In 2022, what are the new technological directions of the innovative drug track worth paying attention to?

With the continuous advancement of China's medical reform and the acceleration of new drug review, China's innovative drug industry has ushered in vigorous development
.
According to the Dingxiangyuan Insight database, as of the beginning of this year, as of December 8, there were 782 new drug varieties approved for clinical trials in China, involving more than 500 companies, of which anti-tumor drugs accounted for more than half
.
Looking forward to 2022, with the support of a series of policies and the continuous going global of domestic innovative drugs, and the rise of CXO companies, domestic innovative drugs still face great opportunities
.
But at the same time, the industry also pointed out that challenges such as the weak research and development foundation of domestic innovative drugs, serious homogenization of research and development, and the greatly shortened life cycle of innovative drugs under medical insurance negotiations are also very prominent
.
In 2022, what are the new technological directions of the innovative drug track worth paying attention to? (Image source: Pharmaceutical Network) So, what new technological directions in the innovative drug track in the future are worth paying attention to? Some securities analysts gave suggestions in several directions such as antibody-conjugated drugs (ADC), double-antibody drugs, cell therapy, and nucleic acid drugs
.
Antibody-conjugated drugs (ADC) In recent years, the market of ADC drugs has been accelerating.
In 2021, there will be 3 first ADC drugs on the market, including a domestic ADC drug Viedix
.
In June 2021, the ADC drug Viedixil independently developed by Rongchang Biologics was approved for marketing by NMPA with conditions.
Adenocarcinoma) patients
.
Then in August, Rongchang Biotech announced that it had reached a cooperation with Seattle Gene to develop and commercialize its new ADC drug vedicitumumab
.
The total transaction amount reached 2.
6 billion U.
S.
dollars without calculating the sales share .
The industry pointed out that the current ADC research and development has entered an explosive period, and the industry's technology platforms are constantly iterating.
For example, some pharmaceutical companies are improving the anti-tumor activity and stability of drugs by improving a series of small molecule toxins, coupling technologies, and linkers.
Improve and continue to extend the connotation of coupled drugs, such as small molecule-drug coupling, peptide-drug coupling, ISAC, etc.

.
Dual antibody drugs The domestic monoclonal antibody PD-1 track has been very crowded, but the field of bispecific antibodies, known as the "next generation of antibody drugs", is still in an emerging field, and the competition pattern is good
.
It is understood that compared to single use/combination of monoclonal antibodies, double antibodies have potential clinical advantages, such as more mature technology and convenient use, and do not require individual preparation like CAR-T
.
In September 2021, NMPA accepted the marketing application of the bispecific antibody "Kadenizumab" independently developed by Kangfang Bio.
The product also received priority review for the treatment of recurrent or metastatic cervical cancer
.
It is reported that this is the first PD-1 based bispecific antibody drug to be submitted for marketing in the world
.
At present, a total of 4 bispecific antibodies have been approved for marketing worldwide, of which 2 have been approved for marketing in China.
If Kadenizumab is successfully listed, it may become China’s first self-developed dual antibody drug approved for marketing.

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According to the company's estimates, the product is expected to be available in the middle of 2022
.
Cell therapy With continuous breakthroughs in technology, cell therapy is developing rapidly, and major achievements have been made in the fields of genetic diseases and malignant tumors
.
According to Frost & Sullivan’s estimates, the market for cell therapy in China will grow from 1.
3 billion yuan in 2021 to 58.
4 billion yuan in 2030, with an average annual growth rate of 53%
.
CAR-T cell therapy is one of the important methods of cell therapy and immune cell therapy.
It mainly transfers CAR-T cells cultured in vitro to the human body, and activates T cells to attack and kill tumor cells in the patient to achieve immunity.
The purpose of treatment
.
At present, more than 20 domestic pharmaceutical companies, including WuXi Biotech, Fosun Kate, Legend Bio, Keji Bio, Reindeer Medical, and Cinda Bio, have deployed in this field.
CGT technologies include carrier delivery technology and gene editing.
Technology, CAR-T cell technology, etc.
make iterative innovations
.
Nucleic acid drugs Nucleic acid drugs have the advantages of strong target specificity, simple design, and rich candidate targets.
The industry expects them to become the drug that will erupt the third industrial revolution of biomedicine after small molecule drugs and antibody drugs.

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In recent years, nucleic acid drugs including small nucleic acid drugs and mRNA drugs have been approved to be marketed at an increasing speed and have received widespread attention from the market
.
Small nucleic acid drugs, or RNAi technology drugs, are currently the focus of research in the industry.
In recent years, with the advancement of delivery technology, this field has grown rapidly.
The main categories currently include ASO, siRNA, mRNA and Aptamer
.
Among them, the antisense oligonucleotide (ASO) drug Nusinersen developed by Biogen for the treatment of spinal muscular atrophy has achieved great commercial success after it went on the market, with sales revenue exceeding 2 billion U.
S.
dollars in 2020
.
In China, the RNAi technology drug track has gradually become popular in recent years
.
On December 6, it was reported that Sinopharm, a small nucleic acid interference drug development company, successfully passed the Hong Kong stock hearing and will be listed in Hong Kong
.
It is understood that the key technology for the development of small nucleic acid interference therapy mainly lies in delivery technology and RNAi molecular design.
At present, RNAi molecules are usually divided into small interfering RNA (siRNA), microRNA and short hairpin RNA
.
Among them, siRNA has the advantages of high targeting and silencing, but the threshold for the development of delivery technology is very high, and Shengnuo Pharmaceutical has a delivery system PNP technology platform with independent intellectual property rights
.
At present, RNAi therapy is mainly used in the treatment of common diseases and malignant tumors, and the market prospect is promising
.
The global RNAi drug market is worth 362 million U.
S.
dollars in 2020.
The industry predicts that it will increase to 20.
9 billion U.
S.
dollars by 2030.
RNAi therapy will become an important therapy in the treatment of global diseases
.