Review and approval of drugs & report on the market situation, upgrade the drug supervision action, attack the tax heavily, and the elimination competition of drug companies has become white hot

Drug review, approval & report of drug listing in May the data of drug acceptance, approval and consistency evaluation application are published! In May, the total acceptance amount of the drug examination center was 562 (calculated according to the acceptance number, excluding reexamination), including 418 chemical drugs, 32 traditional Chinese medicines, 95 biological products, 3 pharmaceutical packaging materials, 7 pharmaceutical excipients, 6 APIs, and 1 in vitro diagnostic reagent Among them, there are 17 acceptance numbers for class 1 new chemical drugs, involving 6 varieties and 6 enterprises, including rmx1002 tablets declared by Hangzhou Ruoming Pharmaceutical Co., Ltd and clinical trial application for zilonapine succinate raw materials and tablets, an innovative drug submitted by Jiangsu Enhua Pharmaceutical Co., Ltd This month, the total number of approved drugs is 19, including the approval of Zhengda Tianqing heavyweight innovative drug - androtinib hydrochloride capsule (trade name: fukewei), the Valsartan tablets declared by Zhejiang Huahai Pharmaceutical Co., Ltd have been approved for listing, Jiangsu Hengrui two class 1 therapeutic drugs - biological products injection shr-a1403 (specification: 40mg), injection shr-1501 (specification: 1mg) have been approved for drug clinical trials, and Jiji Gilead's new drug of hepatitis C, propranolol (suophobuvir 400mg / vpatavir 100mg), has been approved by the State Food and Drug Administration for the treatment of adult patients with gene 1-6 chronic hepatitis C virus (HCV) At the same time, propranolol combined with ribavirin (RBV) has been approved for the treatment of adult patients with hepatitis C and decompensated cirrhosis In addition, this month, the acceptance number of No 43 declaration according to the requirements of consistency evaluation was added, including 21 injection acceptance numbers On June 6, the national drug review and Approval Center released the public list of the 29th batch of drug registration applications to be included in the priority review process, involving 44 acceptance numbers Among them, Changchun hi tech, Zhifei biology, Hengrui medicine, Huahai medicine and other listed companies were selected In terms of application items, there are 12 new drugs on the market, 2 new drugs in clinical practice and 30 generic drugs on the market It is reported that up to now, this year, the drug Audit Center has released four publicity lists of drug registration applications to be included in the priority review process, involving 133 varieties in total 192 drugs are about to go on the market Hengrui, Qilu and Tianshili have released the notice of clinical trial data verification (2015 No 117) since July 22, 2015, which has started serious supervision on the data authenticity and integrity of registered application varieties In the past three years, routine self-examination and normalization verification have entered a new regulatory stage On June 5, the State Food and Drug Administration issued the document No 30 of 2018 on clinical trial data verification, preparing to verify 192 drugs, including 19 new drugs, 153 generic drugs, 7 imported drugs, 8 imported re registration and 5 supplementary applications, which also means that these drugs will cross the final threshold of listing application, and a batch of pharmaceutical enterprises will usher in the harvest period, involving Tianshili, Huabei pharmaceutical, Shiyao and Hengrui , Zhengda Tianqing, hausen, etc National Drug Administration elected member of ICH management committee! At 1:30 p.m local time, on June 7, 2018, at the first meeting of the International Conference for the technical coordination of human drug registration (ICH) held in Kobe, Japan, China drug administration was elected as a member of the ICH management committee In June last year, at the ICH conference held in Montreal, Canada, CFDA was officially approved as the eighth member of the global regulatory body According to the analysis of the insiders, for the pharmaceutical industry, the impact is even greater than that of China's accession to the WTO in that year, and it will bring great challenges to the enterprises: 1 The generic pharmaceutical