2017 China Drug Development Overview
February 24, 2018 Source: Medicine Network
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];In 2017, it is undoubtedly a busy year for the State Food and Drug Administration (CFDA). According to statistics, in 2017, the CFDA issued a consultation draft of only drug-based keywords, and the environment for drug review and approval in China is undergoing tremendous changes. For pharmaceutical companies, 2017 is also a very serious year: the clinical trial data has been further promoted by self-examination and verification, and the consistency of the quality and efficacy of generic drugs has been accelerated. The publication of China's listed drug catalogues has been mixed. Affecting the operation and development of each enterprise, it also affects the hearts of every drug developer.
2017 drug registration of domestic pharmaceutical companies
According to relevant statistics, in 2017, the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as CDE) hosted a total of 4,810 drug registrations (according to the acceptance number), an increase of 32.3% over 2016.
In particular, in the second half of the year, except for the slight decrease in the number of registrations affected by holidays in October, the number of CDE's monthly contractors was relatively stable and there was no significant ups and downs. (see picture 1)
From the development history of new drug research and development in China, there have been two “Waterloo†in the registration of new drugs, one in 2007 and the other in the “722†clinical trial data in 2015. (See Figure 2)
In March 2016, after the CFDA issued the "Notice on the Work Plan for the Reform of the Registration of Chemical Drugs", new drugs and generic drugs were redefined, which changed the pattern of drug declaration. In terms of quantity, the total number of chemical drug declarations in 2017 was 3,813 acceptance numbers, and the number of new drug-based drugs was significantly reduced, but the gold content increased, and the acceptance number of chemical drugs 1 or 1.1 reached 324.
In 2017, the country has introduced a number of favorable policies to encourage the development of innovative drugs. In particular, the implementation of the drug marketing license holder (MAH) system and the implementation of the drug registration priority review and approval policies have become an important driving force for drug research and development. As of December 31, 2017, a total of 431 acceptance numbers were included in the list of priority review varieties, including 245 acceptance numbers for domestically produced drugs, 104 new drugs, and 132 generic drugs. There are 49 new drugs of class 1 or 1.1, including 24 varieties, and there are many clinically urgent drugs such as children's medication, hepatitis C, hepatitis B and AIDS. For example, the recombinant Ebola vaccine was submitted for listing in May 2017. In June, the application for innovative drug registration and major special varieties were included in the priority review. In October, it was approved by the CFDA. (See Figure 3)
With the continuous introduction of national innovative drug incentive policies and further optimization of market resources, pharmaceutical companies' confidence in new drug research and development has gradually increased. Among the domestic enterprises, Jiangsu Hengrui Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd. and Guangdong Dongyang Pharmaceutical Co., Ltd. performed the most prominent in the declaration of Class 1 new drugs. Among the new class 1 drugs declared in 2017, the number of anti-cancer drugs was the highest. (See Table 1)
Table 1 Number of domestic enterprise chemical drugs 1 class of drugs TOP3
At the same time, there are more and more companies willing to invest in research and development. The following is the research and development investment of Jiangsu Hengrui Pharmaceutical Co., Ltd. in recent years. In 2016, its R&D investment reached 1.18 billion yuan, accounting for 14.7% of total operating costs. (See Figure 4)
In 2017, domestic pharmaceutical companies also made great progress in the registration of new biological products, and immuno-oncology entered the golden year: Bristol-Myers Squibb's heavy product Opdivo (Navu monoclonal antibody) has been listed in China, the domestic letter Bio-PD-1 antibody, sidi-mAb, is the second PD-1/PD-L1 drug reported by Opdivo in China. Nanjing legendary CAR-T product-LCAR-B38M CAR-T cell autologous reinfusion preparation (acceptance number CXSL1700201) fills the gap of domestic CAR-T drugs and compares with international companies.
According to the statistics of related databases, in 2017, CDE hosted 66 types of therapeutic biological products (according to the acceptance number). The research and development of biosimilar drugs such as trastuzumab and bevacizumab are still hot spots. Hanlin, Qilu and Xinda are all in the top position.
The application for registration of Chinese medicines in 2017 is still grim, especially in the registration of new drugs, there are only 36 clinical applications, most of which are 6 new drugs. Chongqing Autumn Grain Biotechnology Co., Ltd. applied for a Class 1 Chinese medicine, JNSW10032 and tablets, and only the ginkgolides of Chengdu Baiyu Pharmaceutical Co., Ltd. were applied for listing.
Since 2017, China's Chinese medicine registration application is mainly based on supplementary applications, the number of clinical applications is small, and there are only a handful of production applications. Some negative news on the development of traditional Chinese medicine has sounded the alarm for the development of Chinese medicine. How to break through the bottleneck to develop the Chinese medicine industry is a hot issue that needs to be paid attention to in 2018 and beyond.
