Under the resonance of policies, talents, capital and other factors, pharmaceutical innovation at home and abroad has become the main theme in recent years, and with the continuous increase in R&D investment of pharmaceutical companies, the entire innovative drug industry is showing blowout growth, and new drugs are constantly emerging
.
However, it is worth noting that the risk of new drug research and development is high, the success rate is low, and every step in the process from the laboratory to the market may lead to failure
.
As a result, clinical development discontinuations involving collaborative innovative drugs are also frequent in the global market
.
It is reported that since November, a number of pharmaceutical companies have announced the failure of new drug research and development, and the suspension or termination of clinical trials
.
For example, on November 14, pharmaceutical giant Roche announced that two phase III clinical trials of the Alzheimer's disease drug Gantenylimab had failed
.
The results showed that two phase III studies, GRADUATE 1 and GRADUATE 2, did not meet the primary endpoint of slowing clinical decline and that β-amyloid removal levels were lower than expected
.
At present, Roche has not announced specific research plans
for Alzheimer's disease-related drugs.
On 7 November, GSK's BCMA ADC drug Blenrep failed
to meet the primary endpoint in a phase III study of multiple myeloma.
This phase III clinical trial (DREAMM-3) evaluates the efficacy
of single-agent Blenrep compared with Pomalidomide plus low-dose dexamethasone (Pom/Dex) for relapsed/refractory multiple myeloma (RRMM).
It is worth mentioning that on November 3, GSK announced that the key phase III EAGLE-2 and EAGLE-3 trials of Gepotidacin, an investigational treatment for uncomplicated urinary tract infections (uUTIs) in women and adolescents, will also stop enrolling in the study
early, based on the recommendation of the Independent Data Monitoring Committee (IDMC).
Prior to this, Arbutus Biopharma also decided to stop clinical development
of AB-836.
It is reported that when introducing the new progress in the development of the new hepatitis B drug pipeline, including the AB-729-001 trial, after the new safety signal previously discovered by AB-836, in addition, in the evaluation of the administration of a new batch of healthy subjects (HV) in the AB-836-001 study, there was a low-level ALT elevation, so Arbutus decided to stop the clinical development
of the drug.
On the whole, the reasons for pharmaceutical companies to terminate new drug R&D projects may be due to the physical and chemical properties of drugs, such as the effectiveness and safety of drugs, which do not meet the requirements; Or based on business model, input-output ratio considerations, etc
.
Industry analysts believe that although pharmaceutical companies have frequently stopped clinical trials for various reasons, this does not mean that clinical trials have reached the end
.
For pharmaceutical companies, clinical trials are only a means to conduct clinical research and development, and their ultimate development focus and foothold are still to solve the needs of patients and continue to promote the accelerated launch
of innovative products.
In the future, in order to gain lasting competitiveness, pharmaceutical companies will continue to conduct clinical trials of new drugs, and suspension and termination of development will become the
norm.
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