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[Pharmaceutical Network Industry News] The chemical preparation industry refers to the manufacture of chemical preparations directly used for the prevention and diagnosis of human diseas.
As a very large sub-industry of the pharmaceutical industry, it has always played an important ro.
At present, China already has a relatively complete chemical preparation industry syst.
It is worth mentioning that while the market size of the chemical preparation industry continues to grow, the innovation of chemical drug research and development is also accelerating, especially in the field of Class 1 new dru.
New breakthroughs are being ma.
For example, on July 29, Kanghong Pharmaceutical announced that its subsidiary Honghe Bio had obtained a notification from the.
Food and Drug Administration (FDA) to allow its KH617 to conduct clinical trials of new dru.
According to the data, KH617 is a high-purity API produced by biosynthesis technolo.
It is a class 1 innovative drug intended for the treatment of advanced solid tumor patients (including adult diffuse gliom.
It is understood that KH617 injection is the first product of Honghe biosynthetic biology platform to enter the clinical trial applicati.
It has shown a good tumor inhibitory effect on various solid tumors in several preclinical disease models, especially in plastic In the plasmoblastoma orthotopic model, the efficacy of the drug was more promine.
Prior to this, the "basket drug" BYS10, a self-developed single-target drug developed by GPHL, has also been approved for drug clinical trials in China and the United Stat.
BYS10 is a new class 1 drug of selective RET small molecule inhibitor chemical drug independently developed by Baiyunshan General Pharmaceutical Factory under Baiyunshan, Guangzh.
The preparation size is 25 mg and 100 mg, and the indications are advanced solid tumors with RET fusion or mutation (including non-small cell lung cancer, thyroid cancer, medullary thyroid cancer, e.
In addition to the above drugs, according to the data, a total of 152 chemical drug Category 1 new drug acceptance numbers were accepted by CDE in June (including 39 supplementary applications), of which 82 were domestically produced and 31 were import.
In terms of application types, including 111 clinical applications There are 2 listing applications, involving 77 varieties and 38 compani.
In July, CDE also accepted a total of 77 new domestic chemical drugs (according to the acceptance number), including 2 NDA applications and 77 IND applications, involving 37 varieties (statistics based on the drug + enterprise dimension), including the Yao's EVER001 capsules, Guangwei Pharmaceutical GW201 tablets, Honghe Bio's KH617 for injection,e.
On the whole, domestic pharmaceutical companies are still very enthusiastic about the research and development of new class 1 chemical dru.
The industry believes that this is mainly due to the huge investment and development value in China's chemical drug mark.
According to data, the sales of chemical drugs in public hospitals in key cities in 2019 are close to 180 billion yu.
At present, the domestic chemical drug market is still expanding and attracting, and multinational pharmaceutical companies are also accelerating their deployment in this fie.
For example, on July 19, 2022, the Drug Evaluation Center undertook the clinical application of AstraZeneca's Class 1 chemical drug, AZD5718 tablets, for coronary artery disea.
AZD5718 (atuliflapon) is a 5-LOX activator protein (FLAP) inhibitor independently developed by AstraZene.
Its therapeutic areas involve the cardiovascular system, genitourinary system and respiratory syst.
Currently, the indications for proteinuria, coronary artery disease, end-stage renal disease, and asthma are in the global phase II clinical sta.
According to the industry, from the perspective of pharmaceutical companies accelerating the R&D and innovation of chemical drugs, China's chemical pharmaceutical preparation industry has entered a stage of rapid differentiation, structural upgrading, and elimination of outdated production capaci.
In the future, pharmaceutical companies with independent pharmaceutical innovation capabilities will have more competiti.
power to gain more mark.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
As a very large sub-industry of the pharmaceutical industry, it has always played an important ro.
At present, China already has a relatively complete chemical preparation industry syst.
It is worth mentioning that while the market size of the chemical preparation industry continues to grow, the innovation of chemical drug research and development is also accelerating, especially in the field of Class 1 new dru.
New breakthroughs are being ma.
For example, on July 29, Kanghong Pharmaceutical announced that its subsidiary Honghe Bio had obtained a notification from the.
Food and Drug Administration (FDA) to allow its KH617 to conduct clinical trials of new dru.
According to the data, KH617 is a high-purity API produced by biosynthesis technolo.
It is a class 1 innovative drug intended for the treatment of advanced solid tumor patients (including adult diffuse gliom.
It is understood that KH617 injection is the first product of Honghe biosynthetic biology platform to enter the clinical trial applicati.
It has shown a good tumor inhibitory effect on various solid tumors in several preclinical disease models, especially in plastic In the plasmoblastoma orthotopic model, the efficacy of the drug was more promine.
Prior to this, the "basket drug" BYS10, a self-developed single-target drug developed by GPHL, has also been approved for drug clinical trials in China and the United Stat.
BYS10 is a new class 1 drug of selective RET small molecule inhibitor chemical drug independently developed by Baiyunshan General Pharmaceutical Factory under Baiyunshan, Guangzh.
The preparation size is 25 mg and 100 mg, and the indications are advanced solid tumors with RET fusion or mutation (including non-small cell lung cancer, thyroid cancer, medullary thyroid cancer, e.
In addition to the above drugs, according to the data, a total of 152 chemical drug Category 1 new drug acceptance numbers were accepted by CDE in June (including 39 supplementary applications), of which 82 were domestically produced and 31 were import.
In terms of application types, including 111 clinical applications There are 2 listing applications, involving 77 varieties and 38 compani.
In July, CDE also accepted a total of 77 new domestic chemical drugs (according to the acceptance number), including 2 NDA applications and 77 IND applications, involving 37 varieties (statistics based on the drug + enterprise dimension), including the Yao's EVER001 capsules, Guangwei Pharmaceutical GW201 tablets, Honghe Bio's KH617 for injection,e.
On the whole, domestic pharmaceutical companies are still very enthusiastic about the research and development of new class 1 chemical dru.
The industry believes that this is mainly due to the huge investment and development value in China's chemical drug mark.
According to data, the sales of chemical drugs in public hospitals in key cities in 2019 are close to 180 billion yu.
At present, the domestic chemical drug market is still expanding and attracting, and multinational pharmaceutical companies are also accelerating their deployment in this fie.
For example, on July 19, 2022, the Drug Evaluation Center undertook the clinical application of AstraZeneca's Class 1 chemical drug, AZD5718 tablets, for coronary artery disea.
AZD5718 (atuliflapon) is a 5-LOX activator protein (FLAP) inhibitor independently developed by AstraZene.
Its therapeutic areas involve the cardiovascular system, genitourinary system and respiratory syst.
Currently, the indications for proteinuria, coronary artery disease, end-stage renal disease, and asthma are in the global phase II clinical sta.
According to the industry, from the perspective of pharmaceutical companies accelerating the R&D and innovation of chemical drugs, China's chemical pharmaceutical preparation industry has entered a stage of rapid differentiation, structural upgrading, and elimination of outdated production capaci.
In the future, pharmaceutical companies with independent pharmaceutical innovation capabilities will have more competiti.
power to gain more mark.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
