"One week Jun" 17 kinds of drugs "turn off"; the FDA three documents to help "breakthrough treatment drugs" audit; Heng Rui set up a new company, target ingons of anti-viral fields; Rao Yi sent a new quality ...

Guide: a paper document, 17 kinds of drugs helpless to enter the "OTC" field, good or bad still unknown? !---- this week's look at 17 drugs "turned non-" ; three FDA documents to help "breakthrough therapeutic drugs" review; Hengrui set up a new company to target the field of antivirals; FDA warning letter, involving Lianhua Qing's plague capsule step-step pharmaceutical to transfer a subsidiary to Kyushu Tong; government to hear 17 drugs "turn edified non", July 8, national drug drug According to the regulations of the Regulation Administration's official website on the conversion of 17 drugs, such as dredging particles, to over-the-counter drugs, the regulations on the classification and management of prescription drugs and over-the-counter drugs (Trial) (No10 of the State Drug Administration Order) have been verified and verified by the State Drug Administration, and 17 kinds of drugs have been converted from prescription drugs to over-the-counter drugs, and the list of varieties and the model version of over-the-counter drug instructions have been issuedthese 17 drugs include: dredging particles, exhausting particles, seven-leaf Shen'an dispersion tablets, cocked toothache particles, fennel positive gas capsules, ten drops of drops of gel pills, Sydney cough syrup, compound yimother capsules, antibacterial anti-inflammatory capsules, six-flavored yellow chewing tablets, hundred-year-old tablets, co-capsulecapsules, gegen soup tablets, eight-jin tablets, Sichuan mussels, spleen cake tablets and six-flavored bloodthe three documents of the Drug Administration to assist the "breakthrough therapeutic drugs" review On July 8, the Official Website of the State Drug Administration announced that, in line with the implementation of the Measures for the Administration of Drug Registration, the State Drug Administration organized the "Breakthrough Therapeutic Drug Review Work Procedure (Trial)" "Drug Conditional Approval Application Review and Approval Procedure (Trial)" and the "Drug Market Registration Priority Review and Approval Procedure(Trial)" and was officially releasedWith the deepening of drug review reform, the review backlog has been fundamentally resolved, the review time limit has entered a normal state, learning and learning from international regulatory experience, exploring the construction of more accelerated innovation drug approval and listing of the "highway" has become an important consideration of scientific supervisionthis release of the document, formally defined the scope of breakthrough therapeutic drugs, at the same time in the priority review and approval of breakthrough therapeutic drugs, conditional approval of the market-registered drugs into the scope of application and conditions, from the system to further improve the regulatory path of accelerated review and approvalnew guidelines for cell and gene therapy will be published on July 6th, the Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center) issued the Technical Guidelines for Clinical Trials of Immunocellular Therapeutics Products (the Draft for Comments) (hereinafter referred to as the "Principles")," for public commentsPrinciples apply to immunocellular therapy products developed and registered in accordance with relevant regulations on drug administration, and are intended to provide the necessary technical guidance in the overall planning, design, implementation and data analysis of clinical trials of such products in order to maximize the safety and legitimate rights and interests of subjects to participate in clinical trials, and to standardize the evaluation methods for the safety and effectiveness of immunocellular therapy productsthe Principles are the first technical guidelines issued after the launch of the "Research on The Technical Evaluation and Regulatory System of Cell and Gene Therapy Products" as one of the first research projects of the National Drug Administration's China Pharmaceutical Regulatory Science Action Planindustry hot news seven departments issued: put an end to the pharmaceutical authorities July 6, Guangxi Zhuang Autonomous Region Health and Health Commission and other seven departments issued "on further do a good job in the management of medical institutions to promote rational drug use work notice" (hereinafter referred to as "Notice")the Notice requires that public medical institutions at all levels quickly check the irregularities in the work of pharmacy services, especially the relevant situation