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12 Class 1 new drugs have been approved for clinical use, including anti-CD47 mAb, anti-LAG-3 mAb, SHP2 inhibitor, etc.!
Time of Update: 2022-01-26
Innovative ADCs targeting EGFR in solid tumors According to a previous press release from Lepu Bio, MRG003 demonstrated a manageable safety profile and encouraging antitumor activity in patients with advanced solid tumors, including nasopharyngeal carcinoma and head and neck squamous cell carcinoma, after multiple lines of therapy .
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CDE issues 11 guidelines covering clinical trials, chemical generics, etc.
Time of Update: 2022-01-26
68) In order to encourage the research and development of new drugs, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the "Guidelines for Writing a "Clinical Risk Management Plan" (for Trial Implementation)" (see attachment) .
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Too big to succeed? The return of 100 billion market capitalization pharmaceutical companies is not as good as that of the S&P 500
Time of Update: 2022-01-26
Unlike McDonald's, which sells more than 2 billion hamburgers every year, drug companies usually only rely on the emergence of a few important products to become a Big Mac .
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The way to invest in Biotech in the cold winter
Time of Update: 2022-01-26
First, based on the MMT theory, the trend of currency "paper money" is irreversible, and the overall liquidity There is no solution to the flood, only innovation, which can be infinitely priced, can absorb a huge amount of funds; secondly, the internal development momentum of pharmaceutical innovation still exists for a long time, and the industrial cycle, policy cycle, and capital cycle cannot change this inherent inevitability .
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IQVIA predicts that global drug spending will reach $1.8 trillion in 2026
Time of Update: 2022-01-26
According to the report, driven by multiple factors such as COVID-19, increased drug consumption, new product launches, and brand drug patent expiration, the global Pharmaceutical spending will grow at a compound annual growth rate (CAGR) of 3%-6%, with global pharmaceutical spending expected to reach $1.
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On January 7th, CDE issued 5 more clinically relevant guidelines, involving innovative drugs, improved new drugs, and traditional Chinese medicines. A total of nearly 20 were released this week!
Time of Update: 2022-01-26
Annex: Technical Guidelines for Drug Nonclinical Dependence Research Drug Evaluation Center of the State Food and Drug Administration January 4, 2022 Under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (for Trial Implementation)" (see attachment) .
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$450M to Help Develop Nervous System-Targeted Nucleic Acid Therapy Lilly's Innovative Delivery Technology
Time of Update: 2022-01-26
On January 6, 2022, Eli Lilly and Company announced that it has acquired exclusive rights to Entos Pharmaceuticals' proprietary Fusogenix nucleic acid delivery technology platform to develop and commercialize nucleic acid therapeutics targeting the central and peripheral nervous systems .
Retrieved January 6, 2022, from https:// entos-pharmaceuticals-enter-into-research-and-collaboration-agreement-to-support-the-development-of-innovative-therapies-in-multiple-neurologic-indications-301454740.
Retrieved January 6, 2022, from https:// entos-pharmaceuticals-enter-into-research-and-collaboration-agreement-to-support-the-development-of-innovative-therapies-in-multiple-neurologic-indications-301454740.
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How effective is the new crown vaccine?
Time of Update: 2022-01-26
The first study, from South Africa, where omicron is highly prevalent, analyzed fully vaccinated Covid-19 vaccine (two doses of BNT162b2) based on data from 15 November 2020 (75% of positive cases sequenced with omicron detected) - 7 December 2020 For the effectiveness of preventing COVID-19 hospitalization after Omicron infection, compared with data from the previous epidemic period of Delta variant (September 1-October 30, 2020) .
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Kangmei's reorganization completes the full intervention of GPHL
Time of Update: 2022-01-26
Kangmei Pharmaceutical stated that in the next step, it will further integrate resources, consolidate and enhance the operation capacity of the whole industry chain of traditional Chinese medicine, vigorously invest in the production and operation of the main business of traditional Chinese medicine and its products, fully restore and improve the standard operation ability of the enterprise, and continue to make profits.
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These 10 "blockbuster" drugs will hit the market in 2022
Time of Update: 2022-01-26
The drug topped the TOP10 list of the most valuable R&D projects with a net present value (NPV) of $6.
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Double target!
Time of Update: 2022-01-26
(hereinafter referred to as "Hongri Pharmaceutical") announced that the company's new drug under development, Picromide B mesylate for injection (also known as the "KB Project"), was approved by the United States.
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Sina Pharma's 2022 Forecast Can the FDA Reduce Its Drug Manufacturing Regulatory Review Backlog?
Time of Update: 2022-01-25
McMeekin said the agency does not yet have data on the number of domestic inspections completed since the November update, but the FDA plans to share that information at some point in the future .
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How fragrant is the black technology AI, look here, tens of billions of cooperation has appeared!
Time of Update: 2022-01-25
In recent years, the application of AI in the field of medicine has flourished, and many companies around the world have reached cooperation in the development of new drugs based on AI, as shown in the table below .
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Biomedical research rides the wind and waves, and the transcripts of many countries in the world are remarkable
Time of Update: 2022-01-25
Russia: The first anti-new crown injection drug comes out, 4 new crown vaccines are put into mass vaccinationRussia: The first anti-new crown injection drug comes out, 4 new crown vaccines are put in
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Cell therapy goes through the approval road, and local innovation joins the ADC battle｜Annual
Time of Update: 2022-01-25
According to the statistics of R&D customers, including Pfizer, GlaxoSmithKline, Daiichi Sankyo, Roche and other multinational companies, a total of 10 ADC products have been deployed in the Chinese market, and 5 have entered the phase III clinical or NDA stage; local drugs in this field have been deployed.
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[Xingyan] Review of major pharmaceutical policies in 2021
Time of Update: 2022-01-25
"Notice on the key tasks of deepening the reform of the medical and health system in 2021" On December 30, the State Food and Drug Administration and other 8 departments jointly issued the "14th Five-Year Plan for National Drug Safety and Promotion of High-quality Development" , clarifying the guiding ideology of drug safety and promoting high-quality development during China's "14th Five-Year Plan" period.
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AZ, Sanofi, and Pfizer all adjust!
Time of Update: 2022-01-25
Almost at the same time, another well-known multinational pharmaceutical company, Pfizer, also announced that it would merge its KA department into the sales structure.
As mentioned above, Pfizer China first merged the KA team into the market access department, which is exactly the company's response to this trend .
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The SIP Index released the 2021Q3 pharmaceutical industry development index 128, and the industry's overall profit increased by 67% year-on-year
Time of Update: 2022-01-25
. In the third quarter, the sales revenue and profit of the pharmaceutical industry declined significantly, and the development momentum of chemical preparations and Chinese patent medicine manufacturing was insufficient.
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Review of the development of the medical device field in 2021
Time of Update: 2022-01-25
Figure 3: The implementation of the special approval procedures for innovative medical devices in my country Source: CMDE, Firestone Creation (approved products are calculated based on the registration certificate) Table 2: Products approved for marketing under the special approval process for innovative medical devices in 2021 Source: CMDE, Flint Creation 8 softwares were selected as new highs .
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Brief Analysis of the Progress of Consistency Evaluation of Generic Drugs in 2021
Time of Update: 2022-01-25
CPM New Drug Development Monitoring Database The content of the first reviewed varieties decreased In 2021, the cumulative number of over-evaluated drugs increased from 426 at the beginning of the year to 652 at the end of the year, that is, among the nearly 2,000 over-evaluated generic drug approvals approved this year, 226 were first over-evaluated .