China's generic drug declaration registration has experienced the bottom valley and peak from 2007 to 2017. From the data point of view, it reached its peak around 2014, and the number of application acceptance numbers for generic drugs reached 2,117. With the advancement of the chemical registration classification reform, it will drop to 469 acceptance numbers by 2017 (Note: Statistics here) The medicines include categories 3 and 4 of the new registration classification, and some small quantities of chemical generics classified according to the old registration classification. Among them, there are 236 new four types of generic drugs, which reflects that the level of generic drugs in China is moving towards benign development, and enterprises are turning their attention to innovative drugs and high-level generic drugs. (See Figure 5)
The consistency of the quality and efficacy of generic drugs is a major event in the pharmaceutical industry in 2017. Due to the huge scale and fierce competition in the domestic generic drug market, large companies can only take the lead in passing the consistency evaluation to further seize the market, and further improve the market layout; while smaller enterprises have the opportunity to increase market share through consistency evaluation. Counterattack." At the same time, the leading company in the consistency evaluation is also a comprehensive manifestation of its research and development strength, financial resources, etc., which is conducive to enhancing the visibility of enterprise products.
At present, the first batch of generic drugs published by the CFDA for consistency evaluation involves 11 drugs and 17 products, including gefitinib, clopidogrel, tenofovir, irbesartan, etc. Haizheng Pfizer, Nanjing Zhengda Tianqing, Shenzhen Xinlitai, Sinopharm Group Zhijun (Shenzhen), Chengdu Bite, Qilu Pharmaceutical. Among the 17 specifications, only clopidogrel sulfate tablets, paroxetine hydrochloride tablets, cefuroxime axetil tablets, and risperidone tablets belonged to the 289-based drug list.
Drug approval status of domestic pharmaceutical companies in the US FDA in 2017
According to statistics, in 2017, a total of 38 products declared by the US FDA's Simple New Drug Application (ANDA) were approved by the FDA (in the application number). Zhejiang Huahai Pharmaceutical has obtained 10 products for approval, followed by Hengrui Medicine with 6 varieties approved. (See Figure 6)
As overseas listed products can be transferred to domestic declarations, they can enjoy the special policy of consistency evaluation. Therefore, the leading pharmaceutical companies in the export of preparations have an advantage in the consistency evaluation.
Among the first batch of CFDA-published generic drugs that passed the consistency evaluation, Huahai Pharmaceutical was the biggest winner, and seven varieties passed the consistency evaluation, including paroxetine hydrochloride tablets, fosinopril tablets, irbesartan tablets, Four varieties of lisinopril were transferred to foreign countries for domestic declaration. This is also the case with Herzen Pfizer's irbesartan tablets.
In November 2017, Huahai Pharmaceutical reported five varieties of voriconazole tablets, duloxetine enteric-coated capsules, valsartan hydrochlorothiazide tablets, donepezil hydrochloride tablets and levetiracetam tablets according to the new four classes of chemical drugs. These varieties have been approved by the US FDA, and all four varieties have been reviewed for priority, except for levetiracetam tablets. Kangzhi Pharmaceutical Capsule of Kangyuan Pharmaceutical, Kanglaite Injection of Kanglaite Pharmaceutical, Lianhua Qingyu Capsule of Yiling Pharmaceutical, and Compound Danshen Dropping Pill of Tianshili Pharmaceutical Co., Ltd. also started different stages in the FDA. Clinical Trials. (See Table 2)
Table 2 In recent years, domestic companies have carried out clinical trials overseas (partial)
Objectively speaking, the level of preparations in China still needs to be improved compared with foreign countries. The generic drugs are still far from high quality. There are still a lot of researches on generic drugs that can be done. It is not "new drugs are difficult to do, and generic drugs are good." China is a country with a large population, and the demand for generic drugs is huge. It requires new drug innovation and research on generic drugs. On the journey of innovation internationalization, although domestic companies have not yet obtained marketing approval for new drugs in the United States, some products have obtained relevant approvals to allow clinical trials to be conducted overseas. This is a good starting point for internationalization.
2017 domestic pharmaceutical companies overseas major trading events
At present, China's new drug research and development has explored two major directions: First, to enhance the current level of generic drugs through consistency assessment, to rectify the current research and development environment; second, the state encourages innovation, gives policy support, and creates a conducive R & D and innovation environment.
For large companies, they may not be satisfied with the domestic market. In recent years, overseas biopharmaceutical companies have introduced more and more cases of Chinese pharmaceutical companies' independent research and development of innovative overseas interests.
I have heard a metaphor of the image of the global drug development pattern in running: the United States is the leader; Japan and the EU are running side by side; the Japanese-led improved innovation is following the run; China is the majority of companies running or running behind, and quite Some companies are running around the field. Last year, this pattern was quietly changing.
Internationally, CFDA officially joined ICH, which means that domestic drug research and development is gradually integrated with Europe and the United States, opening a good start to internationalization; in China, drug review and approval reforms are vigorously promoted, pharmaceutical companies are facing reshuffle, for SMEs, perhaps Difficulties, but for large enterprises, innovative companies, but good winds to force me to send me to Qingyun. The author believes that according to the current development trend of China's drug research and development, in the near future, China's pharmaceutical companies will certainly have a place in the global drug research and development field. (See Table 3)
(The data and chart of this article are from the drug intelligence data)
Text / excerpt from "China Food and Drug Administration" magazine 2018 issue 1
We're Professional Supplier Extract Powder manufacturers and suppliers in China specialized in providing high-quality products at low price. We warmly welcome you to buy or wholesale bulk Supplier Extract Powder for sale here from our factory. For a free sample, contact us now.
Supplier Extract Powder,Supplier Extract ,Supplier Powder Manufacturer in China
Shaanxi Kang New Pharmaceutical co., Ltd. , https://www.bio-pharmacies.com