Performance Summary [Financial Summary](index=1&type=section&id=Financial%20Summary) The company's cash and equivalents decreased by 6.9% from the beginning of the year, with loss for the period expanding due to fair value losses on financial assets, partially offset by reduced R&D and administrative expenses Key Financial Indicators for H1 2024 | Indicator | H1 2024 | H1 2023 | Year-over-Year Change | | :--- | :--- | :--- | :--- | | **Cash and Equivalents (End of Period)** | RMB 2.478 billion | - | -6.9% (vs. Beginning of Year) | | **Other Income** | RMB 70.9 million | RMB 85.9 million | -17.5% | | **R&D Expenses** | RMB 126 million | RMB 202 million | -37.6% | | **Administrative Expenses** | RMB 78.6 million | RMB 103 million | -23.5% | | **Loss for the Period** | RMB 283 million | RMB 197 million | +43.9% | - The increase in loss was primarily attributed to **RMB 115 million** in other losses from fair value changes of financial assets, partially offset by reduced R&D and administrative expenses[3](index=3&type=chunk) - The significant decrease in R&D and administrative expenses resulted from the company's pipeline prioritization and organizational optimization during the reporting period, effectively controlling third-party contract costs and employee costs[2](index=2&type=chunk)[3](index=3&type=chunk) [Business Summary](index=3&type=section&id=Business%20Summary) The company strategically focused on HBV functional cure projects, advancing combination therapies with three clinical-stage HBV projects receiving China CDE Breakthrough Therapy Designation, while also seeking external partnerships for non-core projects - The core strategy is to advance HBV functional cure projects, having obtained China CDE IND approval to conduct Phase 2 studies in mainland China evaluating combination regimens of elebsiran, BRII-179, and PEG-IFNα[4](index=4&type=chunk) - The company's three clinical-stage HBV drug candidates, elebsiran (BRII-835), tobevibart (BRII-877), and BRII-179, have all received CDE Breakthrough Therapy Designation[4](index=4&type=chunk) - For non-HBV projects (such as HIV, MDR/XDR, CNS), the company is actively seeking external collaborations and has submitted an IND application to CDE for the MDR project BRII-693[4](index=4&type=chunk) Consolidated Financial Statements [Unaudited Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2024, the company's loss for the period expanded significantly, primarily driven by a substantial shift in net other gains and losses from a gain to a loss, despite reductions in R&D and administrative expenses Condensed Consolidated Statement of Profit or Loss (RMB in thousands) | Item | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Revenue | – | 617 | | Other Income | 70,879 | 85,863 | | Net Other Gains and Losses | (115,374) | 23,326 | | R&D Expenses | (126,169) | (202,175) | | Administrative Expenses | (78,629) | (102,823) | | **Loss for the Period** | **(283,238)** | **(196,826)** | | **Loss for the Period Attributable to Owners of the Company** | **(280,535)** | **(189,917)** | | **Loss Per Share (RMB)** | **(0.38)** | **(0.26)** | [Unaudited Condensed Consolidated Statement of Financial Position](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company maintained a stable financial position with substantial total and net assets, supported by significant net current assets and cash balances, providing ample funding for ongoing R&D activities with low total liabilities Condensed Consolidated Statement of Financial Position (RMB in thousands) | Item | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | **Non-current Assets** | 337,255 | 415,473 | | **Current Assets** | 2,559,350 | 2,782,778 | | *Of which: Cash and Deposits* | *2,460,000* (Estimated) | *2,661,400* | | **Total Assets** | **2,896,605** | **3,198,251** | | **Current Liabilities** | 67,695 | 125,869 | | **Non-current Liabilities** | 18,617 | – | | **Total Liabilities** | **86,312** | **125,869** | | **Net Assets** | **2,810,293** | **3,072,382** | Management Discussion and Analysis [Overview](index=14&type=section&id=Overview) The company's strategic focus is on the HBV functional cure program, advancing multiple late-stage combination therapies with three candidates receiving China CDE Breakthrough Therapy Designation, and expects no impact from recent partner restructuring - The core strategy is the HBV functional cure program, aiming to bring meaningful therapeutic impact to patients in China and globally[23](index=23&type=chunk) - Three leading HBV drug candidates (elebsiran, tobevibart, and BRII-179) have all received Breakthrough Therapy Designation from China's National Medical Products Administration (CDE)[23](index=23&type=chunk) - The company presented direct evidence for the first time, demonstrating that immune responses induced by HBV therapeutic vaccines are associated with HBsAg reduction and viral control in chronic HBV infected individuals, providing key information for late-stage clinical trials[23](index=23&type=chunk) [Product Pipeline Summary](index=15&type=section&id=Product%20Pipeline%20Summary) The company has established a pipeline of 10 innovative product