Recommended logic: 1) Hepatitis B patients are large, and NaS patients treated with CHB in conjunction with PEG-IFN-α treatment are included in the guideline recommendations; 2) As Roche and Roche withdrew from the Chinese market at the end of 2022, only the company Pibinger is selling interferon products with chronic hepatitis B indications, which are expected to achieve faster sales growth in 2023; 3) Rapid progress in the research pipeline, and the long-acting human granulocyte-stimulating factor product topefigersteine injection (Pegin) was approved and marketed.
Hepatitis B patients are large, and patients treated with NAS with CHB in combination with PEG-IFN-α treatment are included in the guidelines and recommended. An estimated 257.5 million people were infected with the hepatitis B virus in 2022, and the global HBV prevalence rate was 3.2%. The global hepatitis B diagnosis rate and treatment rate are 14% and 8%, respectively. The HBV prevalence rate in China was 5.6%, the number of people positive for HBsAg reached 797.47 million, and the hepatitis B diagnosis rate and treatment rate were 24% and 15%, respectively. The 2022 new version of the guideline recommends that eligible dominant groups of patients treated with NAS with CHB can be treated with PEG-IFN-α in combination with PEG-IFN-α to enable some patients to obtain clinical cure.
In 2023, interferon products indicated for chronic hepatitis B were sold only by the company Pibinger. The company's Pibinger (polyethylene glycol interferon alpha-2b injection) sales are growing rapidly year by year. As Roche's Pyroxine (polyethylene glycol interferon alpha-2a injection) withdraws from the Chinese market at the end of 2022 due to the effects of novel drugs and adjustments to Roche's market strategy in mainland China, Pibinger is expected to achieve faster sales growth in 2023.
The research pipeline includes 7 high-value products, and clinical trials are progressing rapidly. Of these, 1 has been approved for marketing, and 6 are in clinical trials. The company's main products under development include polyethylene glycol recombinant human growth hormone (YPEG-GH), macrogol recombinant human erythropotropin (YPEG-EPO), human interferon spray α2b, AK0706, a novel PEG-based protein drug with a novel mechanism targeting V3, ACT60, a combination drug combination of glucocorticoids and IL-2 agonists. The long-acting human granulocyte-stimulating factor product topefigastine injection (pezin) has been approved for marketing and is expected to contribute to increased performance.
Y-type polyethylene glycol recombinant human growth hormone (YPEG-GH) has completed phase 3 clinical research and is expected to submit an NDA in Q1 in 2024; Y-type polyethylene glycol recombinant human erythropotropin (YPEG-EPO) has completed phase 2 clinical research, and preparations for phase 3 clinical study applications are being carried out.
Profit forecasting and investment advice. The company's net profit for 2024-2025 is estimated to be 700 million yuan and 940 million yuan, respectively.
The company is a leader in curative hepatitis B drugs. It includes 7 high-value products in the research pipeline, and its performance is growing rapidly. Investors are advised to pay attention.
Risk warning: industry policy risk, risk of sales falling short of expectations, risk of R&D failure.