[Zhou Jun] a new round of "storm" of adjuvant drugs is coming; Huahai responds to the "media controversy" on 4 points; multinational pharmaceutical companies expose the "layoff tide" again

Looking back on the 40 years of reform, the SFDA strives for the simultaneous listing of innovative drugs at home and abroad in the future On December 12, the official website of the State Food and Drug Administration published a long article titled "go with the times, compose a new chapter of drug supervision - review of drug supervision in the past 40 years of reform and opening-up", reviewing the process of drug supervision in China in the past 40 years of reform and Opening-up: the sales revenue of the drug industry has increased by 346 times compared with that in 1978, 458000 registered licensed pharmacists have been registered, and 326 drug inspection institutions covering the whole country have been established 78 innovative drugs with independent intellectual property rights have been developed successively In terms of drug review and approval, the article mentioned that: the number of drug registration applications waiting in line for review in China has dropped from nearly 22000 at the peak in 2015 to less than 3000; 83 new drug applications independently researched and developed 165 have been approved for listing through the priority review process In addition, put forward the objectives for the evaluation of innovative drugs, accelerate the pace of listing of imported drugs, accelerate the evaluation and approval of drugs urgently needed in clinical practice, and promote the listing of new drugs on the market in China as soon as possible; strive to achieve simultaneous listing of innovative drugs on the market both at home and abroad On December 13, the national health and Health Commission issued the notice on the management of clinical application of auxiliary drugs, which clearly proposed to strengthen the whole process management of auxiliary drug selection, procurement and other links, and will also formulate and publish the national auxiliary drug catalog According to incomplete statistics, up to now, 14 provinces, including Beijing, Hebei, Shanxi, Inner Mongolia, Liaoning and Jiangsu, have issued relevant policies to explicitly regulate or restrict the use of auxiliary drugs, and 9 of them have published specific lists The "notice" released this time has also become a major action of auxiliary drug administration supervision from the country to the region for the first time With the increasingly strict regulatory policies for auxiliary drugs, it is analyzed that the main trend of auxiliary drugs in the future may be from being focused on monitoring to being completely discontinued If the nationwide discontinuation of auxiliary drugs is carried out, it will affect tens of billions of auxiliary drug market, and the whole pharmaceutical industry will face transformation and adjustment A new round of medicine anti-corruption storm has come, 5 medicines are suspected of kickbacks, and are stopped! In August this year, the general office of the State Council issued guiding opinions, which made it clear that public medical and health institutions should be mainly supervised to break the mechanism of supporting medical treatment with drugs and crack down on commercial bribery in the field of pharmaceutical purchase and sale Recently, a notice issued by the Discipline Inspection Committee of Bao'an District Health and Family Planning Commission of Shenzhen circulated in the medical circle The notice shows that recently, in the special action of self inspection and self correction of receiving medical kickbacks launched by the Bureau in August this year, problems of medical kickbacks were found in some hospitals Through verification and comparison, it was preliminarily determined that the kickbacks involved five drugs, including cefixime granules and injection The use of cefoxitin, Compound Pholcodine Oral Solution, Amoxicillin and Clavulanate Potassium for Suspension, Aluminium Phosphate Gel, involving a total of three pharmaceutical companies At present, the hospital has stopped the drugs involved The notice also requires to check the drug supply of the above-mentioned drugs, list the manufacturers and purchasing sources, and stop the drug supply immediately if there are three drug companies In 2018, 22 drug approvals were cancelled, Takeda, Merck, Johnson & Johnson On December 12, the State Food and Drug Administration announced the cancellation of 2 drug approvals, namely, midodrine hydrochloride tablets produced by takedaaustria GmbH and lornoxicam fast-release tablets produced by takedapharma / s According to the domestic drug database of pharmaceutical intelligence, midodrine hydrochloride tablets are currently produced by two enterprises in China, namely Sichuan anti pharmaceutical of Sinopharm group and Chengdu Aobang Pharmaceutical Co., Ltd.; the quick release tablets of lornoxicam are all imported from Wutian company In addition to the above two drugs, since the beginning of the year, the State Food and drug administration has cancelled 22 drug approvals, involving 19 drug companies and 10 enterprises Among them, there are seven foreign enterprises, including Takeda, Merck, Johnson & Johnson, Novo Nordisk, Novartis, and three local enterprises, including Zhengzhou Laishi, Guilin Xingda pharmaceutical, Shanxi KANGYI pharmaceutical The leading drugstores in the industry are "expanding the army", small and medium-sized chains are "difficult to survive", and 2669 drugstores in Chongqing are "disappearing" Recently, according to data from Chongqing food and drug administration, as of the beginning of this year, the number of drug dealers in Chongqing has been reduced from 16099 in 2016 (as of November 2016) to 13430, with a 16% decrease, that is to say, the number of drugstores has been reduced by 1 / 62669 in more than one year At present, Chongqing's retail pattern has been gradually formed The first tier is led by TongJunGe, Heping, Wanhe and Xinhu families; the second tier includes wanjiayan, Zhenshanmei, Yixintang Chongqing company and other rising stars According to the third quarter financial report of xinyitang, it has built 341 new stores in Yunnan, and thousands of new stores in Sichuan, Chongqing, Guangxi, Hainan and other places it relies on On December 11, Yunnan Hongxiang Yixintang Pharmaceutical (Group) announced that it planned to purchase 28 stores' assets and their inventories held by Qujing Kangqiao with no more than 15.1 million yuan In fact, since last year, a large number of small and medium-sized chains have appeared in the list of four private listed chains From January to September, Yifeng carried out 11 mergers and acquisitions, including 9 chains with the size