\u3000\u3 Shengda Resources Co.Ltd(000603) 707 Nanjing King-Friend Biochemical Pharmaceutical Co.Ltd(603707) )
Event: the company announced that the Anda of regalosan injection (0.4mg/5ml (0.08mg / ml)) was approved by FDA.
Regalosen anda has been approved, and the export of injections continues to work. The regalosan injection (0.4mg/5ml (0.08mg / ml)) declared by the company to FDA was approved on April 12, 2022. The company's injection export continues to develop, and the pipeline is further enriched.
The drug was originally developed as astellaspharmausinc. As a load drug used in radionuclide myocardial perfusion imaging (MPI), it is suitable for patients who cannot accept exercise load test and need drug load test. It was listed in the United States in 2008. The original product name is lexiscan, and the specification is 0.4mg/5ml (0.08mg / ml). According to orange book, at present, there is only one document number of regalosan injection in the United States, which is owned by the original astellaspharmausinc. The sales volume of regalosan injection in the US market in 2020 was about 600 million US dollars. Nmpa's official website shows that at present, only one domestic ruiganuosheng injection of Hailong pharmaceutical company in China has been approved for listing. In addition, CDE website shows that three enterprises, including Sichuan Baili pharmaceutical, Sichuan Guorui pharmaceutical and Xi'an Libang pharmaceutical, are in the declaration status. We expect the US sales of this product to have a positive impact on the company's operating performance.
The company's global heparin preparation + U.S. non heparin injection continued to be in high volume, and the approval of Anda injection was accelerated. According to the 2019 and 2020 annual reports, the company has applied to the United States with an average of 10 products in the past few years, with a total of more than 40. In 2020 and 2021, the company obtained 9 and 12 American varieties of non heparin injections respectively. Since 2022, the company has obtained 2 American varieties of non heparin injections, including furosemide injection and reganosen injection, which have been approved for continuous development. At present, there are more than 20 approved products in the international market and 10 approved products in China. It is expected that 5-10 products will be approved every year in the next 2-3 years. The company's variety + capacity + channel layout is perfect, and the acceleration of injection export is worth looking forward to.
Profit forecast and investment suggestions: we estimate that the company's revenue from 2021 to 2023 will be 3.787 billion yuan, 4.872 billion yuan and 6.068 billion yuan, with a year-on-year increase of 29.92%, 28.65% and 24.55%, and the net profit attributable to the parent company will be 1.103 billion yuan, 1.457 billion yuan and 1.916 billion yuan, with a year-on-year increase of 36.84%, 32.08% and 31.47%. The current share price corresponds to 30, 23 and 18 times of PE from 2021 to 2023. Considering that the company's overseas injection new products continue to accelerate the approval and continuous volume, the biological drug cdmo business is expected to gradually harvest, continuously open the growth ceiling and maintain the "buy" rating.
Risk warning event: the risk of narrowing the price gap between raw materials and APIs; Risk of inventory falling price; The risk that anda is not approved as expected; There is a risk that the public information is delayed or not updated in time.
