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In recent years, with the advancement of policies such as the reform of the drug review and approval system and the drug marketing authorization holder system, China's biopharmaceutical industry has continued to grow and develop, and has inspired a large number of local pharmaceutical companies to increase investment in research and development, improve innovation strength, and gradually change from Generic drugs such as me-too are upgraded to First-in-class innovative drugs
.
According to the FDA definition, a drug that has been granted First-in-class qualification refers to a drug that uses a new and unique mechanism of action to treat a disease
.
Some analysts believe that in the pharmaceutical environment where innovation has become a trend, companies that focus on first-in-class product development and have certain past R&D achievements will eventually become long-term giants in the industry, and will be more favored by the market in the future
.
At present, aiming at the first-in-class field, a large number of local pharmaceutical companies, including Legend Bio, Yinming Bio, Chi-Huang Bio, Junshi Bio, and Hengrui Medicine, are actively deploying
.
Among them, Legend Bio has submitted a rolling biologics license application (BLA) for the CAR-T therapy Chidakiorenza to the U.
S.
FDA in December 2020, and the approval has been extended to February 28, 2022
.
This product has been given high expectations.
If it is successfully launched, it is expected to become the first Chinese CAR-T product to be launched in the United States, bringing more treatment options to local multiple myeloma patients
.
In late November 2021, Yinming Bio announced that its first-in-Class tumor immune target HPK1 small molecule inhibitor PRJ1-3024 has passed the IND procedure of the US FDA and officially launched a phase I clinical trial in the United States
.
Chi-Med’s surufatinib is a novel oral anti-angiogenesis-immunomodulatory kinase inhibitor developed in China.
The product was granted Fast Track designation by the U.
S.
FDA in April 2020
.
It is worth noting that in July 2021, the European EMA also accepted the marketing application of surufatinib
.
For another example, Junshi Biology recently stated that the company has submitted to the US FDA the biological product license application (BLA) for the first-line, second- and third-line treatment of nasopharyngeal carcinoma and has been accepted.
In addition, the company will Continue to carefully evaluate the feasibility of submitting multiple registrational clinical studies of toripalimab in the United States and maintain active communication with the FDA
.
In addition to independent research and development, there are also a number of pharmaceutical companies keen to introduce first-in-class drugs
.
For example, Huadong Medicine has recently introduced two First-in-Class innovative drugs from Kiniksa, which have attracted the attention of the industry.
It is understood that this introduction will help enhance the company's core competitiveness in the field of immunity
.
In addition, a number of pharmaceutical companies have also expressed the prospect of attacking the first-in-class field
.
For example, Euho Pharmaceuticals, which has recently been approved by the State Food and Drug Administration for its three-drug combination anti-CD40, anti-CTLA-4 and anti-PD-1 monoclonal antibody Phase I clinical trials, said that with the follow-up Biosceto 1,000 murine and ten thousand anti-antibody plans continue to enrich Euho Pharma.
And the clinical pipeline of medicine will gradually involve the first-in-class field
.
It is worth mentioning that the road to FDA approval for First-In-Class new drugs is not easy
.
At the end of 2021, Wanchun Pharma received a Complete Response Letter (CRL) from the FDA for its marketing application for the treatment of chemotherapy-induced neutropenia (CIN)
.
The FDA believes that the existing single phase III registration clinical trial (106 phase III study) of plinabulin cannot fully prove the therapeutic benefit, so it fails to approve the marketing application and requires the company to conduct a second registration clinical trial to obtain sufficient evidence to support Approval for the CIN indication
.
According to incomplete statistics, from 1999 to 2018, the FDA approved a total of 620 new drugs, of which only 194 were granted First-in-class qualifications, accounting for about 30%
.
It can be seen that the layout of First-In-Class new drugs by local pharmaceutical companies still needs to pass through many barriers and withstand huge challenges
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to the FDA definition, a drug that has been granted First-in-class qualification refers to a drug that uses a new and unique mechanism of action to treat a disease
.
Some analysts believe that in the pharmaceutical environment where innovation has become a trend, companies that focus on first-in-class product development and have certain past R&D achievements will eventually become long-term giants in the industry, and will be more favored by the market in the future
.
At present, aiming at the first-in-class field, a large number of local pharmaceutical companies, including Legend Bio, Yinming Bio, Chi-Huang Bio, Junshi Bio, and Hengrui Medicine, are actively deploying
.
Among them, Legend Bio has submitted a rolling biologics license application (BLA) for the CAR-T therapy Chidakiorenza to the U.
S.
FDA in December 2020, and the approval has been extended to February 28, 2022
.
This product has been given high expectations.
If it is successfully launched, it is expected to become the first Chinese CAR-T product to be launched in the United States, bringing more treatment options to local multiple myeloma patients
.
In late November 2021, Yinming Bio announced that its first-in-Class tumor immune target HPK1 small molecule inhibitor PRJ1-3024 has passed the IND procedure of the US FDA and officially launched a phase I clinical trial in the United States
.
Chi-Med’s surufatinib is a novel oral anti-angiogenesis-immunomodulatory kinase inhibitor developed in China.
The product was granted Fast Track designation by the U.
S.
FDA in April 2020
.
It is worth noting that in July 2021, the European EMA also accepted the marketing application of surufatinib
.
For another example, Junshi Biology recently stated that the company has submitted to the US FDA the biological product license application (BLA) for the first-line, second- and third-line treatment of nasopharyngeal carcinoma and has been accepted.
In addition, the company will Continue to carefully evaluate the feasibility of submitting multiple registrational clinical studies of toripalimab in the United States and maintain active communication with the FDA
.
In addition to independent research and development, there are also a number of pharmaceutical companies keen to introduce first-in-class drugs
.
For example, Huadong Medicine has recently introduced two First-in-Class innovative drugs from Kiniksa, which have attracted the attention of the industry.
It is understood that this introduction will help enhance the company's core competitiveness in the field of immunity
.
In addition, a number of pharmaceutical companies have also expressed the prospect of attacking the first-in-class field
.
For example, Euho Pharmaceuticals, which has recently been approved by the State Food and Drug Administration for its three-drug combination anti-CD40, anti-CTLA-4 and anti-PD-1 monoclonal antibody Phase I clinical trials, said that with the follow-up Biosceto 1,000 murine and ten thousand anti-antibody plans continue to enrich Euho Pharma.
And the clinical pipeline of medicine will gradually involve the first-in-class field
.
It is worth mentioning that the road to FDA approval for First-In-Class new drugs is not easy
.
At the end of 2021, Wanchun Pharma received a Complete Response Letter (CRL) from the FDA for its marketing application for the treatment of chemotherapy-induced neutropenia (CIN)
.
The FDA believes that the existing single phase III registration clinical trial (106 phase III study) of plinabulin cannot fully prove the therapeutic benefit, so it fails to approve the marketing application and requires the company to conduct a second registration clinical trial to obtain sufficient evidence to support Approval for the CIN indication
.
According to incomplete statistics, from 1999 to 2018, the FDA approved a total of 620 new drugs, of which only 194 were granted First-in-class qualifications, accounting for about 30%
.
It can be seen that the layout of First-In-Class new drugs by local pharmaceutical companies still needs to pass through many barriers and withstand huge challenges
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
