The Ministry of industry and information technology is studying and formulating the reorganization and integration plan of vaccine industry: strictly control the newly established vaccine Enterprises

On February 26, the Ministry of industry and information technology, on the basis of previous research, is studying and formulating a work plan to promote the restructuring and integration of the vaccine industry, which will be promoted from market access, quality supervision, policy guidance and other aspects To this end, coordinate relevant departments to provide preferential policies for restructuring and integration enterprises in tax, finance, land and other aspects, support enterprises to carry out joint restructuring through capital market acquisition, approval of document number transfer, production technology equity and other ways, and promote the upgrading and high-quality development of vaccine industry According to a reporter from China Securities News, before the exposure of the * ST Changsheng incident, financial capital was rushing out to buy vaccine manufacturers frequently and wanted to enter the capital market On July 16, 2018, kangxinuo biology Co., Ltd (referred to as "kangxinuo") headquartered in Tianjin submitted the listing application document to the Hong Kong stock exchange The core products of concino are eight new vaccines under development In addition to three near commercial vaccine products to prevent meningococcal infection and Ebola virus, six vaccines under development are in clinical trial stage or clinical trial application stage In addition, there are six preclinical vaccines under development, including a joint vaccine under development At present, conchino is not profitable In 2016, 2017 and the first quarter of 2018, Conoco's net losses were 49.9 million yuan, 64.5 million yuan and 17.1 million yuan, respectively The R & D expenditure in the same period was 51.7 million yuan, 68.1 million yuan and 19 million yuan respectively Chengdu Kanghua Biological Products Co., Ltd (hereinafter referred to as "Kanghua biological") disclosed the IPO application draft on December 28, 2018 Kanghua biology is a vaccine manufacturer integrated with research, development and operation At present, it is the first vaccine manufacturer selling human diploid cell rabies vaccine (core product) on the market in China The company's main products are freeze-dried rabies vaccine for human (human diploid cells) and acyw135 group meningococcal polysaccharide vaccine According to the financial report, from 2015 to 2017, the operating revenue of Kanghua biology in the period was 71.693 million yuan, 92.9164 million yuan and 262 million yuan, respectively, and the corresponding net profit was 11.717 million yuan, 6.6579 million yuan and 74.4579 million yuan, respectively, with the comprehensive gross profit rate of 84.38%, 90.72% and 89.46% From January to September 2018, the company's comprehensive gross profit margin reached 94.59% Prior to Kanghua bio, on November 16, 2018, Beijing Wantai bio Pharmaceutical Co., Ltd also updated and disclosed the IPO application draft The company is engaged in the R & D, production and sales of in vitro diagnostic reagents, in vitro diagnostic instruments and vaccines The main products in the vaccine field are recombinant hepatitis E vaccine and human papillomavirus series vaccine In fact, the global integration of the vaccine industry is also very active After 2005, four pharmaceutical giants, Merck, GlaxoSmithKline, Pfizer and Sanofi, entered the vaccine market one after another through acquisition MSD recently announced that it will acquire immune design for us $300 million through subsidiaries The acquisition aims to enhance the vaccine development capacity of MSD in the field of infectious diseases and cancer Many initiatives have been taken to promote the restructuring of the vaccine industry According to the regulations on the administration of vaccine circulation and vaccination, vaccines are divided into category I and category II vaccines A kind of vaccine refers to the vaccine provided by the government free of charge and received by the public according to regulations Class II vaccine refers to other vaccines that are self funded and voluntarily planted The main difference between the two is that the vaccination cost of the first kind of vaccine is borne by the government, while that of the second kind of vaccine is borne by the recipient or his guardian According to the 2017 annual report on batch issuance of biological products, about 500-1 billion vaccines are issued annually in China Among them, domestic vaccines account for most of the share, while imported vaccines account for only less than 5% State-owned vaccine manufacturers (represented by Zhongsheng group) are the main suppliers of class I vaccines, while private enterprises mainly supply class II vaccines The production scale of domestic vaccine enterprises is about 25 billion yuan At present, of the 45 vaccine manufacturers, 38 are actually in production Among them, 20 enterprises only produce one variety in the whole year Most vaccine enterprises belong to private enterprises, and the operating efficiency is fair, and the willingness of spontaneous restructuring is not strong The production concentration of vaccine industry in overseas market is relatively high, and five transnational giants such as GSK occupy 80% of the global market share *After the exposure of St Changsheng incident, the recombination and integration of vaccine industry accelerated China Securities News reporter learned exclusively that the Ministry of industry and information technology is taking the lead in improving the concentration of vaccine industry On the basis of previous research, the Ministry of industry and information technology is studying and formulating the work plan to promote the restructuring and integration of vaccine industry, the main measures include: improving market access standards, strictly controlling newly established vaccine enterprises; strengthening vaccine quality supervision, gradually guiding the withdrawal of backward products; supporting the Association to formulate and issue industry development guidelines, guiding the orderly development of the industry; encouraging large-scale enterprises to win the bid for vaccine distribution To promote the development of advantageous enterprises In response, a former executive of a private vaccine company pointed out that vaccine enterprises with small scale, single variety, weak R & D ability, poor comprehensive strength and non-standard will bear the brunt of the impact A pharmaceutical researcher at a fund company, who declined to be named, said the vaccine industry would be further regulated Some non-conforming and non-conforming vaccine enterprises will face more severe punishment, and the non-conforming vaccine enterprises will accelerate to exit the market At the same time, with the promotion of merger and reorganization, the scale of compliant large vaccine enterprises is expected to further improve, and the market concentration will be closer to the head enterprises On February 25, when the degree of product homogeneity was relatively high, the 2019 National Symposium on consumer goods industry was held in Chengdu Wang Jiangping, member of the Party group and vice minister of the Ministry of industry and information technology, stressed that in 2019, we should do our best to ensure the supply of drugs and promote the restructuring and integration of the vaccine industry Since the exposure of the * ST longevity event in 2018, the expectation of rectification, integration and reorganization of the vaccine industry has become stronger "We are all equal to each other." The head of a private vaccine company's regional market said that the domestic vaccine market has a large space, and even the vaccine company with a single product can have a better life In addition, although there are many vaccine companies, the product homogeneity is high "Everyone is almost the same Why do you want to buy it?" At present, there are 45 vaccine manufacturers in China, which can produce 63 kinds of vaccines and prevent 34 kinds of infectious diseases However, the overall scale of the enterprise is small and the product homogeneity is serious In addition to the state-owned Zhongsheng group, most enterprises only issue one variety each year In addition, compared with developed countries and regions in Europe and the United States, although there are many kinds of vaccines on the market in China, most of them are traditional attenuated, inactivated or cracked vaccines The product level is relatively low, most of them are imitated or similar products, and the traditional technology is the main technology *The st Changsheng incident has opened the industry gap, and the integration of vaccine manufacturers is expected to increase sharply From 2004 to 2017, the regulatory authorities issued a series of documents to regulate the production, circulation and vaccination of vaccines On September 20, 2018, the fourth meeting of the comprehensive deepening reform committee of the Central Committee deliberated and adopted the opinions on reforming and improving the vaccine management system Subsequently, the General Administration of Market Supervision issued the vaccine administration law of the people's Republic of China (Draft for comments) It is rare to legislate for a single product Now, Wang Jiangping's "promoting the restructuring and integration of vaccine industry" makes many vaccine manufacturers feel uneasy: who will be the target of integration?