Distribution of class 1.1 new drugs in China

In order to get rid of the embarrassing situation of over dependence on imported original research drugs in the domestic market, in recent years, the government has vigorously supported drug research and development from finance to policy, and drug research and development has become increasingly hot Generic drugs are practical and short-lived, but the core competitiveness of Chinese medicine lies in the development of a new class of new drugs As a chemical compound, class 1.1 new drugs can be said to be the necessary trump card for Chinese pharmaceutical enterprises to go to the international stage In 2013 and the first half of 2014, in the clinical application list of class 1.1 new drugs approved by CFDA of the State Food and drug administration, there are 33 anti-tumor drugs with known functions, accounting for about 30% of the application list, which is undoubtedly the most valued type by pharmaceutical enterprises Huge profits stimulate the research and development of hot new drugs, i.e chemosynthetic drugs, which are first marketed at home and abroad, need to be synthesized, purified, animal experiments and clinical experiments in four stages to ensure their safety and effectiveness They are high risk drugs with high investment "From the confirmation of efficacy, extraction and synthesis, to the confirmation of molecular formula, and then animal experiments, the process cost the company nearly 40 million yuan, not including the national project funding," a senior manager of a Southwest Pharmaceutical Company explained to reporters the cost of developing a new class 1.1 drug This is just the early stage of research and development "The next clinical trial cost is higher It will take nearly one year for the hospital and personnel with appropriate screening conditions The number of patients in the fourth phase of clinical trial is more and more later, and the cost is higher and higher." The drug company executives continued However, there are always drug companies facing difficulties In recent one and a half years, there are 118 applications for class 1.1 drugs approved by CFDA to enter the clinical application stage Tumor projects are still hot for new drug development, which can be attributed to two main reasons First, the anti-tumor drug market is huge and growing rapidly According to the data of the World Health Organization (who), since 2007, anti-tumor drugs have been the leader in the global pharmaceutical market, with sales of more than 70 billion US dollars in 2012 With the development of China's economy and the increase of people's income and savings, people tend to regard cancer as a chronic disease that can be treated for a long time rather than a terminal disease According to the 2014 China antitumor drug Market Research Report by CIC consultants, at present, China's antitumor drug market is about 40 billion yuan, with an average annual growth rate of about 20% The second reason is that the success of the research and development of 1.1 anti-tumor drugs will bring a lot of benefits In the drug market, new comers with stable efficacy often bring huge profits In fact, even the first generic drugs are the same Take Hengrui pharmaceutical, the innovation champion, for example It launched the first generic drugs of docetaxel and oxaliplatin around 2002 From 2003 to 2008, the net profit after deducting non recurring losses and benefits rose from 85 million yuan to 570 million yuan As a class 1.1 new drug that has never been marketed before, as long as it has passed clinical trials and obtained production approval, it will be a star product of pharmaceutical enterprises and become a "nuclear weapon" to seize the national or even global market In addition, new anticancer drugs may be more likely to obtain marketing licenses than other new drugs According to statistics quoted by the British cancer society, since 1995, about 18% of the 974 new anticancer drugs applied by western multinational pharmaceutical companies have been approved for marketing, while in this period, the probability of other newly developed drugs being approved for marketing is less than 5% According to the characteristics of each declared drug, the application of class 1.1 anti-tumor drugs in the past one and a half years was reviewed A total of 23 drugs have entered the clinical application stage, including 13 in 2013 and 10 in the first half of 2014 In terms of the objects of action, these declared drugs can be divided into three categories The first group acts on tumor related enzymes, such as laelotinib of dongyangguang, Guangdong Province, and mehuatinib of Huadong medicine, two tyrosine kinase inhibitors, which inhibit the production of proto oncogene or oncogenic RNA virus in human body and control the proliferation of cancer cells The second kind acts on the signal transduction channels, such as the skin cancer drug of Hengrui medicine, cimetidine, which regulates the proliferation of human stem cells and the self-renewal of tumor stem cells by inhibiting the abnormal hedgehog signal pathway The third is the target inhibitors, such as bitinitaz, which can inhibit PI3K protein kinase and histone deacetylase (HDAC), affect the important signal transduction and product synthesis of cancer cells, so as to control the killing of cancer cells On the whole, there are advantages and disadvantages in developing three kinds of drugs The first kind of drugs has obvious efficacy and relatively low R & D cost, but it usually affects the normal operation of human body For example, the inhibited tyrosine kinase plays an important role in cell growth, proliferation and differentiation in human health, and there may be several pharmaceutical companies with similar functions as substitutes The second kind of drugs also has similar disadvantages and higher cost If the new drugs are inhibited The third kind of drug target strike, aiming at the treatment of tumor cells, has relatively minimal impact on the human body, but also has the disadvantages of high cost and high risk The regional distribution characteristics of the above-mentioned drug companies are obvious 40% of the drug companies are concentrated in Jiangsu and Zhejiang In this regard, an analyst of a pharmaceutical industry told reporters that the main reasons are technology accumulation advantages, local government policy advantages and talent advantages "Jiangsu and Zhejiang regions have the advantage of coastal areas, and the chemical industry began to develop 30 years ago By the middle and late 1990s, many enterprises with chemical advantages have invested in the field of drug research and development, and the higher education resources in this region are more concentrated, while many sea The returned talents are also concentrated in this area, which further enhances the local technical strength " The industrial promotion policies of local governments have expanded their advantages Jiangsu Province has established biomedical industrial parks in Taizhou, Nanjing, Suzhou, Lianyungang (market, consultation), Wuxi and other places, created the development layout of biomedical industry centered on Taizhou "China Pharmaceutical (market, consultation) city", and actively introduced professional talents As of May last year, there were more than 1380 high-level people at home and abroad Just settled down to start a business, 14 people were selected into the national "thousand talents plan" In addition, the pharmaceutical industry analysts also believe that the good import and export trade tradition of the region is also the reason At present, many chemical raw materials in China are exported abroad, and an efficient and comprehensive trading system will highlight the transportation advantages of the region From regional segmentation to specific enterprises, the declaration of pharmaceutical enterprises is often closely related to capital In recent years, Hengrui pharmaceutical, which has the most anti-tumor new drug projects, has been on the market as early as 14 years ago With its capital advantages, it has developed two first generic drugs, and then it has grown rapidly with the high growth period in the field of anesthesia and anti-tumor drugs In 2012, its net profit has reached 1.043 billion yuan It has a solid strength and has been a "white horse" stock It is a well-known old pharmaceutical enterprise In addition to its outstanding talent reserve and scientific research and education system, Shanghai Pharmaceutical Research Institute has signed a joint development cooperation agreement with Fosun Pharmaceutical and Servier, a French pharmaceutical company, targeting anti-tumor drugs in recent years, which also makes full use of capital resources Guangdong dongyangguang, which holds two applications, is backed by Dashu Its parent company, dongyangke, is the leader of the medium and high voltage electrode foil industry Hong Kong Nanbei Brothers International Investment Co., Ltd participated in the shareholding Two years ago, it tried to go public Similar to Hutchison Whampoa pharmaceutical, there are the shadow of Hong Kong stock giant Wuba and Hutchison Whampoa, both of which have considerable capital strength Beijing Baiji Shenzhou is a kind of enterprise closer to international capital In June last year, it transferred the R & D and sales rights of bgb-283 in addition to China to Merck, Germany, at a price of 233 million US dollars From a small company only established for three years, Beijing Baiji Shenzhou has become the "Gao fushai" among its peers.