Affected by the global pandemic of the new crown epidemic in the past three years, the biopharmaceutical industry has continued to attract the attention of the capital market. As an important force in the development of the global pharmaceutical industry and one of the best countries in the world to deal with the new crown epidemic, China has adapted to the changes and impacts brought about by the new crown epidemic. Although the scale of investment and financing in the biopharmaceutical industry has fluctuated to a certain extent, it has shown a spiral upward trend as a whole.
According to the Global COVID-19 Vaccine Candidate Report released by the WHO, as of January 4, 2022, there are 137 new crown vaccines under clinical research and 194 in the preclinical stage. To date, 19 vaccines have been approved worldwide.
Domestic Aibo Bio's new crown mRNA vaccine received 7.0974 billion yuan in financing, becoming the vaccine research and development company with the highest financing in the primary market in 2021. The development of non-new crown vaccines is squeezed by new crown vaccines. Since 2020, the number of non-COVID-19 vaccines under development has dropped significantly, and by 2021, the number of vaccines under development is only one-third of that in 2019, with a total of 27. At the same time, the number of non-new crown vaccines approved for marketing has also dropped significantly. From 2020 to 2021, only 4 models have been approved for marketing each year.
In the secondary market, in 2021, a total of 89 biopharmaceutical companies in China will complete IPOs in China and the United States (ie A shares, H shares and US shares). The number of listed companies is 57 (34 listed on the Science and Technology Innovation Board), 24 and 8, with the fundraising amount exceeding 130 billion yuan. Among them, BeiGene is the first Chinese biopharmaceutical company listed in the three places of "US stock + H stock + A stock". In the era of epidemic, Chinese biomedicine is booming.
The epidemic has made people realize the importance of biomedicine. In addition to various countries, the development of biomedicine has been upgraded to a strategic position. More importantly, it has promoted the reform of the regulatory system. In addition to market forces that can promote or frustrate the development and innovation of biotechnology, another more important factor is the regulatory framework. A mature and effective regulatory system can provide a great boost to the development and innovation of biotechnology companies.
The regulatory approval process has always played a key role in the long and resource-intensive journey to market for drugs and diagnostics. At the same time, these products, once approved, require expensive and specialized production processes.
The Covid-19 pandemic has prompted a new and faster regulatory framework. Since December 2020, the U.S. Food and Drug Administration, WHO, and other regulatory agencies have authorized emergency use or approval of at least 20 COVID-19 vaccines, treatments, and tests. mRNA vaccines did not exist commercially in January 2020, and today more than 3 billion doses of mRNA vaccines have been delivered to people around the world. This speed was not seen before the epidemic.
The sectors that have directly benefited from the new crown epidemic include IVD (InVitro Dagnostic products, in vitro diagnostic products), vaccines, and small molecule CDMO (Contract Development and Manufacturing Organization, custom R&D and production institutions).
In the long run, additional orders and revenue from Covid-19 will decrease and disappear. IVD companies and small molecule CDMO companies need to use the funds to expand their business types and regions, digest high valuations, and maintain performance growth; the new track of mRNA in the vaccine sector is developing rapidly in China, despite the challenges of technology and safety It is still a promising direction to overcome challenges in aspects such as performance and application field expansion.
In addition to its direct impact on business, COVID-19 has also reshaped supply chains. During the epidemic, foreign suppliers were greatly affected, and enterprises sought localized alternatives, which brought development opportunities to the upstream of IVD, vaccine and other industries.
Four key points will determine the lifeblood of global biomedicine: coded drugs, machine learning and artificial intelligence, changes in the development environment and value reshaping of biological companies, and the reform of the regulatory system in the post-epidemic era.
Codable drugs refer to the existence of computer-like "program codes" in the biological field. For example, DNA, RNA and proteins all have corresponding codes. The new crown mRNA vaccine encodes the spike protein on the surface of the new coronavirus through mRNA, and produces the same spike protein as the surface of the virus and enters it into the human body, so that the human body can recognize the virus in advance and can immediately generate an immune response.
"Codable" drugs are more precise and effective. Recently, it was reported that 100% of the human genome has been sequenced. Codable drugs are promising in the future. Artificial intelligence can help humans do more than what people know about the coding mechanisms of living things themselves. For example, when we use artificial intelligence to analyze biological big data, we can find many potential causes and effects between biological genetics and diseases, and can use these correlations to conduct biological experiments.
Although it seems that this field has played a great role at the moment, this is actually just the tip of the iceberg of the potential of artificial intelligence in the biological field. Artificial intelligence can now predict the structure of proteins.
While capital is chasing biomedicine, new trends in the biomedical industry are also emerging, such as coded drugs and the integration of artificial intelligence and biomedicine, which are worthy of attention.
