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    Home > Medical News > Medical World News > Medical and Health Industry Weekly Report (September 7 - September 11)

    Medical and Health Industry Weekly Report (September 7 - September 11)

    • Last Update: 2020-11-13
    • Source: Internet
    • Author: User
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    Joint release: Sina Pharmaceuticals, Saidi consultants a week overview of policy and regulations, the State Drug Administration on September 8 issued "on the revision of the yellow lian on the preparation of the notice", the yellow lian on the preparation (including pills, tablets, granules, capsules) instructions "adverse reactions" (taboos) and "precautions" items of the unified revision; 210 cases of drug registration declaration acceptance number, 16 consistent evaluation acceptance number, and 15 declaration of production application number status update; Medical and health industry this week inventory, wonderful continue! Policy direction marked this week only one case of "on the revision of the Yellow Lian on the clearing agent instructions" issued.
    The specific information is as follows: Table 1 This week released a list of policy documents focusing on the analysis of the "Yellow Lian on the prescription drug prescription drug instructions revision requirements" proposed: "adverse reactions" item should include diarrhea, abdominal pain, nausea, vomiting, rash, itching, increased number of stools, abdominal discomfort, fatigue, allergies or allergic reactions and other adverse reactions reported.
    "Taboo" item should increase the spleen and stomach cold disabled, allergic to this product and the ingredients contained in the disabled.
    "Precautions" should include caution against spicy food and allergic physiques.
    The Revision Requirements of the Prescription Drug Instructions for Huang Lian's Prescription Drugs" state that the item "Adverse Reactions" shall include reports of adverse reactions such as diarrhea, abdominal pain, nausea, vomiting, rash, itching, increased number of stools, abdominal discomfort, fatigue, allergies or allergic reactions.
    "Taboo" item should increase the spleen and stomach cold disabled, allergic to this product and the ingredients contained in the disabled. Item
    "Precautions" should include high blood pressure, heart disease, diabetes, liver disease, kidney disease and other patients should be taken under the guidance of a physician; children, lactating women, the elderly and infirm should be taken under the guidance of a physician; strictly in accordance with the dosing, this product should not be taken for a long time;
    210 new cases this week in the registration and declaration of new drugs for research and development.
    From the drug category, the largest number of chemical drug registration and declaration acceptance, 157 cases, accounting for 75%;
    From the registration declaration type, 148 cases were supplementary applications, accounting for 71%, new drugs accounted for 11%, imitation acceptance accounted for 7%, import acceptance accounted for 5%, import re-registration accounted for 3%.
    From the point of view of the declared enterprises, this week's largest number of enterprises for Xi'an Jingxi Shuanghe Pharmaceutical Co., Ltd., the number of cases accepted is 12, followed by Pfizer Investment Co., Ltd., the number of accepted 11 cases.
    Figure 1 This week the national acceptance of registration declaration drug category figure 2 this week the national acceptance of drug registration declaration type figure 3 This week the national enterprise declaration of drug registration quantity TOP5 consistent evaluation, this week added 16 application numbers.
    From the product point of view, mainly involved in benzo bromine malone tablets, dopamine tablets, fluorosterol tablets, nitrite injections, methyl nitrosium tablets, citrate Changchun Ruibin injections, fluoromide tablets, ammonia sulfate There are 15 varieties, such as base glucose capsules, sodium bicarbonate tablets, temoamine capsules, cephalosporine particles, pyridoxine tablets, Klinmycin hydrochloride capsules, growth inhibitor for injection, and tetocycline for injection.
    from the applicant's point of view, Germany's Hermann pharmaceutical factory has the largest number of applications, the number of 2 cases.
    form 2 this week, the list of consistent evaluation application numbers to declare production status, this week a total of 15 application number production status updates.
    From the product point of view, mainly involved in Adamu monoantigen injection, Ebersatan hydrochlorochlorophenidate tablets, fumarate nofovir diazole ester tablets, mixed glycolyte injections, Malay acid afatin tablets, ryschuvastatin calcium tablets, hydrochloric acid quentin slow release tablets, isopropyl bromide inhalation solution, conversion sugar injection, left oxyfluorosar star titrite eye drops and other 10 varieties.
    from the application type, except Thyda Biopharmaceutical (Suzhou) Co., Ltd.'s Adamo single anti-injection as a new drug, all other are generic drugs.
