This drug may become the next outlet, and a large number of domestic pharmaceutical companies rush to the beach

【Pharmaceutical Network Market Analysis】 News on October 21, the pharmaceutical and biological sector of Hong Kong stocks rose, of which Akeso Biotech rose by more than 8%.

In the past 6 trading days, the stock price has risen by nearly 40%.

On the news, on October 20, the Drug Review Center (CDE) of the State Food and Drug Administration announced that the first-in-class bispecific antibody new drug Ilosi (PD-1/VEGF bispecific antibody, AK112), which is completely independently developed by Akeso, intends to be included in the list of breakthrough therapeutic varieties for the treatment of transepidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) in combination with chemotherapy for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer ( nsq-NSCLC)
。 In addition, not long ago, the company announced that the Phase Ib/II clinical trial of the efficacy and safety of zoslimab (CD73, AK119) of Evoci United Company in patients with advanced solid tumors
has been approved.
The recent active stock price performance of Akeso Biotech has attracted attention
from the industry.
Bispecific antibodies, which are also known as bispecific antibodies, refer to artificial antibodies that can specifically bind two antigens or epitopes at the same time, and according to their properties of being able to bind two different targets at the same time, they can simultaneously block the biological functions mediated by two antigens/epitopes, or bring the cells expressing the two antigens closer together, thereby enhancing the interaction
between the two.
The industry believes that bispecific antibody drugs are the next outlet
after PD-1 and PD-L1.
According to the securities research report, the development of bispecific antibody drugs in China started relatively late, and the domestic bispecific antibody market size will be about 50 million US dollars
in 2021.
With the maturity of the bispecific antibody technology platform and the increasing variety of approved drugs, it is expected that China's bispecific antibody market is expected to reach 10.
8 billion US dollars by 2030, with a compound growth rate of 81.
7%
from 2022 to 2030.
At present, in addition to Akeso, there are also a large number of domestic pharmaceutical companies rushing to the beach
.
According to the research report of the securities company, more than 30 domestic companies are involved in the research and development of bispecific antibody drugs, including Hengrui Pharmaceutical, Corning Jereh, BeiGene, Innovent Biologics, Zai Lab, CSPC Group, Henlius, Zejing Pharmaceutical, Junshi Biologics, Betta Pharmaceutical, Kelun Pharmaceutical, Bio-Thera and so on
.
According to other statistics, more than 300 bispecific antibody drugs have been deployed in China, of which nearly 100 drugs have entered the clinical stage, and 6 drugs are in the phase III clinical trial stage
.
Since the beginning of this year, the progress of bispecific antibody drug research and development has been continuously
reported.
In June, Akeso's cadunilimab was approved for marketing in China; Simcere Pharmaceutical recently announced that it has recently submitted new drug clinical trial applications to the State Medical Products Administration for two self-developed anti-tumor biantibody innovation pipeline projects (SIM0348 and SIM0237), both of which have been accepted, and are expected to obtain clinical approval from December 2022 to January 2023
.
In addition, with the continuous maturity of the bispecific antibody technology platform of domestic pharmaceutical companies, the trading of bispecific antibody drugs has continued to heat up
in recent years.
For example, in 2021, 7 cooperation or transactions have occurred in the field of domestic bispecific antibodies, and the number has reached a record high
.
In February 2021, Huadong Pharmaceutical, its wholly-owned subsidiary, introduced the bispecific antibody PRV-3279 from Provention Bio in the United States, obtaining exclusive clinical development and commercialization rights
in Greater China for two clinical indications of PRV-3279 (clinical phase I for the treatment of systemic lupus erythematosus in the United States, and immunogenicity for the prevention or reduction of gene therapy in preclinical research in the United States).
。 According to the company's 2022 half-year report, Provention Bio is conducting phase II.
a clinical trials
of the product for the indication of lupus erythematosus in the United States and Hong Kong, China.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.