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[Quick Overview of CDE Acceptance Week] This week, these drug applications were accepted!
Time of Update: 2022-01-07
They are:There are 11 acceptance numbers for Class 2 new drugs, including 8 for chemical drugs, 2 for therapeutic biological products, and 1 for preventive biological products .
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72% of companies released ESG reports. H shares are generally better than A shares. There is still room for improvement in ESG reports of high-value pharmaceutical companies!
Time of Update: 2022-01-07
A-share listed companies scored less than 40 points on many transparency evaluation indicators, including "report preparation with clear reference standards", "board of directors' management responsibilities for ESG issues", "analysis and disclosure of material issues", and "disclosure of key quantitative performance calculations" Method" and so on .
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The inflection point of China's new drugs in 2022 appears
Time of Update: 2022-01-07
believes that the current Chinese new drug concept is essentially a generic drug model, so if the pipeline involved in listed new drug companies is mostly tracking new drugs, it will be difficult to make a profit .
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Feelings of working in improved new drugs
Time of Update: 2022-01-02
Companies that focus on research and development of improved new drugs, such as Yueyang Pharmaceutical, etc.
However, improved new drug companies that are determined to make high-end preparations do not have such worries, because technologies such as sustained-release microspheres, liposomes, inhalation preparations, microneedles, etc.
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Potential and Competition: Viewing the Landscape of New Breast Cancer Drugs from the SABCS 2021 Conference
Time of Update: 2022-01-02
Corning Jerry announced the preliminary results of KN026 (anti-HER2 bispecific antibody) combined with KN046 (PD-L1/CTLA-4 bispecific antibody) in the treatment of metastatic HER2+ breast cancer patients at the SABCS 2021 meeting, and 36 cases were enrolled in the trial Most of the patients have received HER2 targeted therapy above the 3rd line.
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For the treatment of rare genetic diseases, the new drug authorized by Suoyuan Biotechnology was approved for clinical use in the United States and obtained the qualification of orphan drug
Time of Update: 2022-01-02
On December 14, Suoyuan Biopharmaceuticals announced that its license-out partner Aytu Biopharma has received from the US FDA the critical clinical application of Suoyuan Bio's research product DB102 for the treatment of Vascular Ehlers- Danglow Syndrome (VEDS) The trial was approved by the IND, and the FDA granted DB102 the orphan drug designation for the treatment of VEDS .
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Sanofi/GSK: The initial clinical results of the new crown vaccine booster injection are positive, and the level of neutralizing antibodies is increased by 9-43 times
Time of Update: 2021-12-31
On December 15th, Sanofi and GSK jointly announced that the clinical trial VAT0002 (n=521) of the recombinant adjuvant new crown vaccine co-developed by the two parties was positive and the initial results were positive.
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Expand advantages and accelerate the construction of a new development pattern for the API industry
Time of Update: 2021-12-31
Facing the new changes and new needs of the international competition pattern and domestic development situation, China's API industry still needs to further enhance its green and low-carbon development capabilities and continuously improve the modernization level of the industrial chain and supply chain .
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[Focus] The hospital was named by the Medical Insurance Bureau because it "reported not to collect"!
Time of Update: 2021-12-31
Tibet’s notification pointed out that since the state’s organization of centralized drug procurement, individual medical institutions in the Tibet Autonomous Region have severely decoupled from reporting and procurement, and there is even a problem that the proportion of agreed procurement completions is zero, which has seriously affected the quality and quality of centralized drug procurement in Tibet and the whole country.
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1.6 billion dollars!
Time of Update: 2021-12-31
The drug development steps based on the company’s Gene Traffic Control platform include: 1) Target identification and verification: use complex sequencing and calculation tools to determine the correlation of the chromatin regulation system Genetic dependence .
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CAR-T does not lack basic research, it lacks a high-quality clinical trial translation platform.
Time of Update: 2021-12-31
As of the end of November this year, in the global CAR-T therapy development pipeline, CD19, as a target for a variety of therapies already on the market, ranked first in the number of research and development .
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The seventh batch of national sources, 87 large varieties meet the conditions (list attached)
Time of Update: 2021-12-31
com, among the 3508 applications for consistency evaluation of generic drugs currently accepted, oral regular-release dosage forms and injections account for 47.
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The U.S. Department of Commerce announced that the sanctions list does not involve CXOs and innovative pharmaceutical companies
Time of Update: 2021-12-31
S. Department of Commerce issued a notice stating that dozens of entities located in China, Georgia, Malaysia, and Turkey were included in the Entity List, of which 34 Entities are located in China .
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Kexing: Preliminary research shows that the positive rate of intensive needle neutralization of Omi Keron antibody reached 94%
Time of Update: 2021-12-31
As for whether Omi Keron will affect the effectiveness of the current new crown vaccine, test or treatment, it still needs to be studied .
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Reverse the antiplatelet effect!
Time of Update: 2021-12-31
The indication is for adult patients with uncontrolled bleeding or life-threatening bleeding after receiving ticagrelor treatment, or in emergency surgery or The antiplatelet effect of ticagrelor needs to be reversed before intervention .
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"Nature": The top ten forecasts of global drug sales in 2022
Time of Update: 2021-12-31
Biktarvy (bictegravir, emtricitabine and tenofovir) and Dupixent (dupilumab) However, the new crown pandemic also tells us that some drugs can become blockbusters in just one year, such as the COVID-19 oral antiviral drugs developed by Merck/ Ridgeback and Pfizer .
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New and old negotiated drugs, all included in Zhejiang "dual channel", a total of 275 (list attached)
Time of Update: 2021-12-29
The latest "Zhejiang Province Included in the "Dual Channel" Management Drug List" has a total of 275 kinds of drugs, including 213 kinds of Western medicines and 62 kinds of Chinese patent medicines .
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New trends in cutting-edge technology, Novartis, BMS, Legend Bio and other companies CAR-T cell therapy competition ASH annual meeting; Liu Ruqian team released a new version of the gene editing system
Time of Update: 2021-12-29
In the coming week, the cutting-edge technology of global biomedicine has new trends:In the coming week, the cutting-edge technology of global biomedicine has new trends: Novartis' new-generation CAR
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Over 3.5 billion U.S. dollars to develop antisense oligonucleotide therapy AstraZeneca reached cooperation
Time of Update: 2021-12-29
In ATTR patients, mutant and wild-type TTR proteins will form fibrils in human tissues, such as peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid and bone marrow, which will damage the normal function of the tissues.
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The US Congress released a drug pricing survey report, exposing pharmaceutical companies to manipulate prices for huge profits
Time of Update: 2021-12-29
According to the report, “the committee’s investigation found that the company spent a large portion of its R&D expenditure on research aimed at expanding market monopoly, supporting the company’s marketing strategy, and curbing competition .
According to the 269-page report, the three insulin companies adopted strategies to maintain monopoly pricing and resist competition from biosimilar drugs .
