The Zhitong Finance App learned that Guojin Securities released a research report saying that the chronic hepatitis B cure circuit has broad potential market space, and the implementation of relevant policies will accelerate the construction of clinical hepatitis B treatment clinics and further catalyze market growth. In recent years, real-world evidence-based medical evidence has continued to accumulate. The clinical cure rate based on long-term interferon treatment can reach more than 30%, making it the highest cure available at this stage. Looking at the overall hepatitis B drug landscape, it will be difficult to disrupt in the short term. Long-acting interferons and NAs will continue to be important drugs for the treatment of chronic hepatitis B in the future. We will continue to recommend companies that deploy long-acting interferons and related innovative drugs in the slow hepatitis B cure circuit.

Key companies: Tebao Biotech (688278.SH), China Biopharmaceuticals (01177), Kain Technology (688687.SH), Tengshengbo Pharmaceutical (02137), Geli Pharmaceuticals (01672).

Guojin Securities's views are as follows:

The chronic hepatitis B cure track is one of the tracks that the trip continues to be optimistic about and recommended. Clinical cure for chronic hepatitis B has now entered a new stage from early exploration to international recognition to rapid and in-depth development.

With the release of official guidelines such as the 2022 edition of the “Guidelines for the Prevention and Treatment of Chronic Hepatitis B”, clinical treatment of chronic hepatitis B is progressing to a new stage of expanding the number of people treated with antiviral treatment and expanding the number of people treated clinically. The bank specifically sorted out the current drug pattern for the treatment of chronic hepatitis B hepatitis for investors, summarized the latest clinical trial progress of drugs under development in the field of treatment of chronic hepatitis B according to drug type, and compiled treatment plans and cure rates of the corresponding drugs. There are many hepatitis B patients in China and the diagnosis and treatment rate is low. Unmet clinical demand+policy promotion is expected to continue to catalyze market growth. According to the “Guidelines for the Prevention and Control of Chronic Hepatitis B (2022 Edition)”, chronic hepatitis B is prevalent worldwide. In 2016, the HBsAg prevalence rate among the general population in China was 6.1%, and there were 86 million cases of chronic HBV infection.

According to the WHO's goal of “eliminating viral hepatitis as a public health hazard by 2030”, the diagnosis rate of chronic hepatitis B should reach 90% and the treatment rate should reach 80% at that time, while by 2022, the diagnosis rate and treatment rate for chronic hepatitis B in China will only be 22% and 15%, respectively. In November 2023, the Hospital Management Research Institute of the National Health Commission and other organizations launched the “Standardized Construction and Capacity Enhancement Project for Hepatitis B Clinical Treatment Clinics” across the country. It is planned to build more than 100 hepatitis B clinical treatment clinics nationwide by 2025 to achieve broad coverage of hepatitis B diagnosis, treatment and clinical treatment networks. Unrealized clinical demand+ policy promotion is expected to continue to catalyze market growth.

Real world evidence-based medical evidence continues to improve, and the clinical cure rate of NAS+ long-acting interferon slow B can reach more than 30%.

Interferon α was first approved by the FDA in the 1980s to treat viral hepatitis. Research has found that it plays an important role in regulating host immunity. Long-acting interferon plus ribavirin was once a recommended treatment for hepatitis C, but its use for hepatitis B indications is relatively limited. In recent years, several studies have confirmed that the clinical cure rate of patients treated with nucleosides, people carrying inactive HBsAg, and pregnant women treated with polyethylene glycol interferon α (PEG-IFNα) after delivery can reach more than 30% or higher, and the clinical cure rate is greatly improved compared to single-drug treatment. Among them, 4-year phased data from the Everest Project showed that patients with slow hepatitis B treated with NAS (nucleoside (acid) analogs) for 48 weeks based on PEG-IFNα had an HBsAg clearance rate of 33.2% compared to the previous single-drug treatment plan. Significant improvement. The 2022 guideline added recommendations. It is recommended that some eligible patients may consider adding PEG-IFNα treatment according to the patient's wishes to pursue clinical cure.

Innovative therapies are being explored for a long time, and it is difficult to disrupt the hepatitis B drug landscape in the short term.

Major barriers to hepatitis B cure include cccDNA, HBV DNA integration, high viral load, and impaired host immune response. Currently, many innovative drugs under development have shown good application prospects. Among them, the ASO (antisense oligonucleotide) drug bepirovirsen developed by GSK has now entered clinical phase 3. According to phase 2 clinical trial results, the surface antigen clearance rate after 24 weeks of single-drug treatment is 28 to 29%, but the probability of recurrence after discontinuation of the drug is high. Adding long-term interferon can reduce the probability of recurrence after discontinuation of the drug. Overall, the efficacy of single-agent treatment of innovative drugs in the field of chronic hepatitis B treatment has yet to show corresponding advantages over the current long-term interferon+nAs drug regimens. Most drugs are still in the early clinical stage. Furthermore, innovative drugs and long-acting interferon and NaS multi-drug combinations are important trends in clinical trial plans at this stage.

Investment advice:

The chronic hepatitis B cure circuit has a broad potential market space. The implementation of relevant policies will accelerate the construction of clinical hepatitis B treatment clinics and further catalyze market growth. In recent years, real-world evidence-based medical evidence has continued to accumulate. The clinical cure rate based on long-term interferon treatment can reach more than 30%, making it the highest cure available at this stage. Currently, many innovative drugs under development in the hepatitis B field have shown good application prospects, but the cure rate still does not show a corresponding advantage compared to the current long-term interferon+NAS drug scheme. In addition, monotherapy with innovative drugs often has limitations with a high recurrence rate. Innovative drugs and long-acting interferon and NaS multi-drug combinations are important trends in clinical trial plans at this stage. Clinical trial results of multiple drugs confirm that the addition or combination of long-term interferons can reduce the recurrence rate of patients after discontinuation of the drug. Looking at the overall hepatitis B drug landscape, it will be difficult to disrupt in the short term. Long-acting interferons and NAs will continue to be important drugs for the treatment of chronic hepatitis B in the future. We will continue to recommend companies that deploy long-term interferons and related innovative drugs in the slow hepatitis B cure circuit.

Risk warning: Product sales fall short of expected risk, clinical trial progress falls short of expected risk, risk of industry policy changes, increased risk of market competition, risk of innovative drugs replacing existing treatments.