of pharmacy custody, formulate inspection and correction programs, clarify the division of tasks and time progress, and complete the work of inspection and correction in a solid wayaccording to the "Notice" arrangements, July 29, public medical institutions at all levels to complete the investigation and correction: district medical institutions will report the situation to the Autonomous Region Health and Health Commission;before July 31, by the municipal health and sanitation committee to summarize the situation in their own jurisdiction to form a report and report to the autonomous region health and health committeethe purpose of this circular is to emphasize: strictly prohibit hospitals designated distribution enterprises and pharmacies, put an end to hospital pharmacy contracting, leasing, strengthen the interface of medical union drugs, strengthen clinical monitoring and evaluation of drugs, and further encourage hospitals to be equipped with base drugsFDA warning letter, involving Lianhua Qing pestist capsule July 7, the FDA issued four consecutive warning letters against Chinese medicine, because it promoted the new crown pneumonia-related preventive treatment effects, the FDA identified as "fraudulent" productsin three warning letters, including the encase difosFDA says some of the observation sites offer Chinese medicine (TCM) products sold in the U.S designed to alleviate, prevent, treat, diagnose or cure COVID-19 , according to the FDA, these products violate the federal Food, Drug and Cosmetic Act (FD-C) and are new drugs that are not approved the lack of strong clinical data on the role of "new coronary pneumonia" mentioned in the Rao Yi wrote again to question GV97July, the current president of the Capital Medical University Rao Yi, as a member of the "Cell Research" editorial board, issued a letter questioning the Chinese Academy of Sciences Shanghai Pharmaceutical Institute Geng Meiyu team research fraud this is the second time Rao Yi has pointed the finger at Geng Meiyu's team after reporting his real name at the end of November last year There are two main aspects of questioning: one is that any previous article published by the team in the study, which casts doubt on the magic of GV971, and says that "never met a drug that has so many targets for treating or alleviating a disease." " at the same time according to the official website of the State Drug Administration, "July 08, 2020 drug notice pending release information" shows that GV-971 another specification of the listing application has not been approved, whether or not related, the value of this period, has to be suspicious drug record procurement tightening, in-hospital channels to open up and then the problem! On July 9, the Guangxi Zhuang Autonomous Region Medical Insurance Bureau and the Health and Health Commission jointly issued the Notice on Further Standardizing the Procurement of Drug Filings in Medical Institutions (hereinafter referred to as the Notice), which drew a number of clear "red lines" for the record-keeping procurement enterprise information Hengrui set up a new company, target anti-viral field July 6, Jiangsu Hengrui Pharmaceutical signed a notice, subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd invested 60 million yuan, related natural persons, the company's actual controller Mr Sun Fu fu contributed 40 million yuan, jointly set up a new company - Ruilidi (Shanghai) Biopharmaceutical Co., Ltd (Ruilidi) it is understood that Reddilli is responsible for the development, production, sales and related import and export business of antiviral therapy antiviral drugs are the company's new areas, this transaction is conducive to the company's rich product line, is an important part of the company's development strategy, to improve product structure, improve product market competitiveness has a long-term impact Hengrui into the field of anti-viral, specific deep cultivation of which aspect, we still do not know, but Hengrui management's vision, so that Hengrui can always be a step closer - whether it is the early selection of high-end generic drugs export, or tumor innovation, Hengrui are the fastest speed into the hot track, the future Hengrui will be how layout Reding Pharmaceuticals won the new variety of 1.2 billion recently, u.S.