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[Pharmaceutical Network Industry News] In recent years, the enthusiasm for new drug research and development at home and abroad has been high, but the success of new drug research and development is not easy.
After all, this is a project with "high investment, high risk, high return and long cycle".
, time management, capital investment, personnel allocation, project quality, project coordination, risk management and control, R&D outsourcing, comprehensive management and other challenges, it is easy to make mistakes if you are not careful
.
For example, in the field of hot research and development of oncology drugs, a large number of drugs have ended in clinical failure, including Sanofi's amcenestrant, Celldex's Rintega, Argos' rocapuldencel-T, and Agenus' Prophage G-200
.
Among them, Sanofi announced in March the results of a clinical trial of amcenestrant as a monotherapy in the evaluation of second- or multi-line treatment of ER+/HER2- advanced or metastatic breast cancer: the AMERA-3 trial did not meet the primary endpoint, according to an independent center The review assessed that amcenestrant did not improve progression-free survival (PFS) compared with physician-selected single-agent endocrine therapy, and no new safety signals were identified, with a safety profile consistent with earlier studies
.
Ongoing trials continue as planned, including AMEERA-5 and AMEERA-6
.
Sanofi has previously touted amcenestrant as a "potentially transformative" product with an expected $1 billion in sales in 2026
.
But despite the setbacks in clinical results, the company's head of research and development said in a statement that it will continue to study amcenestrant in patients with early-stage breast cancer with different tumor characteristics and treated with different standards of care
.
In the field of hepatitis B treatment, in January 2022, the S-antigen transport inhibitory oligonucleotide polymer (STOPS™) ALG-010133 developed by clinical-stage biopharmaceutical company Aligos Therapeutics failed to achieve the ideal reduction of hepatitis B surface antigen ( HBsAg) levels stopped development work
.
Recently, researchers at Replicor also re-analyzed ALG-010133 and obtained the specific reasons for its clinical development failure
.
It is believed that there are three main reasons: First, the structural changes that occur in LNA-modified oligonucleotides have the effect of reducing their hydration, and thus, in ALG-010133, the uniform 2'O-methylation present in REP 2165 The doping of LNA significantly reduces the hydration of this NAP and enables it to be efficiently transfected, resulting in significantly (but artificially) increased antiviral activity through transfection; Reduced target participation; third, early preclinical data showed that the hepatic accumulation of ALG-010133 at equivalent doses was approximately 5-fold lower than that of REP 2165, which was below the hepatic accumulation threshold required for the antiviral activity of NAP against HBV
.
For another example, in February 2022, Novi and Regeneron’s anti-inflammatory drug Dupixent in the treatment of chronic spontaneous urticaria (CSU) Phase 3 project was updated
.
In the announcement, the parties said that a Phase 3 trial (CUPID STUDY B) evaluating Dupixent in patients with omalizumab-refractory CSU, based on a pre-specified interim analysis, will be discontinued due to a finding of futility.
.
Although positive numerical trends were observed for reductions in pruritus and urticaria, the results of the interim analysis showed no statistical significance for the primary endpoint
.
However, Nofi and Regeneron remain committed to developing Dupixent as an antihistamine in patients with uncontrolled CSU and are evaluating next steps
.
Some industry insiders who have been engaged in new drug research and development for many years said that there are five main reasons for the failure of the management of new drug research and development projects they participated in, including project approval mistakes, lack of project-matching stakeholders, uncertainty in technical risks, and late R&D application progress.
The transfer from other units, R&D to production is disjointed
.
In general, new drug R&D project management is a systematic, long-term, complex and high-investment project activity.
Based on the analysis and summary of the failure experience of pharmaceutical companies in the past, it may be able to provide some reference for later new drug R&D personnel.
Avoid detours and avoid failure
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
After all, this is a project with "high investment, high risk, high return and long cycle".
, time management, capital investment, personnel allocation, project quality, project coordination, risk management and control, R&D outsourcing, comprehensive management and other challenges, it is easy to make mistakes if you are not careful
.
For example, in the field of hot research and development of oncology drugs, a large number of drugs have ended in clinical failure, including Sanofi's amcenestrant, Celldex's Rintega, Argos' rocapuldencel-T, and Agenus' Prophage G-200
.
Among them, Sanofi announced in March the results of a clinical trial of amcenestrant as a monotherapy in the evaluation of second- or multi-line treatment of ER+/HER2- advanced or metastatic breast cancer: the AMERA-3 trial did not meet the primary endpoint, according to an independent center The review assessed that amcenestrant did not improve progression-free survival (PFS) compared with physician-selected single-agent endocrine therapy, and no new safety signals were identified, with a safety profile consistent with earlier studies
.
Ongoing trials continue as planned, including AMEERA-5 and AMEERA-6
.
Sanofi has previously touted amcenestrant as a "potentially transformative" product with an expected $1 billion in sales in 2026
.
But despite the setbacks in clinical results, the company's head of research and development said in a statement that it will continue to study amcenestrant in patients with early-stage breast cancer with different tumor characteristics and treated with different standards of care
.
In the field of hepatitis B treatment, in January 2022, the S-antigen transport inhibitory oligonucleotide polymer (STOPS™) ALG-010133 developed by clinical-stage biopharmaceutical company Aligos Therapeutics failed to achieve the ideal reduction of hepatitis B surface antigen ( HBsAg) levels stopped development work
.
Recently, researchers at Replicor also re-analyzed ALG-010133 and obtained the specific reasons for its clinical development failure
.
It is believed that there are three main reasons: First, the structural changes that occur in LNA-modified oligonucleotides have the effect of reducing their hydration, and thus, in ALG-010133, the uniform 2'O-methylation present in REP 2165 The doping of LNA significantly reduces the hydration of this NAP and enables it to be efficiently transfected, resulting in significantly (but artificially) increased antiviral activity through transfection; Reduced target participation; third, early preclinical data showed that the hepatic accumulation of ALG-010133 at equivalent doses was approximately 5-fold lower than that of REP 2165, which was below the hepatic accumulation threshold required for the antiviral activity of NAP against HBV
.
For another example, in February 2022, Novi and Regeneron’s anti-inflammatory drug Dupixent in the treatment of chronic spontaneous urticaria (CSU) Phase 3 project was updated
.
In the announcement, the parties said that a Phase 3 trial (CUPID STUDY B) evaluating Dupixent in patients with omalizumab-refractory CSU, based on a pre-specified interim analysis, will be discontinued due to a finding of futility.
.
Although positive numerical trends were observed for reductions in pruritus and urticaria, the results of the interim analysis showed no statistical significance for the primary endpoint
.
However, Nofi and Regeneron remain committed to developing Dupixent as an antihistamine in patients with uncontrolled CSU and are evaluating next steps
.
Some industry insiders who have been engaged in new drug research and development for many years said that there are five main reasons for the failure of the management of new drug research and development projects they participated in, including project approval mistakes, lack of project-matching stakeholders, uncertainty in technical risks, and late R&D application progress.
The transfer from other units, R&D to production is disjointed
.
In general, new drug R&D project management is a systematic, long-term, complex and high-investment project activity.
Based on the analysis and summary of the failure experience of pharmaceutical companies in the past, it may be able to provide some reference for later new drug R&D personnel.
Avoid detours and avoid failure
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
