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With the release of a series of favorable documents from the country, the domestic innovative drug industry has begun to enter a stage of rapid development.
In this context, news of many pharmaceutical companies' new drug listing or approval for clinical trials has also begun to come
.
For example, this week, a number of pharmaceutical companies have issued relevant announcements
.
For example, on the 22nd, Buchang Pharmaceutical issued an announcement saying 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 the 20th, Huadong Medicine issued an announcement that the application for the Phase I clinical trial of DR30303 for injection, which was declared by the holding subsidiary Zhejiang Daoer Biotechnology Co.
, Ltd.
(hereinafter referred to as Daoer Bio), was approved.
Claudin18.
2-positive advanced solid tumors
.
On the 18th, 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 to carry out clinical trials.
The indication is neovascular age-related macular degeneration
.
It is understood that ASKG712 is a bispecific antibody independently developed by Suzhou Osaikang that targets both VEGF and ANG2.
While blocking the VEGF/VEGFR signaling pathway and controlling the formation of new blood vessels, it can effectively inhibit the ANG-2 signal to improve the Vascular stability and reduction of retinal inflammation
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, including the above drugs, more than 100 clinical trial applications have passed "implicit licenses" since 2022
.
Among them, more than ten new Class 1 drugs were added in the last week (excluding supplementary applications)
.
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.
The industry believes that a large number of Class 1 new drugs have been approved for clinical and marketed one after another, which means that the development of the domestic innovative drug industry is accelerating
.
In fact, with the multiple resonances of policies, capital, and talents in recent years, the enthusiasm for research and development of Chinese pharmaceutical companies has continued to rise, and the development is accelerating in the direction of innovation
.
In 2021, domestic innovative drugs have begun to show a blowout trend as soon as they are approved for marketing
.
According to data, last year, China's National Medical Products Administration (NMPA) approved a total of 76 new drugs (excluding new indications and vaccines) for the market, including Cyclopofol Injection, Ainovirine Tablets, Hetropopa Ethanolamine Tablets, Haibo.
Blockbuster drugs such as Maibu Tablets, Sivotinib Tablets, and Levoornidazole Phosphate Disodium for Injection are urgently needed clinical drugs in the fields of tumors, vaccines, and rare diseases
.
It is expected in the industry that in the future, with the support of policies and the increased research and development of enterprises, domestic innovative drugs will continue to be approved for clinical use and marketed, which will not only achieve breakthroughs in the field of major diseases and benefit more patients, but also further reduce the dependence on foreign new drugs and accelerate import substitution
.
In this context, news of many pharmaceutical companies' new drug listing or approval for clinical trials has also begun to come
.
For example, this week, a number of pharmaceutical companies have issued relevant announcements
.
For example, on the 22nd, Buchang Pharmaceutical issued an announcement saying 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 the 20th, Huadong Medicine issued an announcement that the application for the Phase I clinical trial of DR30303 for injection, which was declared by the holding subsidiary Zhejiang Daoer Biotechnology Co.
, Ltd.
(hereinafter referred to as Daoer Bio), was approved.
Claudin18.
2-positive advanced solid tumors
.
On the 18th, 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 to carry out clinical trials.
The indication is neovascular age-related macular degeneration
.
It is understood that ASKG712 is a bispecific antibody independently developed by Suzhou Osaikang that targets both VEGF and ANG2.
While blocking the VEGF/VEGFR signaling pathway and controlling the formation of new blood vessels, it can effectively inhibit the ANG-2 signal to improve the Vascular stability and reduction of retinal inflammation
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, including the above drugs, more than 100 clinical trial applications have passed "implicit licenses" since 2022
.
Among them, more than ten new Class 1 drugs were added in the last week (excluding supplementary applications)
.
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.
The industry believes that a large number of Class 1 new drugs have been approved for clinical and marketed one after another, which means that the development of the domestic innovative drug industry is accelerating
.
In fact, with the multiple resonances of policies, capital, and talents in recent years, the enthusiasm for research and development of Chinese pharmaceutical companies has continued to rise, and the development is accelerating in the direction of innovation
.
In 2021, domestic innovative drugs have begun to show a blowout trend as soon as they are approved for marketing
.
According to data, last year, China's National Medical Products Administration (NMPA) approved a total of 76 new drugs (excluding new indications and vaccines) for the market, including Cyclopofol Injection, Ainovirine Tablets, Hetropopa Ethanolamine Tablets, Haibo.
Blockbuster drugs such as Maibu Tablets, Sivotinib Tablets, and Levoornidazole Phosphate Disodium for Injection are urgently needed clinical drugs in the fields of tumors, vaccines, and rare diseases
.
It is expected in the industry that in the future, with the support of policies and the increased research and development of enterprises, domestic innovative drugs will continue to be approved for clinical use and marketed, which will not only achieve breakthroughs in the field of major diseases and benefit more patients, but also further reduce the dependence on foreign new drugs and accelerate import substitution
.