market will be accelerated to shuffle; 2 China's evaluation standards and regulatory system need to be improved, and the enterprises will be eliminated faster; 3 The number of eliminated pharmaceutical enterprises will reach 90% The State Food and Drug Administration will carry out on-site inspection on 201 pharmaceutical enterprises one by one Recently, the State Food and drug administration has formulated the 2018 drug follow-up inspection plan, which will carry out on-site inspection on 201 drug manufacturers one by one, including 38 enterprises with more problems found in the national sampling inspection in 2017, 40 enterprises producing vaccine biological products, 28 enterprises producing blood products, 15 enterprises producing narcotic drugs, psychotropic drugs and drug precursor, and 15 newly approved injection enterprises There are 60 pharmaceutical imitations manufacturing enterprises and 20 special inspection manufacturing enterprises In addition, the General Administration will increase the intensity of flight inspection For the enterprises with serious problems found in the flight inspection in 2017, the methods of "review" are adopted, focusing on the implementation of rectification after the last flight inspection On June 6, the State Food and Drug Administration issued a notice on Further Strengthening the supervision of medical devices and cosmetics during the institutional reform In the fourth point, strengthening the supervision of the production, circulation and use of drugs, medical devices and cosmetics, it is mentioned that the illegal promotion of retail pharmacies and the sale of prescription drugs by pharmacists should be seriously punished At the same time, we will focus on cracking down on such illegal acts as drug trading enterprises purchasing drugs from illegal channels, and drug manufacturers not producing drugs according to approved prescription processes On June 6, Chengdu Municipal Office of State Administration of Taxation announced the "top ten typical cases of false invoices" and the list of tax arrears in 2017 From the two data, drug companies are the focus of attack Three pharmaceutical enterprises are involved in the "top ten models": Sichuan Longdu Pharmaceutical Group Co., Ltd., Chengdu Chunsheng Pharmaceutical Co., Ltd and Chengdu Huinong traditional Chinese Medicine Development Co., Ltd., with the total amount of the first two involving nearly 700 million yuan Sichuan Longdu Pharmaceutical Group Co., Ltd obtained 4525 special VAT invoices falsely issued by 44 companies through false purchase of traditional Chinese medicine and fictitious entrusted processing business, involving 445 million yuan and 58.4466 million yuan of tax, all of which have been deducted Chengdu Chunsheng Pharmaceutical Co., Ltd adopts the false means of goods procurement, and accepts 1702 special invoices for value-added tax falsely issued from 6 companies in Henan, Chengdu, Suining and other places, involving 219 million yuan and 37.3036 million yuan of tax, and the company has been fully certified and deducted According to the list of enterprises in arrears in 2017, traditional Chinese medicine enterprises have become a "disaster area" with a total number of more than 10 Among them, Sichuan Huanyuan Pharmaceutical Development Co., Ltd and Sichuan Tianzong Pharmaceutical Co., Ltd rank top two in the "tax arrears list", top ten in the list, as well as Chengdu shangshantang Pharmaceutical Co., Ltd and other pharmaceutical companies At the same time, the amount of tax arrears is also very large For example, the enterprise income tax of Sichuan Huanyuan Pharmaceutical Co., Ltd has exceeded 130 million yuan, the value-added tax has also reached 85 million yuan, and the total amount has reached more than 200 million yuan According to CCTV, 93 drug companies in a province closed down and were sold on June 5 From the CCTV financial channel series "looking for the real growth of the pharmaceutical industry", it is learned that in the past six months, 93 drug distribution companies or industries in Henan have closed down or been acquired By the end of 2017, there were 303 pharmaceutical logistics wholesale enterprises in Henan, so far, there are only more than 210 One of the reasons is the national policy, and the other is the merger and reorganization with commercial companies On June 2, Jiangzhong pharmaceutical, a star enterprise