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According to statistics, in October 2021, CDE has undertaken a total of 917 new drug registration applications based on acceptance numbers; including 579 chemical drugs, 190 traditional Chinese medicines, and 148 biological products
.
Among them, it is worth noting that there are a total of 61 new drugs in Category 1 (according to the acceptance number), all of which are IND applications, involving 31 companies in 35 varieties
.
The industry believes that a large number of blockbuster new drugs have been accepted, mainly due to the continuous improvement of the research and development capabilities of local pharmaceutical companies in recent years, and the continuous deepening of the reform of the drug review and approval system and the continuous acceleration of the pace of new drug review and approval
.
At present, as the review and approval of new drugs continues to accelerate, the industry expects that the number of new drugs approved for clinical trials and marketing will continue to increase
.
In fact, the author has learned that since November, a number of domestically produced Class 1 new drugs have been submitted for clinical application and marketing
.
For example, on November 8th, Shanghai Fosun Pharmaceutical issued an announcement stating that its holding subsidiary Chongqing Fuchuang Pharmaceutical has received approval from the State Drug Administration for approval of FCN-342 tablets (hereinafter referred to as "the new drug") developed by it for gout.
The treatment is approved for clinical trials
.
Fuchuang Pharmaceutical plans to carry out a phase I clinical trial of the new drug in China (excluding Hong Kong, Macao and Taiwan, the same below) when the conditions are met
.
It is understood that as of September 2021, the company's cumulative R&D investment in this new drug has reached approximately 18 million yuan (unaudited)
.
Prior to this, Henan Tianfang Pharmaceutical Traditional Chinese Medicine/Shenzhen Shasong Lesheng has also received CDE approval for the marketing application of Brainshang Lesheng Granules submitted by the new drug category 1.
1.
This is the first domestic cerebrovascular Chinese patent medicine to be produced in the first category of new drug.
.
Public information shows that Naoshang Lesheng Granule is a new traditional Chinese medicine developed by Henan Tianfang Pharmaceutical Co.
, Ltd.
under China National Pharmaceutical Co.
, Ltd.
and Shenzhen Shasong Industrial Co.
, Ltd.
Cerebral trauma and after craniocerebral surgery, the symptoms such as weakness of Qi and blood, damage to the brain and collaterals, stasis and meridian paralysis
.
The drug was submitted to the National Food and Drug Administration in 2013 for the marketing application of Naoshang Lesheng Granules (new drug category 6.
1), and it was withdrawn voluntarily in 2016.
After five years, it resubmitted the marketing application with the new drug category 1.
1 and received acceptance. .
In addition, LH-1802 capsules, a new anti-leukemia class 1 drug developed by Jiangsu Lianhuan Pharmaceutical Co.
, Ltd.
, also recently obtained the clinical trial implied permission from 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
.
It is worth mentioning that in addition to LH-1802 capsules, Lianhuan Group is also 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.
.
In general, from an overall point of view, the "new" era of domestic pharmaceutical innovation has arrived, and some early-stage R&D and innovation companies have entered the harvest period
.
Following this trend, in the future, in the context of the continuous promotion of innovation in the domestic pharmaceutical industry, the industry expects that Class 1 new drugs may usher in a major outbreak
.
.
Among them, it is worth noting that there are a total of 61 new drugs in Category 1 (according to the acceptance number), all of which are IND applications, involving 31 companies in 35 varieties
.
The industry believes that a large number of blockbuster new drugs have been accepted, mainly due to the continuous improvement of the research and development capabilities of local pharmaceutical companies in recent years, and the continuous deepening of the reform of the drug review and approval system and the continuous acceleration of the pace of new drug review and approval
.
At present, as the review and approval of new drugs continues to accelerate, the industry expects that the number of new drugs approved for clinical trials and marketing will continue to increase
.
In fact, the author has learned that since November, a number of domestically produced Class 1 new drugs have been submitted for clinical application and marketing
.
For example, on November 8th, Shanghai Fosun Pharmaceutical issued an announcement stating that its holding subsidiary Chongqing Fuchuang Pharmaceutical has received approval from the State Drug Administration for approval of FCN-342 tablets (hereinafter referred to as "the new drug") developed by it for gout.
The treatment is approved for clinical trials
.
Fuchuang Pharmaceutical plans to carry out a phase I clinical trial of the new drug in China (excluding Hong Kong, Macao and Taiwan, the same below) when the conditions are met
.
It is understood that as of September 2021, the company's cumulative R&D investment in this new drug has reached approximately 18 million yuan (unaudited)
.
Prior to this, Henan Tianfang Pharmaceutical Traditional Chinese Medicine/Shenzhen Shasong Lesheng has also received CDE approval for the marketing application of Brainshang Lesheng Granules submitted by the new drug category 1.
1.
This is the first domestic cerebrovascular Chinese patent medicine to be produced in the first category of new drug.
.
Public information shows that Naoshang Lesheng Granule is a new traditional Chinese medicine developed by Henan Tianfang Pharmaceutical Co.
, Ltd.
under China National Pharmaceutical Co.
, Ltd.
and Shenzhen Shasong Industrial Co.
, Ltd.
Cerebral trauma and after craniocerebral surgery, the symptoms such as weakness of Qi and blood, damage to the brain and collaterals, stasis and meridian paralysis
.
The drug was submitted to the National Food and Drug Administration in 2013 for the marketing application of Naoshang Lesheng Granules (new drug category 6.
1), and it was withdrawn voluntarily in 2016.
After five years, it resubmitted the marketing application with the new drug category 1.
1 and received acceptance. .
In addition, LH-1802 capsules, a new anti-leukemia class 1 drug developed by Jiangsu Lianhuan Pharmaceutical Co.
, Ltd.
, also recently obtained the clinical trial implied permission from 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
.
It is worth mentioning that in addition to LH-1802 capsules, Lianhuan Group is also 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.
.
In general, from an overall point of view, the "new" era of domestic pharmaceutical innovation has arrived, and some early-stage R&D and innovation companies have entered the harvest period
.
Following this trend, in the future, in the context of the continuous promotion of innovation in the domestic pharmaceutical industry, the industry expects that Class 1 new drugs may usher in a major outbreak
.
