Praise for the State Food and Drug Administration! In 2018, China approved 48 new drugs to be listed on the market

2018 is a harvest year for innovative drugs, and the National Drug Administration (nmpa) has approved 48 new drugs to be listed Of the 48 new drugs, 38 are imported and 10 are domestic ones List of new drugs approved in 2018 (photo source: China Pharmaceutical News) 2018 is a good year for innovative drugs In this year, the U.S FDA approved 59 new molecular entities to be listed, breaking the historical record of many years of silence; in China, the National Drug Administration (nmpa) also approved 48 new drugs to be listed unprecedented Of the 48 new drugs, 38 are imported and 10 are domestic ones It is worth mentioning that 9 of the 10 domestic drugs are the new molecules approved for the first time in the world - surpassing EMA (European Drug Administration) and PMDA (Japan drug and Medical Devices Agency) in quantity for the first time These gratifying data, on the one hand, show the effectiveness of China's drug review and approval system reform; on the other hand, show the remarkable achievements in the field of innovative drugs in China From the perspective of indications, in 2018, most of the new drugs approved by SFDA were anticancer drugs, antiviral drugs and orphan drugs In these areas, the most cutting-edge international treatment methods are changing with each passing day After the priority review, 48 new drugs with huge treatment needs have been put on the market rapidly, which makes the treatment of related diseases in China step by step in line with international standards Antineoplastic tumor is a major life-threatening disease, with nearly 4 million new cases and 2.3 million deaths each year in China There is a huge clinical demand for antitumor drugs In recent years, the national drug regulatory authorities have launched the reform of drug review and approval system, giving priority to the review of drugs in clinical need, including anticancer drugs Thanks to the priority review mechanism, a large number of anti-tumor drugs have entered the treatment market at the fastest speed Based on the statistics of the author, 18 of the 48 new drugs approved by the State Food and Drug Administration in 2018 are anti-tumor drugs, involving indications including multiple myeloma (mm), non-small cell lung cancer (NSCLC), cervical cancer, ovarian cancer, breast cancer, melanoma, liver cancer, rectal cancer, anterior adenocarcinoma, leukemia and lymphoma In addition, a number of products are also related to tumor indications, such as palonosetron approved for the treatment of chemotherapy-induced vomiting, lablehigh approved for the treatment of childhood leukemia and the control of uric acid level in lymphoma patients The marketing of these products will greatly enrich the choice of cancer treatment in China and change the current situation of "chemotherapy as the mainstream" treatment to a large extent Of the 18 anti-tumor drugs, 13 are imported new drugs Among them, some products have developed into heavy "bombs" in just a few years due to the huge advantages of curative effect (the sales volume has exceeded 1 billion US dollars within five years of listing), such as Pfizer's piperacillin, Bristol Myers Squibb's nevuliu mAb and MSD's pabolizumab Although the sales of some products can not reach the "bomb" level, they have revolutionary progress in the efficacy For example, aletinib, an inhibitor of anaplastic lymphoma kinase (ALK), can significantly prolong the progression free survival (PFS) of patients with ALK positive NSCLC The median PFS is more than twice longer than chemotherapy (16.6 vs Olapali, an inhibitor of poly ADP ribose polymerase (PARP), can significantly prolong the progression free survival of BRCA patients (19.1 months vs 5.5 months) In addition to prolonging the survival period, the benefits of patients also include a substantial improvement in the quality of life Many tumor patients are under the control of targeted drugs, and their mental state is even the same as that of ordinary people Although antiviral drugs are widely used in China, antiviral drugs are very scarce In recent years, the international advanced antiviral therapy is changing with each passing day China is a big country of hepatitis C There are 7.6 million people infected with hepatitis C virus, and there is a huge demand for treatment In addition to hepatitis C, the biggest breakthrough in international antiviral treatment is AIDS According to the data of the independent hospital of health in the United States, the death rate of AIDS in the past 15 years has dropped by 55%; half of the patients with the latest treatment plan have HIV load lower than the detection limit level without continuous medical care There are 1.25 million HIV infected people in China, and the demand for treatment is huge However, due to the influence of many historical factors, the market of AIDS treatment in China is very "cold", and the treatment scheme lags behind the developed countries and regions in Europe and America Hepatitis C and AIDS are both major diseases threatening people's health Therefore, the State Food and drug administration has listed drugs for treating AIDS and hepatitis C as key "care" targets After priority review, since the end of 2017, a number of unilateral "special drugs" for hepatitis C have been approved for marketing Since 2018, the international heavyweight hepatitis C cocktails of elbawegrarevir, sophibuvipatavir and ledipavisoprovir have been approved in succession, which has made China's hepatitis C treatment go beyond the second generation (NS4 / 3 protease inhibitor + interferon) and the third generation (sophibuvir + ribavirin) treatment, directly into the cocktail era In terms of AIDS drugs, the State Food and Drug Administration approved the listing of domestic original new drugs, such as ibovetai and imported cocktails, such as Aikoen propionate tablets, enrutabine, propofol, tenofovir and dalunavir, which greatly improved the accessibility of AIDS drugs in China In addition to drugs for the treatment of hepatitis C and AIDS, the new antiviral drugs approved in 2018 also include the new generation of drugs for the treatment of hepatitis B, propofol tenofovir, and the domestic new hepatitis B drugs recombinant cytokine derived protein The listing of these drugs will benefit the majority of hepatitis B patients According to the data of antiasthmatic and COPD drugs, there are 334 million asthma patients, 328 million chronic obstructive