-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
According to CDE data (excluding supplementary applications), more than 30 Class 1 new drugs were added last week (12.
13~12.
17) (excluding supplementary applications)
.
Among them, including P2X3 receptor antagonists, targeting IL-17A antibodies, anti-TIGIT antibodies, oral PD-L1 inhibitors, antibody-conjugated drugs (ADC) and many other drugs
.
Below, the author has selected a few representative drugs for everyone to introduce
.
On December 16, Zai Lab announced that the National Medical Products Administration (SFDA) has approved the company's application for the company's Class 1 new drug omacycline tosylate
.
It is reported that omacycline tosylate is a new type of antibiotic, available in oral and intravenous infusion formulations, approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)
.
Omacycline tosylate was approved as a Class 1 new drug by the State Food and Drug Administration, and it is produced in China
.
On the same day, Hansen Pharmaceuticals also announced that its subsidiary, Hansen Pharmaceuticals, independently developed a category 1 innovative drug Ametinib mesylate tablets (trade name: Amelox) for use with epidermal growth factor receptor (EGFR) external display.
First-line treatment indications for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with sub19 deletion or exon 21 (L858R) substitution mutation positive, obtained the "Drug Registration Approval Document" issued by the National Medical Products Administration
.
According to the data, Ameile is a Class 1 innovative drug independently developed by Hansen Pharmaceuticals, and it is also the original third-generation EGFR-TKI in China; in addition, this is the second indication that Ameile has been approved
.
In addition, it is worth mentioning that under the general trend of innovation, China's traditional Chinese medicine field has also made many new breakthroughs in new medicines
.
On December 16, the State Drug Administration issued a notice on the approval of two drugs for marketing, announcing the approval of the marketing registration application for Huzhen Qingfeng Capsules and Jieyu Chufan Capsules
.
According to data, the Huzhen Qingfeng Capsules approved for marketing this time are innovative Chinese medicines developed on the basis of clinical experience and the holder is Yili Pharmaceutical Co.
, Ltd.
.
The Jieyu Chufan Capsule is also an innovative Chinese medicine developed on the basis of clinical experience.
The prescription is based on the Banxia Houpu Decoction recorded in the classic Chinese medicine "The Synopsis of the Golden Chamber" and the Zhizi Houpu Decoction recorded in the "Treatise on Febrile Diseases".
In the future, it can be used for the treatment of TCM syndrome differentiation of qi stagnation and phlegm obstruction, and internal disturbance of stagnation and fire in mild to moderate depression
.
Marketing authorization holders, Shijiazhuang Yiling Pharmaceutical Co.
, Ltd
.
From an overall point of view, analysts believe that as the reform of the drug review and approval system continues to deepen, China's new drug development and marketing are accelerating, and a large number of domestic and foreign Class 1 new drugs are approved for clinical and marketing, which is bringing more drugs to patients Treatment options
.
In addition, from the perspective of the number of domestic new drugs approved, targets, and indications, the domestic innovation strength is also constantly improving, and there is a big trend for innovation
.
In the future, the industry predicts that with the support of a series of domestic policies such as accelerated drug approval, patent protection, and tax reduction, the development of domestic innovative drugs will continue to heat up and begin to promote the sustained growth of the domestic innovative drug market
.
In general, under favorable factors such as favorable policies and the return of talents, the domestic research and development of innovative drugs will become more and more popular in the future, and the results will continue to appear
.
However, it should be noted that drug clinical trials have the characteristics of long time, difficult to recruit patients, high costs, and high risks, which will also become a major obstacle to the development of innovative drug companies
.
Data show that the cost of the clinical phase usually accounts for more than 66% of the entire new drug development cost, but in recent years, the actual proportion of many innovative pharmaceutical companies has exceeded this figure
.
In this context, for pharmaceutical companies that want to devote themselves to the research and development of innovative drugs, they still need to choose suitable targets and enter the game cautiously
.
13~12.
17) (excluding supplementary applications)
.
Among them, including P2X3 receptor antagonists, targeting IL-17A antibodies, anti-TIGIT antibodies, oral PD-L1 inhibitors, antibody-conjugated drugs (ADC) and many other drugs
.
Below, the author has selected a few representative drugs for everyone to introduce
.
On December 16, Zai Lab announced that the National Medical Products Administration (SFDA) has approved the company's application for the company's Class 1 new drug omacycline tosylate
.
It is reported that omacycline tosylate is a new type of antibiotic, available in oral and intravenous infusion formulations, approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)
.
Omacycline tosylate was approved as a Class 1 new drug by the State Food and Drug Administration, and it is produced in China
.
On the same day, Hansen Pharmaceuticals also announced that its subsidiary, Hansen Pharmaceuticals, independently developed a category 1 innovative drug Ametinib mesylate tablets (trade name: Amelox) for use with epidermal growth factor receptor (EGFR) external display.
First-line treatment indications for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with sub19 deletion or exon 21 (L858R) substitution mutation positive, obtained the "Drug Registration Approval Document" issued by the National Medical Products Administration
.
According to the data, Ameile is a Class 1 innovative drug independently developed by Hansen Pharmaceuticals, and it is also the original third-generation EGFR-TKI in China; in addition, this is the second indication that Ameile has been approved
.
In addition, it is worth mentioning that under the general trend of innovation, China's traditional Chinese medicine field has also made many new breakthroughs in new medicines
.
On December 16, the State Drug Administration issued a notice on the approval of two drugs for marketing, announcing the approval of the marketing registration application for Huzhen Qingfeng Capsules and Jieyu Chufan Capsules
.
According to data, the Huzhen Qingfeng Capsules approved for marketing this time are innovative Chinese medicines developed on the basis of clinical experience and the holder is Yili Pharmaceutical Co.
, Ltd.
.
The Jieyu Chufan Capsule is also an innovative Chinese medicine developed on the basis of clinical experience.
The prescription is based on the Banxia Houpu Decoction recorded in the classic Chinese medicine "The Synopsis of the Golden Chamber" and the Zhizi Houpu Decoction recorded in the "Treatise on Febrile Diseases".
In the future, it can be used for the treatment of TCM syndrome differentiation of qi stagnation and phlegm obstruction, and internal disturbance of stagnation and fire in mild to moderate depression
.
Marketing authorization holders, Shijiazhuang Yiling Pharmaceutical Co.
, Ltd
.
From an overall point of view, analysts believe that as the reform of the drug review and approval system continues to deepen, China's new drug development and marketing are accelerating, and a large number of domestic and foreign Class 1 new drugs are approved for clinical and marketing, which is bringing more drugs to patients Treatment options
.
In addition, from the perspective of the number of domestic new drugs approved, targets, and indications, the domestic innovation strength is also constantly improving, and there is a big trend for innovation
.
In the future, the industry predicts that with the support of a series of domestic policies such as accelerated drug approval, patent protection, and tax reduction, the development of domestic innovative drugs will continue to heat up and begin to promote the sustained growth of the domestic innovative drug market
.
In general, under favorable factors such as favorable policies and the return of talents, the domestic research and development of innovative drugs will become more and more popular in the future, and the results will continue to appear
.
However, it should be noted that drug clinical trials have the characteristics of long time, difficult to recruit patients, high costs, and high risks, which will also become a major obstacle to the development of innovative drug companies
.
Data show that the cost of the clinical phase usually accounts for more than 66% of the entire new drug development cost, but in recent years, the actual proportion of many innovative pharmaceutical companies has exceeded this figure
.
In this context, for pharmaceutical companies that want to devote themselves to the research and development of innovative drugs, they still need to choose suitable targets and enter the game cautiously
.
