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[Pharmaceutical Network Industry News] There has always been a great risk of failure in the development of new dru.
Recently, Merck announced that its Phase III clinical trial of Keytruda in combination with Lenvima had fail.
It is reported that the clinical trial named LEAP-002, the superiority hypothesis of the study is that the efficacy of pembrolizumab + lenvatinib in the treatment of patients with HCC (ie hepatocellular carcinoma) is better than that of lenvatinib alo.
However, the results backfir.
Compared with lenvatinib alone, clinical data such as overall survival in patients treated with pembrolizumab + lenvatinib showed a trend of improvement, but the results did not have a statistically significant improveme.
The failure of Merck's project R&D has attracted the attention of the indust.
In fact, it is not uncommon for multinational pharmaceutical companies to fail in the R&D of new drugs, including Roche and Sano.
For example, on June 16, Roche and the Banner Alzheimer's Institute jointly announced that the Phase II clinical trial of crenezumab (crenezumab) in the Alzheimer's Prevention Initiative (API) project did not meet the primary study endpoi.
In June, Rigel Pharmaceuticals announced that the global, multicenter, randomized, double-blind, placebo-controlled Phase III FORWARD trial of the Syk inhibitor fostamatinib in warm antibody autoimmune hemolytic anemia failed to meet primary end poi.
On May 11, Roche announced the interim data of SKYSCRAPER-01, a phase III clinical trial of PD-L1+TIGIT combined with first-line treatment of non-small cell lung cancer, which showed that the study did not meet its co-primary endpoint of progression-free surviv.
Also in May, Idorsia Pharmaceuticals' ACT-539313 therapy failed to meet its primary endpoint in a phase II trial, and the company later said it would no longer study the use of ACT-539313 to treat binge eating disord.
In February, Sanofi's Phase 3 program with Regeneron's anti-inflammatory drug Dupixent in chronic spontaneous urticaria (CSU) was updat.
A phase 3 trial evaluating Dupixent in patients with omalizumab-refractory CSU (CUPID STUDY B) will be discontinued due to a prespecified interim analysis, based on a prespecified interim analys.
In January, Aligos Therapeutics announced that its S-antigen transport inhibitory oligonucleotide polymer (STOPS™), ALG-010133, had stopped development work because it failed to achieve the desired reduction in hepatitis B surface antigen (HBsAg) leve.
Earlier, in October 2020, Pfizer announced that Ibrance had failed a second large Phase 3 clinical study, PENELOPE-B, in HR+/HER2- early breast canc.
This is also another failure of Aiboxin in early breast cancer clinical research after the failure of the Phase III clinical study of PALLAS in combination with endocrine therapy for HR+/HER
Not only multinational pharmaceutical companies, but also local pharmaceutical companies have failed in the development of new dru.
For example, in June this year, Watson Bio announced that its holding subsidiary Shanghai Zerun had decided to terminate the research and development of the recombinant EV71 vaccine in consideration of the evolution of the domestic hand, foot and mouth disease epidemic; Clover Bio announced that it would suspend one tumor project and two biosimilars Continued investment in the project is aimed at promoting the launch of vaccin.
Judging from the above cases, most pharmaceutical companies fail in Phase 1 and Phase 2 clinical trials, but there are also cases like Merck’s Phase 3 clinical trials that failed, which may give other pharmaceutical companies more warnings, that is, new drug development even if it is difficult After the first and second phase clinical trials, it may also face new challeng.
The industry pointed out that a new drug R&D project is a project with "high investment, high risk and long cycl.
There are many reasons for R&D failure, including project approval mistakes, lack of project-matching stakeholders, uncertainty in technical risks, and R&D failur.
The application progress is later than other units, and the transfer from R&D to production is out of tou.
Judging from the past experience of pharmaceutical companies' failure in R&D, it may give more inspiration to later new drug R&D personnel, avoid detours, and avoid letting project investment go to was.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
Recently, Merck announced that its Phase III clinical trial of Keytruda in combination with Lenvima had fail.
It is reported that the clinical trial named LEAP-002, the superiority hypothesis of the study is that the efficacy of pembrolizumab + lenvatinib in the treatment of patients with HCC (ie hepatocellular carcinoma) is better than that of lenvatinib alo.
However, the results backfir.
Compared with lenvatinib alone, clinical data such as overall survival in patients treated with pembrolizumab + lenvatinib showed a trend of improvement, but the results did not have a statistically significant improveme.
The failure of Merck's project R&D has attracted the attention of the indust.
In fact, it is not uncommon for multinational pharmaceutical companies to fail in the R&D of new drugs, including Roche and Sano.
For example, on June 16, Roche and the Banner Alzheimer's Institute jointly announced that the Phase II clinical trial of crenezumab (crenezumab) in the Alzheimer's Prevention Initiative (API) project did not meet the primary study endpoi.
In June, Rigel Pharmaceuticals announced that the global, multicenter, randomized, double-blind, placebo-controlled Phase III FORWARD trial of the Syk inhibitor fostamatinib in warm antibody autoimmune hemolytic anemia failed to meet primary end poi.
On May 11, Roche announced the interim data of SKYSCRAPER-01, a phase III clinical trial of PD-L1+TIGIT combined with first-line treatment of non-small cell lung cancer, which showed that the study did not meet its co-primary endpoint of progression-free surviv.
Also in May, Idorsia Pharmaceuticals' ACT-539313 therapy failed to meet its primary endpoint in a phase II trial, and the company later said it would no longer study the use of ACT-539313 to treat binge eating disord.
In February, Sanofi's Phase 3 program with Regeneron's anti-inflammatory drug Dupixent in chronic spontaneous urticaria (CSU) was updat.
A phase 3 trial evaluating Dupixent in patients with omalizumab-refractory CSU (CUPID STUDY B) will be discontinued due to a prespecified interim analysis, based on a prespecified interim analys.
In January, Aligos Therapeutics announced that its S-antigen transport inhibitory oligonucleotide polymer (STOPS™), ALG-010133, had stopped development work because it failed to achieve the desired reduction in hepatitis B surface antigen (HBsAg) leve.
Earlier, in October 2020, Pfizer announced that Ibrance had failed a second large Phase 3 clinical study, PENELOPE-B, in HR+/HER2- early breast canc.
This is also another failure of Aiboxin in early breast cancer clinical research after the failure of the Phase III clinical study of PALLAS in combination with endocrine therapy for HR+/HER
Not only multinational pharmaceutical companies, but also local pharmaceutical companies have failed in the development of new dru.
For example, in June this year, Watson Bio announced that its holding subsidiary Shanghai Zerun had decided to terminate the research and development of the recombinant EV71 vaccine in consideration of the evolution of the domestic hand, foot and mouth disease epidemic; Clover Bio announced that it would suspend one tumor project and two biosimilars Continued investment in the project is aimed at promoting the launch of vaccin.
Judging from the above cases, most pharmaceutical companies fail in Phase 1 and Phase 2 clinical trials, but there are also cases like Merck’s Phase 3 clinical trials that failed, which may give other pharmaceutical companies more warnings, that is, new drug development even if it is difficult After the first and second phase clinical trials, it may also face new challeng.
The industry pointed out that a new drug R&D project is a project with "high investment, high risk and long cycl.
There are many reasons for R&D failure, including project approval mistakes, lack of project-matching stakeholders, uncertainty in technical risks, and R&D failur.
The application progress is later than other units, and the transfer from R&D to production is out of tou.
Judging from the past experience of pharmaceutical companies' failure in R&D, it may give more inspiration to later new drug R&D personnel, avoid detours, and avoid letting project investment go to was.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
