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In recent years, in the new drug application, the number of category 1 new drug applications has been increasing year by year
.
It is understood that there are more than 20 types of Class 1 new drugs (including Class 1.
5, excluding imports, new indications, and vaccines) that have been approved for marketing for the first time in China this year
.
It is worth noting that the number of applications for clinical trials of Class 1 new drugs has also been increasing since the beginning of this year
.
According to the author's understanding, there has been a lot of good news in the clinical aspects of the recent category 1 new drugs
.
Recently, Simcere Pharmaceuticals announced that it has reached a project cooperation with Shanghai Institute of Pharmaceuticals and others on the global development, production and commercialization of the SIM0417 series
.
It is worth noting that Simcere has become a pharmaceutical company guided by innovative drug business
.
At present, the company has nearly 60 innovative drug projects under development, and 14 category 1 new drugs are in the clinical application and above stage, and 4 of them are already on the market.
In terms of generic drugs, 15 varieties have been reviewed (6 are the first ones).
Five varieties rushed for the first copy, of which over $9 billion, the large variety was exclusively reported for production
.
There is also a potent and selective small molecule CSF-1R inhibitor independently developed by Hutchison Pharmaceuticals-HMPL-653 capsules, which have also recently been approved by clinical trials
.
According to data, the clinical research indications approved for HMPL-653 capsule this time are advanced malignant solid tumors and tendon sheath giant cell tumors (TGCT)
.
Studies have shown that the CSF-1R-mediated signaling pathway is the main factor driving the proliferation of abnormal cells in the synovium, and it also plays an important role in the differentiation and survival of mononuclear phagocytes, especially macrophages
.
In addition, some recent studies have shown that CSF-1R inhibitors are also expected to become a combination therapy partner for PD-1 inhibitors and PARP inhibitors
.
Prior to this, the new anti-leukemia class 1 drug LH-1802 capsules developed by Jiangsu Lianhuan Pharmaceutical Co.
, Ltd.
also obtained the clinical trial implied permission of the Drug Evaluation Center of the State Drug Administration
.
This innovative drug is currently not on the market at home or abroad, has high clinical value, and is expected to become an effective anti-leukemia drug candidate
.
The project started research and development in 2018, and it took 3 years to make a major breakthrough.
It is expected that the first phase of clinical trials will be launched next year
.
At present, Lianhuan Group is still accelerating the research and development of nearly a hundred projects including 8 innovative drugs, and is making every effort to strengthen and expand the biomedicine and health industries
.
It is worth mentioning that up to now, Lianhuan Pharmaceutical Group has invested hundreds of millions of yuan in research and development of innovative drugs and high-end products with independent intellectual property rights, including anti-diabetic, anti-leukemia and other innovative drug candidates and dozens of them.
Generic drug projects are advancing side by side.
Among them: innovative anti-diabetic drugs have entered phase I clinical trials; innovative drugs for the treatment of chronic obstructive pulmonary disease have also completed pharmacodynamic research and will complete the new drug clinical trial application
.
In addition to the above-mentioned pharmaceutical companies, since November, Tiankeya Biotechnology, Junshi Biotechnology, Shanghai Pharmaceuticals and other companies have also successively obtained Class 1 new drugs for clinical approval and listing
.
Analysis believes that this is a manifestation of the gradual formation of China's pharmaceutical R&D environment and the continuous improvement of innovation capabilities
.
For a long time, national Class 1 new drugs have been very innovative, representing the high level of drug innovation in China's drug registration classification
.
The industry predicts that the development of innovative drugs in China has been accelerating in recent years.
In the future, with the deepening of the reform of the drug review and approval system, the development of innovative drugs in China will enter a new stage, and more new drugs will continue to emerge
.
.
It is understood that there are more than 20 types of Class 1 new drugs (including Class 1.
5, excluding imports, new indications, and vaccines) that have been approved for marketing for the first time in China this year
.
It is worth noting that the number of applications for clinical trials of Class 1 new drugs has also been increasing since the beginning of this year
.
According to the author's understanding, there has been a lot of good news in the clinical aspects of the recent category 1 new drugs
.
Recently, Simcere Pharmaceuticals announced that it has reached a project cooperation with Shanghai Institute of Pharmaceuticals and others on the global development, production and commercialization of the SIM0417 series
.
It is worth noting that Simcere has become a pharmaceutical company guided by innovative drug business
.
At present, the company has nearly 60 innovative drug projects under development, and 14 category 1 new drugs are in the clinical application and above stage, and 4 of them are already on the market.
In terms of generic drugs, 15 varieties have been reviewed (6 are the first ones).
Five varieties rushed for the first copy, of which over $9 billion, the large variety was exclusively reported for production
.
There is also a potent and selective small molecule CSF-1R inhibitor independently developed by Hutchison Pharmaceuticals-HMPL-653 capsules, which have also recently been approved by clinical trials
.
According to data, the clinical research indications approved for HMPL-653 capsule this time are advanced malignant solid tumors and tendon sheath giant cell tumors (TGCT)
.
Studies have shown that the CSF-1R-mediated signaling pathway is the main factor driving the proliferation of abnormal cells in the synovium, and it also plays an important role in the differentiation and survival of mononuclear phagocytes, especially macrophages
.
In addition, some recent studies have shown that CSF-1R inhibitors are also expected to become a combination therapy partner for PD-1 inhibitors and PARP inhibitors
.
Prior to this, the new anti-leukemia class 1 drug LH-1802 capsules developed by Jiangsu Lianhuan Pharmaceutical Co.
, Ltd.
also obtained the clinical trial implied permission of the Drug Evaluation Center of the State Drug Administration
.
This innovative drug is currently not on the market at home or abroad, has high clinical value, and is expected to become an effective anti-leukemia drug candidate
.
The project started research and development in 2018, and it took 3 years to make a major breakthrough.
It is expected that the first phase of clinical trials will be launched next year
.
At present, Lianhuan Group is still accelerating the research and development of nearly a hundred projects including 8 innovative drugs, and is making every effort to strengthen and expand the biomedicine and health industries
.
It is worth mentioning that up to now, Lianhuan Pharmaceutical Group has invested hundreds of millions of yuan in research and development of innovative drugs and high-end products with independent intellectual property rights, including anti-diabetic, anti-leukemia and other innovative drug candidates and dozens of them.
Generic drug projects are advancing side by side.
Among them: innovative anti-diabetic drugs have entered phase I clinical trials; innovative drugs for the treatment of chronic obstructive pulmonary disease have also completed pharmacodynamic research and will complete the new drug clinical trial application
.
In addition to the above-mentioned pharmaceutical companies, since November, Tiankeya Biotechnology, Junshi Biotechnology, Shanghai Pharmaceuticals and other companies have also successively obtained Class 1 new drugs for clinical approval and listing
.
Analysis believes that this is a manifestation of the gradual formation of China's pharmaceutical R&D environment and the continuous improvement of innovation capabilities
.
For a long time, national Class 1 new drugs have been very innovative, representing the high level of drug innovation in China's drug registration classification
.
The industry predicts that the development of innovative drugs in China has been accelerating in recent years.
In the future, with the deepening of the reform of the drug review and approval system, the development of innovative drugs in China will enter a new stage, and more new drugs will continue to emerge
.
