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In recent years, with the continuous improvement of the research and development capabilities of domestic pharmaceutical companies, domestic innovative drugs have sprung up like mushrooms after a spring rain
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
.
In the past week, more than 20 new category 1 drugs (excluding supplementary applications) have been added, from pharmaceutical companies such as Hengrui Medicine, Buchang Pharmaceutical, and Osaikang
.
On February 23, Guangdong Sunshine Pharmaceutical submitted a new drug clinical application for class 1 new drug HEC169096 tablets
.
Statistics show that the company and its subsidiaries have earlier approved nearly 30 Class 1 new drugs (including chemical drugs and biological drugs) for clinical trials, of which 3 have entered Phase III clinical trials, involving esophageal squamous cell carcinoma, chronic hepatitis B, Type 2 diabetes and other indications
.
In addition, the company has nearly 30 class 1 new drugs approved for clinical use
.
On February 22, Buchang Pharmaceutical announced that the clinical trial application for "BC004 for injection" of its holding subsidiary Luzhou Buchang Bio-Pharmaceutical Co.
, Ltd.
("Luzhou Buchang") was accepted by the State Drug Administration and received.
to the "Notice of Acceptance"
.
The data show that BC004 for injection is a recombinant anti-HER2/CD3 humanized bispecific antibody drug, which is mainly used for the treatment of HER2-positive advanced solid tumors, including HER2-positive breast cancer, gastric cancer/gastroesophageal junction adenocarcinoma,
etc.
At present, there are no drugs with the same target on the market at home and abroad
.
On February 21, Kelun Pharmaceutical issued an announcement stating that the SKB378/HBM9378 injection jointly developed by its holding subsidiary Sichuan Kelun Botai Biopharmaceutical Co.
, Ltd.
and Hebo Pharmaceutical has been notified of clinical trials by the National Medical Products Administration (NMPA).
approved the clinical trial of the injection for moderate to severe asthma indications
.
On February 18, Osaikang announced that the innovative drug ASKG712 injection independently developed by Suzhou Osaikang, a wholly-owned subsidiary, was approved by the State Food and Drug Administration for clinical trials.
The indication is neovascular age-related macular degeneration
.
Prior to this, Osaikang just announced that ASKC202 tablets will be used in clinical trials for the treatment of advanced solid tumors
.
It is reported that in addition to ASKC202 tablets, Osaikang also has 4 class 1 new drugs that have been approved for clinical use
.
Among them, it is worth mentioning that the company's first class 1 new drug ASK120067 is expected to be approved this year
.
After sorting out, the mechanism of action of class 1 new drugs approved this year mainly includes JAK1 inhibitor, JAK2 inhibitor, KARS G12C inhibitor, SHP2 inhibitor, multi-target kinase inhibitor, Claudin 18.
2-targeting monoclonal antibody, BCMA/CD3 dual Anti- and agonists targeting the IL-2 signaling pathway,
etc.
Among them, tumor and anti-virus are still the key areas
.
According to the analysis, judging from the current number of approvals and targets of Class 1 new drugs, the development of the domestic innovative drug industry is accelerating, and the harvest period is about to usher in
.
The industry expects that if these new drugs are successfully launched in the future, they will achieve breakthroughs in the field of major diseases and benefit more patients.
At the same time, they will further reduce domestic dependence on foreign new drugs, accelerate import substitution, and promote the sustainable and healthy development of the domestic innovative drug industry
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
.
In the past week, more than 20 new category 1 drugs (excluding supplementary applications) have been added, from pharmaceutical companies such as Hengrui Medicine, Buchang Pharmaceutical, and Osaikang
.
On February 23, Guangdong Sunshine Pharmaceutical submitted a new drug clinical application for class 1 new drug HEC169096 tablets
.
Statistics show that the company and its subsidiaries have earlier approved nearly 30 Class 1 new drugs (including chemical drugs and biological drugs) for clinical trials, of which 3 have entered Phase III clinical trials, involving esophageal squamous cell carcinoma, chronic hepatitis B, Type 2 diabetes and other indications
.
In addition, the company has nearly 30 class 1 new drugs approved for clinical use
.
On February 22, Buchang Pharmaceutical announced that the clinical trial application for "BC004 for injection" of its holding subsidiary Luzhou Buchang Bio-Pharmaceutical Co.
, Ltd.
("Luzhou Buchang") was accepted by the State Drug Administration and received.
to the "Notice of Acceptance"
.
The data show that BC004 for injection is a recombinant anti-HER2/CD3 humanized bispecific antibody drug, which is mainly used for the treatment of HER2-positive advanced solid tumors, including HER2-positive breast cancer, gastric cancer/gastroesophageal junction adenocarcinoma,
etc.
At present, there are no drugs with the same target on the market at home and abroad
.
On February 21, Kelun Pharmaceutical issued an announcement stating that the SKB378/HBM9378 injection jointly developed by its holding subsidiary Sichuan Kelun Botai Biopharmaceutical Co.
, Ltd.
and Hebo Pharmaceutical has been notified of clinical trials by the National Medical Products Administration (NMPA).
approved the clinical trial of the injection for moderate to severe asthma indications
.
On February 18, Osaikang announced that the innovative drug ASKG712 injection independently developed by Suzhou Osaikang, a wholly-owned subsidiary, was approved by the State Food and Drug Administration for clinical trials.
The indication is neovascular age-related macular degeneration
.
Prior to this, Osaikang just announced that ASKC202 tablets will be used in clinical trials for the treatment of advanced solid tumors
.
It is reported that in addition to ASKC202 tablets, Osaikang also has 4 class 1 new drugs that have been approved for clinical use
.
Among them, it is worth mentioning that the company's first class 1 new drug ASK120067 is expected to be approved this year
.
After sorting out, the mechanism of action of class 1 new drugs approved this year mainly includes JAK1 inhibitor, JAK2 inhibitor, KARS G12C inhibitor, SHP2 inhibitor, multi-target kinase inhibitor, Claudin 18.
2-targeting monoclonal antibody, BCMA/CD3 dual Anti- and agonists targeting the IL-2 signaling pathway,
etc.
Among them, tumor and anti-virus are still the key areas
.
According to the analysis, judging from the current number of approvals and targets of Class 1 new drugs, the development of the domestic innovative drug industry is accelerating, and the harvest period is about to usher in
.
The industry expects that if these new drugs are successfully launched in the future, they will achieve breakthroughs in the field of major diseases and benefit more patients.
At the same time, they will further reduce domestic dependence on foreign new drugs, accelerate import substitution, and promote the sustainable and healthy development of the domestic innovative drug industry
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
