Medical and Health Industry Weekly Report (August 10th - August 14th)

Joint release: Sina Medicine, Saidi consultants a week overview of policy and regulations, the National Health and Safety Commission issued 4 recommended health industry standards on the 10th, respectively, "disinfectant testing microbiological requirements" "antimicrobial testing methods and evaluation requirements in disinfectants and antimicrobial agents" "antifive drug testing methods and evaluation requirements in disinfectants and antimicrobial agents" In terms of research and development development, 96 new drug registration and declaration acceptance numbers, 20 consistent evaluation acceptance numbers, and 7 declaration of production application number status updates this week; investment and financing, a total of 7 investment and financing incidents in the domestic medical and health sector, disclosed financing amount of 1.8475 billion yuan; Medical and health industry this week inventory, wonderful continue! The policy direction is indicated in only one case this week, "on the release of the microbiological requirements for disinfection testing, such as 4 recommended health industry standards" issued.
The specific information is as follows: Table 1 This week's list of policy documents focuses on the analysis of the Requirements for Microorganisms for Disinfection Testing, which sets out the requirements for the preparation of disinfection test microorganisms, media, transmission and preservation, bacterial suspension and bacterial carrier systems, and is applicable to the use and preservation of microorganisms (except viruses and substitutes) for various disinfection tests.
"Antibacterial drug testing methods and evaluation requirements in disinfectants and antimicrobial agents" provides for the testing methods and evaluation requirements of antimicrobial drugs in disinfectants and antibacterial agents, applicable to the disinfectants and antibacterial agents in the tectococtonin (tyrencline, tomycin, kimmycin, mino ringin, strong mycomycin), large Assays and evaluations of erythromycin, beta-endamide (cephalosporadine), sulfonamide (sulfonamide), quinoxone (oxyfluorosa, nofluorosa), lincoamide (Klinmycin), chloramphenicol (chloramphenicol) and other antimicrobial drugs.
"Antifungal drug testing methods and evaluation requirements in disinfectants and antibacterial agents" provides for the testing methods and evaluation requirements of antifungal drugs in disinfectants and antibacterial agents, applicable to the determination and evaluation of anti-bacterial drugs such as aflatoxin, nitrate, fluconazole, ketoconazole, nitrosin, nitrate, fluorinate, hydrochloric acid and other antifungal drugs.
The Antiviral Drug Testing Methods and Evaluation Requirements in Disinfectants and Antibacterial Agents provide for the testing methods and evaluation requirements for antiviral drugs in disinfectants and antibacterial agents, and are applicable to the determination and evaluation of more cylovir, axlove, anti-thyrovirus, anti-thyrovirus and other antiviral drugs in disinfectants and antibacterial agents.
96 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, 73 cases, accounting for 76%;
from the registration declaration type, 62 cases were supplementary applications, accounting for 65%, new drugs accounted for 20%, imitation acceptance accounted for 8%, import re-registration accounted for 2%.
from the declaration of enterprises, this week's largest number of enterprises for Lilly Suzhou Pharmaceutical Co., Ltd., the number of acceptances are 8 cases, followed by Shijiazhuang Four Pharmaceuticals Co., Ltd., the number of accepted for 5 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 enterprises to declare the number of drug registration TOP5 consistent evaluation, this week added 20 application numbers.
From the product point of view, mainly related to amoxicillin particles, iodized oxalol injections, dopamine tablets, doso-tea-alkali injections, methyl nitroquine tablets, roku bromine injections, calcium hydroxybenzene dispersion tablets, head There are 13 varieties, such as spore-clogan suspension, lanso laazole for injection, melopenan for injection, sodium cephalosporin for injection, cephalosporinefor injection, and cephalosporine for injection.
From the applicant's point of view, Fu'an Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd., Shi pharmaceutical group Zhongno Pharmaceuticals (Shijiazhuang) Co., Ltd. and Chongqing Sanhua Pharmaceutical Co., Ltd. have the largest number of applications, the number of cases are 2.
