Medical and health industry weekly (June 8-12)
Last Update: 2020-06-19
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Joint release: there are 5 policy releases this week by CCID consultants and Sina pharmaceutical, They are respectively the announcement of the State Food and Drug Administration on the revision of sodium thiosulfate injection instruction (No68 in 2020), the announcement of the State Food and Drug Administration on the revision of vitamin B2 injection instruction (No69 in 2020), the announcement of the State Food and Drug Administration on the revision of Chuanbei loquat preparation instruction (No67 in 2020), the announcement of the State Food and Drug Administration on the revision of pituitrin houye injection Announcement of the instruction manual (No65 in 2020), notice of the State Food and Drug Administration on the guidelines for the preservation of necessary documents for clinical trials of drugs (No37 in 2020)All belong to normal information disclosure, without key policies< br / > Table 1 notice and announcement list issued from June 8 to June 12 < br / > < br / > < br / / > 252 drug registration applications were accepted this weekAccording to the classification of drugs, the largest number of chemical registration applications was 202 cases, accounting for 80%; biological products and traditional Chinese medicine registration applications accounted for 14% and 5% respectivelyAccording to the types of registration and application, the proportion of supplementary application is 67%; the proportion of generic drug acceptance is 7%; the proportion of import re registration acceptance is 1%; the proportion of import drug acceptance is 11%; the proportion of new drug acceptance is 10%< br / > Figure 1 category of drugs accepted for registration and declaration in China in this week < br / > Figure 2 category of drugs accepted for registration and declaration in China in this week < br / > the most accepted enterprise in this week is Lilai Suzhou Pharmaceutical Co., Ltd., with 20 cases accepted; the second ranked enterprise is Beijing Novartis Pharmaceutical Co., Ltd, The number of applications was 13; AstraZeneca investment (China) Co., Ltdranked third, with 8 applications< br / > Figure 3: Top 10 drug registrations declared by enterprises nationwide in this week < br / > in terms of consistency evaluation, there are 15 application numbers in total in this week, It mainly includes oxytocin injection, cefprozil dispersible tablets, nedaplatin for injection, dextrozzo for injection, Norfloxacin Capsules, ibuprofen sustained-release capsules, lamivudine tablets, gliclazide sustained-release tablets, potassium chloride sustained-release tablets, isoniazid tablets, amlodipine besylate tablets, Azithromycin Capsules, clarithromycin tablets, compound sulfamethoxazole tablets, etcAmong them, Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltdhas the largest number of application for conformity assessment, with 2 cases< br / > Table 2 conformity evaluation application Nocolumn from June 8 to June 12 < br / > < br / > there is no newly approved conformity evaluation drug this week < br / > in terms of domestic investment and financing market, there were 5 investment and financing events in the field of medicine and health this week The investment targets are respectively Sina biology, Neusoft smart, yaomingjunuo, maberi and Clover biology, mainly involving new drug research and development, vaccine preparation production, new coronavirus, genetic engineering and other fields Among them, from the perspective of the disclosed amount, the performance of Macquarie is the most eye-catching, with a financing of 500 million yuan < br / > Table 3 domestic investment and financing events from June 8 to June 12 < br / > < br / > among them, Sina biology mainly focuses on device research and development design, diagnostic manufacturing, gene detection, disease diagnosis, medical equipment, disease early screening and other fields Neusoft Zhirui is a tumor treatment equipment R & D company, inheriting Neusoft medical's accumulation in the field of tumor radiotherapy for more than 10 years, and is committed to providing high-quality radiotherapy products and services through continuous innovation, promoting the popularization of accurate, intelligent and standardized tumor radiotherapy in primary medical institutions, benefiting human health Yaomingjunuo is a cell therapy technology and product R & D provider Based on the technology platform of independent R & D, it is engaged in research in the field of cell biomedicine, involving tumor, new drug R & D, gene engineering drug production, gene engineering, gene editing, targeting technology, immune technology, cell technology, targeting medicine, innovative medicine, biological medicine, tcr-t and many other fields Maibairui is a one-stop outsourcing service provider for biological drug R & D and GMP production The company mainly provides users with a series of outsourcing services for biological drug R & D and production, such as monoclonal antibody, recombinant protein, antibody drug coupling, etc., and also provides the whole process solution from cytotoxin synthesis and linker production to coupling in the process of antibody drug coupling (ADC) drug R & D Trifolium is an innovative biopharmaceutical R & D provider The company focuses on the research and development of innovative bio targeting drugs and innovative bio generic drugs The company has the technology related to the construction of covalent trimeric fusion protein At present, the company is developing the vaccine related to the treatment of AIDS, respiratory syncytiosis and other diseases < br / > in terms of overseas investment and financing market, there were 5 major investment and financing events in the field of medicine and health this week The investment targets are pepper, cerevasc, autobahn therapeutics, histosonics, arch therapeutics, mainly involving in the fields of device R & D and design, new drug R & D, health management, etc Autobahn therapeutics was the best performer in terms of the amount of disclosure, with $76 million < br / > Table 4 overseas investment and financing events from June 8 to June 12 Cerevasc is a pharmaceutical R & D and pharmaceutical device design and manufacturing enterprise, whose business covers brain diseases, device R & D and design, treatment manufacturing, disease treatment, nervous system diseases, medical equipment manufacturing and other fields Autobahn therapeutics is an American drug developer of central nervous system diseases The leading drug under research of autobahn is abx-002, a thyroid hormone receptor β agonist Histosonics is a biotechnology company involved in the fields of tumor, device R & D and design, intelligent hardware manufacturing, auxiliary robot, disease treatment, intelligent medical equipment, etc Arch therapeutics focuses on the field of device research and development design, medical consumables production, treatment manufacturing, operating room, medical equipment, etc.
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