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Notice of the State Drug Administration on Printing and Distributing the "Implementation Plan for the State Drug Administration to Implement the State Council's Deepening the Reform of "Separation of Licenses and Licenses" to Further Stimulate the Development Vitality of Market Entities"
Time of Update: 2021-09-13
doc Attachment 2 Issues concerning the reform of enterprise-related business licenses by the drug regulatory authority (2021 Free Trade Pilot Zone Edition).
doc Attachment 4 Summary Table of the Reform of Business Licensing Issues Related to Enterprises by the Drug Regulatory Authority (2021 Free Trade Pilot Zone Edition).
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23 new varieties (deemed as the same) passed the consistency evaluation, and 6 were the first ones (list attached)
Time of Update: 2021-09-13
. According to public information, the size of China's current contrast agent market is about 12 billion, and the compound growth rate in the past five years is close to about 15%.
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Medical Insurance Bureau: The results of the preliminary review of the National Medical Insurance Drug List in 2021 are released!
Time of Update: 2021-09-13
On August 28, the National Medical Security Administration issued an announcement, according to the feedback from all parties, formally formed the review results of the 2021 national medical insurance drug catalog adjustment form, and applying companies can log on to the national medical insurance public service platform (fuwu.
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CStone Pharmaceuticals announces that the new drug listing application of sugarizumab for stage III non-small cell lung cancer has been accepted by the National Medical Products Administration
Time of Update: 2021-09-13
Shuglizumab is the world's first PD-1 or PD-L1 monoclonal antibody that significantly improves the progression-free survival of patients with stage III non-small cell lung cancer without disease prog
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Targeting difficult-to-drug targets US$50 million to help develop next-generation small molecule discovery platforms
Time of Update: 2021-09-13
Jnana's pilot project aims to reduce the level of Phe in the blood that drives the pathology of PKU disease by inhibiting SLC6A19, so as to provide a new oral small molecule therapy for the treatment of PKU .
Retrieved August 18, 2021, from https:// therapeutics-closes-50-million-series-b-financing-to-advance-lead-pku-program-and-small-molecule-pipeline-based-on-next-gen-chemoproteomic-platform/
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For the fifth batch of national sources, Shanghai requires preparations for admission to the hospital in advance!
Time of Update: 2021-09-13
On August 30, the latest notice of the Shanghai Municipal Pharmaceutical Centralized Bidding and Purchasing Affairs Management Office mentioned that the fifth batch of 61 nationally selected drugs is expected to be officially implemented in Shanghai in late October, requiring preparations for admission to the hospital in advance .
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R&D expenditures increased by 26% in the first half of the year!
Time of Update: 2021-09-13
From the perspective of international market experience, Novartis developed imatinib (trade name Gleevec) is the world’s first targeted BCR-ABL tyrosine kinase inhibitor (TKI) to be used as a treatment for chronic myeloid leukemia The first-line medication of CML can make the 10-year survival rate of CML patients reach 85%-90% .
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Science cover: New AI technology is expected to solve the problem of RNA structure prediction
Time of Update: 2021-09-13
The database contains about 350,000 protein structures predicted by the AlphaFold system, covering humans and 20 commonly used model organisms in biological research.
While AI technology has solved major challenges in the field of protein structure analysis for decades, scientists from Stanford University have also applied AI technology to RNA structure prediction .
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FcRn antagonist efgartigimod enters review in the European Union Zai Lab introduced into China
Time of Update: 2021-09-13
The results showed that the ADAPT trial reached the primary endpoint: in patients with acetylcholine receptor antibody positive (AChR Ab+) gMG, according to myasthenia gravis activity of daily living (MG-ADL) score, compared with the placebo group, the efgartigimod treatment group had more A high proportion of patients are responders (67.
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Notice on the public solicitation of opinions on the "Technical Guidelines for Clinical Pharmacology Research of Innovative Drugs (Draft for Solicitation of Comments)"
Time of Update: 2021-09-13
pdf Annex 3 : "Technical Guidelines for Innovative Drug Clinical Pharmacology Research (Draft for Solicitation of Comments)" feedback form.
docx Annex 3: "Technical Guidelines for Clinical Pharmacology Research of Innovative Drugs (Consultation Draft)" feedback form.