candidates, primarily focusing on HBV functional cure projects in Phase 2 clinical trials for the China market, alongside other projects in infectious and central nervous system diseases Key Pipeline Product Progress | Indication | Project | Development Stage | Rights Scope | | :--- | :--- | :--- | :--- | | **Hepatitis B (Therapeutic)** | BRII-179 | Phase 2 Clinical | Global | | | Elebsiran (BRII-835) | Phase 2 Clinical | Greater China | | | Tobevibart (BRII-877) | Phase 2 Clinical | Greater China | | **HIV Infection** | BRII-732 / BRII-753 | Phase 1 Clinical / Pre-clinical | Global | | **MDR/XDR Infection** | BRII-693 | IND Application Stage | Global | | **Postpartum Depression** | BRII-296 | Phase 2 Clinical | Global | [Business Review](index=15&type=section&id=Business%20Review) During the reporting period, the company strategically increased investment in core HBV projects, advancing clinical trials and presenting key data, while actively seeking external collaborations for non-core projects to concentrate resources on HBV functional cure breakthroughs [Core Pipeline Highlights and Future Milestones](index=16&type=section&id=Core%20Pipeline%20Highlights%20and%20Future%20Milestones) HBV projects achieved key advancements, with Elebsiran and Tobevibart receiving CDE Breakthrough Therapy Designation, new BRII-179 data showing robust immune responses, and future production supply secured, with key data from multiple combination therapy studies expected in Q4 2024 - **Elebsiran & Tobevibart**: Received CDE Breakthrough Therapy Designation; data from SOLSTICE and MARCH Part B studies are expected in **Q4 2024**; preliminary results from the ENSURE study are also expected in **Q4 2024**[28](index=28&type=chunk)[29](index=29&type=chunk) - **BRII-179**: Data presented at the 2024 EASL™ Congress showed that BRII-179 in combination therapy can induce B-cell and T-cell responses associated with antiviral effects, improving HBsAg clearance rates[30](index=30&type=chunk) - The company entered into an agreement with VBI in **February 2024** to acquire the intellectual property and related manufacturing facilities for BRII-179, ensuring supply for future clinical studies[30](index=30&type=chunk) [Other Clinical and Pre-clinical Updates](index=18&type=section&id=Other%20Clinical%20and%20Pre-clinical%20Updates) The company is actively seeking external collaborations for several non-core pipeline projects, including the MDR/XDR project BRII-693 which submitted an IND in China, and HIV and CNS projects that are also seeking partners for continued development - **MDR/XDR (BRII-693)**: An IND application for a Phase 1 PK bridging study was submitted in China in **July 2024** to support global Phase 3 trials[31](index=31&type=chunk) - **HIV (BRII-753/BRII-732)**: Actively seeking development partners[32](index=32&type=chunk)[33](index=33&type=chunk) - **CNS (BRII-296/BRII-297)**: Phase 2 (PPD) and Phase 1 (Anxiety/Depression) studies have been completed, and partners are being sought for subsequent development[34](index=34&type=chunk) [Research and Development](index=20&type=section&id=Research%20and%20Development) The company views R&D as a core competency, focusing on infectious and CNS diseases through in-house development and strategic collaborations, leveraging its experienced team and cross-border capabilities to accelerate clinical development - For the six months ended June 30, 2024, the company's R&D expenses amounted to **RMB 126 million**[36](index=36&type=chunk) - The company employs a multi-pronged strategy combining in-house and collaborative R&D, leveraging its teams and partners in China and the US to accelerate clinical development[36](index=36&type=chunk) [Commercialization](index=20&type=section&id=Commercialization) As a clinical-stage biotechnology company, the current core focus is advancing the drug candidate pipeline, with no product sales or commercialization revenue expected in the short term, and commercialization strategies will be evaluated as the pipeline matures to maximize market potential - Most of the company's projects are still in clinical development, and sales or commercialization of drug candidates are not expected in the short term[36](index=36&type=chunk) [Future Development](index=21&type=section&id=Future%20Development) The company will continue to focus on HBV functional cure, leveraging trial data with partner Vir to improve cure rates and planning confirmatory clinical studies, while optimizing resources for other projects through external collaborations and expanding the pipeline via in-house R&D and strategic licensing for sustainable growth - Core Strategy: Continue to focus on HBV functional cure, advance combination therapies to the next development stage, and develop cost-effective manufacturing and supply chain plans[37](index=37&type=chunk) - Resource Optimization: Seek development collaborations for non-core projects, allowing the company to focus more on core HBV projects[37](index=37&type=chunk) - Long-term Growth: Expand the pipeline through in-house R&D and strategic licensing opportunities (in-licensing and out-licensing), and refine early-stage development