Industry Weekly, the third batch of clinical urgent need for overseas new drugs public quality peptide biological completion of the 100 million yuan melt

In terms of a weekly overview of policies and regulations, three policies were issued this week, namely, "Notice on the Publication of National Drug Abuse Monitoring Posts (Medical Institutions)," "Notice on Matters Related to the Registration and Declaration of Clinically UrgentLy Needed Medical Devices," "Publicity on the Third Batch of Clinically Urgent Need for New Drugs Abroad", etc.; Number, 42 consistent evaluation acceptance number; investment and financing, a total of 12 investment and financing incidents occurred in the field of domestic medical and health, disclosed the amount of financing of nearly 2.33 billion yuan; Medical and health industry this week inventory, wonderful continue! The policy direction is marked by the release of three cases of policy and regulation this week, namely, "Notice on the publication of national drug abuse monitoring posts (medical institutions), notice on matters related to the registration and declaration of medical devices in urgent need of clinical treatment", "Publicity on the third batch of clinically urgent need for new drugs abroad" and so on.
Specific information is as follows: Table 1 The list of policy documents released this week focuses on the implementation of the spirit of the relevant meetings of the Executive Meeting of the State Council, and accelerates the entry of new drugs urgently needed for clinical listing abroad into China, according to the Bulletin on Matters Related to the Review and Approval of New Drugs In Clinical Urgent Needs (No. 2018) No. 79) working procedures, the State Drug Administration, the National Health and Wellness Commission jointly organized experts on the third batch of clinical urgent need for overseas new drug preliminary screening varieties and the second batch of clinical urgent need for foreign new drug public dissenting varieties, the selection of the third batch of clinical urgent need for foreign new drugs.
October 29, the Drug Review Center (CDE) of the State Drug Administration (CDE) published the Public Notice on the Third Batch of Clinically Urgent Need for New Drugs Abroad.
Looking at the development of the list of new drugs in clinically urgent need abroad, in October 2018, the State Drug Administration, together with the National Health And Wellness Commission, in the organization and drafting of the "Clinical Urgent Need for Overseas New Drug Review and Approval Procedure", established a special channel to speed up the review and approval of clinically urgently needed new drugs listed abroad; Arterial hypertension, multiple sclerosis, Goshe disease, hereditary angioedema and other rare diseases were selected; at the end of May 2019, CDE announced the second batch of 26 clinically urgent overseas new drugs, including Biopten Granules, endocrine and metabolic diseases, blood system diseases, respiratory diseases and other rare diseases were selected;
As of October 2020, 37 new overseas drugs, including Amgen's Deshudone anti-injection, Merca East's Pablo Pearl single-dose injection and Pfizer's chlorobenzene softgels, have been approved for sale in China, and the urgent need for medication has been further alleviated.
211 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, 152 cases, accounting for 72%;
From the registration declaration type, 142 cases were supplementary applications, accounting for 67%, new drugs accounted for 13%, imitation acceptance accounted for 4%, import acceptance accounted for 4%, import re-registration accounted for 4%.
From the point of view of the declared enterprises, the largest number of enterprises received this week is Sai-Chen (Beijing) Biotechnology Co., Ltd., the number of cases accepted is 14 cases, followed by Sanofi (China) Investment Co., Ltd., the number of accepted 10 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 42 application numbers.
From the product point of view, mainly involved in hydrochloric acid isopropylene tablets, acetic acid Atosiban injection, omeprazole intestinal capsules, injected boronitezomi, rice nitrogen flat tablets, hydrochloric acid bromosogel capsules, methotrexate tablets, injected cephalosporine sodium Shubatan sodium, hydrochloric acid lidocarin injection, amoxicillin particles, injection of ammonia quercetone, pyridoxine There are 24 varieties of tan tablets, zopi clones, injection retinol, injection of sodium pentolarzole, Grezit slow release tablets, hydrochloric acid pyridine injection, chlorine flat tablets, injection of sodium omeprazole, cephalosporine capsules, injection of penicillin tablets, injection of sodium cephalosporine, and injection of amethyst sulfate.
from the applicant enterprises, Shandong Lu Anti-Pharmaceutical Co., Ltd. has the largest number of applications, the number of 5 cases.
2 this week the list of consistent evaluation application numbers to declare the production status, this week there is no application number production status update.
investment and financing venture capital to the domestic investment and financing market, a total of 12 investment and financing incidents occurred in the field of health care this week, disclosing the amount of financing of nearly 2.33 billion yuan.
the investment target is Servi, Beast Pharmaceuticals, Vili Zhibo, Qixi Bio, Dispectrome Diagnostics, Universal Medical, Shadow Medicine, Fruit Health, Peptide Biology, a piece of medicine, Henglu Biology, Zi and Technology, mainly related to pharmaceutical research and development, pharmaceutical Internet, cell therapy, medical device research and development, CRO, in vitro diagnostics and other fields.
the amount disclosed, the highest amount of financing was 1 billion yuan. Table
3 This week's domestic investment and financing event focused on the analysis of peptide organisms was established in September 2018, affiliated with Beijing Peptide Biopharmaceutical Technology Co., Ltd., focused on the use of E. coli to develop recombinant protein drugs for the treatment of chronic metabolic and geriatric diseases.
October 27th, qualitative peptide bio completed the RMB100 million round of A-round financing, which was jointly funded by Sequoia Capital China Fund, Boyuan Capital, Taiyu Investment, Feifan Ventures and Cuihu Investment.
the funds raised from this financing will be used to advance the clinical declaration and follow-up pipeline reserve projects of the company's two first-in-class and two biosypole products.
's overseas investment and financing market, there were four key investment and financing incidents in the healthcare sector this week, with a total disclosure of approximately $282.4 million, targeting Primmune Therapeutics, Scorpion Therapeutics, BridgeHealth, AavantiBio, and related to biologics, oncology, healthcare and rare disease treatment.
, Scorpion Therapeutics received $108 million in financing, the highest amount.
4 This week's Overseas Investment and Financing Highlights Analysis October 26, 2020, Boston-based Corporation Therapeutics announced the creation of the company and completed a $108 million round of A-round financing, led by Atlas Ventures, Omega Ventures and Vida Ventures, with Abingworth and Partners HealthCare Innovation also involved in the round.
the money will be used to drive the next wave of Precision Medicine's Advance Oncology 2.0. drug development, with the goal of providing safe, well-to-bear, responsive to more cancer patients and providing deeper, more durable, best-in-class small molecule drugs.
Scorpion will develop drugs in three areas: designing best-in-class or first-in-class drugs for known cancer-causing genes; designing drugs for cancer targets that are currently considered "non-drugable"; identifying and identifying new targets that have not yet been developed to transform cancer treatments; and developing treatments accordingly.
with the progress of new technologies such as genomics, next-generation sequencing and artificial intelligence, precision medicine in the field of cancer is entering a stage of rapid development.
have also received capital attention, with a number of companies getting different rounds of financing so far this year, including PMV Pharma, Repare Therapeutics and Black Diamond Therapeutics on NASDAQ.