From 0 to 1: the first generation of drug marketing license held by R & D institutions!

Recently, Shanghai food and drug administration received the variety approval document issued by the State Food and drug administration Recently, a total of 18 product specifications in Shanghai have been approved by CFDA for listing, including the first three, Hutchison Huangpu, Hengrui and other enterprises It is worth noting that two specifications (4mg and 5mg) of montelukast sodium chewable tablets of Shanghai anbisheng pharmaceutical as the main delivery unit have been approved According to the public information, the montelukast sodium chewable tablets (4mg and 5mg specifications, approval number: anda205695) developed by abison have been approved by the US FDA in November 2015, and the montelukast sodium general tablets (approval number: anda 205683) have been approved by the FDA in January 2016 Montelukast sodium chewable tablets (4mg and 5mg) were included in the 12th batch of priority review list by CDE in December 2016 for the reason that "foreign generic drugs have been listed and applied for domestic listing simultaneously" It was approved on June 28, 2018, and became the first montelukast sodium chewable tablet product to be listed in both Chinese and American markets at the same time, At the same time, the munlukast chewable tablets sold in the United States market are produced in the same line and with the same prescription process They are regarded as the first munlukast sodium product that has passed the consistency evaluation and enjoy the same treatment as the original research product "shunerling" (R & D manufacturer: MSD) According to IPM data, the total domestic market size of montelukast sodium preparation in 2017 was 1.75 billion yuan, accounting for 69% of mosadong, while lunambert and Sichuan Otsuka were basically the same, accounting for 16% and 15% respectively In terms of dosage form, about half of the tablets are used by adults, while children are the high incidence population of asthma, and the proportion of special dosage form chewable tablets (4mg) is more than 40%; while 4mg chewable tablets previously were the unique dosage form specifications of methadone, with the approval of the two regulations of abison and deemed to have passed the consistency evaluation, it is expected that the leading position of methadone will be strongly impacted However, the first montelukast sodium product that passed the generic drug consistency evaluation was not the only bright spot of this approval, and "the first drug research and development institution in China holds the drug marketing license" was the highlight that could not be ignored On August 18, 2015, the State Council issued the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), which clearly pointed out that the pilot of drug listing license holder system should be carried out: drug research and development institutions and scientific research personnel should be allowed to apply for registration of new drugs, and the pilot work should be carried out after being authorized in accordance with legal procedures On October 25, 2016, Shanghai food and Drug Administration issued the announcement on the list of varieties that Shanghai has applied to participate in the pilot reform of drug listing license holder system, including 9 drug research and development institutions, 11 drug manufacturers and 12 varieties As the applicant and holder, anbisheng's montelukast sodium preparation commissioned by Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd was included in the first batch of list (picture source: Shanghai food and Drug Administration) On June 28, however, it was not two years before it was included in the MAH list As the holder of the marketing license, anbisheng montelukast sodium chewable tablet has successfully obtained the CFDA listing approval, becoming the first domestic drug research and development institution holding the marketing license of drugs, and the time of product listing has been accelerated, which is the original intention of the country to vigorously promote the drug MAH On August 21 last year, the State Food and Drug Administration issued the notice on promoting the pilot work of drug listing license holder system, which again made specific requirements for the work of 10 pilot provinces (cities) of Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan in the pilot work of MAH system These include: implementing the holder's legal responsibility (full life cycle management of drugs), promoting specialized and large-scale production, allowing the holder to commission production at multiple points, allowing the holder to sell drugs by himself or by Commission, improving the drug regulatory responsibility in both places (the holder and the manufacturer are not in the same place), and actively exploring the pilot model The key significance of the implementation of the drug MAH system lies in the release of the productivity of pharmaceutical enterprises, the "loosening" of drug approvals and production enterprises, which has a structural positive impact on the innovative research and development of drugs, the guarantee of drug supply and the healthy development of the whole pharmaceutical industry chain, at the same time, it can contain the current low-level industry model of replication in China, and it can also affect research and development institutions, scientific researchers and production enterprises The R & D and production power and enthusiasm are stimulated At the same time, with the further implementation and promotion of MAH, the division of labor in each link of the pharmaceutical industry chain will tend to be specialized, and the division of various fields of the industry will be more refined, or lead to the development of the pharmaceutical industry to the light asset operation mode Mah system promotes the rapid development of three pharmaceutical outsourcing services Shanghai anbisheng Pharmaceutical Technology Co., Ltd was founded in October 2007 It is a pharmaceutical technology high-tech enterprise jointly invested and established by dozens of domestic and foreign scientists and technical experts Lei Jifeng, general manager of the company, has worked for more than 20 years in many domestic and multinational pharmaceutical companies, engaged in production, process, engineering and management Anbisheng company is committed to the development and research of generic drugs, the registration in the United States and the European Union, and the cGMP certification services of FDA and other agencies, aiming to help domestic pharmaceutical enterprises to go to the international market At the same time, the enterprise has a group of experts who have worked in FDA and EMEA and scientists and technicians who have worked in innovative pharmaceutical companies and generic pharmaceutical companies at home and abroad, who have a comprehensive and systematic understanding of the agency, personnel, functions, regulations and technical requirements of FDA and EMEA From 2012, Lei Jifeng, CEO of abison, cooperated with Baiyang Pharmaceutical Group to establish Qingdao Baiyang Pharmaceutical Co., Ltd With the characteristics of R & D and production of sustained and controlled release technology drugs, we are committed to building an international manufacturing platform for generic drugs in China and overseas regulatory markets At present, many high-end anda products have been developed and declared successively Baiyang pharmaceutical passed the cGMP on-site inspection of FDA in October 2016 According to the relevant person in charge, Baiyang pharmaceutical will continue to apply for MAH in China after its bupropion hydrochloride sustained-release tablets are approved by FDA On June 20, 2017, a strategic capital increase of 33.75 million yuan was introduced into Zhejiang Yongtai Technology Co., Ltd with 15% equity of Shanghai anbisheng Pharmaceutical Co., Ltd With the successful listing of bupropion sustained-release tablets of its cooperative enterprise, ambroxen pharmaceutical has also achieved rapid development under the favorable MAH system.