[week king] we're going to attack the policy of heavyweight, the hot spots in the pharmaceutical industry, and the frontier news of new drug research and development

Direct attack on the latest policy: pharmaceutical e-commerce is not allowed to sell prescription drugs and release prescription drug information On November 14, the General Administration issued the measures for the supervision and administration of online drug distribution (Draft for comments) (hereinafter referred to as the measures) According to the measures, the scope of online drug sales shall not exceed the scope of drug trading license of the enterprise If a business operator is a drug production or wholesale enterprise, it shall not sell drugs to individual consumers; if a business operator is a drug retail chain enterprise, it shall not sell prescription drugs or drugs with special management requirements of the state through the Internet In addition, the measures also stipulates that "websites selling drugs to individual consumers shall not publish prescription drug information through the Internet." (news source: CFDA) since December 1, there has been a new adjustment in the acceptance of drug registration! On November 13, the State Administration of food and Drug Administration issued the announcement on adjusting the acceptance of drug registration (No 134 in 2017) According to the research decision of the State Administration of food and drug administration, from December 1, 2017, the drug registration application accepted by the provincial food and Drug Administration and reviewed and approved by the State Food and Drug Administration will be adjusted to the centralized acceptance by the State Food and drug administration The above adjustments will be implemented from December 1, 2017 The application for drug registration can be submitted by electronic declaration, mail or on-site submission, with paper and electronic documents submitted at the same time (news source: CFDA) led by Fujian! On the afternoon of November 15, the Bureau of health and knowledge received the latest news The office of leading group for deepening the reform of medical and health system of Fujian Province printed and distributed the letter on Soliciting Opinions on the work plan and cooperation intention letter of "four provinces and one city" drug joint procurement The main idea of the letter is that Fujian medical insurance office and medical reform office have drafted the work plan for cross regional joint procurement of drugs in four provinces and one city and the letter of intent for cooperation in cross regional joint procurement of drugs in four provinces and one city (Draft for comments), and sent the draft to Shanghai, Jiangsu, Zhejiang and Anhui Medical Reform Office for comments We hope that the brother provinces and cities will give feedback before November 20 The closing indicated that the letter had been issued on 13 November (news source: Bureau of health and knowledge) let go! On November 14, Henan food and Drug Administration issued the notice on clarifying issues related to newly established drug wholesale enterprises (Draft for comments) (hereinafter referred to as draft for comments) It can be seen from the opinion draft that for the storage area of new drug batches, there is no specific and hard quantitative standard, but "the storage scale of drugs should be compatible with the expected storage and distribution capacity" It seems that Henan has given more advantages to the new drug wholesale enterprises Warehouse area is no longer specific requirements and rigid standards, which may be beneficial to reduce the cost of new enterprises (news source: Cypress blue) take a closer look at the consistency evaluation The consistency evaluation be exempt varieties are announced, 13 of which need self certification BCS classification On November 11, CDE officially released the list of exempted or simplified human bioequivalence test (be) varieties in 289 base drug catalog (Draft for comments) It is worth noting that this is only the first batch to be released, and there should be at least 2-3 batches later For this draft, according to the API category statistics, do a simple summary without distinguishing the dosage form differences 20 varieties recommend be exemption, 13 varieties recommend BCS classification of self certification, and then apply for be exemption The safety of bismuth preparation needs to be evaluated by PK method It is recommended to simplify be study for 12 varieties, and only after meal be study is needed Among them, CDE only gives varieties and specifications for 13 varieties of BCS classification of self certification, and does not explain the reasons why BCS classification of self certification is needed It can be inferred that the existing BCS classification is not clear or controversial (for example, at the critical point of classification) (news source: yaozhi.com) analysis of the latest be record / test data of consistency evaluation As of November 15, 2017, the be record platform has received 414 records, including 37 new varieties this month, 14 new varieties for the first time and 21 manufacturers for the first time
Further research found that 209 out of 414 had been registered in clinical trials, with 231 trials registered in total, 43 of which had clearly given the trial termination time For example, the number of be filings ranked first in Shenzhen xinlitai Pharmaceutical Co., Ltd was 75mg, which passed the ethical review of the ethics committee of the First Hospital of Jilin University on June 8, 2016 The be test was started on September 3, 2017 and terminated on May 27, 2017, lasting nearly one year In addition, through CDE registration and acceptance information, it is found that as of November 15, 2017, CDE has accepted 21 applications for consistency evaluation of changing prescription technology, 7 applications for not changing prescription technology or applications for exemption from the consistency evaluation, of which 17 applications for consistency evaluation have been filed by be (news source: yaozhi.com) focus on enterprise hot spots Huada's market value has increased 13 times to exceed 100 billion yuan It has only been listed for 4 months! On November 14, just four months after its IPO, the market value of BGI soared from the original 7.885 billion yuan to 100 billion yuan, becoming the second highest price of a share after Maotai, soaring from 13.64 yuan to 250 yuan Recently, BGI announced capital increase to three subsidiaries of Shenzhen BGI clinical laboratory