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Review the five major innovations of cell therapy
Time of Update: 2021-09-13
In essence, the T cells of engineered TCR therapy have specific receptors that can recognize these signals on cancer cells, so it is expected to further enhance the patient's immune response .
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How much money does the new crown vaccine attract?
Time of Update: 2021-09-13
In terms of production capacity, the annual production capacity of China Biotech's new crown vaccine has increased from 200 million, 2 billion, and 3 billion, and has now exceeded 5 billion doses .
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Just now, 4.4 billion prostate cancer blockbuster varieties, Hausen won the first imitation in China
Time of Update: 2021-09-13
In 2020, enzalutamide will be approved for a new indication for non-metastatic castration-resistant prostate cancer (CRPC) adult male patients .
In June of this year, NMPA approved it for monotherapy in adult patients with metastatic castration-resistant prostate cancer who carry BRCA1/2 mutations (germline and/or somatic cell lines) and who have progressed after previous treatment with new hormone drugs.
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Takeda reached a collaboration with US$303 million to help develop liposome-delivered gene therapy
Time of Update: 2021-09-13
On August 23, 2021, Genevant Sciences and Takeda announced that they have reached a global cooperation and licensing agreement to use Genevant’s proprietary lipid nanoparticle (LNP) technology platform to develop new non-viral vector gene therapy and treatment Rare liver disease .
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4 lessons from pharmaceutical companies
Time of Update: 2021-09-13
Regarding the reasons for participating in the centralized procurement and then voluntarily giving up, the company responded that after the selection of ibuprofen sustained-release capsules, due to insufficient existing production capacity, the responsible unit (production unit) did not pay enough attention to it, and related registration and change policy adjustments, plus The impact of the epidemic (the new crown epidemic in Shijiazhuang City repeated in early 2021), resulting in the company's inability to guarantee normal supply .
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Pioneer Pharmaceuticals and Etana reached a partnership on the commercialization of Prokalamide in the treatment of COVID-19 in Indonesia
Time of Update: 2021-09-13
According to the agreement, Kaifeng Pharmaceutical will receive a down payment and milestone payment from Etana.
Since the pandemic of the new crown epidemic in early 2020, Kaixing Pharmaceutical has rapidly started research on the use of procluamide for the treatment of new crowns .
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Eli Lilly invests over 1.6 billion U.S. dollars in LYTAC protein degradation technology
Time of Update: 2021-09-13
The focus of the two cooperation is to use Lycia's proprietary lysosomal targeting chimera or LYTAC protein degradation technology to discover, develop and commercialize new targeted therapies .
The company mainly uses its Lysosome Targeted Chimera (LYTAC) platform to develop protein-degradable therapies .
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Notice on Publicly Soliciting Opinions on the "Procedures and Requirements for Registration Changes (Draft for Soliciting Opinions) of Overseas Produced Drugs After Marketing"
Time of Update: 2021-09-13
Feedback form Drug Evaluation Center of the State Drug Administration August 30, 2021 attachment1 : Procedures and requirements for filing changes of overseas-produced drugs after marketing (draft for soliciting comments).
docx Annex 1: Procedures for filing changes of overseas-produced drugs after marketing And Requirements (Draft for Solicitation of Comments).
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New medicine for children with atopic dermatitis (AD)!
Time of Update: 2021-09-13
net) August 30, 2021/Bio Valley BIOON/ --Sanofi and Regeneron have recently jointly announced the evaluation of the targeted biological agent Dupixent (Chinese trade name: Dabituo, common name: dupilumab, The pivotal phase 3 LIBERTY AD PRESCHOOL trial of Duplizumab in the treatment of children with moderate to severe atopic dermatitis (AD) from 6 months to 5 years of age met the primary and all secondary endpoints .
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A number of blockbuster collaborations have been reached, and major pharmaceutical companies are optimistic. When will the spring of gene therapy products come?
Time of Update: 2021-09-13
On the same day, Vertex Pharmaceuticals and Arbor Biotechnologies announced that they will launch a new collaboration to use Arbor’s proprietary CRISPR gene editing technology to enhance the development of innovative cell therapies for the treatment of serious diseases .
