Industry Weekly Report The State Drug Administration strengthens the supervision and management of the quality of medical devices

Joint release: Sina Pharmaceuticals, Saidi consultants a week overview of policy and regulations, this week issued four policy documents, respectively, "Fujian Province Drug Quality Notice" "On the release of the list of chemical generic drug ginseng preparations (35th batch)" "State Drug Administration on the release of the results of the national medical device supervision and sampling" "National Drug Administration on the approval of the registration of 73 medical device products announcement"; In terms of research and development, 132 new drug registration and declaration numbers, 6 consistent evaluation acceptance numbers, and 14 new status updates for declared production applications were added this week; Medical and health industry this week inventory, wonderful continue! Policy direction marked this week there are four cases of policy release, respectively, "Fujian Province Drug Quality Notice" "On the release of the list of chemical generic drug sampling preparations (35th batch)" "State Drug Administration on the release of the results of the national medical device supervision and sampling" "State Drug Administration on the approval of the registration of 73 medical device products announcement."
information of the policy document is as follows: Table 1 The list of policy documents released this week focuses on the analysis On November 17, 2020, the State Drug Administration issued the Notice of the State Drug Administration on the Release of the Results of the National Medical Device Supervision and Sampling, which is the State Drug Administration. In order to strengthen the supervision and management of medical device quality and ensure the safe and effective use of medical device products, the organization of semiconductor laser treatment machine, ultrasonic cleaning equipment, surgical clothing and other 5 varieties of products for quality supervision and sampling, and then published a total of 27 batches (Taiwan) do not meet the requirements of the product list.
for products found in the sampling that do not meet the standards, the State Drug Administration has requested the provincial drug supervision and administration department where the enterprise is located to make timely administrative decisions and make public announcements to the public in accordance with the relevant regulations and regulations.
the provincial drug supervision and administration department where the enterprise is located is required to urge the relevant enterprises to carry out a risk assessment of products that do not meet the standards for sampling, determine the recall level according to the severity of the medical device defects, actively recall the products and disclose the recall information;
132 new cases this week in the registration of new drugs for research and development.
from the drug category, the largest number of chemical drug registration and declaration, 105 cases, accounting for 79%, biological products accounted for 17% of the number of acceptance, the number of Chinese medicine acceptance accounted for 4%.
from the registered declaration type, 82 cases were supplementary applications, accounting for 62%, new drugs accounted for 13%, import re-registration accounted for 10%, import acceptance accounted for 9%.
from the point of view of declared enterprises, the largest number of enterprises accepted this week is Pfizer Investment Co., Ltd., the number of cases accepted is 8 cases, followed by Jiangsu Hengrui Pharmaceutical Co., Ltd., the number of cases accepted is 7 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 6 application numbers.
from the product point of view, mainly involved in the citric acid metholol tablets, acetate sesame pine tablets, injection growth inhibitor, injection melopenam and other 4 varieties.
from the application enterprises, only Tianhaihai City Pharmaceutical Factory Co. , Ltd. injection mero Pernam application number reached 3 cases, the rest of the enterprise application number is 1 case.
2 this week the list of consistent evaluation application numbers to declare the production status, this week a total of 14 application number production status updates.
From the product point of view, mainly involved in ammonia pills, propofol medium / long-chain fat milk injection, capertabin tablets, risupavastatin calcium tablets, acapulphate tablets, acaposulphate tablets, hydrochloric acid re-release capsules, tegrillo tablets, pomadamine capsules and other 10 varieties.
from the application type, are generic drugs. Form
3 This week's list of applications for production status updates focused on the analysis of November 19, 2020, Fosun Pharma independently developed for the treatment of advanced hepatocellular carcinoma class 1 new drug injection FN-1501 by the State Drug Administration clinical trial registration review and acceptance.
the new drug is an innovative small molecule chemical drug transferred by the Group by the Chinese Pharmaceutical University and subsequently independently developed, which is intended to be mainly used for leukemia, solid tumor treatment, etc.
Currently, the new drug is in Phase I clinical trials in the United States and Australia (for the treatment of leukemia, solid tumors) and China (for the treatment of leukemia), and the new drug for the treatment of acute myeloid leukemia has been recognized by the U.S. FDA as an orphan drug.
as of October 2020, the Group's cumulative research and development investment in the new drug at this stage is approximately RMB91.78 million.
investment and financing venture capital to the domestic investment and financing market, a total of 15 investment and financing incidents occurred in the field of medical and health this week, disclosing the amount of financing more than 3.21 billion yuan.
The investment targets are Hui medical Hui shadow, Zhongsheng Kangyuan, Prijin, Guinga, Maimer vacuum, and Yellow Medicine, Chisun Medical, Wisker Biology, Rice and Xiaomi, Deji Pharmaceuticals, Dexian Health, Yaohai Bio, Heyuan Bio, Kaide Pharmaceuticals, Shenzhen Anke, mainly involved in medicine, medical equipment, medical services and other fields.
the amount disclosed, Deji Pharmaceuticals had the highest amount of financing, reaching 1.31 billion yuan. Table
4 This week's domestic investment and financing event focuses on the analysis of Deji Pharmaceuticals, a global biotechnology company focused on the development and commercialization of precision therapy drugs, dedicated to improving existing standard treatment options or developing alternatives to meet the needs of patients.
Deji Pharmaceuticals has a unique method of drug discovery and development, based on laboratory results based on research and development to further investigate the clinical reality, in order to find that the existing standard treatment program clinical efficacy is not satisfactory, patient needs have not been met outstanding areas.
Dedreji Pharmaceuticals believes that a clear understanding of the relevant tumor biomarkers and therapeutic improvement or replacement objectives in preclinical development can maximize the efficiency and relevance of drug discovery and development.
November 18, 2020, Deji Pharmaceuticals received a $200 million round of financing from investors including Boyu Capital, Latitude China, Sequoia China, Temasek and Pharmaceutical Mingkangde Venture Capital Fund.
this round of financing will be used to support Deji Pharmaceuticals in developing a portfolio of product pipelines for the treatment of cancer and immunological diseases.
overseas investment and financing markets, there were 15 key investment and financing incidents in the pharmaceutical and health sector this week, with total disclosures of more than $700 million, targeting Chooch.ai, Nereids, AliveCor, InterVenn BioSciences, Troy Medicare, Upfront Healthcare Services, Levels, Pharvaris, Health Spring, Elevation Oncology, Umoja Biopharma, MedAvail, K Health, Subtle Medical, Medable, medical services, pharmaceuticals, medical devices, and more.
, Medable received $90 million in financing, the highest amount.
Table 5 This week's overseas investment and financing event focused on Medable's focus on building a unified platform for clinical trial execution, enabling patient-generated data to drive clinical research as well as precision and predictive medicine.
Medable provides a globally dispersed pilot platform that simplifies design, recruitment, retention and data quality, replacing isolated systems with integrated digital tools, data, and interfaces to accelerate trial execution.
the platform connects patients, sites, and clinical trial teams to improve patient access, experience, and outcomes.
now used by the world's leading biopharmaceutical sponsors and clinical research organizations and has been tested in more than 30 countries and 26 languages.
November 19, 2020, Medable received a round C financing of $91 million, led by Sapphire Ventures, followed by subsequent investments by existing investors GSR Ventures, PPD, Inc. and Streamlined Ventures, with a total financing of more than $136 million.
will be used to accelerate the transition of the life sciences industry to digital and decentralized clinical trials.