Under the background of the surge of global bispecific antibody drug research and development, a number of domestic companies have also engaged in the research and development
of bispecific antibody drugs.
The author learned that a number of pharmaceutical companies have recently made new progress
in the research and development of bispecific antibody drugs.
For example, on November 2, Anko Biotech issued an announcement that the clinical trial application of PD-L1/4-1BB bispecific antibody "HK010 injection" jointly declared by the company and its holding subsidiary Hefei Hanke Mabo Biotechnology Co.
, Ltd.
has been approved
.
On November 1, the website of the Center for Drug Evaluation of the National Medical Products Administration announced that the clinical trial application of AK129 injection declared by Akeso Biologics has been implicitly approved, and the innovative drug is LAG-3 (lymphocyte activation gene 3)/PD-1 (programmed death protein 1) biantibody, which is intended to be developed for the treatment of advanced malignant tumors
.
According to Acro Biologics, HK010 injection is a new type of PD-L1/4-1BB bispecific antibody with independent intellectual property rights, and the proposed indication is advanced malignant tumor
.
It is understood that the bispecific antibody HK010 of PD-L1/4-1BB can not only block the immunosuppressive PD-L1/PD-1, but also conditionally activate the 4-1BB co-stimulation signal, so as to achieve the dual role of lifting immunosuppression and activating the immune system, and improve safety while enhancing the efficacy of the drug, which is a potential anti-tumor bispecific antibody
.
At present, there are no PD-L1/4-1BB bispecific antibodies on the market at home and abroad, and related products are in the clinical research stage
at home and abroad.
At the 2022 American Association for Cancer Research (AACR) annual meeting, Akeso announced the results of preclinical studies
of AK129.
The data showed that AK129 could mediate stronger immune activation than PD-1 antibody and LAG-3 antibody combination therapy.
AK129 not only has good antigen binding, effectively blocks PD-1/LAG-3 signaling pathway, but also promotes IL-2 and IFN-γ production in peripheral blood mononuclear cells (PBMCs).
In addition, AK129 has also shown good anti-tumor activity
in animal experiments.
The so-called bispecific antibody refers to an artificial antibody
that can specifically bind two antigens or epitopes at the same time.
Compared with ordinary monoclonal antibodies, bispecific antibodies have the function of binding to two specific epitopes or target proteins at the same time, so they can play a special function to play biological functions
that are difficult to achieve with monoclonal antibody drugs.
In recent years, the global wave of bispecific antibody drug research and development has
surged.
Data show that since 2022, bispecific antibody drugs have been intensively approved, as of September 12, 4 drugs have been approved for marketing worldwide, and another 2 drugs have submitted marketing applications, which are expected to be approved for marketing
in the near future.
Under the surge of the global market, a number of companies in China have also begun to devote themselves to the research and development
of bispecific antibody drugs.
For example, among the domestic enterprises, Beijing Tianguangshi, Kelun Pharmaceutical, Chia Tai Tianqing, Henlius, Hengrui Pharmaceutical, Innovent Biologics, Regeneron Pharmaceutical, Shimai Pharmaceutical, Yuheng Pharmaceutical and many other enterprises are also deploying new bispecific
antibody drugs.
Among them, Akeso's cardonilil is the first domestic bispecific antibody drug approved for marketing, which was approved
in June this year.
In addition, Akeso's Cadonilimab (AK104) has submitted a marketing application to the NMPA in September 2021 for the treatment of relapsed or refractory cervical cancer, and is expected to be the first to be listed
.
Analysts pointed out that with the maturity of the technology platform, the types of approved drugs will increase day by day, and the scale of the domestic bispecific antibody drug market may expand
rapidly.
According to forecasts, this market is expected to reach $10.
8 billion by 2030, with a compound growth rate of 81.
7%
from 2022 to 2030.
However, compared with monoclonal antibodies, the research and development of bispecific antibodies is still in the early stage of rapid development, the market competition pattern of products is not clear, and the research and development competition of enterprises is not sufficient
.
The industry said that affected by technical barriers, companies that master relevant technology platforms may stand out and become representative enterprises
in the field of bispecific antibodies in the future.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"Share to:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
