HONG KONG, Feb. 14, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460) ("Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that the progress achieved by the Group in the research and development of drugs for treating digestive system and liver related diseases. "Anaprazole Sodium", the Group's self-developed innovative patented drug, has commenced phase III clinical trial in the PRC' (the "Study"), while "Huineng®", which is available in the market, has been included in Class B of the Medicine Catalog for National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (the "National Reimbursement Drug List") in the PRC.
Anaprazole sodium is the only self-developed proton pump inhibitor ("PPI") in the PRC, with Chinese and international patents. The results of the completed phase II clinical trial, a multi-centre, randomized, double-blind, double-simulation, positive drug parallel controlled study to assess the effectiveness and safety of the new drug in duodenal ulcer treatment, showed that it is effective in treating duodenal ulcer, conducive to ulcer healing and relieves ulcer-related symptoms. Gastroscopy demonstrated that the drug has a healing rate for duodenal ulcer comparable to similar products and is positive in safety and drug tolerance, thus successfully entering phase III clinical trial. The Study will be conducted in about 30 to 45 clinical centres across the PRC. A multi-centre, randomized, double-blind, doublesimulation, positive drug parallel controlled study will be adopted to assess the effectiveness and safety of anaprazole sodium enteric-coated tablets in treating duodenal ulcer. The Study will adopt a fine categorization approach to divide duodenal ulcer subjects into groups, with a view to providing more precise treatment approaches and options for clinical practice.The Study achieved significant progress with the first subject being enrolled in January 2020 after its launch.
According to the official announcement of the "National Reimbursement Negotiation Drug List 2019" promulgated by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security of the PRC, monoammonium glycyrrhizinate and cysteine and sodium chloride injection (Huineng®), the Group's existing drug available in the market, has also been officially included in Class B of the National Reimbursement Drug List. The Group believes that this will contribute to rapid sales growth of Huineng®.
According to IQVIA's China Hospital Pharmaceutical Audit Report (CHPA, sales data of hospitals with over 100 beds), the market for acid suppression and peptic ulcer drugs in the PRC is huge with continuous growth. Sales in 2019 amounted to approximately RMB26.9 billion. PPI drugs dominated market share and among the top 10 anti-ulcer drugs in terms of market share, six are PPI drugs. The market for hepatoprotective drugs like "Huineng®" also maintained impressive growth, with an overall sales in 2019 amounting to approximately RMB5.4 billion with a rapid growth rate of 107%. Huineng® is among the top 3 monoammonium glycyrrhizinate injection products.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical said, "With the rapid progress in its clinical trial, anaprazole sodium will create synergy with Jie'ao® (Roxatidine acetate hydrochloride for injection), the Group's new generation of histamine H2 receptor antagonist available in the market, in the area of acid suppression drugs. While Huineng® has been included in the National Reimbursement Drug List in recognition of the Group's efforts in expediting the development of liver disease treatment, the Group is still pushing forward the development of other drugs in the same area. Our product lines for treating digestive system and liver related diseases will be more extensive and diversified. "
About Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has formed a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.
