Industry Weekly launched a pilot project of electronic registration certificate for medical devices, and ThoughtDi Diagnostics received 1.5 billion financing.

Joint release: Sina Pharma, Saidi consultants a week overview of policy and regulations, this week issued "on the pilot launch of electronic medical device registration certificate announcement" "on the adjustment of the sub-catalogue of in-body diagnostic reagents (2013 edition) and part of the content of the announcement" and other 6 cases of policy and regulations; This week, 170 new drug registration declaration acceptance number, 5 consistent evaluation acceptance number, investment and financing, a total of 10 investment and financing incidents occurred in the field of domestic medical and health, the amount of disclosure of financing is 3.25 billion yuan, a total of 3 key investment and financing incidents in the field of foreign medicine and health, the total amount of disclosure of financing is about 102 million U.S. dollars ... Medical and health industry this week inventory, wonderful continue! Policy direction marked this week there are six cases of policy and regulations issued, including the "State Drug Administration on the pilot implementation of electronic registration certificate of medical devices" "on the adjustment of the sub-catalog of in-body diagnostic reagents (2013 edition) and part of the announcement."
The specific information is as follows: Table 1 This week released a list of policy documents focusing on the implementation of the State Council on deepening the reform of "management services", optimize the business environment, promote the "Internet and government services" work of important decision-making deployment, to provide enterprises with more efficient and convenient government services, the State Drug Administration issued "on the pilot implementation of electronic registration certificates for medical devices", the pilot implementation of electronic registration certificates for medical devices.
the scope of the pilot issuance is the newly approved domestic third category, import second and third category of first-time registration of medical devices registration certificate, registration changes and renewal registration will be gradually issued as the case may be.
relying on the national electronic license sharing service system, electronic registration certificate can achieve cross-sectoral, cross-regional license sharing mutual recognition, the State Drug Administration business units can also be directly transferred from the electronic license library.
in certain inspections or business activities, businesses can demonstrate their corporate identity and qualifications by means of a "bright certificate in the cloud" without the need to produce a copy with a stamp on it.
170 new cases were added this week to the registration and declaration of new drugs for research and development.
from the drug category, the largest number of chemical drug registration and declaration, 140 cases, accounting for 82%, the number of biological products received 17%.
from the registered declaration type, 86 cases were supplementary applications, accounting for 51%, new drugs and imports accounted for 9%, imitation acceptance accounted for 8%, import re-registration accounted for 2%.
From the point of view of the filing enterprises, the largest number of enterprises received this week are AstraZenecon Pharmaceutical Co., Ltd. and Beijing Novarma Pharmaceutical Co., Ltd., the number of cases accepted is 4 cases, followed by Aer Jian Information Consulting (Shanghai) Co., Ltd. and Jiangsu Hengrui Pharmaceutical Co., Ltd., the number of accepted cases are 3 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 number of national enterprises to declare the number of drug registration TOP10 consistent evaluation, this week added 5 application numbers.
from the product point of view, mainly involved in greta pyridine tablets, Pidomod tablets, methazole tablets, hydrochloric acid fluorinated guilin capsules and hydrochloride iodide tablets 5 varieties. Table
2 This week's list of consistent evaluation application numbers focuses on the analysis of fluorocarbon hydrochloride, calcium channel blockers, preventive treatment of typical (with precursor) or atypical (without precursor) migraines, and treatment of dizziness caused by frontal dysfunction.
The pharmaceutical production enterprises as many as 51, the application for consistency evaluation of the enterprise is 5, respectively, Jiangsu Pingguang Pharmaceutical Co., Ltd., Shandong Fangming Pharmaceutical Group Co., Ltd., Hunan Dino Pharmaceutical Co., Ltd., Zhengda Youth Bao Pharmaceutical Co., Ltd. and Shanxi Zhendong Ant Biopharmaceutical Co., Ltd., but there are no products through the consistent evaluation, it is expected that the first adopted enterprises will receive priority procurement, medical insurance support, production support, extensive publicity and other policy dividends.
investment and financing wind to the domestic investment and financing market, a total of 10 investment and financing incidents occurred in the field of medicine and health this week, disclosed the amount of financing is about 3.25 billion yuan.
investment target for the idea of Di diagnosis, birch biology, pre-health care, mainly involved in medicine, medical equipment, medical services and other fields.
the amount disclosed, the highest amount of financing for the diagnosis and financing of the idea, reaching 1.5 billion yuan. Table
3 This week's domestic investment and financing events focus on the analysis of ideas Di diagnostics, the original idea of Di's precision diagnostic business sector, with the focus on cancer drug research and development of another sector of ideas Di Pharmaceuticals in 2018 from the idea of Di split independent.
's line of business is divided into two main categories: third-party medical testing services, in-body diagnostic equipment and reagents, and a range of product development pipelines have been laid out in the fields of tumor (from early diagnosis, accompanying diagnosis to dynamic monitoring) and microbial diagnostics.
this round of financing is the second round of independent financing after the spin-off of Thoughty Diagnostics, which completed the first round of RMB280 million financing in 2019.
this round of financing will be mainly used for the development of equipment and reagent products in the field of precision medicine, as well as the expansion of commercial teams and overseas business development.
Overseas investment and financing market, there were three key investment and financing incidents in the pharmaceutical and health sector this week, with a total amount of about US$102 million disclosed, with the investment targeting WhisperAI, AbSci and MindLabs, mainly in the fields of medical devices, health management, medicine and so on.
, AbSci received $65 million in financing, the highest amount.
4 This week's overseas investment and financing event focused on AbSc, founded in 2011 in Vancouver, Washington, and dedicated to developing cutting-edge protein production technologies that reduce costs in the biopharmaceutical industry.
the company is working on a protein that is "as simple as DNA synthesis", including the use of E. coli to produce antibodies, insulin, and so on, creating the conditions for pharmaceutical companies to quickly produce biological drugs that were previously harder to produce.
comes after six rounds of financing, which will be used to expand production capacity and build a new 60,000-square-foot plant in Vancouver.
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