On December 24, according to the official website of CDE, Yingke Rui's Class 1.1 new Chinese medicine "Shendai Rectal Suppository" obtained implicit approval for clinical trials. It is indicated for mild to moderate active ulcerative colitis with damp-heat and blood stasis syndrome.
Inflammatory bowel disease (IBD) is a type of disease that causes inflammation of the digestive system, and the number of patients worldwide is on the rise. IBD mainly includes ulcerative colitis and Crohn's disease, of which ulcerative colitis is common in patients aged 20 to 30 years old. Clinical manifestations include persistent or recurrent diarrhea, mucus, pus and blood in the stool accompanied by abdominal pain, and even skin lesions and mucosal lesions. At present, the cause of the disease has not been fully clarified.
According to statistics, the global prevalence of ulcerative colitis in 2023 is about 5 million cases, and the incidence rate continues to show an upward trend; in China, there are about 600,000 patients with ulcerative colitis in 2022, and it is expected that the number will exceed 1 million in 2030, almost doubling that of 2019. The huge market demand has made ulcerative colitis a "must-fight place" for various pharmaceutical companies. In the field of traditional Chinese medicine, many companies have also begun to lay out for this indication.

Shen Dai rectal suppository is a Class 1.1 new drug developed by Yingke Rui. The clinical indication approved this time is mild and moderate active ulcerative colitis, which belongs to damp-heat and blood stasis syndrome. Traditional Chinese medicine believes that blood stasis is not only an important pathological change of ulcerative colitis locally or even systemically, but also one of the important pathological bases of its recurrence. The treatment of ulcerative colitis should be based on the method of promoting blood circulation and removing blood stasis.

According to statistics, in addition to Shen Dai rectal suppositories, Yingke Rui has a number of potential innovative Chinese medicine pipelines in its pipeline, involving pediatrics, gynecology, gastroenterology and other departments. Just earlier this month, Yingke Rui's Class 1.1 new drug "Ganke Granules" also obtained implicit approval for clinical trials.
It shows that since 2020, the total sales of China's traditional Chinese medicine market has shown an upward trend, with total sales exceeding 220 billion yuan in 2023. As more innovative traditional Chinese medicines are launched, the clinical advantages of traditional Chinese medicine will be further verified.

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