Abstract
Since the beginning of this year, many domestic and foreign pharmaceutical companies have stopped researching and developing new drugs.
Innovative drugs have a long R&D cycle, high investment and high risks. It is not easy to achieve success. Therefore, the story of a near-death experience in the development of new drugs often appears. It is reported that since the beginning of this year, many pharmaceutical companies have announced the termination of research and development of new drugs.
For example, recently, the clinical failure of Sanofi’s oral SERD amcenestrant combination. This is another failure following the single-agent clinical failure in March. Based on this, Sanofi decided to stop all clinical trials of amcenestrant. This means that Sanofi has completely conceded defeat in the field of oral SERD. It is reported that many pharmaceutical companies have failed in the field of oral SERD (estrogen receptor degrader), which is crowded with big pharmaceutical companies. In addition to Sanofi, Roche’s oral SERD also showed danger signs. In April this year, One clinical trial of oral SERD was unsuccessful.
In the process of the termination of research and development of new drugs, Biogen also decided to stop the observational ICAREAD trial of the Aduhelm drug in the first half of this year. Biogen stated in the clinical trial registry that the reason for terminating the trial was mainly because the drug did not receive national medical insurance. Coverage policy support.
Since the beginning of this year, there have also been frequent clinical development terminations involving innovative collaborative drugs in the global market. In April of this year, AbbVie announced that it had terminated its cooperation with BioArctic to stop the follow-up clinical development of ABBV-0805, an alpha-synuclein (aSyn) antibody for the treatment of Parkinson’s disease. Also in April, Nektar and Bristol-Myers Squibb announced the termination of the global clinical development program for Bengadil in combination with Opdivo.
In addition, in July, the Phase II clinical trial of MacroGenics’ core product B7-H3 monoclonal antibody, ibrutinib, was terminated. Before that, Tianjin Bio and MacroGenics reached a cooperation to obtain the exclusive clinical trial of ibrutinib in Greater China. Development and sales rights; Sesen Bio announced that it will terminate the clinical development of the immunotoxin Vicineum in the United States, and Qilu Pharmaceutical previously introduced Vicineum’s domestic rights for $35 million.
Analysts said that the reasons for the termination of innovative drug research and development of various pharmaceutical companies are different, but they are mainly divided into active and passive. The initiative is mostly due to the fact that companies choose to suspend research and development on their own initiative due to changes in the market competition pattern or concerns about intensifying market competition in the future during the research and development of innovative drugs.
For example, GenScript recently announced that Legend Bio, a non-wholly-owned subsidiary, notified the US FDA that it had terminated the Phase I clinical trial of its New Drug Application (IND) for LB1901. The termination was reportedly based on the lack of clinical benefit of a similar CAR-T product candidate from Legend Bio that expresses the same CAR protein as LB1901.
Legend Bio has judged that the future prospects of LB1901 will not be very optimistic, and voluntarily terminated it in order to give priority to other candidate products in its product line under development. Passive means that the drug is rejected by the drug regulatory department because the efficacy or safety is not as expected.
In the process of drug development, R&D failures have long been commonplace. However, focusing on medium and long-term development, the industry said that this also forces companies to speed up their thinking, on how to achieve innovation in the future while ensuring the improvement of scientific value, which will further improve the quality of innovation of pharmaceutical companies and improve Creativity.
Article source: https://mp.weixin.qq.com/s/AQ4AhfoJejDhNi6RX09fSA
