Six one years ago, the National Health Planning Commission and other six departments issued a number of opinions on the protection of children's medication, which is an important policy guidelines for the pharmaceutical industry, will have an important impact on the industry.
Three policies affecting the medical industry
Read the six department "a number of opinions", the pharmaceutical industry influence policy three:
First, the establishment of a special review channel for foreign companies have been listed on the use of domestic shortage, and the clinical needs of children in urgent need of varieties, dosage forms, specifications, to speed up the progress of reporting review. This for a large number of backlog in the trial of the project and the limited approval of resources, it means that the urgent need of children's medicine will open up the green channel. In the experience of the first generic drugs to infer, children in urgent need of drugs is expected to in declaration after one to two years to get approval, compared with the general 5 to 7 years of examination and approval time, shortened cycle.
Two is a listed species, the requirements of drug production enterprises in a timely manner to supplement and improve the children's clinical trial data. This policy means that a number of adult drug use in improving the clinical treatment can be converted to children, the approval cycle is shorter than the new drug approval, may not be a year of time.
Three is to give policy support to children's drug prices, children's special dosage forms can be a separate representative, not affected by the level of adult drug pricing. For children suitable dosage forms, the study provides a more relaxed formulation of the price ratio. At the same time to play the protection of medical insurance for children's medication function, according to the provisions of the appropriate dosage forms, specifications into the basic medical insurance payment range. This means that children can get a better price and more easily into the health insurance system.
In the above policy, the core of the pharmaceutical enterprises is good for what varieties can be converted into drug use in children, so as to obtain a new market and a substantial profit. According to the document analysis, abroad has been approved for use in children, while the domestic only for adult species is most likely to obtain priority approval. According to statistics pharmaceutical cube data ", this kind of variety in about 14. The spirit of aripiprazole, buspirone, seven varieties and types of digestive a farmer for Ding, lansoprazole six varieties, antibiotics have a varieties of voriconazole, effort is a species of olmesartan medoxomil, it can also be used for treatment of hemophilia, diabetes insipidus in acetic acid to ammonia pressure a variety.
Benefit from the new deal listing Corporation
In these potential varieties, Shanghai Pharma's enterprises have most of famotidine for injection Ding, olmesartan medoxomil tablet, lansoprazole tablets, hydrochloric acid of loperamide capsule, sertraline hydrochloride and 5 varieties, and its multiple company has the same variety; Livzon Group, Kang edge medicine, Enhua pharmaceutical, Hisun, Huahai has two varieties; Zhendong pharmaceutical, Zhejiang Zhenyuan, Beijing University of Chinese medicine, Beijing new pharmaceutical, Baiyun Mountain, Sanjing pharmaceutical, pharmaceutical, modern pharmaceuticals, Conba etc.are has only a variety.
The varieties, production enterprises have 9 listing Corporation or its famotidine, cimetidine injection (for gastroesophageal reflux). Livzon Group injected with voriconazole (systemic anti infection drugs), citric acid bismuth ranitidine capsules (for gastroesophageal reflux) the two varieties are listed pharmaceutical company exclusive varieties. The pharmaceutical desmopressin acetate injection is also the exclusive varieties of pharmaceutical listing Corporation. The odd bit of buspirone hydrochloride tablets (anti anxiety) for Peking medicine, Enhua pharmaceutical companies production. Risperidone dispersible tablets (schizophrenia) and also Enhua pharmaceutical huahaiyaoye two companies production.
The understanding to the hospital in Shanghai, aripiprazole, escitalopram oxalate and right methylphenidate and other mental medicine has been applied in pediatric patients, the farmer for satin and so on as the main varieties of digestive medicine. Aripiprazole is the main drug in the treatment of schizophrenia, there is no production of listing Corporation. This species Enhua pharmaceutical will enter the on-site inspection, it is expected to become the first production of a variety of listing Corporation. At the same time, risperidone is the main product Enhua pharmaceutical company, is expected this year, this species will maintain stable growth.
Desmopressin acetate injection is the main product of the pharmaceutical. Last year's annual report shows that its sales revenue accounted for about 10% of the company's total revenue for the 29 million yuan. However, last year's sales of this product is down. Also last year, desmopressin acetate injection vasopressin selected national essential drug list, squire pharmaceuticals in that year's annual report said company will use this opportunity, promote acetic acid to ammonia vasopressin injection of sales. It seems simple, Enhua pharmaceutical, pharmaceutical will directly benefit from the children's drug deal.
The generics priority review of policy, the first generic drug approval process faster, two generic drug approval process to much slower and deduced to children's drug approval of priority, for the above is expected to translate for the children of non exclusive varieties, to see which company to complete the first prepare the corresponding clinical data. So, it is not good to judge which listing Corporation most benefit. In addition, the exclusive varieties of competition is not so intense, but also depends on whether it can be successfully transformed into children's drugs.