[Zhou Jun] the focus of the vaccine event shifted, and many departments went to Wuhan for biological verification; Hengrui, Qilu, and Ouyi heavy weight varieties of petrochemicals first passed the consistency evaluation!

In this week's hot spot, the State Food and Drug Administration issued a notice to adjust the review and approval procedures of drug clinical trials, and the new 60 day rule officially arrived The focus of vaccine event was transferred from Changsheng biology to Wuhan biology In response to this event, the State Food and drug administration, together with many departments, has gone to Wuhan for biological verification There are four varieties of consistency evaluation passed and 13 varieties were accepted, and the European medicine metformin hydrochloride has been accepted Tablets, ambroxol hydrochloride tablets of Jiangsu Hengrui and terbinafine hydrochloride tablets of Qilu pharmaceutical were first approved; what are the hot spots? Let's take a look: 1 The State Administration of drugs and Drug Administration issued the "60 days" new rules On July 27, the State Food and Drug Administration issued the announcement of the State Food and Drug Administration on adjusting the review and approval procedures of drug clinical trials (No 50, 2018), which adjusted the relevant matters of the review and approval of drug clinical trials: if the application for drug clinical trials is filed in China, the applicant has not received the General Administration of food and drug administration within 60 days from the date of application acceptance and payment If the drug review center of CAAC (hereinafter referred to as the drug review center) negates or questions the opinions, it may carry out drug clinical trials in accordance with the submitted scheme 2 Technical specification for e2b (R2) security message processing and individual security report In order to implement the notice of the former State Food and Drug Administration on the application of the secondary guiding principles of the International Conference for the registration of human drugs (No 10, 2018), CDE officially released the e2b (R2) safety information processing and individual safety on July 30, following the release of the standards and procedures for rapid reporting of safety data during drug clinical trials and the notice on relevant matters Technical specification for full report It is reported that at present, CDE has successfully received the individual case safety report (ICSR) during the clinical trial of drugs transmitted by the applicant according to e2b (R3) or e2b (R2) This technical specification is to ensure that applicants who have the transmission conditions of e2b (R2) before May 1, 2019, but have not been able to transmit according to e2b (R3) can report ICSR during clinical period as required 2 The latest development of the vaccine event: Wuhan biology, please don't be silent! On July 30, an industry person sent a message saying that the focus of online public opinion has shifted from longevity to Wuhan vaccine, after all, Shandong is to replant Wuhan biological vaccine It is reported that the focus of this public opinion is that there are 803985 pieces of Wuhan biosorption acellular pertussis combined vaccine 201607050 (1-2), and 400520 pieces of 201607050-2 batches are found to be substandard Then, whether Wuhan bio 201607050-1 has the same quality problem as the - 2 batch, after all, the batch is issued with a certificate number Some colleagues pointed out that - 1 and - 2 belong to sub batch number However, from which process is the dividing point of sub batches, Wuhan biology did not disclose any information Two state food and Drug Administration: the reason for the unqualified potency of Wuhan biological pertussis vaccine was accidental on July 31st The State Food and Drug Administration introduced the relevant situation of Wuhan biological pertussis vaccine It is found that in 2016, Wuhan Bio Technology Co., Ltd produced 201607050-2 batches of substandard vaccines with a total titer of 400520, sold 190520 to Chongqing Center for Disease Control and prevention, and sold 210000 to Hebei Center for Disease Control and prevention The enterprise recalled all unused vaccines and destroyed them under the supervision of Wuhan food and Drug Administration on May 4, 2018 By analysis, the main reason for the unqualified titer of this batch of vaccine is the short-term failure of the subpackage equipment, resulting in the uneven suspension of the products to be subpackaged, which belongs to an accident Sanoccasionally made a sound, which