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[Pharmaceutical Network Enterprise News] The first generic drug has always been the focus of the R&D layout of domestic pharmaceutical companies, and has gradually entered a period of intensive approval in recent years
.
According to the data, in the past three years (2019-2021), more than 150 first imitations (including the first imitations of dosage forms) have been approved for marketing
.
From the perspective of drugs, over 150 first generic drugs cover 13 major categories of treatment, focusing on nervous system drugs, digestive system and metabolic drugs, anti-tumor and immunomodulatory agents; High-barrier dosage forms such as preparations and eye drops have been approved
.
From the perspective of the approved companies, Yangtze River Pharmaceutical, Qilu Pharmaceutical, and China Biopharmaceutical are at the forefront, with 31, 21, and 20 approved varieties, respectively
.
It is worth mentioning that many pharmaceutical companies are still developing generic drugs this year, and many pharmaceutical companies have recently approved a number of first generic drugs
.
Recently, the CDE website shows that Qilu Pharmaceutical's riociguat tablet (riociguat) marketing application has been accepted, which is the first riociguat generic drug to be declared for listing in China
.
It is reported that this drug is also the second first generic drug declared by Qilu within a week
.
Riociguat is a soluble guanylate cyclase (sGC) agonist, jointly developed by Bayer and Merck, and was first approved for marketing in the United States in 2013 under the trade name: Adempas
.
Its original drug was approved by the State Food and Drug Administration in September 2017 through the priority review process for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and arterial pulmonary hypertension (PAH)
.
According to the financial reports of Bayer and Merck, the drug will bring sales revenue of 738 million euros and 252 million US dollars to the two companies in 2021
.
In China, in addition to Qilu Pharmaceutical, the companies currently developing generic drugs for Riociguat include Zhengzhou Deep Blue Ocean Biomedical Technology and Warwick Pharmaceuticals
.
On March 22, the CDE website showed that Qilu Pharmaceutical's marketing application for roprostim for injection has also been accepted for the treatment of immune thrombocytopenia
.
This is the first roprostim generic drug to be declared for listing in China
.
Data show that roprostim (English trade name: Nplate) is a second-generation oral TPO-R agonist that stimulates intracellular transcriptional pathways by binding to TPO receptors, thereby increasing platelet production
.
The original research was developed by Amgen.
In August 2008, the drug was first approved for marketing in the United States, followed by dozens of countries and regions such as the European Union and Japan, and entered the Chinese market in January 2022 for the treatment of immune thrombocytopenia.
.
Currently, roprostim has been approved for multiple indications, including immune thrombocytopenia, acute radiation syndrome, and aplastic anemia
.
It is understood that with the approval of more indications, the sales of roprostim have continued to grow
.
According to Amgen's 2021 financial report, Nplate has revenue of $1.
027 billion and has become the company's blockbuster drug
.
In fact, relying on a rich cluster of generic drugs, Qilu Pharmaceutical has long been at the forefront of the country in terms of the number of over-reviewed drugs
.
In the past three years, more than 50 generic drugs of Qilu Pharmaceutical have been approved for marketing, of which 9 are the first generic drugs, and 4 will be approved for marketing in 2021
.
The industry predicts that under the background of continuous innovation, Qilu Pharmaceutical may make new breakthroughs in the number of generic drugs this year
.
Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to the data, in the past three years (2019-2021), more than 150 first imitations (including the first imitations of dosage forms) have been approved for marketing
.
From the perspective of drugs, over 150 first generic drugs cover 13 major categories of treatment, focusing on nervous system drugs, digestive system and metabolic drugs, anti-tumor and immunomodulatory agents; High-barrier dosage forms such as preparations and eye drops have been approved
.
From the perspective of the approved companies, Yangtze River Pharmaceutical, Qilu Pharmaceutical, and China Biopharmaceutical are at the forefront, with 31, 21, and 20 approved varieties, respectively
.
It is worth mentioning that many pharmaceutical companies are still developing generic drugs this year, and many pharmaceutical companies have recently approved a number of first generic drugs
.
Recently, the CDE website shows that Qilu Pharmaceutical's riociguat tablet (riociguat) marketing application has been accepted, which is the first riociguat generic drug to be declared for listing in China
.
It is reported that this drug is also the second first generic drug declared by Qilu within a week
.
Riociguat is a soluble guanylate cyclase (sGC) agonist, jointly developed by Bayer and Merck, and was first approved for marketing in the United States in 2013 under the trade name: Adempas
.
Its original drug was approved by the State Food and Drug Administration in September 2017 through the priority review process for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and arterial pulmonary hypertension (PAH)
.
According to the financial reports of Bayer and Merck, the drug will bring sales revenue of 738 million euros and 252 million US dollars to the two companies in 2021
.
In China, in addition to Qilu Pharmaceutical, the companies currently developing generic drugs for Riociguat include Zhengzhou Deep Blue Ocean Biomedical Technology and Warwick Pharmaceuticals
.
On March 22, the CDE website showed that Qilu Pharmaceutical's marketing application for roprostim for injection has also been accepted for the treatment of immune thrombocytopenia
.
This is the first roprostim generic drug to be declared for listing in China
.
Data show that roprostim (English trade name: Nplate) is a second-generation oral TPO-R agonist that stimulates intracellular transcriptional pathways by binding to TPO receptors, thereby increasing platelet production
.
The original research was developed by Amgen.
In August 2008, the drug was first approved for marketing in the United States, followed by dozens of countries and regions such as the European Union and Japan, and entered the Chinese market in January 2022 for the treatment of immune thrombocytopenia.
.
Currently, roprostim has been approved for multiple indications, including immune thrombocytopenia, acute radiation syndrome, and aplastic anemia
.
It is understood that with the approval of more indications, the sales of roprostim have continued to grow
.
According to Amgen's 2021 financial report, Nplate has revenue of $1.
027 billion and has become the company's blockbuster drug
.
In fact, relying on a rich cluster of generic drugs, Qilu Pharmaceutical has long been at the forefront of the country in terms of the number of over-reviewed drugs
.
In the past three years, more than 50 generic drugs of Qilu Pharmaceutical have been approved for marketing, of which 9 are the first generic drugs, and 4 will be approved for marketing in 2021
.
The industry predicts that under the background of continuous innovation, Qilu Pharmaceutical may make new breakthroughs in the number of generic drugs this year
.
Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone
.
