According to the new response of the special group, all other batches of Wuhan biological baibaipo are qualified; according to the big plan of the medical insurance bureau, can these two kinds of drugs get the lowest price and get 70% market share?

This week, there was a new response to the disqualification of biological vaccine potency in Wuhan; the big plan that the national health insurance bureau is brewing came to the surface; two 289 catalog drugs will be the first to pass the consistency evaluation; the prices of various raw materials drugs skyrocketed, and drug companies are suffering; Baiji Shenzhou officially landed on the Hong Kong stock exchange, and Jun shibio submitted the listing application What other hot spots? Let's take a look at the latest news of the vaccine incident The latest progress of Wuhan biological diphtheria incident: all other batches are qualified, and the administrative penalty is light On August 10, according to Xinhua news agency, according to the verification team composed of the State Food and Drug Administration and the national health and Health Commission, Wuhan biological production batch number 201607050-2 potency unqualified pertussis vaccine was produced on July 19, 2016 Stop the machine for 20 minutes due to the failure of the transmission chain of the subpackage equipment During the shutdown period, due to the insufficient shaking of the semi-finished product buffer tank before filling, the distribution of the effective ingredients of the batch of vaccine is uneven During the factory self inspection of the enterprise, no special inspection was carried out for the sub packed products during the failure period, so that the self inspection potency results could not truly reflect the quality of the batch of vaccines After verification, Wuhan biological company has recalled all unused vaccines in this batch and destroyed them under the supervision of Wuhan drug regulatory authority The quality indexes of other batches of DPT vaccine of Wuhan biological company were all qualified In addition, the inspection team found that the local regulatory authorities had the problem of inadequate supervision, the punishment for the accident was not strictly and seriously in accordance with the relevant national laws and regulations, and the administrative punishment was relatively light Progress of Changchun Changsheng vaccine case: four years ago, the investigation team of the State Council announced the progress of investigation on the illegal production of rabies vaccine by Changchun Changsheng company According to the investigation team, Changchun Changsheng company has seriously violated the relevant provisions of the drug production quality management specifications and the national drug standards in the production of rabies vaccine since April 2014 Some batches were mixed with expired stock solution, the date and batch number were not filled in, and some batches were later marked with the production date At present, the recall work is in progress At the same time, the experts of the expert group made a comprehensive evaluation and suggested that those who have not yet completed the vaccination procedures should be vaccinated with the qualified vaccines of other companies for free According to the characteristics of rabies, those who have completed the vaccination procedure do not need to be replanted Recently, the investigation team went to Shangluo, Shaanxi Province to check the issue of children's vaccination In response to the "problem of children's vaccination in Shangluo" reflected by the network, the national health and Health Commission attached great importance to it and the leaders of the Commission made prompt instructions On August 5, the national health and Health Commission sent an investigation team to Shangluo City, Shaanxi Province to carry out on-site inspection Progress of consistency evaluation: two 289 catalogue drugs will be the first one to pass the evaluation by August 8, with a total of 287 acceptance numbers applied for consistency evaluation, involving 119 varieties of 120 enterprises, and 60 acceptance numbers This week (August 2 to August 9), there are 16 new acceptance numbers of conformity assessment, involving 12 varieties of 12 enterprises; the application for conformity assessment of lamivudine tablets of Shanghai desino biomedical Co., Ltd and glimepiride tablets of Yangtze River Pharmaceutical Co., Ltd has shown "approval completed - to be certified" It is worth mentioning that these two drugs are 289 catalogue varieties, and are also the first enterprises Declared varieties In addition, Hengrui's desflurane for inhalation also went on the market in China this week According to the relevant policies of consistency evaluation, the drug is deemed to pass the consistency evaluation and overtake in the corner (for more detailed analysis of consistency evaluation varieties involved in this week, please click to view "good drug record") review and approval dynamic 31 batches of proposed priority review list are released, and more than half of the varieties are expected to pass the consistency evaluation quickly On August 9, CDE announced that 17 drugs in the 31st batch were included in the list of priority review drugs Among them, 9 varieties belong to the situation that the European and American co production has been put on the market in Japan and transferred to domestic approval, and re declared after the information has been improved according to the consistency evaluation standard after the initiative withdrawal, and the other two are the first declaration one year before the patent expires These varieties will have priority review, which is undoubtedly faster than the review according to the normal process Competitive products have more advantages After passing, it can be seen that they pass the consistency evaluation There are 15 manufacturers in the priority review list, including 13 domestic enterprises and 2 foreign enterprises Among them, Ouyi and Huahai pharmaceutical have the largest number of products, each with two These 48 imported drugs are expected to speed up the market On August 8, CDE issued a draft for comments on the list of 48 overseas clinical urgently needed new drugs, and made it clear that for those who have not yet applied or are carrying out clinical trials in China, if the applicant considers that there is no ethnic difference through research, they can submit or supplement all the research materials and supporting materials obtained abroad and directly apply for listing SFDA will Accelerate the review and approval in accordance with the priority review and approval procedures Among the 48 varieties, 4 have been approved for listing, 22 have been declared by enterprises, and 22 have not yet found the declaration information of enterprises On August 7, 8 drug approvals were cancelled, and the State Food and Drug Administration issued 8 drug approval documents, 7 of which are from Guilin