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[Pharmaceutical Network Enterprise News] With the rise of biopharmaceutical innovation companies and the continuous opening of the market, pharmaceutical companies have begun to develop new drugs more and more frequentl.
However, due to the long R&D cycle, high investment and high risk of innovative drugs, it is not easy to achieve success in the en.
Therefore, in recent years, it is obvious that the termination of clinical development of innovative drugs has gradually become the nor.
Recently, the biotechnology company Ideaya Biosciences announced in its second-quarter earnings report that GlaxoSmithKline dropped one of three cancer projects it collaborated wit.
The project intends to study a protein-coding gene called methionine adenosyltransferase 2a (MAT2A) in patients with solid tumors deficient in methylthioadenosine phosphorylase (MTAP), which account for approximately 15 percent of all solid tumor patient.
%, the resulting MAT2A inhibitor is called IDE397.This is not the first time that GlaxoSmithKline has terminated new drug developmen.
As early as 2021, GlaxoSmithKline's OX40 agonist GSK3174998 was suspended due to "lack of sufficient clinical activity" for the treatment of tumor.
The products on hold, like GSK3174998, also include the anti-OSM drug GSK2330811 for systemic sclerosis and Benlysta-Rituxan for Sjögren's syndrome, which were "discontinued for not meeting efficacy criteria.
In addition, Benlysta is a specific inhibitor of B lymphocyte stimulating factor (BLyS), which has been approved by the FDA as the first drug for the treatment of lupus nephritis (LN.
In addition, in February 2019, Merck and GlaxoSmithKline reached a cooperation on the research and development of bintrafusp alfa (M7824) in refractory cancer, and the two pharmaceutical giants signed a global cooperative development agreement totaling up to 2 billion US dollar.
However, because the phase II INTR@PID BTC 047 of bintrafusp alfa alone in second-line treatment of locally advanced or metastatic biliary tract cancer (BTC) has not met the primary endpoint, the trial has to be terminated again in 2021.Analysts believe that with the deepening of clinical trials and the continuous increase of uncontrollable factors, the requirements for enterprises' clinical development and financial support capabilities are getting higher and highe.
Once the clinical development is terminated, all the previous efforts and costs will be waste.
So, when new drug research and development is becoming more and more difficult and the cost is getting higher and higher, how should companies control research and development risks? In this regard, industry insiders said that companies should focus more on clinical trials themselve.
It is reported that its company will carefully look at all clinical data, whether it is animal data, phase I, phase II, or phase III data, or drug toxicolog.
"When choosing a cooperation project, we will also comprehensively evaluate the scientific and technological strength of the invested company to avoid the risk of clinical trial failure as much as possibl.
" In addition to focusing on the clinical trial itself, from the perspective of the current clinical trial failure reasons, further promote the integration of resources It has also become one of the directions that urgently needs to be broke.
In addition, strengthening international cooperation may also become a major directio.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyon.
However, due to the long R&D cycle, high investment and high risk of innovative drugs, it is not easy to achieve success in the en.
Therefore, in recent years, it is obvious that the termination of clinical development of innovative drugs has gradually become the nor.
Recently, the biotechnology company Ideaya Biosciences announced in its second-quarter earnings report that GlaxoSmithKline dropped one of three cancer projects it collaborated wit.
The project intends to study a protein-coding gene called methionine adenosyltransferase 2a (MAT2A) in patients with solid tumors deficient in methylthioadenosine phosphorylase (MTAP), which account for approximately 15 percent of all solid tumor patient.
%, the resulting MAT2A inhibitor is called IDE397.This is not the first time that GlaxoSmithKline has terminated new drug developmen.
As early as 2021, GlaxoSmithKline's OX40 agonist GSK3174998 was suspended due to "lack of sufficient clinical activity" for the treatment of tumor.
The products on hold, like GSK3174998, also include the anti-OSM drug GSK2330811 for systemic sclerosis and Benlysta-Rituxan for Sjögren's syndrome, which were "discontinued for not meeting efficacy criteria.
In addition, Benlysta is a specific inhibitor of B lymphocyte stimulating factor (BLyS), which has been approved by the FDA as the first drug for the treatment of lupus nephritis (LN.
In addition, in February 2019, Merck and GlaxoSmithKline reached a cooperation on the research and development of bintrafusp alfa (M7824) in refractory cancer, and the two pharmaceutical giants signed a global cooperative development agreement totaling up to 2 billion US dollar.
However, because the phase II INTR@PID BTC 047 of bintrafusp alfa alone in second-line treatment of locally advanced or metastatic biliary tract cancer (BTC) has not met the primary endpoint, the trial has to be terminated again in 2021.Analysts believe that with the deepening of clinical trials and the continuous increase of uncontrollable factors, the requirements for enterprises' clinical development and financial support capabilities are getting higher and highe.
Once the clinical development is terminated, all the previous efforts and costs will be waste.
So, when new drug research and development is becoming more and more difficult and the cost is getting higher and higher, how should companies control research and development risks? In this regard, industry insiders said that companies should focus more on clinical trials themselve.
It is reported that its company will carefully look at all clinical data, whether it is animal data, phase I, phase II, or phase III data, or drug toxicolog.
"When choosing a cooperation project, we will also comprehensively evaluate the scientific and technological strength of the invested company to avoid the risk of clinical trial failure as much as possibl.
" In addition to focusing on the clinical trial itself, from the perspective of the current clinical trial failure reasons, further promote the integration of resources It has also become one of the directions that urgently needs to be broke.
In addition, strengthening international cooperation may also become a major directio.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyon.