Priority evaluation and favorable evaluation: Top 3 of the most beneficial domestic pharmaceutical companies, with a closer look at the performance of key varieties after listing

Since the first batch of priority review varieties at the beginning of 2016, 25 batches of priority review catalogue have been issued, involving nearly 391 acceptance numbers The latest batch of publicity time is December 18, 2017, with a total of 44 registration applications From the list of varieties, it focuses on meeting the urgent clinical needs, mainly including children's drugs, cancer drugs, antiviral drugs, rare disease drugs and the first generic drugs of some patent expired varieties The original intention of setting up the priority review channel is that once these drugs pass the priority review and go on the market, the treatment cost of patients with major diseases can be significantly reduced, more treatment drugs can be selected clinically, and the clinical needs of special patients such as the elderly and children can also be met From the current situation, the goal is being achieved step by step In terms of the reasons for inclusion in the list, it focuses on meeting the urgent clinical needs, mainly including varieties with obvious treatment advantages compared with the existing treatment methods, children's drugs, antiviral drugs, drug production applications one year before the expiration of the patent, drugs for rare diseases and some major special varieties From the perspective of enterprises, Bayer, Hengrui, Novartis, Boehringer Ingelheim, Zhengda Tianqing and other domestic enterprises that have benefited most from the implementation of the priority review system are top 3 enterprises According to the acceptance number of manufacturers in the list, Jiangsu Hengrui, Guangdong dongyangguang and Zhengda Tianqing are the top three domestic enterprises In addition to its own R & D strength, Hengrui has also made full use of national incentive policies, involving children's drugs, synchronous application for listing in the United States, first imitated varieties, patent expired varieties, etc at present, its priority evaluation variety kapofungin has been approved for listing Qilu pharmaceutical's first generic product, gefitinib, has also been approved for marketing Zhengda Tianqing is in the innovation of medicine, the first imitation of two hair force No.1 Hengrui [concerned variety] pyrrolidine (independent research and development of EGFR / HER2 inhibitor, anti-tumor) At present, the main products that Hengrui has obtained the priority review are: thiopefigeristine injection, bensulfonaatracurium injection, paclitaxel for injection (albumin binding type), gadolinium butoxide injection, dexmedetomidine hydrochloride nasal spray, caspofungin acetate for injection, pyrrolidine maleate tablet, etc Pyrrolidine is a class 1.1 EGFR / HER2 inhibitor independently developed by Hengrui, which has been applied for clinical application since May 2011 According to the statistics of new drug development and testing database in China, there are 9 clinical trials of pyrrolidine registered in China, including HER2 + breast cancer and HER2 mutant non-small cell lung cancer The priority review of pyrrolidine will undoubtedly speed up its entry into the market In addition to Hengrui's strong marketing ability in the field of domestic cancer treatment, Hengrui will add another heavy variety No.2 East Sunshine [concerned varieties] imitavir phosphate (hepatitis C drug) For a long time, China has been a country with a heavy burden of liver diseases, with nearly 40 million hepatitis C virus carriers and 10 million patients, and 35000-50000 people die of hepatitis C every year At the same time, there is a lack of prevention and treatment drugs, neither hepatitis C vaccine nor effective hepatitis C treatment drugs There is an urgent need for new direct antiviral drugs to be listed in China Therefore, CDE has included hepatitis C antiviral drugs into the priority review process and encouraged the listing process of hepatitis C drugs Emeltamivir phosphate is an NS5A protein inhibitor of hepatitis C virus It is proposed to be combined with other drugs for the treatment of chronic hepatitis C with liver function compensation Dongyangyao has developed a series of NS5A inhibitor imitavir phosphate products, expanding the product portfolio of hepatitis C drugs The huge patient base will become a stable and solid market foundation in the field of hepatitis C treatment in the future It is expected that with the successful R & D and marketing of DAA drugs in China, the domestic market scale in the field of hepatitis C treatment will show a steady growth trend No.3 Zhengda Tianqing [concerned variety] androtinib (independent research and development of multi-target tyrosine kinase inhibitor, anti-tumor) is the most popular variety in the priority review list of Zhengda Tianqing The drug is a new anti-tumor 1.1 drug independently developed by Zhengda Tianqing Pharmaceutical Co., Ltd at present, a variety of cancer clinical trials are under way, including non-small cell lung cancer, soft tissue sarcoma, gastric cancer, colorectal cancer, medullary thyroid cancer, differentiated thyroid cancer and esophageal squamous cancer Enrotinib is a new type of small molecule and multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-kit, met and other kinases, and has the effect of anti-tumor angiogenesis and tumor growth; on the other hand, the drug "take two stop one" has a unique way of administration, which can keep the blood concentration stable in the treatment window for two