The medical insurance catalogue was dynamically adjusted, and the volume of innovative drugs continued to accelerate. Driven by policies, talents and capital, China's innovative drugs have entered the harvest period of achievements and opened the road of internationalization.
Key points supporting rating
China's financing has exceeded 100 billion, and the popularity of the pharmaceutical field has not decreased. China's financing events and amount in 2021 further increased compared with 2020, reaching 533 cases and 111.3 billion yuan. Macromolecular and small molecule drugs still account for a large proportion. Emerging biotech enterprises continue to emerge, and the financing demand is still strong.
The R & D of innovative drugs in China is over competitive, and the allocation of resources has become a problem. Biological drug targets mostly focus on popular targets such as PD-1 and VEGF, and cell therapy focuses on CD19, resulting in uneven distribution of clinical resources and slow development of clinical trials. Geriatric diseases and childhood diseases also lack attention.
Within this year, FDA approved ten new drugs, including two JAK inhibitors. JAK fever continues to rise due to its wide range of indications, especially its excellent performance in the field of autoimmune diseases. The sales of inhibitors also confirm the market potential of the target. Zhengda Tianqing, Hengrui and other enterprises have been laid out.
PD-1 is temporarily blocked, and going to sea is still more preferred. The first domestic PD-1 monoclonal antibody, cindilimab, has been applied for suspension by FDA, and clinical trials need to be supplemented. China's PD-1 target competition is still enthusiastic, extremely fierce and uneven resource distribution. Going abroad or better choice, there are still four domestic PD-1 drugs continue to sprint to the U.S. market.
Domestic cell therapy drugs opened in the first year and entered the harvest period. The investment and financing in the field of cell therapy reached 10 billion yuan. In 2021, China was approved two domestic car-t drugs with outstanding income generating ability. In February this year, Cinda biological bcmacar-t was approved by FDA, and the first domestic cell therapy drug went to sea successfully. FDA issued the draft of car-t drug research and development to guide and further standardize the technical development.
ADC track is hot, and overseas licensing is highly beneficial. The overseas authorization of Rongchang biological ADC drugs benefited us $2.6 billion, setting a new record. Chinese enterprises scrambled to layout ADC drugs and focus more on HER2. Under the situation of readiness, technological advantage will become the core competitiveness of enterprises.
International cooperation in innovative drugs has increased, and the introduction of patents and going to sea have made enterprises more dynamic. Last year and unfashionable "produce 101", a series of international cooperation was carried out between the pharmaceutical companies. The patent introduction (license-in) made up the short board and rich R & D pipelines for local innovative pharmaceutical enterprises. The amount of domestic patents has been continuously confirmed on the international stage.
Key recommendation
\u3000\u30 China Baoan Group Co.Ltd(000009) 63 Haisco Pharmaceutical Group Co.Ltd(002653) Shanghai Junshi Biosciences Co.Ltd(688180)
Main risks of rating
The risk of drug R & D failure, the risk of drug R & D progress not meeting expectations, the risk of clinical research failure, the risk of covid-19 epidemic uncertainty, the risk of drug marketization and the risk of international relations.