In 2021, the API sector was under heavy pressure, the industry experienced business fluctuations, and the negative growth factor of API business gradually weakened in 2022. The commercialization of covid-19 small molecule oral drugs contributes to the new trend in the industry, and covid-19 industrial chain provides new opportunities for API enterprises.
Key points supporting rating
In 2022, the negative growth factors of API business were alleviated, and the industry ushered in a period of development and recovery. In 2021, the API industry was affected by the price rise of upstream raw materials, exchange rate fluctuations, destocking and other factors, and API enterprises experienced business fluctuations one after another. In addition, the appreciation of RMB in 2021 interfered with the performance of API export business, and the obvious rise in the price of upstream raw materials was also one of the important reasons for the decline of gross profit margin. However, the overseas API industry has been affected by the epidemic one after another, and the supply has shrunk. While the epidemic in China has been gradually controlled and the supply is relatively sufficient, the export business of Chinese api enterprises has benefited from this. In 2022, the impact of destocking of overseas generic pharmaceutical enterprises will be weakened, and the overseas export business is still expected to maintain growth. Chinese api enterprises are competing to layout the preparation integration, improve the proportion of new products and high value-added products, continuously increase R & D investment and expand capacity construction, and the API sector is expected to increase business volume.
Covid-19 small molecule drugs gradually show commercial development value, and covid-19 industrial chain brings new opportunities. Significant progress has been made in the research and development of covid-19 drugs in various countries. The MPPs of Merck and Pfizer have been launched one after another, the phase II clinical data of yanyeyi have been released, and local pharmaceutical enterprises such as Shanghai Junshi Biosciences Co.Ltd(688180) , real biology / wangshanwangshui in China have increased the research and development of covid-19 small molecule oral drugs. Pfizer paxlovid (namatvir / ritonavir combination) is newly added to the covid-19 diagnosis and treatment scheme (Ninth Edition) newly released by the National Health Commission. Covid-19 small molecule oral drug has gradually entered the commercialization stage from the R & D stage, and the demand for upstream intermediates and APIs has increased rapidly, which has brought good development opportunities to Chinese enterprises. China's leading cdmo enterprises, which have been deeply cultivated for many years, have also successively joined covid-19 industrial chain.
Pfizer leads the global commercialization process of covid-19 small molecule drugs, and yanyeyi s-217622 supply chain is nearly driven. At present, Pfizer paxlovid's MPP project has been implemented, and 35 enterprises including Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) , Apeloa Pharmaceutical Co.Ltd(000739) , Desano medicine, Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , have been selected. Paxlovid has great market potential and its production capacity is expected to increase rapidly. The intermediate links of relevant industrial chains involve preparations, APIs and multiple intermediate links. However, there are many enterprises in China that can supply relevant products. The demand for products is expected to grow rapidly, and relevant enterprises will usher in development opportunities. Yanyeyi ensitrelvir (s-217622) can take a single drug orally. Recently, some clinical phase II results were published. The data show that s-217622 can significantly reduce virus titer and mRNA, and significantly improve the clinical symptoms of covid-19. On March 25, 2022, yanyeyi signed a basic agreement with the Ministry of health and welfare on covid-19 oral drug s-217622. After obtaining the approval of the Japanese regulatory authorities, s-217622 will be manufactured and sold, and the supply chain start-up period is close.
Focus on
\u3000\u30 Shenzhen Quanxinhao Co.Ltd(000007) 396 Guangdong Sunwill Precising Plastic Co.Ltd(002676) 03456 Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196)
Main risks of rating
The risk of exchange rate fluctuation, the risk of rising raw material prices, the risk that the results of clinical trials are less than expected, the risk of covid-19 virus strain variation, and the risk that the growth rate of the industry is less than expected.
