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The development of innovative drugs and innovative therapies is a long-term and high-risk work that will be affected by many factors.
Under the traditional Me-too model, it seems that people rarely see failed projects
.
However, in recent years, as more and more pharmaceutical companies accelerate the development of innovative drugs, the number of new drug R&D failures and terminations has also begun to increase
.
For example, many large multinational pharmaceutical companies have successively announced the termination of new drug development projects
.
Recently, Eli Lilly disclosed an important news in its third-quarter earnings report
.
In October of this year, the company and its partner Pfizer terminated the global clinical development project of the antibody drug tanezumab
.
It is reported that the drug is a nerve growth factor (NGF) inhibitor developed for the treatment of osteoarthritis pain
.
According to the information disclosed by Eli Lilly, the two parties made the above decision because tanezumab has suffered serious setbacks in the US and Europe supervision
.
In the United States, the FDA has issued a complete response letter to the Biological Products Licensing Application (BLA) of tanezumab for the treatment of osteoarthritis (OA); in the European Union, the European Medicines Agency (EMA) Human Medical Products Committee has targeted tanezumab for the treatment of OA.
The marketing authorization application (MAA) issued a negative opinion
.
In fact, the continuous development of NGF inhibitors has always been regarded as a high-risk, high-reward job
.
For Eli Lilly and Pfizer, this result can be expected when the US FDA and the EU EMA successively rejected approval requests
.
At present, Eli Lilly has officially confirmed the termination of the global clinical development project of the antibody drug tanezumab, which also means that the massive investment in the tanezumab project by both parties has been in vain
.
In addition to Eli Lilly, there are reports that Novartis has also decided to abandon the gene therapy AVXS-201 research and development plan in the near future
.
According to its disclosure, "the entire content of the preclinical data does not support the further human clinical trials of the gene therapy AVXS-201", which is the main reason why Novartis cancelled the next step of the research and development work of the gene therapy AVXS-201 for Rett syndrome..
It is worth noting that in its third quarter results, Novartis, in addition to its decision to terminate the gene therapy AVXS-201, the list of terminated R&D projects also includes 177Lu-PSMA-R2 in prostate cancer
.
In addition, Novartis’s other PD-1 drug, Spartalizumab, has been delayed to 2025 or later due to the difficulty in recruiting subjects
.
In general, the lack of efficacy is one of the main reasons for the failure of drug development
.
The efficacy of drugs is affected by many factors.
An in-depth understanding of the pathogenic mechanism and target action mechanism of the disease is a necessary condition for designing a drug with curative effect.
However, the pathogenesis of most diseases has not been clearly explained, and drug development has to be Step by step on the basis of preliminary research, while the opportunities are huge, the R&D risks are also inevitable
.
Therefore, the industry believes that companies that want to invest in innovative drug research and development must enter the game carefully
.
Especially with the domestic vigorous promotion of pharmaceutical innovation and innovative drugs gradually becoming the mainstream, domestic pharmaceutical companies and related investment institutions should also fully anticipate the failure of drug development
.
Under the traditional Me-too model, it seems that people rarely see failed projects
.
However, in recent years, as more and more pharmaceutical companies accelerate the development of innovative drugs, the number of new drug R&D failures and terminations has also begun to increase
.
For example, many large multinational pharmaceutical companies have successively announced the termination of new drug development projects
.
Recently, Eli Lilly disclosed an important news in its third-quarter earnings report
.
In October of this year, the company and its partner Pfizer terminated the global clinical development project of the antibody drug tanezumab
.
It is reported that the drug is a nerve growth factor (NGF) inhibitor developed for the treatment of osteoarthritis pain
.
According to the information disclosed by Eli Lilly, the two parties made the above decision because tanezumab has suffered serious setbacks in the US and Europe supervision
.
In the United States, the FDA has issued a complete response letter to the Biological Products Licensing Application (BLA) of tanezumab for the treatment of osteoarthritis (OA); in the European Union, the European Medicines Agency (EMA) Human Medical Products Committee has targeted tanezumab for the treatment of OA.
The marketing authorization application (MAA) issued a negative opinion
.
In fact, the continuous development of NGF inhibitors has always been regarded as a high-risk, high-reward job
.
For Eli Lilly and Pfizer, this result can be expected when the US FDA and the EU EMA successively rejected approval requests
.
At present, Eli Lilly has officially confirmed the termination of the global clinical development project of the antibody drug tanezumab, which also means that the massive investment in the tanezumab project by both parties has been in vain
.
In addition to Eli Lilly, there are reports that Novartis has also decided to abandon the gene therapy AVXS-201 research and development plan in the near future
.
According to its disclosure, "the entire content of the preclinical data does not support the further human clinical trials of the gene therapy AVXS-201", which is the main reason why Novartis cancelled the next step of the research and development work of the gene therapy AVXS-201 for Rett syndrome..
It is worth noting that in its third quarter results, Novartis, in addition to its decision to terminate the gene therapy AVXS-201, the list of terminated R&D projects also includes 177Lu-PSMA-R2 in prostate cancer
.
In addition, Novartis’s other PD-1 drug, Spartalizumab, has been delayed to 2025 or later due to the difficulty in recruiting subjects
.
In general, the lack of efficacy is one of the main reasons for the failure of drug development
.
The efficacy of drugs is affected by many factors.
An in-depth understanding of the pathogenic mechanism and target action mechanism of the disease is a necessary condition for designing a drug with curative effect.
However, the pathogenesis of most diseases has not been clearly explained, and drug development has to be Step by step on the basis of preliminary research, while the opportunities are huge, the R&D risks are also inevitable
.
Therefore, the industry believes that companies that want to invest in innovative drug research and development must enter the game carefully
.
Especially with the domestic vigorous promotion of pharmaceutical innovation and innovative drugs gradually becoming the mainstream, domestic pharmaceutical companies and related investment institutions should also fully anticipate the failure of drug development
.
