The citrate mosapride tablets developed by Fujian Haixi New Drug Creation Co., Ltd. were successfully approved for marketing by the National Medical Products Administration on June 17, 2020 (drug approval number: National Medical Products Administration Approval No. H20203264), which is considered to have passed the consistency evaluation. It is the first new Class IV drug of the same variety in China to be approved! At the same time, it is the first research and development enterprise in Fujian Province to obtain national drug approval as a Marketing Authorization Holder (MAH).
Mosapride citrate is a highly selective 5-HT4 receptor agonist with high safety (low adverse reactions, no cardiac toxicity), wide range of action sites (gastrointestinal motility drug), and broad indications. It can be clinically used for functional dyspepsia, esophageal reflux, gastroparesis, constipation, capsule endoscopy, etc. According to data from MiNet, the terminal sales of public medical institutions in China reached 1.219 billion yuan in 2019, a year-on-year increase of 4.63%. In the competitive landscape of gastric motility drugs, they occupy nearly 45% of the market share and will further replace traditional drugs such as metoclopramide, occupying the main market for gastric motility drugs.
Haixi New Drug has been established for 8 years and has always adhered to the values and development philosophy of "innovation, integrity, sharing, and goodness". It adheres to the dual track development strategy of innovative drugs and generic drugs, with research and development of innovative drugs as the core and high-end generic drug research and development as the foundation, taking into account the growth and risk control of the enterprise. After years of accumulation, there will be continuous achievements in the development pipeline of innovative and generic drugs, and 2020 will undoubtedly become a milestone year for the company.
Haixi New Drug is a "Fujian Province 12th Five Year Public Service Platform", "Fujian Province's first batch of provincial-level new research and development institutions", "Fujian Province's technology-based small and medium-sized enterprises", and "high-tech enterprises". And it has been listed as a "key (top priority) listed reserve enterprise in Fuzhou" and a key supporting unit for the biopharmaceutical industry in Cangshan District, Fuzhou. The Long March is just the first step, and we would like to express our special thanks to the governments at all levels and colleagues from all walks of life for their support and encouragement over the years. We will continue to work hard and achieve even better results. (News wording modification explanation: Our company obtained the marketing approval of Mosapride Citrate Tablets from the National Medical Products Administration on June 17, 2020. It is the first oral preparation under the same generic name in China to pass the evaluation according to the same standards as the original drug in terms of quality and efficacy, and is considered to have passed the consistency evaluation. To ensure strict writing and avoid ambiguity, this modification is made.)