of over-the-counter Chinese patent medicine, was sold Jiangzhong pharmaceutical issued a summary of the report on acquisition by offer, which made it clear that China Resources pharmaceutical, based on the offer price of 25.03 yuan per share, held 56.97 shares of Jiangzhong pharmaceutical with a total capital of 4.278 billion yuan According to the comprehensive statistical ranking of China OTC Association, Jiangzhong brand Jianwei Xiaoshi tablet won the first place of "Chinese patent medicine digestion" in 2017 In addition to Jianwei Xiaoshi tablets, Jiangzhong pharmaceutical also has Jiangzhong compound Caoshanhu buccal tablets, Jiangzhong Liangsheng and other fist products In addition, Jiangzhong pharmaceutical has signed contracts with more than 1500 distributors across the country, and has built a channel fine control system covering 21 provinces, 5 autonomous regions and 4 municipalities directly under the central government On June 7, Kangze pharmaceutical, the first-line distribution platform in China, was sold Zhongzhu medical intended to purchase 74.5262% shares of Kangze pharmaceutical held by 27 shareholders of Kangze pharmaceutical in cash According to the estimated value, 74.5262% equity of Kangze pharmaceutical is about 1.833 billion yuan, and the estimated price range is 1.833 billion yuan to 2.012 billion yuan The estimated price is 0% - 9.76% higher than the estimated value It is reported that Kangze pharmaceutical industry was established in 2003 Its main business is pharmaceutical distribution Its core business is full platform distribution of foreign drugs, chronic disease prescription drugs and domestic first-line brand varieties Hunan Xiangzhong Pharmaceutical Co., Ltd., the production base of antiepileptic drugs, has been sold recently Huarun Shuanghe announced that it would use its own funds to acquire 40% of the equity of Huarun Shuanghe Limin Pharmaceutical (Ji'nan) Co., Ltd., with a purchase price of 847 million 660 thousand yuan Upon completion of the acquisition, the company will hold 100% equity of China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd On the same day, China Resources Shuanghe also announced that it had publicly delisted 45% of the shares of Hunan Xiangzhong Pharmaceutical Co., Ltd through Chongqing United Property Rights Exchange, with a transaction price of about RMB 143.87 million It is reported that China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd has three dosage forms: tablet, capsule and small volume injection, including more than 100 products such as antibiotics, cardio cerebrovascular, vitamins, digestive system and antiviral hormones Among them, citicoline sodium tablets, irbesartan dispersible tablets and nifedipine sustained-release tablets belong to more than 100 million varieties Hunan Xiangzhong Pharmaceutical Co., Ltd is the national production base of antiepileptic drugs Its main products are sodium valproate, valproamide, magnesium valproate and magnesium valproate sustained-release tablets Among them, valproic acid series products occupy 80% market share of similar products in China In addition, the company has the right to import and export its products to Europe, the United States, Southeast Asia and other countries and regions Shanghai Yunjia Huangpu Pharmaceutical Co., Ltd., the largest pharmaceutical manufacturer for external use in China, was sold recently Yuanda Pharmaceutical Co., Ltd announced that its affiliated Yuanda Pharmaceutical (China) Co., Ltd plans to purchase 100% equity of Shanghai Yunjia Huangpu Pharmaceutical Co., Ltd from Yunjia Far East Co., Ltd at a price of 1.551 billion yuan (the same below) It is reported that Shanghai Yunjia Huangpu Pharmaceutical Co., Ltd is one of the largest and most complete pharmaceutical product manufacturers in China It is a well-known brand of over-the-counter drugs, accounting for more than 90% of all products, and its over-the-counter drug distribution network covers 29 provinces and regions in China In addition, according to the announcement, of the nearly 60 varieties produced and operated by Shanghai Yunjia Huangpu Pharmaceutical Co., Ltd., eight are national essential drugs, and more than 50% are listed in the national medical insurance catalogue As of December 31, 2017, Shanghai Yunjia Huangpu Pharmaceutical Co., Ltd realized net profit after tax of 118 million yuan and net assets of 266 million yuan.