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In recent years, the development of innovative drug industries at home and abroad has been in full swing, and the number of new drugs approved has also begun to increase
rapidly.
However, it should be noted that new drug development is a high-risk, low-success rate of technological innovation, from the laboratory to the launch of new drugs is a long and complex process, every step in this process may lead to failure
.
It is understood that a number of pharmaceutical companies have recently announced the suspension or termination of the development of new drugs
.
On October 18, biopharmaceutical company Ambrx Biopharma underwent a strategic restructuring and business update, announcing a suspension of internal development of the HER2 antibody conjugate ARX788 to seek partners to continue development and lay off 15% of its workforce to ensure that its cash, cash equivalents and marketable securities can remain operational until 2025
.
On October 14, Japan's Fujifilm Corporation announced that it had decided to stop developing its anti-influenza
drug favipiravir tablets (Avigan) to treat novel coronavirus pneumonia.
The decision was made by Fujifilm mainly based on two points: in addition to Avigan's failure to confirm its effectiveness in clinical trials, the current mainstream Omicron strain has a relatively low
rate of severe disease.
On October 10, Harbour Bio announced the end of its phase III clinical trial of tenarcept and no longer enrolled new subjects, which means that the clinical trial of the drug has pressed the end button
.
Based on the observed trend of insufficient efficacy, the Independent Data Monitoring Committee (IDMC) recommended that the company terminate the trial in accordance with the clinical trial
protocol, the announcement said.
Tenarcept is known to be a TNF-α inhibitor that was developed as a topical eye drop for the treatment of moderate to severe dry eye disease (DED
).
Harbour Biomed has acquired exclusive rights to
develop and commercialize the drug in Greater China.
In August 2020, Harbour Biomed launched a phase III registration trial of tenacept in China, and completed the first interim analysis
of a phase III clinical trial in January this year.
On September 27, Exicure announced plans to restructure the company and consolidate resources to continue exploring strategic alternatives
to maximize shareholder value.
Exicure will cut approximately 66% of its workforce, which is expected to be completed
in the fourth quarter of 2022.
Exicure will also cease all research and development activities, including the suspension of all collaborative projects
.
In general, there are many reasons why pharmaceutical companies terminate new drug research and development projects, either to allocate R&D resources, eliminate non-essential product lines, or to adjust the R&D structure and R&D direction, or market profit and risk considerations, but in the final analysis, they are all comprehensive trade-offs between continued development risks and future clinical value, in order to reduce the loss
of corporate profits.
Under the current wave of innovation in the pharmaceutical industry, the industry expects that the termination or suspension of clinical trials will become the
norm.
It is worth noting that in this context, it may force enterprises to accelerate their thinking about how to achieve innovation quickly and economically while ensuring the enhancement of scientific value in the future, which will further improve the innovation quality and innovation ability
of pharmaceutical companies.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.