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Recently, the CDE website shows that Hengrui Medicine's clinical trial application for HRS-2261 tablets has been approved for the treatment of chronic cough
.
It is estimated that 5%-10% of adults worldwide suffer from chronic cough, and the clinical demand for this drug will be huge
.
Coincidentally, the marketing application of the new anti-tumor drug MET inhibitor Gumetinib, jointly developed by Haihe Pharmaceuticals and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, has also been accepted by the State Food and Drug Administration and is being announced for priority review
.
Data show that MET is a receptor tyrosine kinase that plays an important role in tumor growth, angiogenesis, and tumor metastasis, and MET exhibits abnormal function in many types of solid tumors
.
The industry expects that with the successful launch of this product in China, it will bring good news to the vast number of non-small cell lung cancer patients in China and provide more treatment options
.
In fact, in addition to the above two new drugs, many pharmaceutical companies have ushered in new progress in new drug trials and listings this year
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
.
In the past week, more than 20 new category 1 drugs (excluding supplementary applications) have been added, from pharmaceutical companies such as Hengrui Medicine, Harbin Pharmaceutical, and Osaikang Pharmaceuticals
.
For example, on February 21, Kelun Pharmaceutical announced that the SKB378/HBM9378 injection jointly developed by its holding subsidiary, Sichuan Kelun Botai Biomedical Co.
, Ltd.
and Hebo Pharmaceuticals, was approved by the National Medical Products Administration (NMPA) for clinical trials.
Trial notice, agreeing to carry out clinical trials of the injection for moderate to severe asthma indications
.
Prior to this, ASKC202 tablets, a class 1 new drug declared by Osaikang Pharmaceuticals, also obtained an implied license for clinical trials, targeting advanced solid tumors
.
ASKC202 is a highly selective oral small molecule c-MET inhibitor, according to a press release from Osaikang Pharmaceuticals
.
Currently, no drug has been approved for use in patients with EGFR-TKI-resistant c-MET-amplified tumors
.
If Osaikang Pharmaceutical's innovative c-MET inhibitor progresses smoothly in the follow-up clinical research, it will bring more treatment options to patients with advanced tumors earlier
.
From the above point of view, the industry believes that the new progress of a large number of pharmaceutical companies' new drugs is mainly a manifestation of the vigorous development of China's innovative drug industry in recent years
.
In fact, according to data, the number of new drug clinical trials in China has continued to grow since 2016
.
For example, as of November 2019, 2020, and 2021, the number of Phase I clinical projects increased by 118, 54, and 172, respectively
.
In addition, according to statistics, the number of Class I new drugs listed in China from 2018 to 2021 is also more than 10, of which 26 are in 2021
.
In this context, the industry expects that the number of domestic clinical trial projects will continue to grow in 2022, and the number of innovative achievements will also increase further
.
However, although the achievements of domestic new drugs are constantly emerging, 41% of the new drugs focus on the top 6% of the popular targets in terms of targets involved in new drugs in recent years
.
Therefore, the industry suggests that pharmaceutical companies need to achieve product differentiation, accelerate the improvement of clinical value, and strive to realize the ability to realize the value of innovative drugs in the international market, in order to better avoid homogenization and develop towards higher quality
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
It is estimated that 5%-10% of adults worldwide suffer from chronic cough, and the clinical demand for this drug will be huge
.
Coincidentally, the marketing application of the new anti-tumor drug MET inhibitor Gumetinib, jointly developed by Haihe Pharmaceuticals and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, has also been accepted by the State Food and Drug Administration and is being announced for priority review
.
Data show that MET is a receptor tyrosine kinase that plays an important role in tumor growth, angiogenesis, and tumor metastasis, and MET exhibits abnormal function in many types of solid tumors
.
The industry expects that with the successful launch of this product in China, it will bring good news to the vast number of non-small cell lung cancer patients in China and provide more treatment options
.
In fact, in addition to the above two new drugs, many pharmaceutical companies have ushered in new progress in new drug trials and listings this year
.
According to data on the website of the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
.
In the past week, more than 20 new category 1 drugs (excluding supplementary applications) have been added, from pharmaceutical companies such as Hengrui Medicine, Harbin Pharmaceutical, and Osaikang Pharmaceuticals
.
For example, on February 21, Kelun Pharmaceutical announced that the SKB378/HBM9378 injection jointly developed by its holding subsidiary, Sichuan Kelun Botai Biomedical Co.
, Ltd.
and Hebo Pharmaceuticals, was approved by the National Medical Products Administration (NMPA) for clinical trials.
Trial notice, agreeing to carry out clinical trials of the injection for moderate to severe asthma indications
.
Prior to this, ASKC202 tablets, a class 1 new drug declared by Osaikang Pharmaceuticals, also obtained an implied license for clinical trials, targeting advanced solid tumors
.
ASKC202 is a highly selective oral small molecule c-MET inhibitor, according to a press release from Osaikang Pharmaceuticals
.
Currently, no drug has been approved for use in patients with EGFR-TKI-resistant c-MET-amplified tumors
.
If Osaikang Pharmaceutical's innovative c-MET inhibitor progresses smoothly in the follow-up clinical research, it will bring more treatment options to patients with advanced tumors earlier
.
From the above point of view, the industry believes that the new progress of a large number of pharmaceutical companies' new drugs is mainly a manifestation of the vigorous development of China's innovative drug industry in recent years
.
In fact, according to data, the number of new drug clinical trials in China has continued to grow since 2016
.
For example, as of November 2019, 2020, and 2021, the number of Phase I clinical projects increased by 118, 54, and 172, respectively
.
In addition, according to statistics, the number of Class I new drugs listed in China from 2018 to 2021 is also more than 10, of which 26 are in 2021
.
In this context, the industry expects that the number of domestic clinical trial projects will continue to grow in 2022, and the number of innovative achievements will also increase further
.
However, although the achievements of domestic new drugs are constantly emerging, 41% of the new drugs focus on the top 6% of the popular targets in terms of targets involved in new drugs in recent years
.
Therefore, the industry suggests that pharmaceutical companies need to achieve product differentiation, accelerate the improvement of clinical value, and strive to realize the ability to realize the value of innovative drugs in the international market, in order to better avoid homogenization and develop towards higher quality
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
