Hong Kong, 19 July, 2022 - Sihuan Pharmaceutical Holdings Group Ltd. is pleased to announce that the Anaprazole Sodium enteric solution tablets, independently developed by Xuanzhu Biopharmaceutical Co., Ltd. (“Xuanzhu Biopharm”), a non-wholly owned subsidiary of the Group, has obtained approval from the National Medical Products Administration (“NMPA”)of the People’s Republic of China (“China”) on the investigational new drug (IND) application of phase II clinical trials for the treatment for new indication of reflux esophagitis (RE) in adults and the control of its associated symptoms (acid reflux, heartburn, retrosternal pain or discomfort, belching reflux, etc.).
Anaprazole Sodium is the only new generation proton pump inhibitor (“PPI”) independently developed in China. Its first indication for the treatment of duodenal ulcer has submitted for new drug application (NDA) in 2021. Anaprazole Sodium is metabolised by multiple enzymes and non-enzymes, and has a low risk of drug interaction.
According to IQVIA data, the market size of PPI drugs in China in 2021 exceeded RMB20 billion of which oral preparations reached RMB10 billion. RE is a common disease of the digestive system with a high prevalence rate of 6.4% in the general population in China.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holding Group, said:” Clinical data showed that the safety and symptom relief of the Group’s developed Anaprazole Sodium are the best-in-class. PPI is often used in clinical practice to treat RE, with significant therapeutic effects and effective improvement of symptoms such as pain, acid reflux and heartburn, and has significant clinical value. This is expected to further boost sales growth, enhance the Group’s comprehensive strength and significantly strengthen the Group’s core competitiveness.”
About Xuanzhu Biopharm
Xuanzhu Biopharm is the innovative drug subsidiary of Sihuan Pharmaceutical, a large domestic pharmaceutical and medical aesthetic group. After 10 years of construction and development, the company has gathered an outstanding team of nearly 400 led by returned scientists. The company owns the ability to research and develop innovative drugs independently, forms a complete R&Dsystem, with complete drug development and industrialization capabilities, and does not heavily rely on license-in and CRO. Xuanzhu Biopharm owns two first-class innovative drug R&D platforms for both small molecular and large molecular, and is dedicated to the development of category 1.1 innovative drugs for small molecular and bio-macromolecular. It currently has morethan 25 innovative drugs in pipeline under development, focusing on tumors, metabolism, digestion, and other fields. Among them, Xuanzhu Biopharm has a full coverage on major targets of breast cancer, and thus becomes one of the companies in China with the most comprehensive coverage in breast cancer therapeutic areas. The R&D of Xuanzhu Biopharm is progressing rapidly, with the NMPA accepting its NDA for Anaprazole Sodium for the treatment of duodenal ulcer. In addition, it has nearly 10 products in clinical stage. The pipeline layout is complete and balanced in long, medium, and short terms, with strong capability to innovate continuously, in order to ensure that at least 1–2 products could apply for IND every year in the future. Riding on the commercialization capabilities of its parent company Sihuan Pharmaceutical, Xuanzhu Biopharm is now transforming from a Biotech company to a Biopharm company, and is gradually becoming a company with excellent R&D and industrialization capabilities.
About Sihuan Pharmaceutical
Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical is an international medical aesthetic and pharmaceutical enterprise led by innovation, with an independent and leading research and development technology platform, a rich global product pipeline, strong product registration capability, a full dosage form production platform with high efficiency and low cost and a mature and excellent sales system. Adhering to the overall strategic goal for the “full promotion of a two-wheel drive strategy of its medical aesthetics and biopharmaceutical businesses”, Sihuan Pharmaceutical endeavors to build itself into a leading medical aesthetics and biopharmaceutical company in China.