China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that on July 16, two new drug applications (NDA) for Ursofalk® (ursodeoxycholic acid oral suspension) (the “Product”), jointly applied by the Group and Dr. Falk Pharma, have been approved by the National Medical Products Administration (NMPA), covering the following indications:
- 1) The NDA for the treatment of liver disease associated with a condition called cystic fibrosis in children aged 1 month to 18 years has been approved, which is a rare disease.
- 2) The NDA for the treatment of dissolution of cholesterol gallstones in the gallbladder (the gallstones must be radiolucent, and the gallbladder function must be intact); cholestatic liver diseases (such as primary biliary cirrhosis) and biliary reflux gastritis has been approved. The application was previously included in the priority review by NMPA’s Center for Drug Evaluation (CDE) for its accordance with the term that “new varieties, dosage forms and specifications of pediatric drugs that meet the physiological characteristics of children”.
The approved product is an oral suspension of ursodeoxycholic acid. Compared to tablets and capsules, oral suspension is more suitable for children or patients with dysphagia, providing them with more convenient clinical medication options. The Group will leverage its existing gastroenterology products and resources to methodically advance the commercialization and academic promotion efforts related to the Product, aiming to better meet the clinical medication needs of children and patients with rare diseases, thereby benefiting patients with relevant indications as soon as possible.
Concurrently, pediatric diseases and rare diseases continue to be the areas that urgently require attention within the pharmaceutical industry, and the issue of drug accessibility remains a significant challenge. CMS will consistently be guided by clinical needs, actively embracing corporate social responsibility, and collaborate closely with various sectors of society to jointly elevate the standards of diagnosis and treatment levels for pediatric diseases and rare diseases, thereby offering more care and support to patients and other groups who are desperately in need of ‘being seen’.
About ursodeoxycholic acid
Ursodeoxycholic acid (UDCA) is a hydrophilic, non-cytotoxic bile acid that is effective in treating predominantly cholestatic liver disorders and can be regarded as the first-line treatment [1]. Extensively used for the dissolution of gallstones and the treatment of chronic cholestatic liver diseases, UDCA not only promote the dissolution of cholesterol stones but, crucially, it replaces toxic endogenous bile acids in the human bile acid pool. This substitution plays a pivotal pharmacological role by protecting bile duct epithelial cells, inhibiting hepatocyte apoptosis, regulating hepatocyte immunity, and stimulating bile secretion [2].
The Product is produced by Dr. Falk Pharma, including tablets, capsules and oral suspensions. The Group has been the exclusive agent of ursodeoxycholic acid capsules (trade name Ursofalk) since 1998. The Product adopts a semi-synthetic production process, and the purity of its active ingredient, ursodeoxycholic acid, is as high as 99% or more [3]. The Product approved this time is an oral suspension of ursodeoxycholic acid, which may provide a more convenient treatment option for patients with dysphagia.
Reference:
- National Center for Clinical Research of Infectious Diseases. Expert consensus on the diagnosis and treatment of Intrahepatic cholestasis (2021 edition) [J]. Chinese Journal of Clinical Infectious Diseases, 2021, 14(6): 401-412.
- Ding Jingsong, Wang Anna, Huang Liang, et al. Metabolism of ursodeoxycholic acid in human raises challenges to its bioequivalence studies [J]. Acta Pharmaceutica Sinica, 2020, 55(9): 10.
- Sun Xueliang, Xu Wenfeng, Hu Xin. Research progress in impurity control of ursodeoxycholic acid [J]. China Pharmacy, 2022, 33(21): 2681-2684.
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.