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On December 28, Fosun Pharma announced that its subsidiary Jiangsu Wanbang had decided to terminate the clinical trial and subsequent development of the SGLT-2 inhibitor vanpagliflozin
.
It is understood that in recent years, both the number of applications for clinical trials and the number of new drug approvals for innovative drugs in China have been rising steadily
.
It is gratifying that China's innovative drugs continue to make breakthroughs, but at the same time, the failure of China's innovative drugs is also worthy of attention
.
The industry said that regardless of success or failure, they are all respectable explorers and an important force in the rise of China's innovative drugs
.
Below, the author will take a look at some of the setbacks encountered in the research and development of innovative drugs in China in the past year
.
Fosun Pharma Terminates Phase I Clinical and Follow-up Development of SGLT-2 Inhibitor On December 28, Fosun Pharma announced that its subsidiary Jiangsu Wanbang has decided to terminate the clinical trial and follow-up development of SGLT-2 inhibitor Vanpagliflozin
.
At present, Fosun Pharma has accumulated a total R&D investment of approximately RMB 55.
23 million for the drug
.
According to the data, vanpagliflozin is an SGLT-2 inhibitor introduced by Wanbang Medicine from Sirona Biochem in January 2014, and it is intended for the treatment of type II diabetes
.
In June 2018, the drug was approved by the CDE to conduct clinical trials for the indication of type II diabetes
.
Since Vanpagliflozin is still in the phase I clinical trial stage, a number of SGLT-2 inhibitors have been launched at home and abroad, and the market competition has become relatively fierce.
Jiangsu Wanbang, after careful consideration, based on the follow-up development investment and market value of the new drug In order to rationally allocate R&D resources and focus on advantageous projects in the R&D pipeline, it was decided to terminate the clinical trial and subsequent development of the new drug after a comprehensive evaluation of other factors
.
Wanchun Pharmaceutical's listing of plinabulin was rejected Wanchun Pharmaceutical announced on the evening of December 1 that its innovative drug, plinabulin, for the treatment of chemotherapy-induced neutropenia (CIN), has received the FDA (U.
S.
Food and Drug Administration) complete response letter
.
FDA says it has completed review of the application and determined it cannot approve the application in its current form
.
The data show that, as a "First-in-Class" immune anti-tumor drug, plinabulin can accelerate the maturation of dendritic cells and promote the Antigen presentation, direct activation of T cells to kill tumor cells
.
In addition, the drug can block the damage of bone marrow neutrophils induced by chemotherapy drugs and prevent early CIN
.
In September 2020, plinabulin was awarded the double designation of "breakthrough therapy" in the field of CIN prevention by the Chinese and American drug regulatory agencies
.
Renfu Medicine terminated the clinical trial of ALK inhibitor On November 12, Renfu Medicine announced that the company and the holding subsidiary Hubei Biomedical Industry Technology Research Institute (50.
24% shareholding) jointly developed a new type of drug RF-A089 capsule ( ALK inhibitor), recently decided to terminate the clinical trial and follow-up research and development of this project
.
Regarding the reasons for terminating the clinical trial, Renfu Medicine stated that the drug has not found a sufficient number of enrolled patients in the phase I clinical study, and in the clinical application of tumors, it will be difficult to compete with many targeted anti-tumor drugs in the future.
In order to gain advantages, follow-up investment and listing risks are higher
.
Up to now, the project has invested about 25 million yuan in total
.
Zejing Pharmaceuticals Terminates the Clinical Trial of Donafenib for Colorectal Cancer Treatment On August 17, Zejing Pharmaceuticals issued an announcement that Donafenib Tosylate Tablets in the treatment of advanced colorectal cancer in the second line and above showed that the median overall survival time (mOS) did not achieve the pre-set superiority target compared to the control group, and the company decided to discontinue further development of donafenib monotherapy for this indication
.
The data show that Donafenib is an oral multi-target, multi-kinase inhibitor small molecule anti-tumor drug, which will be approved for first-line treatment of advanced liver cancer in 2021
.
However, its use in the treatment of colorectal cancer did not achieve good results, and the clinical trial had to be terminated
.
Bio-Tech terminated the clinical trials of BAT8003 and BAT1306 In March this year, Bio-Tech Bio-Pharmaceutical Co.
, Ltd.
announced that after careful consideration of the risk of subsequent development of the drug, the company decided to terminate BAT8003 (recombinant humanized anti-Trop2 monoclonal for injection).
Clinical trials of antibody-maytansine conjugates, hereinafter referred to as "BAT8003") and BAT1306 (ie recombinant humanized anti-PD-1 monoclonal antibody injection, hereinafter referred to as "BAT1306")
.
It is reported that BAT8003 is an ADC drug targeting Trop2, and a phase I clinical trial of Trop2-positive advanced epithelial cancer patients was launched in March 2019; while BAT1306 is a PD-1 monoclonal antibody, and BAT1306 combined with XELOX first-line treatment has been launched EBV-related gastric cancer clinical trials and clinical trials of BAT8001 combined with BAT1306 in second-line treatment of HER2-positive advanced solid tumors
.
Summary 2021 is a year of harvest for innovative drugs in China
.
A total of more than 20 innovative drugs have been approved by the NMPA for marketing, hitting a new high in the past three years
.
