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According to information from the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, since this year, three new drugs have been added to the list of priority review varieties, namely Boehringer Ingelheim (China)'s sebersolizumab injection, Shanghai Gumetinib tablets from Haihe Pharmaceutical Research and Development Co.
, Ltd.
and quadrivalent influenza virus split vaccine from Shanghai Institute of Biological Products Co.
,
Ltd.
Image source: The spesolimab (spesolimab injection) developed by Boehringer Ingelheim, the Center for Drug Evaluation, China State Food and Drug Administration, is a new drug for generalized pustular psoriasis, the so-called pustular psoriasis (GPP).
) is a rare type of psoriasis, accounting for only less than 1% of the total psoriasis, but it can be life-threatening
.
At present, the main treatment drugs for pustular psoriasis are antibiotics to prevent infection, anti-TNF drugs and immunosuppressants to control inflammation
.
According to reports, sembresolizumab injection is an IL-36R monoclonal antibody that blocks the action of the interleukin-36 receptor, which is a signaling pathway in the immune system.
, plays an important role in many inflammatory diseases including pustular psoriasis
.
Gumetinib tablets of Haihe Medicine are used to treat patients with locally advanced or metastatic non-small cell lung cancer with MET14 exon skipping
.
This is an oral potent and highly selective c-MET inhibitor.
Preclinical studies have shown that Gumetinib 50mg/kg has a strong tumor inhibitory effect
.
It is reported that Haihe Pharmaceuticals is conducting a number of clinical trials of Gumetinib in China, the United States and Japan at the same time
.
The quadrivalent influenza virus split vaccine of Shanghai Institute of Biological Products Co.
, Ltd.
was recently included in the priority review and approval list
.
It is understood that the quadrivalent influenza virus split vaccine is mainly used to stimulate the body to produce immunity against influenza virus and prevent influenza caused by this strain
.
According to the data of Minet, in 2020, the converted batch issuance of influenza virus split vaccine in China is 983 million yuan.
.
It is understood that in November 2019, the Drug Evaluation Center of the State Food and Drug Administration organized the drafting of the "Working Procedures for Breakthrough Therapy Drugs" and the "Working Procedures for Priority Review and Approval", which aim to encourage the research and creation of new drugs, and accelerate the development of drugs with obvious clinical advantages.
drug development process
.
Since the beginning of this year, 16 new drugs, including Nipocalimab injection and BeiGene BGB-3111 capsules, have been added to the list of breakthrough treatment varieties
.
Up to now, 94 innovative drugs have been included in the list of breakthrough therapy varieties, many of which have been marketed, such as Hengrui's camrelizumab, Junshi Bio's toripalizumab, WuXi Junuo's Ruijirenzai, Fosun Kite's Akilensee, Rongchang Bio's Vidicitumumab,
etc.
According to statistics, 1,332 drugs have been included in the priority review list
.
From the perspective of enterprises, the product is included in the list of breakthrough therapy varieties or in the list of priority review varieties, which is expected to further shorten the listing process
.
It is worth mentioning that, according to the “Procedures for Accelerating the Review of Innovative Drug Marketing Applications (Trial)” issued by CDE on February 22 (Draft for Comment), the standard threshold for the identification of breakthrough therapeutic drugs may be higher in the future.
The clinical value of the drug has become an important consideration factor for regulatory agencies.
Therefore, the industry believes that in the future, the products of pharmaceutical companies will only be eligible to compete for this golden track of breakthrough therapeutic drugs if they achieve actual breakthroughs in clinical efficacy
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
, Ltd.
and quadrivalent influenza virus split vaccine from Shanghai Institute of Biological Products Co.
,
Ltd.
Image source: The spesolimab (spesolimab injection) developed by Boehringer Ingelheim, the Center for Drug Evaluation, China State Food and Drug Administration, is a new drug for generalized pustular psoriasis, the so-called pustular psoriasis (GPP).
) is a rare type of psoriasis, accounting for only less than 1% of the total psoriasis, but it can be life-threatening
.
At present, the main treatment drugs for pustular psoriasis are antibiotics to prevent infection, anti-TNF drugs and immunosuppressants to control inflammation
.
According to reports, sembresolizumab injection is an IL-36R monoclonal antibody that blocks the action of the interleukin-36 receptor, which is a signaling pathway in the immune system.
, plays an important role in many inflammatory diseases including pustular psoriasis
.
Gumetinib tablets of Haihe Medicine are used to treat patients with locally advanced or metastatic non-small cell lung cancer with MET14 exon skipping
.
This is an oral potent and highly selective c-MET inhibitor.
Preclinical studies have shown that Gumetinib 50mg/kg has a strong tumor inhibitory effect
.
It is reported that Haihe Pharmaceuticals is conducting a number of clinical trials of Gumetinib in China, the United States and Japan at the same time
.
The quadrivalent influenza virus split vaccine of Shanghai Institute of Biological Products Co.
, Ltd.
was recently included in the priority review and approval list
.
It is understood that the quadrivalent influenza virus split vaccine is mainly used to stimulate the body to produce immunity against influenza virus and prevent influenza caused by this strain
.
According to the data of Minet, in 2020, the converted batch issuance of influenza virus split vaccine in China is 983 million yuan.
.
It is understood that in November 2019, the Drug Evaluation Center of the State Food and Drug Administration organized the drafting of the "Working Procedures for Breakthrough Therapy Drugs" and the "Working Procedures for Priority Review and Approval", which aim to encourage the research and creation of new drugs, and accelerate the development of drugs with obvious clinical advantages.
drug development process
.
Since the beginning of this year, 16 new drugs, including Nipocalimab injection and BeiGene BGB-3111 capsules, have been added to the list of breakthrough treatment varieties
.
Up to now, 94 innovative drugs have been included in the list of breakthrough therapy varieties, many of which have been marketed, such as Hengrui's camrelizumab, Junshi Bio's toripalizumab, WuXi Junuo's Ruijirenzai, Fosun Kite's Akilensee, Rongchang Bio's Vidicitumumab,
etc.
According to statistics, 1,332 drugs have been included in the priority review list
.
From the perspective of enterprises, the product is included in the list of breakthrough therapy varieties or in the list of priority review varieties, which is expected to further shorten the listing process
.
It is worth mentioning that, according to the “Procedures for Accelerating the Review of Innovative Drug Marketing Applications (Trial)” issued by CDE on February 22 (Draft for Comment), the standard threshold for the identification of breakthrough therapeutic drugs may be higher in the future.
The clinical value of the drug has become an important consideration factor for regulatory agencies.
Therefore, the industry believes that in the future, the products of pharmaceutical companies will only be eligible to compete for this golden track of breakthrough therapeutic drugs if they achieve actual breakthroughs in clinical efficacy
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
