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Medical Network News, March 2 At the beginning of 2021, the Drug Evaluation Center of the China Medical Products Administration issued the "Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilars" to further standardize and guide the research and development and development of biosimilars.
Evaluation provides technical reference for industry, researchers and regulatory agencies
.
This makes the research and development of biopharmaceuticals more and more a key project in drug research and development, so today we will follow the domestic biopharmaceutical research and development "big guys" to take a look at their Pipeline distribution
.
Shanghai Fosun Pharma
As of June 30, 2020, Fosun Pharma has 17 small molecule innovative drugs under development, 2 chemically improved new drugs, 21 innovative biological drugs, 21 biosimilar drugs, 2 traditional Chinese medicines, and cumulatively introduced projects 22 items (9 imported innovative drugs and 13 imported generic drugs)
.
There are a total of 25 monoclonal antibody drugs in the distribution of Fosun Pharma’s pipeline, of which 9 are biosimilar drugs, 9 are innovative biological drugs, and 7 are used as combination therapy
.
Shanghai Fosun Pharma announced on March 16, 2020 that it was awarded BionTech SE licenses the exclusive development and commercialization of vaccine products against COVID-19 based on its proprietary mRNA technology platform in China
.
And on January 25, 2021, Shanghai Fosun Pharmaceutical (Group) Co.
, Ltd.
and BionTech SE jointly announced that the new crown vaccine COMIRNATY® (ie BNT162b2, Chinese trade name: FubitaiTM) based on BioNTech's mRNA technology has been approved by the Food and Health Bureau of the Hong Kong Special Administrative Region for emergency use in Hong Kong
.
In the future, the vaccine supplied to Hong Kong will be directly produced by BioNTech’s plant in Germany for the supply, distribution and administration of the Hong Kong Special Administrative Region Government’s new crown vaccination plan
.
Jiangsu Hengrui Medicine
in terms of innovative drugs, Henry has formed a listed number, clinical batch, develop a virtuous cycle number, the creation of new drugs in the field of targeted therapy, immunotherapy, ultra-long-acting insulin, has been an international leader of
.
According to the pipeline data published on the official website of Hengrui Medicine, there are a total of 31 product lines, including 1 clinical application, 13 entering clinical phase I, 2 clinical phase II, 8 clinical phase III, and 7 product lines in the market stage (1 product is listed Applying)
.
In all product lines, 14 tumor/blood related products accounted for 45%
.
On February 22, 2021, Hengrui Medicine announced that its in-development PARP inhibitor (fluzoparib capsule) has obtained the FDA international multi-center clinical trial qualification
.
Cinda Biopharmaceuticals
Cinda Biopharmaceuticals has established a product chain including 23 new drug varieties, covering multiple disease fields such as tumors and metabolic diseases
.
Among them, 4 products are on the market, 6 varieties have been approved for the national "Major New Drug Creation" major scientific and technological project, 4 products have entered phase III or relevant clinical studies, and 15 products have entered clinical studies
.
According to the pipeline information released by Cinda Pharmaceuticals, there are as many as 27 blood/tumor drugs, accounting for 79.
4% of the total; 6 of them have entered the market stage, and 9 drugs have entered clinical phase III.
You can see To Cinda Pharmaceutical's research and development direction is still mainly anti-tumor
.
Biotech Biopharmaceuticals
Biotech Biopharmaceuticals is committed to developing a new generation of antibody drugs for the treatment of tumors, autoimmune diseases, cardiovascular diseases and other major diseases that endanger human life or health .
According to the research and development pipeline announced by Biotech, there are 15 tumor-related drugs, 6 autoimmune disease drugs, 2 cardiovascular disease drugs, and 2 ophthalmic disease drugs.
.
On January 28, 2021, Biotech announced that the U.
S.
Food and Drug Administration (FDA) has accepted a biological product marketing authorization application (BLA) for BAT1706 (bevacizumab) injection
.
The applied indications include metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent or metastatic cervical cancer
.
Makes Biotech one step closer to entering the US market
.
Shanghai Junshi Biology
Junshi Biology is the first Chinese company in China that has obtained the approval of the anti-PD-1 monoclonal antibody NMPA and the clinical application of the anti-PCSK9 monoclonal antibody NMPA, and obtained the world’s first anti-BTLA blocking antibody for the treatment of tumors.
The clinical application of China NMPA and US FDA is approved
.
At present, it has a rich pipeline of products under research, including 19 innovative drugs and 2 biosimilars, which mainly cover the fields of tumor, metabolism, autoimmunity, nervous system, anti-infection and other major diseases.
Innovative monoclonal antibody drugs include: PD-1 monoclonal antibody (JS001) for tumor immunotherapy, PCSK9 monoclonal antibody (JS002) for hypercholesterolemia treatment BTLA monoclonal antibody (JS004) for tumor immunotherapy
.
Among them, the PD-1 monoclonal antibody Tuoyi (Treprizumab, product code: JS001) has been put on the market
.
Through the statistics of the TOP5 enterprise pipeline, we can see that the current research and development focus of the domestic pharmaceutical industry is still on the development of anti-tumor drugs, of which the development of monoclonal antibodies is the top priority.
With the acceleration of the domestic population aging process, The development progress of drugs for cardiovascular diseases is also on an upward trend
.
With the introduction of a series of relevant national policies, it is believed that the development of domestic bio-innovative drugs and bio-similar drugs will usher in a spurt of development
.
Data source: corporate website
Evaluation provides technical reference for industry, researchers and regulatory agencies
.
This makes the research and development of biopharmaceuticals more and more a key project in drug research and development, so today we will follow the domestic biopharmaceutical research and development "big guys" to take a look at their Pipeline distribution
.
Shanghai Fosun Pharma
As of June 30, 2020, Fosun Pharma has 17 small molecule innovative drugs under development, 2 chemically improved new drugs, 21 innovative biological drugs, 21 biosimilar drugs, 2 traditional Chinese medicines, and cumulatively introduced projects 22 items (9 imported innovative drugs and 13 imported generic drugs)
.
There are a total of 25 monoclonal antibody drugs in the distribution of Fosun Pharma’s pipeline, of which 9 are biosimilar drugs, 9 are innovative biological drugs, and 7 are used as combination therapy
.
Shanghai Fosun Pharma announced on March 16, 2020 that it was awarded BionTech SE licenses the exclusive development and commercialization of vaccine products against COVID-19 based on its proprietary mRNA technology platform in China
.
And on January 25, 2021, Shanghai Fosun Pharmaceutical (Group) Co.
, Ltd.
and BionTech SE jointly announced that the new crown vaccine COMIRNATY® (ie BNT162b2, Chinese trade name: FubitaiTM) based on BioNTech's mRNA technology has been approved by the Food and Health Bureau of the Hong Kong Special Administrative Region for emergency use in Hong Kong
.
In the future, the vaccine supplied to Hong Kong will be directly produced by BioNTech’s plant in Germany for the supply, distribution and administration of the Hong Kong Special Administrative Region Government’s new crown vaccination plan
.
Jiangsu Hengrui Medicine
in terms of innovative drugs, Henry has formed a listed number, clinical batch, develop a virtuous cycle number, the creation of new drugs in the field of targeted therapy, immunotherapy, ultra-long-acting insulin, has been an international leader of
.
According to the pipeline data published on the official website of Hengrui Medicine, there are a total of 31 product lines, including 1 clinical application, 13 entering clinical phase I, 2 clinical phase II, 8 clinical phase III, and 7 product lines in the market stage (1 product is listed Applying)
.
In all product lines, 14 tumor/blood related products accounted for 45%
.
On February 22, 2021, Hengrui Medicine announced that its in-development PARP inhibitor (fluzoparib capsule) has obtained the FDA international multi-center clinical trial qualification
.
Cinda Biopharmaceuticals
Cinda Biopharmaceuticals has established a product chain including 23 new drug varieties, covering multiple disease fields such as tumors and metabolic diseases
.
Among them, 4 products are on the market, 6 varieties have been approved for the national "Major New Drug Creation" major scientific and technological project, 4 products have entered phase III or relevant clinical studies, and 15 products have entered clinical studies
.
According to the pipeline information released by Cinda Pharmaceuticals, there are as many as 27 blood/tumor drugs, accounting for 79.
4% of the total; 6 of them have entered the market stage, and 9 drugs have entered clinical phase III.
You can see To Cinda Pharmaceutical's research and development direction is still mainly anti-tumor
.
Biotech Biopharmaceuticals
Biotech Biopharmaceuticals is committed to developing a new generation of antibody drugs for the treatment of tumors, autoimmune diseases, cardiovascular diseases and other major diseases that endanger human life or health .
According to the research and development pipeline announced by Biotech, there are 15 tumor-related drugs, 6 autoimmune disease drugs, 2 cardiovascular disease drugs, and 2 ophthalmic disease drugs.
.
On January 28, 2021, Biotech announced that the U.
S.
Food and Drug Administration (FDA) has accepted a biological product marketing authorization application (BLA) for BAT1706 (bevacizumab) injection
.
The applied indications include metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent or metastatic cervical cancer
.
Makes Biotech one step closer to entering the US market
.
Shanghai Junshi Biology
Junshi Biology is the first Chinese company in China that has obtained the approval of the anti-PD-1 monoclonal antibody NMPA and the clinical application of the anti-PCSK9 monoclonal antibody NMPA, and obtained the world’s first anti-BTLA blocking antibody for the treatment of tumors.
The clinical application of China NMPA and US FDA is approved
.
At present, it has a rich pipeline of products under research, including 19 innovative drugs and 2 biosimilars, which mainly cover the fields of tumor, metabolism, autoimmunity, nervous system, anti-infection and other major diseases.
Innovative monoclonal antibody drugs include: PD-1 monoclonal antibody (JS001) for tumor immunotherapy, PCSK9 monoclonal antibody (JS002) for hypercholesterolemia treatment BTLA monoclonal antibody (JS004) for tumor immunotherapy
.
Among them, the PD-1 monoclonal antibody Tuoyi (Treprizumab, product code: JS001) has been put on the market
.
Through the statistics of the TOP5 enterprise pipeline, we can see that the current research and development focus of the domestic pharmaceutical industry is still on the development of anti-tumor drugs, of which the development of monoclonal antibodies is the top priority.
With the acceleration of the domestic population aging process, The development progress of drugs for cardiovascular diseases is also on an upward trend
.
With the introduction of a series of relevant national policies, it is believed that the development of domestic bio-innovative drugs and bio-similar drugs will usher in a spurt of development
.
Data source: corporate website