However, behind the rapid increase in the number of new drug approvals, we must also clearly recognize that the research and development of innovative drugs is not a smooth road, but risks and benefits coexist
.
.
It is understood that in recent years, both the number of applications for clinical trials and the number of new drug approvals for innovative drugs in China have been rising steadily
.
It is gratifying that China's innovative drugs continue to make breakthroughs, but at the same time, the failure of China's innovative drugs is also worthy of attention
.
The industry said that regardless of success or failure, they are all respectable explorers and an important force in the rise of China's innovative drugs
.
Below, the author will take a look at some of the setbacks encountered in the research and development of innovative drugs in China in the past year
.
Fosun Pharma Terminates Phase I Clinical and Follow-up Development of SGLT-2 Inhibitor On December 28, Fosun Pharma announced that its subsidiary Jiangsu Wanbang has decided to terminate the clinical trial and follow-up development of SGLT-2 inhibitor Vanpagliflozin
.
At present, Fosun Pharma has accumulated a total R&D investment of approximately RMB 55.
23 million for the drug
.
According to the data, vanpagliflozin is an SGLT-2 inhibitor introduced by Wanbang Medicine from Sirona Biochem in January 2014, and it is intended for the treatment of type II diabetes
.
In June 2018, the drug was approved by the CDE to conduct clinical trials for the indication of type II diabetes
.
Since Vanpagliflozin is still in the phase I clinical trial stage, a number of SGLT-2 inhibitors have been launched at home and abroad, and the market competition has become relatively fierce.
Jiangsu Wanbang, after careful consideration, based on the follow-up development investment and market value of the new drug In order to rationally allocate R&D resources and focus on advantageous projects in the R&D pipeline, it was decided to terminate the clinical trial and subsequent development of the new drug after a comprehensive evaluation of other factors
.
Wanchun Pharmaceutical's listing of plinabulin was rejected Wanchun Pharmaceutical announced on the evening of December 1 that its innovative drug, plinabulin, for the treatment of chemotherapy-induced neutropenia (CIN), has received the FDA (U.
S.
Food and Drug Administration) complete response letter
.
FDA says it has completed review of the application and determined it cannot approve the application in its current form
.
The data show that, as a "First-in-Class" immune anti-tumor drug, plinabulin can accelerate the maturation of dendritic cells and promote the Antigen presentation, direct activation of T cells to kill tumor cells
.
In addition, the drug can block the damage of bone marrow neutrophils induced by chemotherapy drugs and prevent early CIN
.
In September 2020, plinabulin was awarded the double designation of "breakthrough therapy" in the field of CIN prevention by the Chinese and American drug regulatory agencies
.
Renfu Medicine terminated the clinical trial of ALK inhibitor On November 12, Renfu Medicine announced that the company and the holding subsidiary Hubei Biomedical Industry Technology Research Institute (50.
24% shareholding) jointly developed a new type of drug RF-A089 capsule ( ALK inhibitor), recently decided to terminate the clinical trial and follow-up research and development of this project
.
Regarding the reasons for terminating the clinical trial, Renfu Medicine stated that the drug has not found a sufficient number of enrolled patients in the phase I clinical study, and in the clinical application of tumors, it will be difficult to compete with many targeted anti-tumor drugs in the future.
In order to gain advantages, follow-up investment and listing risks are higher
.
Up to now, the project has invested about 25 million yuan in total
.
Zejing Pharmaceuticals Terminates the Clinical Trial of Donafenib for Colorectal Cancer Treatment On August 17, Zejing Pharmaceuticals issued an announcement that Donafenib Tosylate Tablets in the treatment of advanced colorectal cancer in the second line and above showed that the median overall survival time (mOS) did not achieve the pre-set superiority target compared to the control group, and the company decided to discontinue further development of donafenib monotherapy for this indication
.
The data show that Donafenib is an oral multi-target, multi-kinase inhibitor small molecule anti-tumor drug, which will be approved for first-line treatment of advanced liver cancer in 2021
.
However, its use in the treatment of colorectal cancer did not achieve good results, and the clinical trial had to be terminated
.
Bio-Tech terminated the clinical trials of BAT8003 and BAT1306 In March this year, Bio-Tech Bio-Pharmaceutical Co.
, Ltd.
announced that after careful consideration of the risk of subsequent development of the drug, the company decided to terminate BAT8003 (recombinant humanized anti-Trop2 monoclonal for injection).
Clinical trials of antibody-maytansine conjugates, hereinafter referred to as "BAT8003") and BAT1306 (ie recombinant humanized anti-PD-1 monoclonal antibody injection, hereinafter referred to as "BAT1306")
.
It is reported that BAT8003 is an ADC drug targeting Trop2, and a phase I clinical trial of Trop2-positive advanced epithelial cancer patients was launched in March 2019; while BAT1306 is a PD-1 monoclonal antibody, and BAT1306 combined with XELOX first-line treatment has been launched EBV-related gastric cancer clinical trials and clinical trials of BAT8001 combined with BAT1306 in second-line treatment of HER2-positive advanced solid tumors
.
Summary 2021 is a year of harvest for innovative drugs in China
.
A total of more than 20 innovative drugs have been approved by the NMPA for marketing, hitting a new high in the past three years
.
However, behind the rapid increase in the number of new drug approvals, we must also clearly recognize that the research and development of innovative drugs is not a smooth road, but risks and benefits coexist
.
