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【PharmaNet Market Analysis】According to drug target, mechanism of action (MoA) and new development stage compared with similar drugs globally, drugs can be divided into three categories, including first-in-class, fast-follower and me-too drugs
.
In the past, China's pharmaceutical market was dominated by me-too drugs.
In recent years, a series of favorable domestic policies have supported the development of pharmaceutical innovation, which has accelerated the pace of industrial transformation and upgrading.
R&D investment has continued to increase, and at the same time, a large number of companies have actively introduced clinical-stage products through authorized cooperation, resulting in the continuous emergence of first-in-class and fast-follower drugs in the domestic market
.
The prosperity of the innovative drug industry is gradually heating up, and pharmaceutical companies are accelerating their efforts to enter the field of FIC research and development (Source: Pharmaceutical Network) In the long run, the era of Me too drugs will eventually pass, and "pseudo-innovation" does not actually help companies go further.
In the long run, the sustainable development of pharmaceutical companies also needs to have hard power and core competitiveness
.
In particular, the "Guidelines for Clinical Value-Oriented Clinical Research and Development of Anti-Tumor Drugs" issued by CDE in November 2021 clarified the development direction of innovative drugs oriented by clinical value, and further promoted pharmaceutical companies to accelerate their efforts to the field of FIC research and development
.
Compared with taking shortcuts to authorize the introduction, the technical threshold for independent research and development of FIC is high.
At present, most of the multinational pharmaceutical companies such as Pfizer, Novartis, Bristol-Myers Squibb, Merck, and Roche are in the field of FIC
.
Of course, the harvest and progress of local pharmaceutical companies in the field of FIC research and development have also attracted much attention in the industry
.
For example, the first-in-Class new drugs Chidamide and Siglitastat independently developed by Chipchip Bio have both been approved for marketing, and there are a number of potential new drugs waiting to be launched
.
Among them, Chidamide was approved for marketing in 2015 for the treatment of peripheral T-cell lymphoma, and in 2019, an indication for breast cancer was added
.
This product is the world's first subtype-selective histone deacetylase (HDAC) oral inhibitor.
It is a drug with novel mechanism.
It can be applied to a single tumor symptom or combined with epigenetic regulators for comprehensive tumor therapy.
, the path to achieve long-term benefits; sitaglita sodium is the first drug variety for the treatment of metabolic diseases, belonging to a configuration-restricted peroxidase proliferator whose chemical structure is completely different from thiazolidinediones (TZDs).
Activated receptor full agonist
.
The product was approved for marketing in October 2021 for the treatment of type 2 diabetes, bringing more treatment options to the majority of diabetic patients
.
In recent years, Henlius has accelerated its progress towards the goal of being an innovative leading enterprise by increasing investment in research and development
.
It is reported that for innovation, 80% of the company's energy is used for differentiation, and 20% is used for first-in-class that few people do
.
In 2021, the company's two potential first-in-class dual antibodies HLX301 (innovative PD-L1 × TIGIT dual antibody) and HLX35 (innovative 4-1BB × EGFR dual antibody) completed the first phase I clinical study in Australia Subject dosing
.
On April 12, Zhongsheng Pharmaceutical stated on the interactive platform that ZSP1601 tablets, an innovative drug for the treatment of non-alcoholic steatohepatitis, have a new mechanism of action and global independent intellectual property rights.
An innovative drug that has entered clinical trials for the treatment of NASH.
Currently, Phase Ib/IIa clinical trials have been completed.
The trials have achieved positive results and achieved the primary endpoint.
The company supports ZSP1601 tablets to continue conducting Phase IIb clinical trials.
The company will review the project according to relevant regulations.
Follow-up progress to fulfill the obligation of information disclosure
.
Another example is Innovent Bio.
On February 11, CDE information showed that the clinical application of Innovent Bio's dual-antibody drug IBI322 targeting CD47/PD-L1 was accepted
.
This product is a potential "First-in-Class" new drug in the true sense
.
The results of the study show that IBI322 has shown preliminary efficacy signals and good safety and tolerability in patients with advanced malignant tumors who have failed standard therapy.
safety and efficacy
.
According to a research report, as of July 1, 2021, there were 2,251 drugs (including drugs and biologics) under research in all therapeutic areas in China, including 418 first-in-class, 473 fast-follower and 923 me-too drugs
.
Among the subdivided therapeutic areas, the oncology therapeutic area is particularly active, accounting for half of the total drugs
.
The industry pointed out that compared with the research and development of fast-follow and me-too drugs, domestic pharmaceutical companies still have certain difficulties in doing First-in-Class, including the company's research and development capabilities, innovation platforms, and human resources
.
At present, some capitals also hope that artificial intelligence will quickly break through the research and development of First-in-Class, but there is a view that it is difficult for AI to make First-in-Class now, and it is basically me-too
.