pulmonary disease (COPD) patients, 3.2 million people die of COPD every year, 400000 people die of asthma, COPD and asthma are even more terrible than lung cancer The incidence rate of COPD in China is 8.6%, and the total number of patients is 99 million 900 thousand In terms of asthma, according to the 2014 epidemiological survey, there are about 25-30 million asthmatics in China Asthma and COPD seriously affect the quality of life of Chinese people The huge drug market makes the inhaler, as the first choice of asthma and COPD therapy, become the competing target of domestic and multinational drug companies The combined mortality rate of asthma and COPD is higher than that of lung cancer, and the demand for treatment is huge However, compared with the United States, China's treatment program is still very single, with fewer products, and the market is highly concentrated in multinational enterprises led by AstraZeneca In 2018, the State Food and Drug Administration approved the tiotropium, ODA and ODA inhalers of bringer Ingelheim, umamium and fluticasone of GlaxoSmithKline These four drugs are the latest generation of therapies, and they have been on the market for more than three years The clinical evidence has been relatively sufficient In 2017, the global total sales reached 3.3 billion US dollars The marketing of these products can greatly enrich the clinical treatment options of asthma and COPD, and it is expected to change the status quo of "one big company" in asthma and COPD treatment market In recent years, orphan drugs have become a huge driving force for the growth of international innovative drug market However, compared with developed countries and regions in Europe and America, the accessibility of orphan drugs in China is still relatively low, and many patients with rare diseases have not been effectively treated Rare disease experts in China have reached a consensus that rare diseases are defined as diseases with a prevalence rate below 0.002 per thousand or a neonatal incidence rate below 0.1 per thousand Based on this standard, there are nearly 20 million patients with rare diseases in China, and the demand for treatment is huge In recent years, orphan drugs have attracted the attention of the state and drug regulatory departments Many orphan drugs with great clinical value have obtained the priority evaluation qualification, and some products have entered the green channel In 2018, many drugs approved by the State Food and drug administration were defined as orphan drugs by the US FDA under the same indications, including aleutinib and serenitinib for the treatment of ALK positive non-small cell lung cancer, pabolizumab for the treatment of melanoma, prosaff for the treatment of non Hodgkin's lymphoma, bendamostine for the chemotherapy of leukemia, and special for the treatment of multiple sclerosis Rifluoramine, hemophilic drug koyueqi (recombinant clotting factor Ⅷ) and aimesuzumab, drug lablihai for hyperuricemia, drug srapag for pulmonary hypertension, drug ekuzumab for paroxysmal sleep hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), etc the listing of these drugs will greatly improve the rare diseases in China Treatment level Domestic new drugs In 2018, the State Food and Drug Administration approved nine independent innovative drugs, including pyrrolidine and tiopefiglitazine of Hengrui, enrotinib of Zhengda Tianqing, furquitinib of Huangpu, treprizumab of Junshi, sindelimab of Cinda, tenovir of Geli, ibovetai of cutting-edge biology, and recombinant cytokine derivative of Gehua Protein and so on The listing of these products, on the one hand, shows that China has made great achievements in encouraging and guiding innovation policies; on the other hand, it also shows that China's innovation ability and level need to be improved urgently, because these products are still dominated by "me to" innovative drugs, and the repeated layout is relatively serious Data shows that up to 40 PD-1 antibodies are in the development stage in China In addition to nine independent innovative drugs, the first domestic new drug approved by the State Food and drug administration is losartan, which is a "first in class" drug Up to now, the global multi center clinical trial results of the product have reached the end of treatment, and it is expected to be approved by FDA and EMA in 2019 The author believes that the approval of "first in class" innovative drugs by SFDA before FDA and EMA is unprecedented Once this historic step is taken, it will become a normal in the future Innovative drugs account for more than 70% of the global drug market and are the main source of profit for the pharmaceutical industry In my opinion, with the promotion of drug volume purchase, generic drugs will no longer be the main growth point of China's pharmaceutical market in the next few years If enterprises want to be bigger and stronger, they must actively innovate According to data reported by the European Pharmaceutical Industry Association, 64.7% of sales of new drugs launched in 2011-2016 came from the United States Therefore, Chinese pharmaceutical enterprises should not only actively innovate, but also actively go out Although in the 21st century, FDA has tightened the evaluation scale of "me to o" drugs, some high-quality domestic "me to o" innovative drugs are also expected to break through national boundaries and move from "China new" to "world new" (the data in this paper is sorted out by the author according to the official disclosure) in 2018, 48 new drugs were approved for marketing, and the accessibility of many indication drugs will be greatly improved However, the improvement of accessibility is only to realize the transformation from "no medicine available" to "medicine available" In order to truly benefit the patients, we need to realize the transformation from "medicine available" to "medicine available and affordable" Up to now, China is still a developing country, and its medical consumption capacity is far lower than that of developed countries Although many people think that the proportion of sales of auxiliary drugs and generic drugs in China is too high, through the "cage for birds", medical insurance resources can cover innovative drugs with huge clinical needs But in front of many high priced drugs, the "bird cage" that can be vacated is still very small Therefore, to solve the problem of difficult and expensive drug use, we need to join the medical insurance camp In the past two years, the country has made substantial progress