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In recent years, affected by the acceleration of new drug review and approval, a large number of innovative drugs are accelerating their listing in China
.
According to statistics, from the beginning of 2021 to December 31 of that year, the State Food and Drug Administration has approved 81 new drugs for the market, which is a record high compared with the 48 new drugs in 2020
.
Now, 2022 has come, a brand new year, a brand new beginning, and a batch of new drugs has seen new developments recently! Genting Shinyao: Gosatuzumab new drug listing application accepted in Taiwan, China Recently, Genting Shinyao, a biopharmaceutical company focused on the development and commercialization of innovative drugs, announced that the Food and Drug Administration of Taiwan, China has accepted the gosatuzumab list The new anti-drug application is for the treatment of locally advanced or metastatic triple-negative breast cancer that is unresectable in adult patients.
It has received two systemic treatments before, and at least one of them is used for metastatic disease
.
It is understood that triple-negative breast cancer is a highly aggressive disease.
This type of disease lacks sufficient expression of estrogen, progesterone or HER2 receptors, and endocrine therapy or HER2 targeted therapy is basically ineffective
.
For a long time in the past, patients with triple-negative breast cancer lacked new and effective treatment options
.
The key results of the Gosartuzumab Phase 2b EVER-132-001 study showed that the study reached its primary endpoint with an objective response rate (ORR) of 38.
8%
.
This study was carried out in 80 patients in China, and the results were consistent with the results shown in the global Phase 3 ASCENT study, and showed similar efficacy in the Chinese population
.
Hengrui Pharmaceuticals: Two new class 1 drugs were approved.
Recently, the State Food and Drug Administration public information showed that Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
approved the first class innovative drug isethionate Dalciline tablets (commodity) through the priority review and approval procedure.
Name: Airuikang) and Proline Henggligliflozin tablets (trade name: Ruiqin) were launched
.
Up to now, Hengrui Medicine has launched a total of 10 innovative drugs
.
It is reported that Airerikon combined with Fulvestrant is suitable for patients with hormone receptor positive and human epidermal growth factor receptor 2 negative recurrent or metastatic breast cancer who have experienced disease progression after receiving endocrine therapy.
.
Ruiqin is an innovative drug independently researched and developed by China with independent intellectual property rights, which is suitable for improving the blood glucose control of adult patients with type 2 diabetes
.
CStone Pharmaceuticals: ROR1 ADC drug was approved by the FDA On January 3, Hong Kong stock-listed innovative drug company CStone Pharmaceuticals announced that its antibody-conjugated drug (ROR1 ADC) CS5001 clinical trial application (IND) has been approved by the US FDA in 2021 Approved
.
This product has the potential of the global Best-In-Class
.
Data show that CS5001 is a ROR1ADC clinically developed by CStone Pharmaceuticals.
Compared with similar drugs, its structure has obvious differentiating features, including proprietary site-specific coupling, tumor-selective cleavable linker And prodrug technology
.
The preclinical research data shows that CS5001 exhibits strong selective cytotoxicity in a variety of tumor cell lines expressing ROR1, and shows significant in vivo anti-tumor activity in both blood and solid tumor xenograft mouse models
.
The CS5001 preclinical research data has attracted much attention, and it was selected as the blockbuster research abstract of the 33rd International Conference on Molecular Targets and Cancer Treatment in October 2021
.
It is worth mentioning that CS5001 was approved for clinical use, and CStone Pharmaceuticals has made significant progress in the development of new drugs following the approval of the IND of the multispecific antibody CS2006/NM21-1480 in September 2021 by the National Food and Drug Administration of China
.
.
According to statistics, from the beginning of 2021 to December 31 of that year, the State Food and Drug Administration has approved 81 new drugs for the market, which is a record high compared with the 48 new drugs in 2020
.
Now, 2022 has come, a brand new year, a brand new beginning, and a batch of new drugs has seen new developments recently! Genting Shinyao: Gosatuzumab new drug listing application accepted in Taiwan, China Recently, Genting Shinyao, a biopharmaceutical company focused on the development and commercialization of innovative drugs, announced that the Food and Drug Administration of Taiwan, China has accepted the gosatuzumab list The new anti-drug application is for the treatment of locally advanced or metastatic triple-negative breast cancer that is unresectable in adult patients.
It has received two systemic treatments before, and at least one of them is used for metastatic disease
.
It is understood that triple-negative breast cancer is a highly aggressive disease.
This type of disease lacks sufficient expression of estrogen, progesterone or HER2 receptors, and endocrine therapy or HER2 targeted therapy is basically ineffective
.
For a long time in the past, patients with triple-negative breast cancer lacked new and effective treatment options
.
The key results of the Gosartuzumab Phase 2b EVER-132-001 study showed that the study reached its primary endpoint with an objective response rate (ORR) of 38.
8%
.
This study was carried out in 80 patients in China, and the results were consistent with the results shown in the global Phase 3 ASCENT study, and showed similar efficacy in the Chinese population
.
Hengrui Pharmaceuticals: Two new class 1 drugs were approved.
Recently, the State Food and Drug Administration public information showed that Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
approved the first class innovative drug isethionate Dalciline tablets (commodity) through the priority review and approval procedure.
Name: Airuikang) and Proline Henggligliflozin tablets (trade name: Ruiqin) were launched
.
Up to now, Hengrui Medicine has launched a total of 10 innovative drugs
.
It is reported that Airerikon combined with Fulvestrant is suitable for patients with hormone receptor positive and human epidermal growth factor receptor 2 negative recurrent or metastatic breast cancer who have experienced disease progression after receiving endocrine therapy.
.
Ruiqin is an innovative drug independently researched and developed by China with independent intellectual property rights, which is suitable for improving the blood glucose control of adult patients with type 2 diabetes
.
CStone Pharmaceuticals: ROR1 ADC drug was approved by the FDA On January 3, Hong Kong stock-listed innovative drug company CStone Pharmaceuticals announced that its antibody-conjugated drug (ROR1 ADC) CS5001 clinical trial application (IND) has been approved by the US FDA in 2021 Approved
.
This product has the potential of the global Best-In-Class
.
Data show that CS5001 is a ROR1ADC clinically developed by CStone Pharmaceuticals.
Compared with similar drugs, its structure has obvious differentiating features, including proprietary site-specific coupling, tumor-selective cleavable linker And prodrug technology
.
The preclinical research data shows that CS5001 exhibits strong selective cytotoxicity in a variety of tumor cell lines expressing ROR1, and shows significant in vivo anti-tumor activity in both blood and solid tumor xenograft mouse models
.
The CS5001 preclinical research data has attracted much attention, and it was selected as the blockbuster research abstract of the 33rd International Conference on Molecular Targets and Cancer Treatment in October 2021
.
It is worth mentioning that CS5001 was approved for clinical use, and CStone Pharmaceuticals has made significant progress in the development of new drugs following the approval of the IND of the multispecific antibody CS2006/NM21-1480 in September 2021 by the National Food and Drug Administration of China
.
