Incident review
On March 15, 2024, the company issued an announcement. The company recently received the “Notice of Acceptance” issued by the State Drug Administration). The company's product Pegbin? (Generic name: polyethylene glycol interferon alpha-2b injection) combined with nucleoside (acid) analogs for increased indications for clinical treatment of chronic hepatitis B in adults was accepted by the State Drug Administration.
Management analysis
The degree of in-depth application of Pegobin in the treatment of chronic hepatitis B is expected to increase further. Pegbin? It is the company's current core product. It is the first domestically produced and marketed polyethylene glycol (PEG) modified interferon variety (national class 1 new drug for therapeutic biological products). According to the company's previous announcement, the chronic hepatitis B clinical cure registration clinical trial initiated by the company is the first long-term interferon registration clinical trial for clinical cure in the industry. It is a large-scale, randomized controlled trial clinical study. The research results will raise the level of evidence-based medical evidence for clinical cure of slow hepatitis B and further increase the depth of application of Pegobin in the field of chronic hepatitis B treatment.
The concept of clinical cure for hepatitis B continues to spread, and the core product Pegbin is expected to maintain a high growth rate.
As evidence-based medical evidence for clinical cure of slow hepatitis B continues to accumulate and real-world clinical applications continue to be enriched in people treated with nucleosides, the 2022 edition of the official guidelines included recommendations for such people considering the use of polyethylene glycol interferon alpha to pursue clinical cure, and further deepened the exploration of scientific issues surrounding clinical treatment of hepatitis B. With the continuous spread of clinical treatment concepts for hepatitis B and the accumulation of scientific evidence, clinical application of the key product Pegobin will be further promoted, and sales revenue is expected to maintain a high growth rate.
The exploration of hepatitis B treatment plans continues to be deepened, and R&D projects are progressing in an orderly manner. The company is actively exploring combined and better treatment plans with drugs with different mechanisms. The new hepatitis B drug AK0706, which was carried out in cooperation with AGCO Baifat, has successfully entered clinical research and development. At the same time, it is carrying out cooperative R&D projects with oligonucleotide drug development company Aligos Therapeutics, Inc., to further expand the R&D pipeline layout in the field of hepatitis B treatment, which is expected to provide more treatment options for clinical cure in the future.
Profit Forecasts, Valuations, and Ratings
We maintain our profit forecast. We expect the company to achieve net profit of 5.54 (+93%), 7.74 (+40%), and 10.30 (+33%) billion yuan in 2023-2025, corresponding to current EPS of 1.36 yuan, 1.90 yuan, and 2.53 yuan, respectively, corresponding to the current P/E of 48, 35, and 26 times, respectively. Maintain a “buy” rating.
Risk warning
New product approval falls short of expectations; new product sales promotion falls short of expected risk; risk of technical results not being effectively transformed.