China Medical System Gained the Exclusive License of Cidine, an Exclusive, Marketed Oral Gastrointestinal Prokinetic Agent in China

Company News
  • An exclusive, marketed product in China, Cidine (Cinitapride Hydrogen Tartrate tablets), is a new generation of gastrointestinal prokinetic agents. It has good efficacy in relieving the symptoms of dyspepsia and good tolerance and cardiac safety performance.
  • Cidine will enrich the Group’s marketed product portfolio in the Gastroenterology field and synergize with other marketed products and advantageous resources, to address unmet needs and benefit more patients with gastroenterology diseases.

Recently, China Medical System Holdings Limited (“CMS” or the “Group”), through its subsidiary, entered into a long-term agreement (the “License Agreement”) with ALMIRALL S.A.(“ALMIRALL”), a Spanish pharmaceutical company. In accordance with the License Agreement, the Group gained the exclusive rights to import, package, and commercialize Cinitapride Hydrogen Tartrate Tablets in Mainland China and the first right to negotiate the collaboration with respect to Cinitapride Hydrogen Tartrate Tablets in Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan, and eleven Southeast Asian countries (Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor-Leste, and Brunei).

About Cinitapride Hydrogen Tartrate Tablets

Cinitapride Hydrogen Tartrate is a new molecular entity developed by Almirall. Cinitapride Hydrogen Tartrate Tablets (the brand name: Cidine), was approved in China in 2015, and it is an exclusive product. As the fourth-generation gastrointestinal prokinetic agent, Cidine is indicated to improve the symptoms of early satiety, postprandial fullness discomfort, and abdominal distension in mild to moderate functional dyspepsia.

Cinitapride, the active pharmaceutical ingredient of Cidine, increases the release of acetylcholine by acting on the 5-hydroxytryptamine 4 (5-HT4) receptor of the nerve plexus in the alimentary tract, which in turn increases the movement and secretion through the whole digestive system by acetylcholine, and improves gastrointestinal function. Additionally, Cinitapride has a certain anti-dopamine activity, and can act on dual targets to further stimulate the release of acetylcholine and help improve the therapeutic effect.

A China phase III clinical trial, evaluating the efficacy and safety of Cidine in the treatment of mild to moderate functional dyspepsia, presented positive results: the remission rate of postprandial discomfort syndrome (PDS) of Cidine was not inferior to that of the active control—domperidone tablets (Cidine group 85.8% vs. active control group 81.8%, P = 0.332). After 4 weeks of treatment, the clinical results showed that Cidine significantly reduced the overall severity of postprandial fullness, early satiation, and bloating, and it was superior to the effects of domperidone tablets. In addition, in terms of safety profile, the incidence of adverse events of Cidine was significantly lower than that of domperidone tablets. Furthermore, “Chinese Expert Consensus on Chronic Gastritis in the Elderly (2018)” stated that current research has showed Cinitapride has good efficacy on relieving the symptoms of dyspepsia, and has good tolerance and cardiac safety.

The Group has been deeply engaged in the Gastroenterology field for more than 20 years, and established the powerful academic platform and the compliant and efficient operation system, which has gained leading academic and market positions for its marketed products, such as Ursofalk (ranking the first in the market share among products in Chinese cholagogue market according to 2022 IQVIA data), Salofalk (ranking the first in the market share of aminosalicylic acid, the first-line treatment for inflammatory bowel disease in China according to 2022 IQVIA data), Bioflor (the probiotics preparations with abundant medical evidence and high-level recommendations from authoritative domestic and overseas guidelines), Combizym (effective in both stomach and intestines, the recommended digestive enzyme preparation for the replacement therapy of pancreatic exocrine insufficiency). Cidine will enrich the Group’s marketed product portfolio in Gastroenterology field, and synergize with other marketed products and advantageous resource. Based on Cidine’s evidence based medical evidence, the Group will explore product’s differentiated academic advantages in-depth and customize its promotion strategies, to improve clinical diagnosis and treatment, so as to benefit more patients with functional dyspepsia.

About Functional dyspepsia (FD)

FD is a common clinical functional gastrointestinal disease with no characteristic clinical manifestations, mainly including epigastric pain, epigastric distension, early satiation, belching, loss of appetite, nausea, and vomiting. The incidence of FD is high. According to the diagnostic criteria of ROME III, the prevalence rate of FD in Asia is 12.8%, and it is estimated about 180 million people with FD in China. The “Chinese Expert Consensus on Functional Dyspepsia (2015)” recommends gastrointestinal prokinetic agents as the first-line empirical treatment for FD, especially for PDS. According to IQVIA data, the sales of gastroprokinetic agents reached about RMB1,200 million in China in 2022.