In general, the domestic FIC research and development road is long, and it will take time to cultivate
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
In the past, China's pharmaceutical market was dominated by me-too drugs.
In recent years, a series of favorable domestic policies have supported the development of pharmaceutical innovation, which has accelerated the pace of industrial transformation and upgrading.
R&D investment has continued to increase, and at the same time, a large number of companies have actively introduced clinical-stage products through authorized cooperation, resulting in the continuous emergence of first-in-class and fast-follower drugs in the domestic market
.
The prosperity of the innovative drug industry is gradually heating up, and pharmaceutical companies are accelerating their efforts to enter the field of FIC research and development (Source: Pharmaceutical Network) In the long run, the era of Me too drugs will eventually pass, and "pseudo-innovation" does not actually help companies go further.
In the long run, the sustainable development of pharmaceutical companies also needs to have hard power and core competitiveness
.
In particular, the "Guidelines for Clinical Value-Oriented Clinical Research and Development of Anti-Tumor Drugs" issued by CDE in November 2021 clarified the development direction of innovative drugs oriented by clinical value, and further promoted pharmaceutical companies to accelerate their efforts to the field of FIC research and development
.
Compared with taking shortcuts to authorize the introduction, the technical threshold for independent research and development of FIC is high.
At present, most of the multinational pharmaceutical companies such as Pfizer, Novartis, Bristol-Myers Squibb, Merck, and Roche are in the field of FIC
.
Of course, the harvest and progress of local pharmaceutical companies in the field of FIC research and development have also attracted much attention in the industry
.
For example, the first-in-Class new drugs Chidamide and Siglitastat independently developed by Chipchip Bio have both been approved for marketing, and there are a number of potential new drugs waiting to be launched
.
Among them, Chidamide was approved for marketing in 2015 for the treatment of peripheral T-cell lymphoma, and in 2019, an indication for breast cancer was added
.
This product is the world's first subtype-selective histone deacetylase (HDAC) oral inhibitor.
It is a drug with novel mechanism.
It can be applied to a single tumor symptom or combined with epigenetic regulators for comprehensive tumor therapy.
, the path to achieve long-term benefits; sitaglita sodium is the first drug variety for the treatment of metabolic diseases, belonging to a configuration-restricted peroxidase proliferator whose chemical structure is completely different from thiazolidinediones (TZDs).
Activated receptor full agonist
.
The product was approved for marketing in October 2021 for the treatment of type 2 diabetes, bringing more treatment options to the majority of diabetic patients
.
In recent years, Henlius has accelerated its progress towards the goal of being an innovative leading enterprise by increasing investment in research and development
.
It is reported that for innovation, 80% of the company's energy is used for differentiation, and 20% is used for first-in-class that few people do
.
In 2021, the company's two potential first-in-class dual antibodies HLX301 (innovative PD-L1 × TIGIT dual antibody) and HLX35 (innovative 4-1BB × EGFR dual antibody) completed the first phase I clinical study in Australia Subject dosing
.
On April 12, Zhongsheng Pharmaceutical stated on the interactive platform that ZSP1601 tablets, an innovative drug for the treatment of non-alcoholic steatohepatitis, have a new mechanism of action and global independent intellectual property rights.
An innovative drug that has entered clinical trials for the treatment of NASH.
Currently, Phase Ib/IIa clinical trials have been completed.
The trials have achieved positive results and achieved the primary endpoint.
The company supports ZSP1601 tablets to continue conducting Phase IIb clinical trials.
The company will review the project according to relevant regulations.
Follow-up progress to fulfill the obligation of information disclosure
.
Another example is Innovent Bio.
On February 11, CDE information showed that the clinical application of Innovent Bio's dual-antibody drug IBI322 targeting CD47/PD-L1 was accepted
.
This product is a potential "First-in-Class" new drug in the true sense
.
The results of the study show that IBI322 has shown preliminary efficacy signals and good safety and tolerability in patients with advanced malignant tumors who have failed standard therapy.
safety and efficacy
.
According to a research report, as of July 1, 2021, there were 2,251 drugs (including drugs and biologics) under research in all therapeutic areas in China, including 418 first-in-class, 473 fast-follower and 923 me-too drugs
.
Among the subdivided therapeutic areas, the oncology therapeutic area is particularly active, accounting for half of the total drugs
.
The industry pointed out that compared with the research and development of fast-follow and me-too drugs, domestic pharmaceutical companies still have certain difficulties in doing First-in-Class, including the company's research and development capabilities, innovation platforms, and human resources
.
At present, some capitals also hope that artificial intelligence will quickly break through the research and development of First-in-Class, but there is a view that it is difficult for AI to make First-in-Class now, and it is basically me-too
.
In general, the domestic FIC research and development road is long, and it will take time to cultivate
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
