Summary of the Conference Call Company and Industry - **Company**: 博济医药 (Boji Pharmaceutical) - **Industry**: Hepatitis B treatment and research Key Points and Arguments Research and Development Progress - In 2024, Boji Pharmaceutical made significant advancements in the research for functional cure of Hepatitis B, optimizing its pipeline by terminating or pausing some projects to focus on clinical research for Hepatitis B functional cure [3][5] - The company has three core candidates in its Hepatitis B pipeline: V179, psi, and tobia_bar_antibody, which are expected to achieve higher rates of functional cure through various combinations [3][5] - The Elexxion study revealed that siRNA combined with long-acting interferon significantly improves the functional cure rate compared to long-acting interferon alone, with data showing a notable increase in Hepatitis B surface antigen clearance rates [3][8] - The 2BT study evaluated a three-drug combination therapy aimed at maximizing functional cure rates, confirming the strategy of combination therapy and guiding registration pathway decisions [3][9] Financial Status - As of December 31, 2024, the company had over 2.4 billion RMB in cash and cash equivalents, sufficient to support operations until after 2028 [3][16] - R&D expenses decreased by 38% from 400 million RMB in 2023 to 250 million RMB in 2024, reflecting a focus on pipeline optimization [3][16] Market Strategy - In China, Boji Pharmaceutical focuses on developing three Hepatitis B assets recognized as breakthrough therapies by the CDE, targeting the largest Hepatitis B patient population globally [3][7] - The company collaborates with Lear to obtain fast track and breakthrough therapy designations from the FDA for HDV treatment, as well as orphan drug designations from the EMA [3][7] Clinical Trials and Future Plans - The company plans to initiate Phase III clinical trials in 2026, aiming for optimized functional cure outcomes [3][25] - Key milestones to watch for in 2025 include data from imaging studies and ongoing clinical trials, which will inform future development and registration pathways [3][14] Unique Drug Mechanisms and Patent Protection - V179 is a recombinant protein vaccine that induces strong immune responses, while psi is an siRNA and tobia_bar_antibody is a comprehensive antibody, each with unique mechanisms [3][5][19] - The company has extensive patent protection for its Hepatitis B candidates, with B179's patent expected to last until 2040 [3][19] Long-term Strategy - Boji Pharmaceutical aims to optimize its organizational structure and control operational costs while focusing on advancing Hepatitis B projects and seeking partnerships for other potential candidates [3][18] - The company is committed to creating long-term value for shareholders by expanding treatment options and patient accessibility through innovative therapies [3][18] Commercialization Strategy - The company is considering various commercialization strategies, including partnerships and direct market expansion in key cities, to enhance its market development capabilities [3][30] - Future commercialization plans will be based on the results of Phase III clinical trials [3][29] Additional Insights - The company is actively seeking partnerships to advance non-HBV projects, including those targeting multi-drug resistant infections and HIV therapies [3][6][17] - The focus remains on Hepatitis B cure research, with a commitment to not deviate from this core mission [3][32]

Core Viewpoint - The 34th Asia-Pacific Association for the Study of the Liver (APASL) conference focused on "Diverse Cooperation: Creating Miracles of Elimination and Cure," emphasizing the breakthrough value of "functional cure" for hepatitis B [1] Group 1: Achievements in Hepatitis Prevention and Control - China has integrated the prevention and control of major infectious diseases, including hepatitis B, into the "Healthy China 2030 Planning Outline" [2] - The hepatitis B virus carrier rate in China has decreased from 9.72% in 1992 to 5.86%, with the rate among children under 5 dropping over 96% from 9.67% to 0.30%, achieving the target set for 2030 ahead of schedule [2] Group 2: Systematic Approach to Hepatitis Management - The success in hepatitis prevention and control in China is attributed to national top-level design, optimized prevention measures, advancements in biomedical technology, and a solid foundation of community-based prevention [3] - Continuous optimization of chronic hepatitis management strategies is essential to achieve the goals of the "Healthy China 2030" initiative [3] Group 3: Focus on Functional Cure - "Functional cure" is defined as the absence of detectable hepatitis B virus and surface antigen in the blood after stopping treatment, significantly improving patients' quality of life [4] - Traditional antiviral treatments have struggled to achieve the disappearance of hepatitis B surface antigen, leading to long-term treatment burdens for patients [4] - The National Medical Products Administration of China has issued guidelines emphasizing "functional cure" as a key endpoint for new drug development in chronic hepatitis B treatment [4]

Summary of Tengsheng Bo Pharmaceutical Conference Call Company and Industry Overview - **Company**: Tengsheng Bo Pharmaceutical - **Industry**: Hepatitis B treatment and infectious disease therapeutics Key Points and Arguments 1. **Core Pipeline in Hepatitis B Treatment**: Tengsheng Bo Pharmaceutical focuses on infectious diseases, particularly Hepatitis B, with three therapeutic drugs: SIRNA (B835), specific antibodies (B877), and a therapeutic vaccine (B179). B835 and B877 aim to reduce Hepatitis B surface antigens, while B179 acts as an immune stimulant, inducing T and B cell responses in approximately 40% of patients, leading to serological conversion [3][4][5]. 2. **Clinical Trials and Research**: - The INSURE study showed that adding SIRNA increased the 48-week seroconversion rate from 5% to 33% when combined with long-acting interferon [4][6]. - The ENRICH study is crucial for evaluating the impact of B179 pre-treatment followed by siRNA and antiviral drugs on Hepatitis B surface antigen seroconversion. Successful replication of INSURE study data will advance registration trials [4][7]. 3. **Innovative Treatment Approach**: The company emphasizes restoring patients' immune responses through immune stimulants to clear viral materials released from cccDNA, thereby reducing the risk of end-stage liver disease and achieving functional cures [4][5][6]. 4. **Key Data Milestones in 2025**: - March: Release of INSURE study's fourth group 24-week interim data. - May and November: Follow-up data from INSURE study. - ENRICH study's 24-week interim analysis will be shared in the second half of the year [10][11]. 5. **Differentiation from Competitors**: Tengsheng Bo Pharmaceutical's unique combination of SIRNA, antibodies, and immune stimulants allows for personalized treatment strategies, significantly enhancing cure rates and providing a competitive edge [8][9]. 6. **Future Clinical Trial Plans**: The ENRICH study is set to start in July 2024, with completion expected in November. The company anticipates entering Phase III clinical trials for Hepatitis B treatment by 2026, contingent on the consistency and reproducibility of clinical trial data [4][7][14]. 7. **Current Limitations of Mainstream Treatments**: Existing treatments, such as nucleoside analogs and long-acting interferons, can control but not completely eliminate the virus, leaving patients at risk for severe liver diseases [5][6]. 8. **Other Pipeline Developments**: Besides Hepatitis B, the company is advancing projects in HIV and antibiotics, including a new polymyxin for resistant bacteria and two investigational HIV drugs [12]. 9. **Investor Interest in B179**: Investors are particularly interested in B179 due to its unique therapeutic vaccine profile and the completeness of available data, with a focus on whether it can significantly differentiate itself in the Hepatitis B treatment landscape [20][22]. 10. **Financial Stability**: As of 2024, the company has over $300 million in cash reserves, sufficient to support its pipeline development until the Hepatitis B treatment reaches the market [32]. Additional Important Content - **Monitoring Immune Response**: The company continuously monitors surface antigen levels and immune responses during trials, which is critical for understanding treatment efficacy [23][30][31]. - **Potential for Future Collaborations**: The data generated from ongoing studies may attract partnerships with larger pharmaceutical companies, enhancing the company's market position [21][22]. This summary encapsulates the key insights from the conference call, highlighting the strategic direction, clinical advancements, and market positioning of Tengsheng Bo Pharmaceutical in the Hepatitis B treatment sector.