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2021 is a bumper year for China's innovative drugs.
According to statistics, a total of 24 innovative drugs have been approved for marketing by the NMPA, a record high in the past three years
.
It is worth mentioning that, in addition to the continuous increase in the number of new drugs approved, the speed of domestic innovative pharmaceutical companies is also continuing to accelerate
.
A large number of pharmaceutical companies, including BeiGene, Rongchang Biotechnology, Jacosi, Iris Pharmaceuticals, and Junshi Bio, are accelerating local innovative drugs to the global market through overseas authorization and other forms
.
However, with the development of the domestic innovative drug industry in full swing, and behind the rapid increase in the number of new drugs approved, the industry believes that it is also necessary to clearly realize that the research and development of innovative drugs is by no means easy, and risks and benefits coexist
.
According to incomplete statistics, in 2021, domestic companies such as Biotech, Renfu Pharmaceutical, and Zejing Pharmaceutical have terminated the research and development of a batch of innovative drugs under its umbrella
.
For example, in March of this year, Biotech Biopharmaceutical Co.
, Ltd.
announced that the company decided to terminate BAT8003 (recombinant humanized anti-Trop2 monoclonal antibody-maytansine conjugate for injection after careful consideration of the subsequent development risks of the drug).
, Hereinafter referred to as "BAT8003") and BAT1306 (ie recombinant humanized anti-PD-1 monoclonal antibody injection, hereinafter referred to as "BAT1306") clinical trials
.
It is reported that BAT8003 is an ADC drug that targets Trop2, and a phase I clinical trial for patients with Trop2-positive advanced epithelial cancer was launched in March 2019; BAT1306 is a PD-1 monoclonal antibody, and BAT1306 combined with XELOX has been used for first-line treatment.
EBV-related gastric cancer clinical trials and BAT8001 combined with BAT1306 second-line treatment of HER2-positive advanced solid tumors
.
On August 17, Zejing Pharmaceutical issued an announcement that Donafenib tosylate tablets in the treatment of stage Ⅲ colorectal cancer above second-line showed that the median overall survival (mOS) did not reach the preset superiority compared with the control group.
Goal
.
The company decided to terminate the further development of Donafenib monotherapy for this indication
.
In the same month, Xinlitai announced that it intends to terminate the "Nanatinostat" "Exclusive License Agreement" signed with VIRACTA of the United States.
.
In 2018, Xinlitai signed an agreement with VIRACTA to obtain the exclusive license to use Nanatinostat in Mainland China
.
On November 12, Renfu Medicine issued an announcement to terminate the research and development of a new class 1 drug RF-A089 capsule (ALK inhibitor)
.
RF-A089 capsule is currently in Phase I clinical, and its indication is ALK-positive locally advanced or metastatic non-small cell lung cancer
.
Industry analysts believe that, on the whole, the reasons for the termination of innovative drug research and development of various pharmaceutical companies are different, but they are mainly divided into active and passive
.
The initiative is mostly due to the fact that companies choose to actively suspend research and development due to changes in the market competition pattern or concerns about intensified market competition in the future in the research and development of innovative drugs
.
Passiveness means that a drug is rejected by the drug regulatory department because of its efficacy or safety is not as good as expected; in the process of drug development, R&D failure is actually commonplace
.
In short, the research and development of pharmaceutical companies has always been a risky activity
.
Its success and failure are two "watersheds".
Once the research and development is successful, the profits that pharmaceutical companies can enjoy will be huge; on the contrary, the manpower, material resources, and time consumed will be huge losses
.
However, focusing on the medium and long-term development, under the background that innovative R&D has become the general trend of the industry, the difficulties of high R&D costs, long R&D cycles, and low R&D success rates encountered in clinical R&D will also force companies to accelerate their thinking about the future.
While ensuring the enhancement of scientific value, innovation can be achieved as quickly and economically as possible, which will further enhance the innovation quality and innovation capabilities of pharmaceutical companies
.
