\u3000\u3 China Vanke Co.Ltd(000002) 019 Yifan Pharmaceutical Co.Ltd(002019) )
F-627 China has accepted the listing application and has a good market prospect in the future
On February 23, 2022, the listing application of f-627 was accepted by the State Drug Administration of China. The formal acceptance of the domestic listing application of f-627 is an important step in the global layout of f-627 following the acceptance of the listing application by FDA and EMA in Europe. The acceptance of the listing application of f-627 has laid a solid foundation for China’s commercialization. The commercialization partner of f-627 in China has been confirmed as Zhengda Tianqing and agreed to exclusively license the commercialization rights and interests related to f-627 in China to Tianqing Nanjing Shunxin. Yiyi biology will receive a license fee of up to 210 million yuan and a graded royalty on net sales. Zhengda Tianqing’s strong R & D and commercialization capabilities in the field of cancer will effectively promote the commercialization process of f-627 and benefit Chinese CIN patients. Meanwhile, China’s long-term G-CSF market in 2030 is expected to reach 14 billion yuan. At present, more than 20 G-CSF drugs have been approved for marketing in China, of which only 4 are long-term varieties. With the advantages of long duration of efficacy, long-acting varieties have better market prospects than short-acting preparations, and have the trend of becoming mainstream varieties.
F-627 apogepha is exclusively authorized by Germany and recognized by the European market
Singapore Yiyi f-627, a holding subsidiary, granted the exclusive distribution right to apogepha in Germany. Apogepha needs to pay an advance payment of US $400000, a development milestone payment of up to US $1 million and a sales milestone payment of up to US $37.5 million to Singapore Yiyi. The signing of this agreement is the second exclusive license agreement of f-627 in the overseas market after Greece and Cyprus, marking the smooth development of the global commercialization cooperation process of f-627. Apogepha’s commercial resources that have been cultivated in Germany for many years will help f-627 quickly open the market in Germany. In addition, Yiyi and apogepha may reach in-depth cooperation on business cooperation areas in other high-value regions of the EU and jointly create a beautiful blueprint in the European market. In September 2021, f-627 has been accepted by EMA’s application for listing permission (MAA), and it is expected to be approved within 2022. The f-627 has been recognized by key European markets, highlighting the commercial value of the f-627.
F-627 clinical trial data are solid and effective, helping to accelerate the process of global commercialization
The global clinical trial data of f-627 has been complete. A total of 1200 patients have been enrolled from phase I to phase III, and two global phase III clinical trials and one phase III clinical trial in China have been carried out. Among them, the second international phase III clinical trial (“05 trial”) carried out in the United States and Europe successfully reached the preset primary efficacy endpoint and secondary efficacy endpoint, and the drug efficacy is equivalent to that of the control drug. F-627 passed the FDA special protocol evaluation (SPA) procedure for the “05 trial” and reached a binding agreement on the f-627 international phase III clinical trial protocol (gc-627-05 protocol). Spa is a high-level statement rarely granted by FDA, which indicates that FDA Approves the clinical trial scheme and the statistical analysis method of clinical results. Therefore, when pharmaceutical companies conduct clinical research in accordance with the spa agreement approved by FDA, the probability of successful application for new drug listing will increase significantly. Based on good clinical data, the BLA of f-627 in the United States was accepted by FDA in May 2021. It has entered the stage of technical review and is expected to be approved for listing in 2022. Thus, Yiyi biological f-627 has been accepted by China, the United States and the European Union, and the process of globalization has been significantly accelerated.
Profit forecast
Considering the sharp decline in the price of API in 2021, we will reduce the net profit in 2021 from 389 to 270 million yuan. We predict that the company’s operating revenue from 2021 to 2023 will be 4.508 billion yuan, 6.862 billion yuan and 8.609 billion yuan respectively; The net profit attributable to the parent company was 270 million yuan, 1.041 billion yuan and 1.081 billion yuan respectively; EPS is 0.22 yuan, 0.84 yuan and 0.88 yuan respectively. Maintain the “buy” rating.
Risk warning: the risk of not being approved for listing, the risk that the commercialization progress is less than expected, and the risk that the internationalization progress is blocked
