\u3000\u3000 Yifan Pharmaceutical Co.Ltd(002019) (002019)
Events
On February 23, the company announced that the holding company Yiyi biological is developing the product Albertine α Injection (proposed trade name: Yilishu, hereinafter referred to as “f-627”) was used to prevent and treat neutropenia caused by chemotherapy in tumor patients. On February 23, 2022, the listing application of the State Food and drug administration was accepted.
Comments
F-627 is an innovative biopharmaceutical variety developed based on the di kinetm bimolecular technology platform with the independent intellectual property rights of Yiyi biology. It is a rhGCSF dimer expressed by CHO cells based on Fc fusion protein technology, which has long-term and powerful biological characteristics. At present, f-627 is mainly used to prevent and treat neutropenia caused by chemotherapy in tumor patients.
G-CSF drugs maintained rapid growth, and long-acting preparations dominated. In 2020, the total revenue of G-CSF drugs listed in China was about 9.731 billion yuan, of which the sales of long-acting products was 6.329 billion yuan, and the market share of long-acting preparations exceeded 70%. Under the background of the rising number of new cancer patients in China, long-acting G-CSF drugs are needed for cancer patients after chemotherapy, and its market scale is expected to further expand. The sales scale of long-acting G-CSF drugs is expected to reach 10.270 billion yuan in 2025 and 13.537 billion yuan in 2030, with a CAGR of about 8%.
The pace of the f-627 global process has accelerated. In May 2021, the company has completed the acceptance of the biological product license application (BLA) of the heavy product under development f-627 in the FDA, and has entered the stage of technical review; In September 2021, f-627 was accepted by the European Drug Administration (EMA) for marketing license application (MAA). The marketing application in China is also advancing in an orderly manner. The preparation process verification of Beijing preparation factory is under way. In August 2021, the commercialization cooperation agreement between f-627 and Zhengda Tianqing has been reached, which is expected to open the market with the help of Zhengda Tianqing’s sales capacity in the field of cancer. Neutral forecast, it is estimated that the global market sales peak of f-627 will reach 2 billion yuan.
The acceptance of f-627 domestic listing application is another important progress made in the world. F-627 is a product under development in the current global G-CSF therapeutic drugs, which has conducted head-to-head comparative research with both long-acting and short-acting original research products, achieved the preset clinical objectives and achieved the synchronous declaration of China, the United States and Europe. The smooth promotion of the product has laid a solid foundation for China’s commercialization and global sales, It is conducive to the subsequent approval and listing of products in other countries around the world.
Profit forecast
We maintain the profit forecast: the operating revenue of the company from 2021 to 2023 is RMB 4.504/64.76/7.317 billion respectively, with a year-on-year increase of – 16.59% / 43.78% / 12.99%; The net profits attributable to the shareholders of the listed company were 277 / 10.91 / 1.321 billion yuan and EPS were 0.22/0.88/1.07 yuan respectively. The current share price corresponds to PE from 2021 to 2023, which are 75.33/19.11/15.78 respectively. Maintain the “buy” rating.
Risk tips
Covid-19 epidemic risk, R & D less than expected risk, raw material price fluctuation risk, international operation risk, goodwill impairment risk, etc.