Xingda Pharmaceutical Co., Ltd., involving 6 varieties One is zoledronic acid for injection of Novartis, which is applied for automatically by the enterprise Subsequently, the media released an article titled "Novartis star drug, voluntarily withdraw from the Chinese market" In response, Novartis issued a clarification statement on August 8, saying that zoledronic acid for injection (Zetai) only cancelled the previous approval number, changed the dosage form of the product, and replaced all the powder injections by the water injection type, and did not withdraw from the Chinese market Recently, according to relevant media reports, the national medical insurance bureau is preparing the most radical plan since its establishment - the first drug centralized procurement pilot at the national level, asking for opinions from four municipalities directly under the central government, seven sub provincial cities and cities specifically listed in the plan If this plan can be passed in each pilot city, whether it is the original research drug or the generic drugs and reference reagents that have passed the consistency evaluation, as long as the lowest price in China can be quoted, 70% market share of each pilot city will be obtained Under the leadership of the state health insurance bureau, the initiator of this round of centralized drug procurement will become the largest single purchaser in China It is reported that 11 cities participated in the pilot project, including 4 municipalities directly under the central government (Beijing, Shanghai, Tianjin, Chongqing), 7 sub provincial cities and cities with separate planning (Shenyang, Dalian, Guangzhou, Shenzhen, Xiamen, Chengdu, Xi'an) These cities are either large and medium-sized cities with large medical institutions or provincial capitals with radiation effects in surrounding areas 18 varieties have been included in the new round of special negotiations on anticancer drugs, with 2 domestic drugs recently Xiong Xianjun, the health insurance leader of the National Medical Security Bureau, told CCTV that it is expected to complete the health insurance negotiations on 18 anticancer drugs by the end of September After 60 tumor clinicians voted to select and obtain the will of the enterprise, 18 drugs were determined to be included in the negotiation scope, and all of them are necessary clinical drugs for the treatment of blood tumors and solid tumors, including 16 imported drugs and 2 domestic innovative drugs Drug companies cry, a variety of API prices skyrocketed! Recently, according to Qianjiang Evening News, a senior pharmaceutical company disclosed that the price of APIs increased from 5 kinds to 14 kinds, the highest price increase record was set, phenol increased from 230 yuan / kg to 23000 yuan / kg, up 99 times Phenol is an important raw material for aspirin and other drugs According to the database of domestic pharmaceutical products, there are nearly one thousand approval documents for aspirin, involving many domestic pharmaceutical enterprises In addition to phenol, the price of chlorphenamine maleate, inosine, isoniazid, allopurinol tablets, amino acids, vitamins, uric acid, camphor and other APIs also increased On August 6, CDE issued a notice to regulate clinical medication and control the risk of clinical medication On the basis of summarizing and analyzing the safety information at home and abroad, it revised and improved some contents of the instruction of invert sugar injection and invert sugar electrolyte injection It is reported that the companies involved in the revision of the specification include: Yangzijiang Pharmaceutical Group Shanghai haini Pharmaceutical Co., Ltd., Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd., Bikang pharmaceutical Xinyi Group Holding Co., Ltd and Sichuan meidakangjiale Pharmaceutical Co., Ltd On August 9, Yifeng pharmacy chain Co., Ltd (hereinafter referred to as Yifeng) held the seventh meeting of the third board of directors and deliberated and passed the proposal on applying for M & A loans from banks It is agreed that the company shall apply to one of the commercial banks, such as China Merchants Bank, Shanghai Pudong Development Bank and Industrial Bank, for a total amount of no more than RMB 830 million M & a loan, with a term of no more than seven years, to pay or replace the equity consideration for acquisition of emerging pharmacy At the same time, in order to facilitate the implementation of the "chain drugstore construction project" in Jiangsu, Hubei, Guangdong, Jiangxi, Shanghai and other regions, special storage accounts for raised funds were opened for six subsidiaries respectively On August 8, Baiji Shenzhou stock listed on the Hong Kong stock exchange, Baiji Shenzhou officially landed on the Hong Kong Stock Exchange (Stock Code: 06160), becoming the first Chinese Biomedical Company to be listed in the US stock market and Hong Kong stock market at the same time The shares opened flat at HK $108 After the opening, the share price dived to HK $103 By the end of the day, Baiji Shenzhou had closed at HK $107.0, down 0.93%, with a market value of HK $82.1 billion Baiji Shenzhou focuses on the development and commercialization of innovative molecular targeting and tumor immunotherapy drugs for cancer treatment At present, it has three candidate drugs in the later stage of clinical research, zanubrutinib, tislilizumab and pamiparib On August 6, junshibio submitted its listing application in Hong Kong Junshibio (833330 OC), a new third board company, submitted its listing application in Hong Kong, intending to issue H shares CICC is the sole sponsor Junshi biology was listed on the new third board on August 13, 2015 The current trading mode is market making transfer, with a market value of RMB 12.876 billion At present, Junshi biology has obtained the ind approval of the State Food and Drug Administration for four drugs under research, and its core product, anti PD-1 monoclonal antibody injection js001, is carrying out phase I-III clinical trials of more than 10 indications, such as melanoma, NPC, gastric cancer, with a number of clinical centers in China Dongyao Pharmaceutical Co., Ltd obtained 102 million USD round B financing Dongyao Pharmaceutical Co., Ltd announced to complete 102 million USD round B financing (about 680 million RMB), which was participated by huitianfu and a number of domestic and foreign investment institutions, as well as the existing investors including Shengde group, vivo capital and so on Dongyao specializes in the R & D, production and marketing of high-end anti-tumor drug product pipelines At present, more than 10 drugs are under research This round of financing will be used to promote and ensure that the company further accelerates the research and development of new products and the commercialization of existing products Cctv.com official account, CCTV network, Qianjiang Evening News, cypress blue official account, health point public number, etc.