led to a heated discussion The State Food and drug administration, together with many departments, went to Wuhan for biological verification on July 31 The statement issued by the spokesperson of the State Food and drug administration that the disqualification of Wuhan biological diphtheria vaccine is accidental caused a heated discussion in the society Some insiders believe that the information in the article is not clear about the specific details On August 1, the State Food and Drug Administration (SFDA) issued a notice, and together with the health and Health Commission and other departments, a verification team headed by Li Li Li, Secretary of the Party group and deputy director of SFDA, went to Wuhan to carry out verification on the disposal of the unqualified pertussis vaccine in 2017 Four officials of Shandong Provincial Center for Disease Control committed suicide, which was once the bid evaluation committee member of DPT vaccine on July 31 According to the exclusive news from China times, song Lizhi, director of the Institute of immunology of Shandong Provincial Center for Disease Control and prevention, tried to commit suicide by injecting excessive insulin At present, he is being rescued in the ICU ward of Shandong Provincial Hospital, and he is not out of danger of life It is understood that song Lizhi is one of the five members of the bid evaluation committee of DPT vaccine won by Changsheng biology Five Changchun Changsheng is suspected of the crime of producing and selling substandard drugs 18 people were arrested on the evening of July 29 Xinhua News Agency announced that after the public security organ of Changchun carried out the investigation work, it basically found out the fact that Changchun Changsheng Biotechnology Co., Ltd is suspected of the crime of producing freeze-dried human rabies vaccine According to Article 79 of the criminal procedure law of the people's Republic of China, Changchun New Area Public Security Bureau, suspected of producing and selling substandard drugs, applied to the procuratorial organ for approval of the arrest of 18 suspects, including Gao Xifang, chairman of Changchun Changsheng Biotechnology Co., Ltd On July 31, Changsheng biology released the announcement of abnormal stock trading fluctuation of Changsheng Biotechnology Co., Ltd The announcement mentioned that at present, in addition to the production suspension of DPT combined vaccine and freeze-dried human rabies vaccine products, other products of the company have also taken a comprehensive and independent production suspension The current resumption time is uncertain The company's production and operation activities are seriously affected and it is expected that they will not return to normal within three months According to other announcements on the same day, 34 bank accounts of Changsheng biology and all its subsidiaries were frozen In addition, due to the freezing of bank accounts, the project of Changsheng Yungang biopharmaceutical Industrial Park, which plans to invest 1.2 billion yuan, has also been suspended 3 The latest trend of consistency evaluation: 4 passed, 3 first; 13 accepted, 4 289 catalog varieties as of August 3, 276 application acceptance numbers of consistency evaluation, involving 113 varieties of 116 enterprises, of which 61 acceptance numbers have passed the consistency evaluation What's the new trend of this week's consistency evaluation? Let's take a look at it with the editor This week (from July 25 to August 3), four varieties passed the consistency evaluation The export transfer of Omega hydrochloride tablets from the stone drug Ouyi to the domestic market was approved as the first one to pass the consistency evaluation Ambroxol hydrochloride tablets from Jiangsu Hengrui, terbinafine hydrochloride tablets from Qilu pharmaceutical, amlodipine besylate tablets from China Resources SECCO, and fumaric acid, a 289 catalogue of Chengdu Yuandong biology Co., Ltd One variety of bisoprolol tablet has been approved and passed soon This week, 15 new acceptance numbers of conformity assessment were undertaken, involving 13 varieties of 12 enterprises, among which 6 varieties were the first to be declared, namely, anastrozole tablets of Yangzi Pharmaceutical Group, tegacyclin for injection of Zhengda Tianqing, parixib sodium for injection of Hunan Kelun, cetirizine hydrochloride tablets of Xinhua Pharmaceutical, fluconazole tablets of Sichuan Kelun pharmaceutical and aipson pharmaceutical of Jiangsu Yabang In addition, there are four 289 categories of propranolol hydrochloride tablets, including cefuroxime