Co., Ltd., Tianjin BGI medical laboratory Co., Ltd and Wuhan BGI medical laboratory Co., Ltd as an important part of the gene detection industry chain, BGI strengthened laboratory investment and technical strength In addition, Huada has also established strategic cooperation with Kangmei pharmaceutical in the development of traditional Chinese medicine products, gene detection of traditional Chinese medicine, efficacy evaluation of traditional Chinese medicine, and both sides are willing to build a joint research institute and company (news source: e drug manager) is committed to developing the world's first new drug for myocardial cell therapy Zesheng technology announced that it plans to raise 507 million yuan On the evening of November 15, Zesheng Technology (871392 OC) announced that the company plans to increase no more than 507 million yuan The raised funds will be mainly used for the project of restructuring people's Newland green, other projects under research, new experimental building project and supplementary operating funds The company has two major innovative drug R & D platforms with cardiomyocyte treatment technology and cell energy metabolism treatment technology as the core It has applied for 186 patents worldwide and obtained 73 authorizations Relying on the Zesheng cardiomyocyte treatment platform and leading technology, Zesheng technology has developed the core product neucardin for the treatment of chronic heart failure Gamma (reorganized by Newland green) This product is the first in class new drug with global patents and rights Once it is launched, it will break the magic spell of no major breakthrough in this field in recent 20 years (news source: arterial network) Guangzhou to add an all-round listed pharmaceutical enterprise! On November 16, the RMB common stock of yipinhong Pharmaceutical Co., Ltd was listed on the gem of Shenzhen Stock Exchange The securities are abbreviated as "Poinsettia" and the securities code is "300723" According to the latest information in the domestic drug database of pharma intelligence, there are 134 listed drug messages (calculated according to the approval number, the same below), including 98 chemical drugs and 36 traditional Chinese medicines Among them, 45 have been included in class B medical insurance and 34 have been included in class a medical insurance At present, only poinsettia is in production in China, such as compound Elsholtzia water, Huixinkang tablet, Fuganlin oral liquid, yiqijianpi oral liquid, qinxiangqingjie oral liquid and Shenbai lotion Chemicals such as dextrisoclonidine hydrochloride, clindamycin palmitate hydrochloride dispersible tablets, gentian soda tablets, acetylkitasamycin dry suspension, clindamycin palmitate hydrochloride dispersible tablets are only produced by this enterprise (news source: yaozhi.com) there is a "risk catalogue" of drug use for the elderly in China, which is led by China geriatric healthcare Medical Research Association, In conjunction with the geriatric branch of the Chinese Medical Association, the geriatric Professional Committee of the Chinese Pharmaceutical Association, the anti-aging and Alzheimer's Professional Committee of the Chinese Pharmacological Society, and the four university associations jointly revised the catalogue of potential inappropriate drugs for the elderly in China (revised simplified version) According to Wang Yuqin, chairman of the rational use of Drugs Branch of China geriatric healthcare Medical Research Association, the catalogue lists 72 potential inappropriate drugs for the elderly, including warfarin and clopidogrel, as well as the potential risks and ratings of each drug In clinical use, medical staff can guide the elderly to use drugs reasonably according to the risk point and risk intensity of drugs, combined with the disease status of the elderly (news source: ScienceNet) breakthrough products of several companies were approved by the FDA for listing On November 13, local time in the United States, the ability mycote of Otsuka Pharmaceutical Co of Japan was approved by the FDA, that is, the world's first digital drug was born It is reported that this is an antipsychotic drug It uses digital tracking to record whether to take the drug Once it reaches the intestine, it will send a signal to the smart phone, so that the doctor can track whether the patient takes the medicine according to the doctor's order In addition to Otsuka pharmaceuticals, breakthrough drugs from several companies were approved this week: Dynavax announced the approval of its hepatitis B vaccine, heplisav-b, which is used to prevent all known hepatitis B virus subtypes from infecting adults over the age of 18, the first new hepatitis B vaccine in the United States in 25 years, and the only dual dose hepatitis B vaccine for adults Roche announced that the FDA approved its hemlibra (emisizumab kxwh) as a routine prevention, prevention or reduction of haemorrhagic events in adult and child patients with hemophilia A A with factor VIII inhibitors It is also the first new hemophilia drug approved in 20 years Mepsevii (vestronidase Alfa vjbk), a new drug of ultragenyx pharmaceutical, was approved for marketing to treat MPS VII This is the first FDA approved innovative treatment for children and adults with MPS VII (news source: yaozhi.com) recently, Sangamo therapeutics announced that its first patient in the research and development of sb-913 has completed the drug administration This is the first time in human history to apply gene therapy and correct genes in patients This gene therapy is aimed at MPS II Sb-913 brought by Sangamo uses Sangamo's zinc finger nuclease (ZFN) genome editing technology to insert correct genes into specific sites of hepatocyte genome In order to limit the effect of this therapy to hepatocytes, AAV vector, which is responsible for delivering ZFN and correct genes, can target the liver After arriving at the liver, ZFN can be specifically activated in hepatocytes and recognize, bind and cut off specific sites in albumin gene Using the innate DNA repair mechanism of cells, hepatocytes can insert the gene encoding normal IDS into this site Unlike other gene therapies that use AAV to import cDNA and express functional proteins in vivo, Sangamo's technology can permanently insert IDS gene into human genome In other words, from the moment the treatment works, the patient's genes will never be the same Recently, Pfizer announced that the newly developed lung cancer drug dacomitinib is in a phase III clinical trial, which is similar to the current target drug (Iressa)