Wuhu Kangwei class 1 new gastritis vaccine is about to obtain production license

Wuhu Kangwei class 1 new drug "oral Recombinant Helicobacter pylori vaccine" of Yueyang Xingchang joint stock company is in the stage of production license examination This means that by the end of this month, Wuhu Kangwei, a subsidiary of Yueyang Xingchang, will be able to obtain a production license for the vaccine if there is no major problem Insiders confirmed that the company is about to obtain the production license of the vaccine After obtaining the drug production license, it needs GMP certificate and drug approval number, which will take about 2 years The company has said on the interactive platform that trial production of "oral Recombinant Helicobacter pylori vaccine" will be completed in June this year According to the above insiders, the organization of trial production and the application of production license are two parallel and independent processes At present, the vaccine is in the process transfer stage, i.e the laboratory process is transferred to the workshop, and the trial production is expected to be completed in the first half of the year According to the public information, the project of "capacity building of oral Recombinant Helicobacter pylori vaccine new product industrialization of class I new drug" was listed in the "national strategic emerging industry development special fund plan", and in 2014, the company had received the national fund of 24 million yuan The insiders said that with the support of the state, the follow-up work is likely to accelerate "Oral Recombinant Helicobacter pylori vaccine", also known as gastric disease vaccine, belongs to "human Helicobacter pylori bivalent subunit intramolecular adjuvant vaccine" As a preventive vaccine, it can be used in all patients who are not infected by H pylori Wuhu Kangwei, a joint-stock subsidiary of Yueyang Xingchang, has been granted a new drug certificate in 2009, but there has been no breakthrough in the industrialization process Helicobacter pylori can cause chronic gastritis, gastric ulcer, duodenal ulcer, gastric mucosa related lymphoma and other upper gastrointestinal diseases In 1994, WHO has confirmed that it is closely related to the occurrence of gastric cancer, and listed it as a kind of carcinogen According to relevant analysis, more than 600 million people are infected with Helicobacter pylori in China, and about 200000 people die of gastric cancer every year Due to the lack of appropriate animal models, the lack of effective treatment of Helicobacter pylori, almost all based on clinical experience, due to regional and population differences have greater limitations According to the CFDA website, at present, only two institutes, Wuhu Kangwei and Bioengineering Institute of Military Medical Sciences of the people's Liberation Army, are involved in the research and development of Helicobacter pylori vaccine in China.