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The so-called First-in-Class refers to the development of original drugs that are completely unavailable on the market through new structures, new targets, and new mechanisms.
It is fundamentally different from Me, which improves existing drug targets and molecular structures.
Too drugs
.
In recent years, the development of China's innovative medicine industry has been in full swing, and pharmaceutical companies and capital have continuously poured into this high-risk, long-period, and high-investment industry
.
The domestic innovative drug industry is showing a situation of "targets are clustered together and R&D pipelines are severely homogenized"
.
According to data from the Center for Drug Evaluation, from 2018 to 2021, the State Food and Drug Administration approved 64 new drugs, of which anti-tumor drugs and anti-infective/viral drugs accounted for 58%
.
Compared with the US FDA, it has approved 53 new drugs, of which 58% are used to treat rare diseases, and anti-tumor drugs account for only 40%
.
In addition, compared with the 160 innovative drugs approved by the U.
S.
FDA in 2018-2020, there is also a clear gap in the number of first-in-class drugs in China
.
In this context, in July this year, the Center for Drug Appraisal publicly solicited opinions on the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines" (hereinafter referred to as the "Principles")
.
The document pointed out that from determining the direction of research and development to launching clinical trials, the research and development of anti-tumor drugs should implement the concept of taking clinical needs as the core, and carry out clinical value-oriented research and development of anti-tumor drugs
.
The industry believes that this will help reconstruct the competitive landscape of the innovative drug industry.
Innovative drug companies of Best-in-class (BIC) and First-in-class (FIC) drugs are more favored by the capital market
.
The author has learned that since 2021, many companies focusing on FIC drugs have gained capital into the game
.
For example, on October 18th, Hodo Bio, which insists on the research and development of First-in-class innovative drugs, announced the completion of the Pre-A round of financing
.
It is reported that this round of financing is led by CDH Investment, with Daoyuan Capital, Longmen Capital and Zhongying Xinda as co-investors, which will be used to accelerate the research and development of Hedu Bio-innovative drugs and promote the development of microbial and bacterial vector gene therapy into preclinical drug development stage
.
On September 26th, Inno Pharmaceuticals, which is also committed to the development of First-in-Class drugs, announced that it has completed tens of millions of US dollars in Series B financing.
This round of financing is led by the Shanghai Biomedical Fund.
Saizhikang and Shangshi Tianxin followed in the investment, and the old shareholder Zhang Ke led the additional investment
.
Also in September, Yinming Bio, which is committed to the research and development of first-in-class drugs with global competitiveness, announced the completion of nearly US$50 million in A+ round of financing
.
Yinming Bio's original investors Gaorong Capital, Jingcheng Capital, and Huacheng Venture Capital continued to invest in additional investment, and new investors Franciscan Capital, Yixian E-commerce, Haisong Capital, Yifeng Capital, Taixin Capital, etc.
joined this round of financing to help Yinming Bio Accelerate development
.
On March 17, Yinming Bio, which is committed to the research and development of first-in-class drugs with global competitiveness, announced the completion of US$60 million in Series A financing
.
This round of financing was led by Gaorong Capital, followed by Lightspeed China, Huacheng Venture Capital, Jingcheng Capital, Huajin Capital, Hengqin Investment and other institutions
.
The industry believes that the very difficult bones of FIC drugs in the pharmaceutical industry have obvious characteristics of "high investment, high risk, and long cycle".
The entry of capital will help the research and development of FIC drugs
.
From the perspective of the general background, the competition in the innovative drug market has become increasingly fierce.
Under the background of the development of BIC or FIC drugs in the future, the era of "pseudo-innovative" Me too drugs will eventually pass, and pharmaceutical companies It is necessary to speak up with real innovative strength in order to gain a firm foothold in the market
.
It is fundamentally different from Me, which improves existing drug targets and molecular structures.
Too drugs
.
In recent years, the development of China's innovative medicine industry has been in full swing, and pharmaceutical companies and capital have continuously poured into this high-risk, long-period, and high-investment industry
.
The domestic innovative drug industry is showing a situation of "targets are clustered together and R&D pipelines are severely homogenized"
.
According to data from the Center for Drug Evaluation, from 2018 to 2021, the State Food and Drug Administration approved 64 new drugs, of which anti-tumor drugs and anti-infective/viral drugs accounted for 58%
.
Compared with the US FDA, it has approved 53 new drugs, of which 58% are used to treat rare diseases, and anti-tumor drugs account for only 40%
.
In addition, compared with the 160 innovative drugs approved by the U.
S.
FDA in 2018-2020, there is also a clear gap in the number of first-in-class drugs in China
.
In this context, in July this year, the Center for Drug Appraisal publicly solicited opinions on the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines" (hereinafter referred to as the "Principles")
.
The document pointed out that from determining the direction of research and development to launching clinical trials, the research and development of anti-tumor drugs should implement the concept of taking clinical needs as the core, and carry out clinical value-oriented research and development of anti-tumor drugs
.
The industry believes that this will help reconstruct the competitive landscape of the innovative drug industry.
Innovative drug companies of Best-in-class (BIC) and First-in-class (FIC) drugs are more favored by the capital market
.
The author has learned that since 2021, many companies focusing on FIC drugs have gained capital into the game
.
For example, on October 18th, Hodo Bio, which insists on the research and development of First-in-class innovative drugs, announced the completion of the Pre-A round of financing
.
It is reported that this round of financing is led by CDH Investment, with Daoyuan Capital, Longmen Capital and Zhongying Xinda as co-investors, which will be used to accelerate the research and development of Hedu Bio-innovative drugs and promote the development of microbial and bacterial vector gene therapy into preclinical drug development stage
.
On September 26th, Inno Pharmaceuticals, which is also committed to the development of First-in-Class drugs, announced that it has completed tens of millions of US dollars in Series B financing.
This round of financing is led by the Shanghai Biomedical Fund.
Saizhikang and Shangshi Tianxin followed in the investment, and the old shareholder Zhang Ke led the additional investment
.
Also in September, Yinming Bio, which is committed to the research and development of first-in-class drugs with global competitiveness, announced the completion of nearly US$50 million in A+ round of financing
.
Yinming Bio's original investors Gaorong Capital, Jingcheng Capital, and Huacheng Venture Capital continued to invest in additional investment, and new investors Franciscan Capital, Yixian E-commerce, Haisong Capital, Yifeng Capital, Taixin Capital, etc.
joined this round of financing to help Yinming Bio Accelerate development
.
On March 17, Yinming Bio, which is committed to the research and development of first-in-class drugs with global competitiveness, announced the completion of US$60 million in Series A financing
.
This round of financing was led by Gaorong Capital, followed by Lightspeed China, Huacheng Venture Capital, Jingcheng Capital, Huajin Capital, Hengqin Investment and other institutions
.
The industry believes that the very difficult bones of FIC drugs in the pharmaceutical industry have obvious characteristics of "high investment, high risk, and long cycle".
The entry of capital will help the research and development of FIC drugs
.
From the perspective of the general background, the competition in the innovative drug market has become increasingly fierce.
Under the background of the development of BIC or FIC drugs in the future, the era of "pseudo-innovative" Me too drugs will eventually pass, and pharmaceutical companies It is necessary to speak up with real innovative strength in order to gain a firm foothold in the market
.