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New drug research and development is a technological innovation with high risk and low success rate.
It has always been a long and complicated process from the laboratory to the launch of a new drug.
Every step in this process may lead to failure
.
Since the beginning of this year, many pharmaceutical companies have announced the suspension or termination of project research due to R&D failures
.
For example, recently, Merck announced an update on the Phase 2 IMAGINE-DR clinical study (MK-8507-13)
.
The trial is evaluating an experimental combination of MK-8507 and islatravir (Islavir, ISL) as a weekly oral regimen for the treatment of HIV-1 infection
.
MK-8507 is a non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir is a new oral nucleoside reverse transcriptase inhibitor (NRTTI)
.
It is understood that due to random assignment to patients receiving ISL+MK-8507 treatment, a decrease in the total number of lymphocytes and CD4+T cell counts was observed
.
According to eDMC's recommendation, Merck is stopping the administration of patients in the trial and has notified researchers to suspend the development of MK-8507
.
In addition to Merck, according to media statistics, no less than 20 pharmaceutical companies have announced the termination or suspension of research and development in the drug field this year
.
On August 23, Merck also announced that based on a data review conducted by the Independent Data Monitoring Committee (IDMC), it decided to terminate the Phase II INTR@PID BTC 055 study
.
The study aims to evaluate bintrafusp alfa (M7824) combined with gemcitabine (gemcitabine) and cisplatin in the first-line treatment of patients with locally advanced or metastatic cholangiocarcinoma (BTC)
.
It is understood that Bintrafusp alfa is a PD-L1/TGF-β double antibody developed internally by Merck
.
In February 2019, Merck and GlaxoSmithKline reached a cooperation on the research and development of bintrafusp alfa in refractory cancer, and the two pharmaceutical giants signed a global cooperative development agreement of up to 4.
2 billion US dollars.
.
In addition to foreign companies, many domestic pharmaceutical companies have terminated some drug R&D projects.
For example, as early as March 4, Biotech issued an announcement stating that it would terminate BAT8003 (recombinant humanized anti-Trop2 monoclonal antibody for injection-maytansine).
Conjugate) and BAT1306 (recombinant humanized anti-PD-1 monoclonal antibody injection) clinical development
.
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; BAT1306 is a PD-1 monoclonal antibody, and BAT1306 combined with XELOX first-line treatment has been carried out.
EBV-related gastric cancer clinical trials and BAT8001 combined with BAT1306 second-line treatment of HER2-positive advanced solid tumors
.
Regarding the suspension, Biotech stated that it was to rationally allocate the company's R&D resources and focus on advantageous projects in the R&D pipeline
.
It is worth noting that the announcement shows that as of December 2020, Biotech has invested 61.
565 million yuan in R&D in the BAT8003 project, and the BAT1306 project has also invested 51.
974 million yuan in R&D
.
In general, the research and development of pharmaceutical companies has always been a risky acquisition
.
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, in the case of failure, then the manpower, material resources, and resources consumed in the process of drug research and development Time is also a huge loss
.
However, focusing on the medium and long-term development, under the background that innovative R&D is still the general trend in 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 speed up thinking about how to ensure While enhancing the value of science, innovation can be achieved as quickly and economically as possible
.
It has always been a long and complicated process from the laboratory to the launch of a new drug.
Every step in this process may lead to failure
.
Since the beginning of this year, many pharmaceutical companies have announced the suspension or termination of project research due to R&D failures
.
For example, recently, Merck announced an update on the Phase 2 IMAGINE-DR clinical study (MK-8507-13)
.
The trial is evaluating an experimental combination of MK-8507 and islatravir (Islavir, ISL) as a weekly oral regimen for the treatment of HIV-1 infection
.
MK-8507 is a non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir is a new oral nucleoside reverse transcriptase inhibitor (NRTTI)
.
It is understood that due to random assignment to patients receiving ISL+MK-8507 treatment, a decrease in the total number of lymphocytes and CD4+T cell counts was observed
.
According to eDMC's recommendation, Merck is stopping the administration of patients in the trial and has notified researchers to suspend the development of MK-8507
.
In addition to Merck, according to media statistics, no less than 20 pharmaceutical companies have announced the termination or suspension of research and development in the drug field this year
.
On August 23, Merck also announced that based on a data review conducted by the Independent Data Monitoring Committee (IDMC), it decided to terminate the Phase II INTR@PID BTC 055 study
.
The study aims to evaluate bintrafusp alfa (M7824) combined with gemcitabine (gemcitabine) and cisplatin in the first-line treatment of patients with locally advanced or metastatic cholangiocarcinoma (BTC)
.
It is understood that Bintrafusp alfa is a PD-L1/TGF-β double antibody developed internally by Merck
.
In February 2019, Merck and GlaxoSmithKline reached a cooperation on the research and development of bintrafusp alfa in refractory cancer, and the two pharmaceutical giants signed a global cooperative development agreement of up to 4.
2 billion US dollars.
.
In addition to foreign companies, many domestic pharmaceutical companies have terminated some drug R&D projects.
For example, as early as March 4, Biotech issued an announcement stating that it would terminate BAT8003 (recombinant humanized anti-Trop2 monoclonal antibody for injection-maytansine).
Conjugate) and BAT1306 (recombinant humanized anti-PD-1 monoclonal antibody injection) clinical development
.
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; BAT1306 is a PD-1 monoclonal antibody, and BAT1306 combined with XELOX first-line treatment has been carried out.
EBV-related gastric cancer clinical trials and BAT8001 combined with BAT1306 second-line treatment of HER2-positive advanced solid tumors
.
Regarding the suspension, Biotech stated that it was to rationally allocate the company's R&D resources and focus on advantageous projects in the R&D pipeline
.
It is worth noting that the announcement shows that as of December 2020, Biotech has invested 61.
565 million yuan in R&D in the BAT8003 project, and the BAT1306 project has also invested 51.
974 million yuan in R&D
.
In general, the research and development of pharmaceutical companies has always been a risky acquisition
.
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, in the case of failure, then the manpower, material resources, and resources consumed in the process of drug research and development Time is also a huge loss
.
However, focusing on the medium and long-term development, under the background that innovative R&D is still the general trend in 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 speed up thinking about how to ensure While enhancing the value of science, innovation can be achieved as quickly and economically as possible
.
