Pharmaceutical and Health Industry Weekly Report (July 27 - July 31)

Joint release: Sina Pharmaceuticals, Seddy consultants a week overview of policies and regulations, the State Council issued "on further strengthening the drug adverse reaction monitoring and evaluation system and capacity-building opinions", and continuously improve the drug adverse reaction monitoring and evaluation system; In addition, 25 declared production application number status updates, investment and financing, a total of 10 investment and financing events occurred in the field of domestic medical and health, disclosed financing amount of 228 million yuan, a total of 22 key investment and financing events in the field of foreign medicine and health, disclosed the total amount of financing is about 1.146 billion U.S. dollars ... The pharmaceutical and health industry this week inventory, wonderful continue! Policy directions Only one policy and regulation was issued this week, namely, opinions on further strengthening the monitoring and evaluation system and capacity-building of adverse drug reactions, as follows: Table 1 The list of policy documents released this week focuses on the analysis of the Opinions on Further Strengthening the Monitoring and Evaluation System and Capacity-building of Adverse Drug Reactions (hereinafter referred to as Opinions) point out that in recent years, China's drug adverse reaction monitoring and evaluation work has achieved remarkable results, providing a strong support for drug supervision and evaluation work, but there are still short boards in the monitoring and evaluation of adverse drug reactions, the number of grass-roots monitoring and evaluation institutions has decreased, the number of professional personnel is insufficient, monitoring and evaluation capacity needs to be improved.
Opinions emphasize that we should always put the protection of the people's health rights and interests first, adhere to the scientific, rule of law, internationalization, modernization of the direction of development and professional, professional construction requirements, continue to strengthen the drug adverse reaction monitoring and evaluation system, and continuously improve monitoring and evaluation capabilities, and comprehensively promote the public use of medical makeup safety.
Drug adverse reaction monitoring is an important technical support for drug safety risk prevention and control, is the last line of defense of drug safety supervision, so China will continue to promote the construction of adverse reaction monitoring and evaluation system and capacity-building, improve the scientific and systematic system construction, continue to strengthen risk monitoring, risk identification, risk assessment and risk control, focus on risk prevention and control "front-line" role, improve the drug monitoring and evaluation system.
131 new acceptance numbers this week in the registration of new drugs for research and development.
drug category, the largest number of chemical drug registration declarations received, 112 cases, accounting for 86%;
1 This week, the national acceptance of registered drugs categories from the type of registration declaration, 79 cases as supplementary applications, accounting for 63%;
Figure 2 This week the national acceptance of drug registration declaration type from the reporting enterprises, this week's largest number of enterprises are Beijing Fessen Yuskaby Pharmaceutical Co., Ltd. and AstraZeneca Investment (China) Co., Ltd., the number of acceptances are 8 cases, followed by Astellas Pharmaceuticals (China) Co., Ltd., the number of accepted 6 cases.
15 new application numbers this week in terms of top3 consistency evaluation of the number of drug registrations filed by companies nationwide this week.
From the product point of view, mainly involved in osteosterone softgels, hydroxychloroquine tablets, injection sodium cephalosporine, hydrochloric acid Isil injection, hydrochloric acid Iritikon injection, Shubili tablets, ribavelin tablets, thiathylamphenol tablets, hydrochloric acid diformin tablets, zocanitin injection 11 varieties.
from the applicant enterprises, Shanghai Shanghai Shanghai Sino-Western Pharmaceutical Co., Ltd. and Shanghai Tsano Pharmaceutical Co., Ltd. have the largest number of applications, the number of 2 cases.
24 application numbers were updated this week to report production status in the consistency evaluation application number list.
From the product point of view, mainly involved in bone triol softgels, hydroxychloroquine sulfate tablets, hydroxychloroquine sulfate tablets, libavelin tablets, acetaminophen tablets, hydrochloric acid thiopelli tablets and other 20 varieties.
from the application type, 20 varieties are chemical drugs.
Table 3 This week reported the production status update of the application number list investment and financing wind to the domestic investment and financing market, this week in the field of medical and health a total of 10 investment and financing events, disclosed financing amount of 228 million yuan.
's investment targets are Bomai Medical, Kenit Medical, Kyuno Medical, Gaomei Gene, Vision Eye, Kang Salt Information, Huidu Medical, Proting, Tuggeranah Medical, Kai-He Biological, mainly involved in biotechnology, in-body diagnosis, antibody drug research and development and other fields.
from the disclosed amount, Huidu Medical financing amount is the highest, reaching 100 million yuan.
Table 4 This week's domestic investment and financing events focused on analysis with the increasing incidence of cancer, the rapid development of second-generation sequencing technology, the gradual liberalization of national policies, the market has emerged a large number of basic research-oriented gene sequencing service providers and end-user-oriented clinical, medical gene detection service providers, gene sequencing industry, especially in the domestic market, its mature products and services have become increasingly competitive.
Huidu Medical in the fierce market competition, on the one hand, through continuous financing and increase investment in research and development, enhance technological advantages, on the other hand, for domestic disease maps for technological innovation.
This financing, Huidu Medical will set up and improve the smart medicine big data platform, further vertical deep into the global clinical trials of new drugs, tumor recurrence monitoring and early cancer screening field, to promote rapid development in the field of tumor screening and surveillance.
In terms of overseas investment and financing markets, there were 22 key investment and financing events in the pharmaceutical and health sector this week, revealing a total financing amount of approximately US$1,146 million, with the investment targeting companies such as Alydia Health, Sema4, Medzy.ca, mainly in the fields of medical devices, medical services and pharmaceuticals.
, Thrive Earlier Detection received the largest $257 million in financing.
Table 5 This week's overseas investment and financing event focused on the development of a cancer surveillance system, Thrive Earlier Detection, will be used to fund the company's ongoing research to support its cancer early screening product application for FDA approval.
diagnosis is an important means to reduce cancer mortality.
, liquid biopsies have become one of the most popular research directions in the field of early cancer detection, and many research teams at home and abroad are pursuing this goal.
, a company focused on cancer blood testing, Thrive's fist product, CancerSEEK, is expected to detect signs of the disease early in life, allowing patients to get more effective treatment before they develop symptoms.
this round of funding, Thrive plans to extend CancerSEEK to routine medical care to detect cancer in the early stages of cancer and thus treat or cure it more effectively.
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