Bay Area. As the prevalence of ulcerative colitis continues to rise in China, especially in the Greater Bay Area, where the total number of patients with ulcerative colitis in 2022 was approximately 600,000, with Guangdong Province accounting for 10% of the proportion, the demand for innovative therapies among patients has become more urgent. With the support of the "Hong Kong-Macao Medical Device Platform" policy, Vedolizumab has already benefited patients in the Greater Bay Area. Its new drug listing application has also been officially accepted in mainland China and is expected to be widely used in clinical treatment of domestic patients in the future. Ulcerative colitis and Crohn's disease (CD) are the two main types of inflammatory bowel disease (IBD). Due to the high recurrence rate and incurable nature of IBD, patients need long-term medication, and even lifelong use. The huge patient population of IBD has led to the establishment of a market space, attracting many pharmaceutical giants to lay out. Currently, there are several blockbuster products with annual sales reaching billions of dollars. According to Transparency Market Research, with the rapid growth of the prevalence rate, the IBD market is expected to reach $49 billion by 2030. Autoimmune diseases have always been the focus of YunDing XinYao's research. With the continuous disclosure of positive results from Vedolizumab clinical trials and the expansion of coverage, its commercial potential will be fully unleashed in the future. Industry forecasts suggest that with the increasing number of patients, Vedolizumab sales peak is expected to reach 2 billion yuan.