    3 This week's application number list for production status updates focuses on the development, production and marketing of innovative drugs for the treatment of major diseases such as tumors, founded in 2011.
    Since its inception, the company has established a product chain of 23 new drug species, covering tumors, metabolic diseases, autoimmune and other diseases, 3 products approved for sale by NMPA, 1 single anti-product market application was accepted by NMPA and included in the priority review, 4 products into Phase III or key clinical research, and 15 products have entered or are about to enter clinical research.
    Xinda bio "Adamo single anti-injection" was approved for listing, becoming the third domestic Adamu single anti-bio-similar drug after Baiotai's Greli, Haizheng Pharmaceuticals' An Jianning.
    Adamo monoclonal antibody, the world's first approved all-human source anti-tumor necrotic cause ɑ (TNF-ɑ), plays a role in treating the disease by neutring the biological activity of TNF-α in the body.
    Original research manufacturers for AbbVie, as early as 2002 by the FDA approved the listing of the product named Humira (Shumeile), is now listed in more than 90 countries or regions around the world, approved adaptive disorders include rheumatoid arthritis, strong straightening spina bifida, psoriasis, childhood idylpathy, crohn's disease, ulcerative colitis, septic sweat glanditis, vineitis and so on.
    investment and financing wind to the domestic investment and financing market, this week in the field of medicine and health, a total of 10 investment and financing incidents, disclosed the amount of financing of 4.423 billion yuan.
    The investment targets are zero-standard technology, Hengrun Dasheng, Xiantong Pharmaceuticals, Pharmaceutical Friends Pharmaceuticals, Huatai Chenguang, Weimei Medical, Dr. Chunyu, Xintong Pharmaceuticals, Pharmaceuticals, Tonghua Dongbao, mainly involved in drug research and development, mobile medical, medical equipment production, artificial intelligence and medical big data and other fields.
    the amount disclosed, Tonghua Dongbao had the highest amount of financing, reaching 1.94 billion yuan.
    4 This week's domestic investment and financing events focus on the analysis of Tonghua Dongbao is the domestic diabetes, especially insulin industry leader.
    since 1998 developed the first domestic recombinant human insulin "Ganshuyu", the company has long been deeply cultivated in the field of diabetes.
    , the company's recombinant human insulin products market share remains the leading, insulin glycerol approved for market in 2019 after rapid growth, mendong insulin, GLP-1 and other products are also in the clinical later stages.
    is the country with the most diabetes in the world.
    The International Diabetes Federation (IDF) estimates that there will be about 120 million people with diabetes in China in 2019.
    , compared with the large number of sick people, there is still room for improvement in the standardized treatment and management level of diabetic patients in China.
    in the context of increasing social concern for the prevention and treatment of chronic diseases and the government's continuous increase in investment in the management of chronic diseases, there is still huge room for the future development of leading pharmaceutical companies represented by Tonghua Dongbao.
    overseas investment and financing market, there were six key investment and financing incidents in the pharmaceutical and health sector this week, with a total amount of $483.6 million disclosed, targeting Oncocross, Inversago Pharma, Zymergen, Truepill, Silk and Sonder, OncoImmune, mainly in the areas of drug development, biomass, B2B telemedicine platforms, and healthcare services.
    , Zymergen received $300 million in financing, the highest amount.
    5 This week's overseas investment and financing event focused on Zymergen, founded in 2013 in Emoryville, California, a biotech start-up dedicated to the use of genetically modified microorganisms to produce materials.
    Zymergen has conducted four rounds of financing since its inf establishment, including a $130 million Round B financing led by Japan's SoftBank in October 2016 and a $400 million Round C financing from Japan's SoftBank in December 2018.
    C round of financing, Zymergen is also the second unicorn to be valued at more than $1 billion, after Ginkgo Bioworks, a microbial-based synthetic biology start-up.
    's $300 million round of round D financing has driven Zymergen into the $3 trillion chemical and materials industry, accelerated its groundbreaking Production of Hyline films, and commercialized more breakthrough products in electronics, agriculture, consumer care and healthcare.
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