Hpatinib, a new drug of Hengrui medicine, has a flat performance in the full moon

As of January 25, apatinib, a national first-class new drug developed by Hengrui Pharmaceutical Co., Ltd in Lianyungang, has been on the market for one month, with flat performance As expected, arixib, a new arthritis drug of the company, has been on the market for three years, with annual sales less than 100 million yuan, not even comparable to generic drugs In contrast, the sales of new hepatitis C drugs developed by Gilead, an American pharmaceutical company, exceeded $10 billion last year Although the strength of Chinese and American pharmaceutical companies is different, China's medical demand is also very large, and the sales volume is so wide that it is worth pondering why they are both innovative drugs? Apatinib is a new drug of class 1.1 It is the first targeted drug for the treatment of advanced gastric cancer in the world Class I new drugs refer to the drugs that are not listed and sold at home and abroad, and have completely independent intellectual property rights Class 1.1 new drugs refer to chemical synthetic drugs, with the strongest technical content and market competitiveness New drug research and development to market, the process is complex and long - several years of research and development to obtain patents, applications for clinical trials, production approvals and sales approvals Relevant people from the State Food and Drug Administration said frankly that China is a large country of generic drugs, and there is no ready-made standard for the evaluation of innovative drugs, which is more cautious In addition, the lack of reviewers leads to a long time, and it is difficult to adapt to the latest trend of pharmaceutical innovation Gingko diterpenoid lactone meglumine is a new stroke drug developed by Jiangsu Kangyuan Pharmaceutical Co., Ltd its application for production was completed in 2005, and it was not approved until 2012 The period of patent protection is 20 years in China If the period of approval is too long, it will delay the time for new drugs to be put on the market Once the period of patent protection is over, other enterprises can copy it, and the sales of patent owning enterprises will drop "precipitously" After 7 years of delay, the "new drug" will become "old drug", and all losses will be borne by the enterprise Gu Hai, director of the Research Center for public health management and medical security policy of Nanjing University, thinks that the patent protection period should be adjusted in time with the development of innovative drugs in China It is suggested that the protection period should be extended appropriately to make up for the time spent in research and approval of innovative drugs In the United States, the period of patent protection will be extended for up to five years according to the clinical cycle It's difficult to get medical insurance, and the sales volume is still flat to get new drug certificate, which is only the first step in the long march Drugs entering hospital sales must pass provincial access and hospital access Provincial access means drug bidding At present, the average bidding period of 31 provinces in China is 14 months If you fail to make it, you can only wait for the next period After the provincial bidding, most hospitals will go through the hospital procurement, and only once a year or two will open a pharmaceutical committee to select drugs If you can't get into the hospital, the doctor can't prescribe Even if the provincial access and hospital access are passed, it will take a long time for new drugs to enter the medical insurance catalogue if they want to become reimbursable drugs According to the current system, the medical insurance catalog is updated once every four years, and it has been five years since the last adjustment During this period, no matter how good the new drugs are, there is no chance to enter the catalog Failure to enter the medical insurance means that patients can only pay their own expenses, and the high price makes most people "look forward to medicine." Gilead's new hepatitis C drug is a treatment cycle for three months, with a cost of $100000 "The price of domestic innovative drugs is slightly lower than that of imported drugs, but due to more investment in early research and development, the price is still higher than that of ordinary drugs, so it is difficult to open the market." Bi Yu'an, R & D director of Haosen pharmaceutical, said that ginkgolide glucosamine was listed in 2013, with a sales volume of 1 million yuan in that year, and the R & D investment of more than 50 million yuan, "I don't know which day to recover the cost" The enterprise innovation enthusiasm is frustrated In European and American countries, the original new drugs will experience animal and human experiments for less than 5 years and more than 10 years before they go on the market Once they are approved by the regulatory authorities, they will be considered safe and reliable, and will automatically enter the medical insurance catalog Experts suggest that the reform of China's medical examination and approval system should be linked as a whole to get through the system obstruction Countermeasures: multi sharing, so that people benefit from innovative drugs are generally "life-saving drugs", the price is high, it is not feasible to completely rely on the limited medical insurance fund to bear, it is urgent to explore a new mechanism of multi sharing Before that, Jiangsu Province took the lead in the negotiation among the three parties of medical insurance (medical insurance department, medical institutions and drug suppliers) to include some special high-priced drugs beyond medical insurance into the payment scope Herceptin, a breast cancer drug produced by Roche in Shanghai, was the first to land The treatment fee for insured patients was jointly borne by the provincial medical insurance fund, Roche pharmaceutical and patients Patients were selected in designated hospitals When Herceptin is treated, it can get the double guarantee of provincial medical insurance fund and Herceptin breast cancer assistance project The cost of a course of treatment is 200000 yuan, and the insured shall pay 30000-40000 yuan at their own expense A certain proportion of medical insurance is paid at the stage of self payment After the end of the stage of self payment, patients can apply for drug donation according to regulations Negotiation is an effective way to let high priced drugs enter the medical insurance Breaking the rules and regulations to enter the catalogue of medical insurance innovative new drugs can not only meet the urgent needs of patients, but also encourage the development of industry In this regard, Zhejiang took the lead in "breaking the problem", including the cancer drug produced by the pharmaceutical enterprises in the province, exetinib hydrochloride, into the medical insurance subsidy, adopting the medical insurance assistance and charity donation mode, and the patients can take it for life at their own expense for more than 10000 yuan, so that the vast majority of applicable patients can use it The annual expenditure of Zhejiang medical insurance is 80 million yuan, which is highly praised by the society Innovative drugs are included in the medical insurance in an unusual way Jiangsu has no "timetable" to expand its scale, but gave a "roadmap" in the early part of this month, which is considered "a big step forward" by the industry The four departments of human resources and social security, science and technology, price and drug supervision of the province jointly issued the confirmation of civilization After 2009, the pharmaceutical enterprises in the province independently developed and marketed the clinically necessary and effective drugs of category 1.1 of chemical drugs, category 1 of biological products, category 1-5 of traditional Chinese medicine and natural drugs one year later, which were included in the medical insurance preferentially Qualified pharmaceutical enterprises can apply to the human resources and social security department, negotiate and agree on the payment scope, settlement price, etc On November 3, 2014, apatinib mesylate, a new national class 1.1 drug independently developed by Jiangsu Hengrui Pharmaceutical Co., Ltd., obtained the new drug certificate and production registration issued by CFDA This is another major breakthrough in the field of anti-tumor in China, and it also adds new vitality to the targeted drug treatment market of advanced gastric cancer This is the only oral preparation of targeted drugs for advanced gastric cancer, which can significantly prolong the survival time of patients with advanced gastric cancer The success of the research and development of the drug marks that the pharmaceutical enterprises in China have embarked on a strategic development path from "imitation" to "innovation".