weeks In 2015, arotinib was awarded the qualification of orphan drugs for ovarian cancer by the US FDA Enrotinib hydrochloride began to apply for clinical application in July 2010, and entering the priority review will undoubtedly speed up its listing Androtinib hydrochloride is expected to become the leader of the third-line treatment of advanced NSCLC, which can provide a new affordable choice of treatment drugs for patients with advanced lung cancer after the failure of the first-line and second-line treatment Favorable evaluation: the market performance of the first generic drugs is eye-catching From the perspective of the varieties already on the market, it takes only 21 days (azd9291 of AstraZeneca is approved in China) and 324 days at most for the listed products to obtain the priority evaluation qualification through public announcement and CFDA approval After the policy dividend of priority review was released, the first domestic drug on the market was Chengdu Yuandong's caffeinated citrate injection; the first imported drug on the market was Roche's trodzumab injection, adding the indications of systemic juvenile idiopathic arthritis Both drugs fall into the category of children's drugs So far, there are more and more varieties coming into the market through priority evaluation channels How about the performance of these varieties after coming into the market? In this paper, the author selected two varieties of kapofungin from Hengrui and gefitinib from Qilu to analyze the market competition pattern Kapofungin and gefitinib are both large varieties with a market scale of nearly 1 billion yuan, and they are currently listed as the first imitation Currently, only the original research and first imitation manufacturers are in the market pattern, and the market performance is of great significance for other varieties Kapofungin (first imitated enterprise: Hengrui) has broken the monopoly of foreign enterprises and has a good prospect Kapofungin entered the priority review channel in March 2016, and was approved in January 2017 It is the first imitated variety approved by Hengrui through the priority review Kapofungin was developed by MSD and first approved by FDA in 2001 The product is used for the treatment of invasive Aspergillus that cannot tolerate other antifungal drugs In 2005, it was approved to be imported and listed in China According to IMS data statistics, in 2016, the scale of drug use in China's sample hospitals with more than 100 beds was 740 million yuan From the perspective of growth trend, it is increasing year by year and the market growth is good Although the market share of Hengrui was about 2% in the first three quarters of 2017, it broke the previous market situation of moshadong and had an impact on the original research manufacturers Due to the promising market in the field of treatment, many enterprises are stepping up the research and development of kapofungin According to the statistics of China's new drug research and development test database, there are 53 acceptance numbers in the current research and development stage The market share of gefitinib (first imitated enterprise: Qilu) reaches 10%, which has a huge impact on the original research drug Gefitinib is an EGFR kinase inhibitor It was first developed by AstraZeneca, a pharmaceutical giant It has long been used as a first-line drug in the treatment of lung cancer Gefitinib is suitable for local advanced or metastatic non-small cell lung cancer that has received chemotherapy or is not suitable for chemotherapy On January 12, 2017, CFDA approved the anti-cancer drug gefitinib tablets produced by Qilu Pharmaceutical (Hainan) Co., Ltd., which is the first imitation of AstraZeneca "Iresa" After the gefitinib tablet of Qilu pharmaceutical enters the market, it will have a huge impact on the EGFR market of lung cancer According to IMS data statistics, the market scale in the first three quarters of 2017 was nearly 60 million yuan, breaking the previous AstraZeneca's dominant market situation, with a market share of 0-10%, which had a huge impact on the original research manufacturers According to the statistics of China's new drug R & D and testing database, 50 domestic companies are applying for the imitation of gefitinib Summary: since the priority review mode was launched, the time to market of the urgently needed drugs in the domestic market has been shortened From the perspective of the listed varieties, it only takes 21 days at the fastest and 324 days at the longest, indicating that this policy is close to the original target The priority review system will have a positive impact on the industry in the medium and long term On the micro level, the priority review system reduces the waiting time of new drugs, improves the efficiency of new drug research and development, and speeds up the listing of new drugs; on the macro level, the priority review system makes the limited review resources incline to the innovation and clinical urgently needed varieties, and the situation that the industry varieties are out of touch will be alleviated gradually From the perspective of current registration application, the probability of future benefits of pharmaceutical enterprises in the field of children's drugs, hepatitis antiviral drugs, antineoplastic drugs, first generic drugs and European and American Certified drugs will be greatly increased From the perspective of the listed varieties, the listed varieties can quickly integrate into the market, especially the first imitated varieties, which will have a huge impact on the original research manufacturers.