2 this week the list of consistent evaluation application numbers to declare the production status, this week a total of 7 application number production status updates.
from the product point of view, mainly involved insilica non-tablets, toluene sulfonate soraffinib tablets, thioic acid injections and other 3 varieties.
from the application type, are generic drugs. Table
3 This week's application number list for production status update focuses on the analysis of August 12, 2020, Qingfeng Pharmaceutical Group's Jiangxi Shanxiang Pharmaceutical Co., Ltd. developed four types of chemical generic drug toluene sulfonate soraphine tablets (commodity name: Ligeste) the first national copy approved for listing, as if through generic drug consistency evaluation.
toluene sulfonate sorafinib tablets are a multi-target, multi-kinase inhibitor, can inhibit the growth of tumor cells, clinically used for liver cancer, kidney cancer treatment, while local late stage or metastatic radioactive iodine (RAI) refractive differentiated thyroid cancer also has a very good effect.
Sorafini was developed by Bayer and approved by the FDA in December 2005 for first-line treatment for advanced kidney cancer, was approved for entry into the domestic market in September 2006, and was negotiated into the National Health Insurance Category B directory in 2017 at a price of 203 yuan per tablet.
another 53% reduction in health care negotiations in 2019, successfully renewed the contract at a price of 95 yuan per piece.
Soraphini has been approved in more than 100 countries around the world, more than 1 million people benefit from extensive clinical verification, is the domestic and foreign authoritative guidelines consistently recommended for liver, kidney, thyroid cancer standard treatment drugs.
investment and financing wind to the domestic investment and financing market, a total of seven investment and financing incidents occurred in the field of medicine and health this week, disclosed the amount of financing is 1,847.5 million yuan.
investment targets for the Pharmaceutical Research Institute, Ameda, Mei envy health, micro-gene, Koya Medical, Hanyu Medical, ZeChengTianCheng, mainly involved in medicine, medical equipment, medical services and other fields.
the disclosed amount, Ameda had the highest amount of financing, reaching 675 million yuan. Table
4 This week's domestic investment and financing events focus on the analysis of Shanghai Ameda Investment Management Consultants Co., Ltd. (Ameda) was founded in 2004 (stock code: 02393), is a professional in-body diagnostic products medical company, is the world's leading diagnostic field leader Roche Diagnostics in the Shanghai region of the exclusive agent.
Ambeda's clients include hospitals at all levels, independent laboratories, universities, research institutes and regional inspection centers, to help customers with a complete set of test equipment, laboratory equipment, testing software, after-sales service, reagent supplies and other integrated laboratory solutions.
this round of investors superstar medical holding is Roche Diagnostics medical in-body diagnostic products in China's largest distributors, whether in terms of sales channels or product services, have an innate advantage.
In recent years, Superstar Medical Holdings has completed a number of acquisitions in the domestic in-body diagnostics market, and established pipelines for the distribution of various in-body diagnostic products in more developed provinces and cities such as Beijing, Guangzhou, Shanghai and Shenzhen, with a growing market share.
's overseas investment and financing market, there were seven key investment and financing incidents in the healthcare sector this week, with a total disclosure of approximately $434 million, targeting VicariousSe, Dynes, Lumeon, Atomwise, TearClear, F2G, Mission Bio, and other sectors, mainly in the medical device, medical services, pharmaceutical and other fields.
, Atomwise received $123 million in financing, the highest amount. table
5 This week's overseas investment and financing event focused on Atomwise, a company that uses supercomputers for drug development, using supercomputers, AI and sophisticated algorithms to simulate pharmaceutical processes to predict the effectiveness of new drugs while reducing research and development costs.
To date, Atomwise has provided AI technologies for more than 750 research collaborations, addressed more than 600 disease targets, and worked with top pharmaceutical and biotechnology partners to design new drugs for "non-drugable" targets at speed and scale.
through new investments, Atomwise will continue to expand its AI technology platform and team.
, the company will also use the financing to build its own internal pipeline to address historically elusive diseases and other challenging disease targets.
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