-listed re-ding Pharmaceuticals announced that it has entered into a licensing agreement with anti-cancer drug research and development company TurningPoint Therapeutics for a new generation of tyrosine kinase inhibitor Repotrectinib, which is in the process of being studied under the agreement, Reding Pharma will receive exclusive rights to develop and commercialize Repotrectinib in Greater China the total value of the deal was $176 million (rmb1,233 million) is understood to be working on a new generation of kinase inhibitors to be used to treat non-small cell lung cancer and advanced solid tumors caused by cancer-induced gene changes in ROS1 and TRK, and is conducting phase 2 registered studies worldwide Chengdu Bete IPO application accepted on July 6, 2020, Chengdu Bete Pharmaceutical Co., Ltd (hereinafter referred to as Chengdu Bete) ipo application on the GEM has been accepted by The Shenzhen Stock Exchange Chengdu Bete's initial public offering of shares and the GEM listing prospectus shows that the proposed public offering of no more than 50 million shares (excluding the over-allotment option), the total share capital after the issue does not exceed 50 million shares, after the issuance of the total number of shares issued after the total number of shares shall not be less than 10% is understood that Chengdu Bete company currently has more than 40 products have been located in the approval and listing stage its main business income mainly comes from the sale of preparation products, including anti-infection, reproductive system, cardiovascular, blood and hematopoietic systems and other sub-types of varieties , anti-infective drugs are their main source of income during the reporting period, Chengdu Bete anti-infective drugs sales revenue was 755.5909 million yuan, 151.78695 million yuan and 175.20569 million yuan, respectively, accounting for 67.30 percent, 60.19 percent and 54.24 percent of the main business income Sansheng Guojian next Monday to open the purchase of the evening of July 8, Sansheng Guojian Pharmaceutical (Shanghai) Co., Ltd (hereinafter: Sansheng Guojian) issued an initial public offering of shares and listed on the company board announcement, said that after the initial inquiry, the company determined that the IPO price of 28.18 yuan / share, the corresponding price-earnings ratio of 75.73 times, and will start on July 13 online and online purchase Founded in 2002, Sansheng Guojian is an innovative biopharmaceutical company focused on the research, development, production and commercialization of antibody drugs, and is also a subsidiary of Sansheng Pharmaceuticals, a Hong Kong-listed company according to the prospectus disclosed that the company is currently in good business, the product pipeline on the 3 products approved to market, 14 antibody drugs in research, mainly related to tumors, autoimmune diseases and other diseases treatment areas the company's main source of revenue is the "Recombinant Human ii Tumor Necrosis Receptor- Antibody Fusion Protein" (commodity name: Isep), the fund-raising is mainly used for antibody drug production new projects Step Pharmaceuticals proposed to transfer its subsidiary and Kyushu Tong's equity on the evening of July 6, Step Pharma announced that, in order to optimize the company's asset structure, the company held the third (interim) meeting of the 3rd Board of Directors on July 6, 2020, to consider and approve the On the proposal to transfer the stake of the controlling subsidiary of the Company, it agreed that the Company will transfer 51% of the shares of the controlling subsidiary Of Hubei Step-Long Kyushu Tong Pharmaceutical Co., Ltd (hereinafter referred to as The Hubei Step-Long Kyushu Tong) to Kyushu Tong Pharmaceutical Group Co., Ltd for RMB21.7523 million said in the announcement that the equity transfer is in line with the company's strategic planning and long-term interests, is conducive to optimizing the company's asset structure, will not have a significant adverse impact on the company's financial position and future operating results, there is no harm to the company and the interests of all shareholders sources of information: Pharmaceutical Intelligence News, Sina Pharmaceutical News, NetEase News, Cyber-Blue, E Pharmaceutical Manager, Pharmaceutical Economics, China Pharmaceutical News, Pharmacy Manager, Oriental Fortune Choice Data, Daily Economic News, Interface News, etc Recommended reading: 1 "A week jun" new version of the Chinese Pharmacopoeia affects the entire pharmaceutical industry; 2 "One-week Jun" DRG sub-group program, pharmaceutical companies to plan ahead is the key! The 29th batch of generic reference preparation catalogue published; 3 "One week Jun" the precise use of antimicrobial drugs, hundreds of billions of market pattern turbulence; First Sound Pharmaceuticals went to Hong Kong stock exchange listed; micro-medical this year.. 4 "A week jun" "defamation of Chinese medicine will be punished" is pure "misreading"; Vaccine Summit Raises.. 5 The closing of the two sessions: "Chinese medicine" has become the industry's "keyword";