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In recent years, with the multiple resonances of policies, capital, and talents, China's local innovative drugs have flourished, and the enthusiasm of enterprises in research and development has been high
.
For example, Kelun Pharmaceuticals recently announced that a class 1 new drug KL340399 injection has been approved for clinical use.
This drug is a new generation of small molecule STING agonists, and no drug with the same target has been approved for marketing
.
It is reported that KL340399 injection is a new generation of small molecule STING agonist of acyclic dinucleotide (CDN) type developed by Kelun Pharmaceutical with independent intellectual property rights
.
Its molecular structure is stable, can be administered systemically, and has outstanding performance in in vitro and in vivo pharmacodynamic activity
.
In addition, in the safety evaluation, the animal tolerability was generally favorable
.
On January 10, the State Food and Drug Administration announced that the State Food and Drug Administration recently approved the 1.
2 category innovative drug icariin soft capsule with conditions through the priority review and approval process
.
The drug will be used for the treatment of liver cancer and is the first innovative traditional Chinese medicine drug approved for marketing in China since 2022
.
It is an original Chinese medicine new drug independently developed by Beijing Shennuoji Pharmaceutical Technology Co.
, Ltd.
, which is a small molecule immunomodulator
.
On January 6, Zai Lab also announced that the China National Medical Products Administration has accepted the new drug marketing application for magetuximab
.
The data show that magetuximab is a novel monoclonal antibody targeting Fc-engineered HER2
.
The New Drug Application for Magetuximab involves combination chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more anti-HER2 regimens, at least one of which is for metastatic disease
.
In addition to the above drugs, in 2021, data show that the National Medical Products Administration (NMPA) of China has approved 76 new drugs (excluding new indications and vaccines) for the market, including cyclopofol injection, ainovirine tablets, Blockbuster drugs such as sivotinib tablets and levoornidazole disodium phosphate for injection, involving urgently needed clinical treatment drugs in the fields of tumors, vaccines, rare diseases, etc.
Hengrui Medicine, Baiji, Hansoh and other pharmaceutical companies layout
.
On the whole, the development of local new drugs is different from what it used to be
.
It is expected in the industry that the continuous approval and marketing of domestic innovative drugs will not only achieve breakthroughs in the field of major diseases and benefit patients, but also further reduce the dependence on foreign new drugs
.
However, it should be noted that the industry has also proposed that behind the hot research and development of new drugs, there will also be more challenges, such as homogenization and commercialization
.
Taking PD-1/PD-L1 as an example, the blue ocean of PD-1/PD-L1 in China used to be as high as 10 billion yuan, so it has also attracted the layout of many multinational pharmaceutical companies such as Eli Lilly and AstraZeneca, and even has clinical advantages.
Domestic monoclonal antibodies and foreign companies work together to develop and promote
.
However, with the increasing number of entrants, the competition in this field has also become fiercer
.
According to data, as of January 6, 2022, the total number of global clinical trials of PD-1 target drugs has reached 3,471, of which China (CDE registration) is 675, accounting for about 19.
5% of the world
.
In general, behind the rapid increase in the number of new drug approvals and the continuous emergence of innovative results, pharmaceutical companies need to clearly understand that the research and development of innovative drugs is not a smooth road, but that risks and benefits coexist
.
.
For example, Kelun Pharmaceuticals recently announced that a class 1 new drug KL340399 injection has been approved for clinical use.
This drug is a new generation of small molecule STING agonists, and no drug with the same target has been approved for marketing
.
It is reported that KL340399 injection is a new generation of small molecule STING agonist of acyclic dinucleotide (CDN) type developed by Kelun Pharmaceutical with independent intellectual property rights
.
Its molecular structure is stable, can be administered systemically, and has outstanding performance in in vitro and in vivo pharmacodynamic activity
.
In addition, in the safety evaluation, the animal tolerability was generally favorable
.
On January 10, the State Food and Drug Administration announced that the State Food and Drug Administration recently approved the 1.
2 category innovative drug icariin soft capsule with conditions through the priority review and approval process
.
The drug will be used for the treatment of liver cancer and is the first innovative traditional Chinese medicine drug approved for marketing in China since 2022
.
It is an original Chinese medicine new drug independently developed by Beijing Shennuoji Pharmaceutical Technology Co.
, Ltd.
, which is a small molecule immunomodulator
.
On January 6, Zai Lab also announced that the China National Medical Products Administration has accepted the new drug marketing application for magetuximab
.
The data show that magetuximab is a novel monoclonal antibody targeting Fc-engineered HER2
.
The New Drug Application for Magetuximab involves combination chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more anti-HER2 regimens, at least one of which is for metastatic disease
.
In addition to the above drugs, in 2021, data show that the National Medical Products Administration (NMPA) of China has approved 76 new drugs (excluding new indications and vaccines) for the market, including cyclopofol injection, ainovirine tablets, Blockbuster drugs such as sivotinib tablets and levoornidazole disodium phosphate for injection, involving urgently needed clinical treatment drugs in the fields of tumors, vaccines, rare diseases, etc.
Hengrui Medicine, Baiji, Hansoh and other pharmaceutical companies layout
.
On the whole, the development of local new drugs is different from what it used to be
.
It is expected in the industry that the continuous approval and marketing of domestic innovative drugs will not only achieve breakthroughs in the field of major diseases and benefit patients, but also further reduce the dependence on foreign new drugs
.
However, it should be noted that the industry has also proposed that behind the hot research and development of new drugs, there will also be more challenges, such as homogenization and commercialization
.
Taking PD-1/PD-L1 as an example, the blue ocean of PD-1/PD-L1 in China used to be as high as 10 billion yuan, so it has also attracted the layout of many multinational pharmaceutical companies such as Eli Lilly and AstraZeneca, and even has clinical advantages.
Domestic monoclonal antibodies and foreign companies work together to develop and promote
.
However, with the increasing number of entrants, the competition in this field has also become fiercer
.
According to data, as of January 6, 2022, the total number of global clinical trials of PD-1 target drugs has reached 3,471, of which China (CDE registration) is 675, accounting for about 19.
5% of the world
.
In general, behind the rapid increase in the number of new drug approvals and the continuous emergence of innovative results, pharmaceutical companies need to clearly understand that the research and development of innovative drugs is not a smooth road, but that risks and benefits coexist
.