of 20 stores, accounting for 72.7%; 8 chains with the number of stores less than 20 for ordinary people, accounting for 100% Industry insiders believe that with the gradual landing of classified and hierarchical management and the "expansion" of regional leaders, the living space of drugstores will be further compressed Another drug is out of production due to a shortage of APIs! On December 12, Shanxi Pharmaceutical Machinery Co., Ltd issued the notice on publicizing the cancellation of the qualification of compound Amway capsule hanging on the net, which showed that due to the shortage of raw materials, the production of compound Amway capsule of Lepu pharmaceutical had stopped, so the enterprise applied for the cancellation of hanging on the net in Shanxi Province, and promised to cancel the hanging on the net and supply nationwide The product manual shows that the compound Amway capsule is used for auxiliary treatment of hypoproteinemia caused by various diseases At present, 5 pharmaceutical companies hold their approval numbers According to the quotation of kangaido, an online pharmacy, Wuxi Zhengdong Pharmaceutical Co., Ltd has 30 compound Amway capsules per box with a retail price of 18.5 yuan, which is relatively low Cost control, focus on advantage business, multinational pharmaceutical companies again exposed the "layoff tide" this week, Boehringer Ingelheim, Sanofi was exposed layoff news Boehringer Ingelheim plans to cut more than 10% of the French workforce, 327 jobs in total; Sanofi also plans to cut 670 jobs in France For the reasons of layoffs, both pharmaceutical companies have given similar answers: cost control, focus on the advantage business Apart from Boehringer Ingelheim and Sanofi, this year's job cuts for similar reasons include: Bayer's total job cuts of 12000; Novartis' more than 2200 jobs in its headquarters in Switzerland; Novo Nordisk officials' 400 job cuts in China and Denmark; GlaxoSmithKline's 650 job cuts in the United States, etc The latest, the 2018 FDA new drug review report is published! Recently, CDER under FDA released the drug review report for 2018 (as of November 30) So far, FDA has approved 55 new molecular entities (NME), 41 of which are NDA and 14 are bla, a new record Among these new drugs, more than half of them have obtained the qualification of orphan drugs, 30 of which have obtained the qualification of orphan drugs, including 9 Blas and 21 NDA (for details of orphan drugs, please refer to the article [inventory] new orphan drugs approved by FDA in 2018, a new record!) The enterprise hot spot FDA warning letter cited disputes Huahai 4 points responded on December 12 The U.S FDA disclosed on its official website a warning letter issued to Huahai pharmaceutical after conducting a cause based inspection of the South Sichuan API production base of Huahai pharmaceutical from July 23 to August 3, 2018 After the warning letter was issued, it caused heated discussion in various media On December 14, Huahai pharmaceutical released a notice, explaining the discovery process of NDMA impurities, how to deal with the problem batch, whether there are related unknown peaks that have not been investigated, and the investigation on the causes of NDMA impurities In response to the hot discussion of NDMA impurity discovery process, Huahai responded that the customer reminded Huahai to pay attention to an unknown impurity during the determination of valsartan residual solvent, and then Huahai actively informed the customer and relevant regulatory authorities after investigation and confirmation In response to the hot discussion on how to deal with the problem batches, Huahai said: in the FDA warning letter, "on September 13, 2016, the company received a complaint" and "Huahai had APIs that were returned and sold to the non-U.S market after reworking" The products mentioned here are the company's levetiracetam APIs, and there is no media report that valsartan APIs were returned and reworked and sold to the non-U.S market Condition In addition, in view of whether there is an unknown peak, Huahai said that the company reported by the media did not make an investigation several years ago because it confused a known impurity (ethyl carbamate) in another product of the company (levetiracetam) mentioned in the warning letter with the NDMA impurity in valsartan Huahai did not have the situation that customers complained about the unknown peak several years ago and did not make an investigation Changsheng biology was forced to withdraw from the market, Gao Junfang and others were banned from entering the market for life on December 11, * ST Changsheng issued a notice saying that it had received the notice of major illegal compulsory delisting from Shenzhen Stock Exchange, the decision of administrative penalty from CSRC and the decision of market prohibition from relevant personnel, and Shenzhen Stock Exchange planned to implement major illegal compulsory delisting of its shares This also means that Changchun Changsheng, which has been debating about the issue of vaccine since the issue, is really going to bid farewell to the secondary market for the time being In addition, the CSRC decided to ban Gao Junfang, Zhang Jing, Liu Jingye and Jiang Qianghua from entering the market for life, and Zhang Youkui, Zhao Chunzhi and Zhang Minghao from entering the market for five years Great Hengrui! Three innovative drugs have been approved for clinical use, and one of them has entered phase 3 On December 10, Hengrui Medicine released a notice Its first class chemical new drug, shr2150 capsule, has been approved for clinical use and is intended to be used for the treatment of advanced cancer In addition, since December, Hengrui has also announced the approval of three innovative drugs It includes 1-class chemical shr2285 tablets (to be used for the prevention or treatment of arteriovenous thrombosis), 1-class chemical shr2150 capsules (to be used for the treatment of advanced cancer), 1.1-class chemical shr0302 tablets (to be used for the treatment of moderate and severe ulcerative colitis and Crohn's disease) In addition, according to the announcement in December, Hengrui will also open the phase 3 clinical application of its own developed humanized anti-PD-L1 monoclonal antibody shr-1316 injection in the near future, which is mainly used for the treatment of malignant tumors Hengrui has spent 150.78 million yuan on the above four innovative drugs Content source: Chongqing business daily, medical network, health and Information Bureau, cypress blue, announcement of listed enterprises, State Food and Drug Administration and other statements: this point of view only represents the author, not the position of pharmaceutical intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.