According to statistics, a total of 24 innovative drugs have been approved for marketing by the NMPA, a record high in the past three years
.
It is worth mentioning that, in addition to the continuous increase in the number of new drugs approved, the speed of domestic innovative pharmaceutical companies is also continuing to accelerate
.
A large number of pharmaceutical companies, including BeiGene, Rongchang Biotechnology, Jacosi, Iris Pharmaceuticals, and Junshi Bio, are accelerating local innovative drugs to the global market through overseas authorization and other forms
.
However, with the development of the domestic innovative drug industry in full swing, and behind the rapid increase in the number of new drugs approved, the industry believes that it is also necessary to clearly realize that the research and development of innovative drugs is by no means easy, and risks and benefits coexist
.
According to incomplete statistics, in 2021, domestic companies such as Biotech, Renfu Pharmaceutical, and Zejing Pharmaceutical have terminated the research and development of a batch of innovative drugs under its umbrella
.
For example, in March of this year, Biotech Biopharmaceutical Co.
, Ltd.
announced that the company decided to terminate BAT8003 (recombinant humanized anti-Trop2 monoclonal antibody-maytansine conjugate for injection after careful consideration of the subsequent development risks of the drug).
, Hereinafter referred to as "BAT8003") and BAT1306 (ie recombinant humanized anti-PD-1 monoclonal antibody injection, hereinafter referred to as "BAT1306") clinical trials
.
It is reported that BAT8003 is an ADC drug that targets Trop2, and a phase I clinical trial for patients with Trop2-positive advanced epithelial cancer was launched in March 2019; BAT1306 is a PD-1 monoclonal antibody, and BAT1306 combined with XELOX has been used for first-line treatment.
EBV-related gastric cancer clinical trials and BAT8001 combined with BAT1306 second-line treatment of HER2-positive advanced solid tumors
.
On August 17, Zejing Pharmaceutical issued an announcement that Donafenib tosylate tablets in the treatment of stage Ⅲ colorectal cancer above second-line showed that the median overall survival (mOS) did not reach the preset superiority compared with the control group.
Goal
.
The company decided to terminate the further development of Donafenib monotherapy for this indication
.
In the same month, Xinlitai announced that it intends to terminate the "Nanatinostat" "Exclusive License Agreement" signed with VIRACTA of the United States.
.
In 2018, Xinlitai signed an agreement with VIRACTA to obtain the exclusive license to use Nanatinostat in Mainland China
.
On November 12, Renfu Medicine issued an announcement to terminate the research and development of a new class 1 drug RF-A089 capsule (ALK inhibitor)
.
RF-A089 capsule is currently in Phase I clinical, and its indication is ALK-positive locally advanced or metastatic non-small cell lung cancer
.
Industry analysts believe that, on the whole, the reasons for the termination of innovative drug research and development of various pharmaceutical companies are different, but they are mainly divided into active and passive
.
The initiative is mostly due to the fact that companies choose to actively suspend research and development due to changes in the market competition pattern or concerns about intensified market competition in the future in the research and development of innovative drugs
.
Passiveness means that a drug is rejected by the drug regulatory department because of its efficacy or safety is not as good as expected; in the process of drug development, R&D failure is actually commonplace
.
In short, the research and development of pharmaceutical companies has always been a risky activity
.
Its success and failure are two "watersheds".
Once the research and development is successful, the profits that pharmaceutical companies can enjoy will be huge; on the contrary, the manpower, material resources, and time consumed will be huge losses
.
However, focusing on the medium and long-term development, under the background that innovative R&D has become the general trend of the industry, the difficulties of high R&D costs, long R&D cycles, and low R&D success rates encountered in clinical R&D will also force companies to accelerate their thinking about the future.
While ensuring the enhancement of scientific value, innovation can be achieved as quickly and economically as possible, which will further enhance the innovation quality and innovation capabilities of pharmaceutical companies
.