ester tablets of Jiangsu Sinochem, propranolol hydrochloride tablets of Jiangsu Yabang Epson pharmaceutical, fluconazole tablets of Sichuan Kelun pharmaceutical and montmorillonite powder of Beijing Hanmei pharmaceutical (for more detailed analysis of consistency evaluation varieties involved in this week, please click to check "good medicine record") the second batch of 15 exempted or simplified be varieties was released On July 31, CDE issued a notice to draw up a list of the second batch of exempted or simplified human bioequivalence test varieties, involving 15 varieties, including vitamin C effervescent tablets (specifications: 0.3g, 0.5g, 1.0g), coenzyme Q10 capsules (specifications: 5mg, 10mg, 15mg), glucosamine oral solid preparations (all approved specifications), etc Before that, the first batch of be exempt varieties involved 57 varieties, and 48 varieties were determined in May this year On July 31, CDE issued a notice on the release of the draft for comments on the evaluation of 289 domestic endemic varieties in the catalogue, forming evaluation suggestions for 289 domestic endemic varieties in the catalogue and asking for public comments Previously, there were 19 domestic unique varieties in the 289 catalog, and CDE has stipulated these varieties: enterprises choose to carry out clinical trials again to prove their safety and effectiveness, and if they pass the follow-up review, they will pass the consistency evaluation; if enterprises do not choose to carry out clinical trials again, they are not recommended to use In this round, there are 22 unique varieties in China, and among the evaluation suggestions for each variety, 6 varieties CDE require the revision of the manual, because of the lack of clinical evidence 4 other hot information - drug bidding led by the National Health Insurance Bureau, here comes! Recently, the industry circulated a national health insurance bureau "on the convening of drug centralized procurement Symposium notice." The persons in charge of drug procurement and medical insurance in Beijing, Shanghai, Tianjin, Chongqing, Liaoning, Guangdong, Fujian, Sichuan, Shaanxi and other provinces, as well as those in charge of drug procurement and medical insurance in Shenyang, Dalian, Guangzhou, Shenzhen, Xiamen, Chengdu, Xi'an and other cities were called to the meeting According to the notice, the symposium will be held on August 3, which will introduce the basic ideas and implementation plans of the pilot drug centralized procurement organized by the state, listen to local opinions and make plans for the near future work From these information, it is more and more close to the State Medical Insurance Bureau's official bid invitation and purchase of drugs On August 1, two Geli companies officially went public in Hong Kong stock market, and Geli Pharmaceutical (01672 HK) rang the bell in Hong Kong stock market, officially becoming the first non revenue biotechnology company to IPO in Hong Kong stock market The offering price is HK $14 per share, which is in the middle of HK $12-16 After opening, it rose slightly, fluctuated above HK $14, and its market value is around HK $16 billion Geli obtained 55 million rounds a financing in 2015, and completed 100 million rounds B financing in January 2017 From 2016 to 2017, the company lost 62.689 million yuan and 130 million yuan respectively At present, Geli has five antiviral drug discovery and development plans, including two drugs under development near the commercialization stage of hepatitis C, of which the HCV treatment drug "gonovi" has been put on the market More than three drugs have been abandoned! Pfizer, Sanofi, Bayer and shire have adjusted their product lines In recent two years, the global pharmaceutical giants seem to recognize the focus on core products and technologies, reduce unnecessary product pipelines and fields, constantly adjust their corporate strategies, sell products (lines) acquired by huge amounts, and reduce employees Recently, Pfizer, Sanofi, Bayer and shire have made new moves: Pfizer has eliminated diabetes and anti-cancer drugs from the clinical product line; Sanofi's performance in phase 2 has declined and ADC tumor drugs and tuberculosis vaccine plans have been eliminated; Bayer has sold prescription dermatology business to Leo for drug preparation; shire has been approved by fast track to terminate phase 2 trials of Nash drugs Source: official account official website, drug review center official website, China times, drug Chi Hui official account, Sina medical public number, cypress blue official account, etc.