Inventory: 2022 Biopharmaceutical R & D Pipeline
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drugs on the market has declined, and the pace of innovative drugs remains the same.
By 2022, there are nearly 2100 biopharmaceutical research and development pipelines in China's clinical stage, with a year-on-year growth rate of 22%, accounting for about 20% of the global pipeline, second only to the United States in the world. From the research and development stage, in the first phase of the most, accounting for 37%. The NMPA approved a total of 18 biopharmaceuticals for the year, down from last year, mainly due to a decline in the number of vaccines and antibodies approved.
photo source: Hualing Medicine
from the perspective of all approved innovative drugs (including biological drugs and small molecules), 18 products were approved in 22 years, which is also a significant drop from 43 products in 21 years. However, the pace of innovation has not slowed down. Among the 18 innovative drugs, 6 products are bio-innovative drugs, and there are also some First in class and Best in class products, such as Kangfang Bio's world's first PD-1/CTLA-4 dual anti-resistance and Hualing Pharmaceuticals's world's first glucokinase activator doxagliatine.
Figure 1: Biopharmaceutical R & D pipeline at different stages by 2022
data source: Pharmaceutical Rubik's Cube
Chart 2: The number of antibodies and vaccines listed in 2022 is down year-on-year.
data source: Pharmaceutical Rubik's Cube
Antibody drug targets remain concentrated and rely on maturation pathways
among all the research and development molecules in China, HER2,TNF-α,PD-(L)1,VEGF and other major targets are still the most concentrated. Some emerging targets such as CD3,BCMA,IL6,IL23 and so on have also begun to apply for registration, but the number is still relatively small. Most enterprises still have path dependence due to risk considerations and take the road of research and development of mature targets.
Figure 3: Distribution of the number of pipelines of Top10 antibody drug targets in China.
data source: Pharmaceutical Rubik's Cube
looking at the global data, the total number of drug targets under research in 22 years is 1952, nearly 100 more than 1858 in 21 years, a record high. And 2021 is a year of vigorous development of new drug targets, reaching 131.
2022, the top drug target is CD3, replacing HER2, which has won the first place in a row, and the number of drugs has increased from 149 in 2021 to 199. The pipeline of hot target PD-1 is also expanding, ranking second, and CD19 has become the mainstream due to its widespread use in CAR-T cell therapy.
Figure 4: Distribution of global hot target pipelines in 2022
data source: Pharmaprojects
2022, a total of 8 were approved in China, of which 4 were innovative drugs, including a dual anti-drug, with targets focused on PD1 and TNF-α.
Figure 5: China Approved Antibody Drugs in 2022
data source: Pharmaceutical Rubik's Cube
were approved in the United States, of which 4 were double-resistant drugs, namely tebentafusp, faricimab, mosunetuzumab and teclistamab, and 1 ADC drug (mirvetuximab soravtansine)
can be seen by comparing the targets of listed antibodies,is still mainly based on the number of innovative drugs, while innovation in the United States is beginning to be reflected in new targets and new mechanisms of action.
Figure 6: US antibody drugs approved in 2022
data source: Antibodies to watch 2023,(as of 2022.11.18)
cell and gene therapy become a hot research and development
has risen rapidly in recent years, and cell and gene therapy have become the focus of the industry. Both domestically and globally, the number of cell and gene therapies has exploded in recent years.
photo source: Healthcentral
With the gradual rise of China's drug research and development, China's layout in the field of cutting-edge treatment has increased rapidly. At present, the number of clinical research registrations in cell therapy in China ranks second in the world, including CAR-T, NK cells, BCMA targeted therapy and other fields. At present, two CAR-T therapies have been approved in China, namely, Fosun's Akirensai injection and the medicine's Rekeolensai injection.
As of 2022, the number of cell and gene therapy drugs developed worldwide exceeds 2000, and the number of approvals in 2022 will reach a new high, with a total of 8. AAV is the most commonly used viral vector in gene therapy and T cells in cell therapy.
Figure 7: Domestic clinical-stage cell and gene therapy pipelines are growing rapidly.
data source: Pharmaceutical Rubik's Cube
Figure 8: Cellular Gene Therapy Approved Worldwide in 2022
data source: EMA official website, FDA official website
cell gene therapy are mainly rare diseases. Due to the narrow population of rare patients, superimposed on the high cost of production and other factors, often priced, so that its market capacity is limited. For example, the Zynteglo of Bluebird Bio is priced at US $2.8 million in the United States and US $3 million in Skysona. The Hemgenix price of CSL Behring has reached US $3.5 million, making it the most expensive drug in the world.
is high, but from the foreign gene therapy into the national health insurance precedent, domestic health insurance is also expected to open up gene therapy, on the basis of commercial health insurance to form a supplement, will greatly enhance the confidence of rare disease drug research and development enterprises, the market for emerging therapies is expected to expand.taking into account the rich early pipeline reserves, it is expected that more cell gene therapies will be launched in China.
Conclusion
Looking at the overall situation, although the neo-crown epidemic has brought various difficulties to the global research and development of new drugs, there is a positive development trend in terms of the scale of research and development, the number of sponsors, the progress of research and development, and the field of treatment, especially in China, as a booming backbone, expanding its global influence.
, there is still a long way to go in terms of source innovation, especially under the logic of policy talks and state procurement, Chinese pharmaceutical companies still need to continue to innovate and transform. As well as in the limited domestic market, drug targets together in the environment, China's innovative drugs need to continue to integrate with international standards, seeking differentiation.