strategies[37](index=37&type=chunk) Financial Review [Revenue](index=22&type=section&id=Revenue) For the six months ended June 30, 2024, the company's revenue decreased to zero from **RMB 0.6 million** in the prior year, primarily due to the termination of COVID-19 related projects - Due to the termination of COVID-19 projects, the company's revenue for H1 2024 decreased to zero from **RMB 0.6 million** in the prior year[39](index=39&type=chunk) [Other Income](index=22&type=section&id=Other%20Income) Other income for H1 2024 was **RMB 70.9 million**, a 17.5% year-over-year decrease, primarily due to a **RMB 17.3 million** reduction in recognized government grants, while bank interest income slightly increased Other Income Details (RMB in thousands) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Government Grants | 22,155 | 39,480 | | Bank Interest Income | 48,724 | 46,383 | | **Total** | **70,879** | **85,863** | [Other Gains and Losses](index=22&type=section&id=Other%20Gains%20and%20Losses) Other gains and losses significantly deteriorated, shifting from a **RMB 23.3 million** gain in the prior year to a **RMB 115 million** loss in H1 2024, a **RMB 139 million** change, primarily due to fair value losses on financial assets - Other gains and losses shifted from a **RMB 23.3 million** gain in H1 2023 to a **RMB 115 million** loss in H1 2024, primarily due to fair value losses on financial assets[40](index=40&type=chunk) [Research and Development Expenses](index=23&type=section&id=Research%20and%20Development%20Expenses) R&D expenses for H1 2024 were **RMB 126 million**, a significant 37.6% year-over-year decrease, primarily due to the company's strategic prioritization of HBV functional cure projects and organizational optimization, leading to reductions of **RMB 36.6 million** in third-party contract costs and **RMB 36.4 million** in employee costs R&D Expenses Details (RMB in thousands) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Third-Party Contract Costs | 72,081 | 108,720 | | Employee Costs | 52,902 | 89,295 | | Others | 1,186 | 4,160 | | **Total** | **126,169** | **202,175** | [Administrative Expenses](index=23&type=section&id=Administrative%20Expenses) Administrative expenses for H1 2024 were **RMB 78.6 million**, a 23.5% year-over-year decrease, primarily benefiting from reduced employee costs of **RMB 21.7 million** due to organizational optimization Administrative Expenses Details (RMB in thousands) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Employee Costs | 43,345 | 65,016 | | Professional Fees | 16,741 | 16,133 | | Others | 18,543 | 21,674 | | **Total** | **78,629** | **102,823** | [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company's total bank and cash balances (including restricted bank balances, time deposits, and cash equivalents) were **RMB 2.478 billion**, a decrease from **RMB 2.661 billion** at the end of 2023, primarily used for daily operations and R&D activities - As of June 30, 2024, total bank and cash balances were **RMB 2.478 billion**, a decrease of **RMB 183 million** from the beginning of the year[44](index=44&type=chunk) [Non-IFRS Measures](index=24&type=section&id=Non-IFRS%20Measures) To better assess operating performance, the company disclosed non-IFRS adjusted loss, which, after excluding non-cash items like share-based payment expenses, amounted to an adjusted loss of **RMB 280 million** for H1 2024, compared to **RMB 164 million** in the prior year Reconciliation of Adjusted Loss (RMB in thousands) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Loss for the Period | (283,238) | (196,826) | | Add: Share-based Payment Expenses | 3,139 | 33,126 | | **Adjusted Loss for the Period** | **(280,099)** | **(163,700)** | [Key Financial Ratios](index=25&type=section&id=Key%20Financial%20Ratios) As of June 30, 2024, the company's current ratio significantly increased to **3,781%**, reflecting strong short-term solvency, primarily due to reduced other payables from payments of most third-party contract costs, while the debt-to-asset ratio is not meaningful as interest-bearing borrowings are lower than cash Key Financial Ratios | Ratio | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Current Ratio | 3,781% | 2,211% | | Debt-to-Asset Ratio | Not Meaningful | Not Meaningful | [Debt](index=26&type=section&id=Debt) As of June 30, 2024, the company's debt level was extremely low, with no bank borrowings, significant pledges, or other similar debts apart from **RMB 17.8 million** in bills payable, and no contingent liabilities or pledged assets - Apart from **RMB 17.8 million** in bills payable, the Group has no bank financing, loans, or other similar debts[48](index=48&type=chunk) - As of June 30, 2024, the Group had no contingent liabilities or pledged assets[49](index=49&type=chunk)[52](index=52&type=chunk) Other Information [Employees and Remuneration](index=27&type=section&id=Employees%20and%20Remuneration) As of June 30, 2024, the company had **95** employees, with **66% (63 individuals)** in R&D, and total remuneration costs for H1 2024 were **RMB 96.2 million**, a significant decrease from **RMB 155 million** in the prior year, reflecting the effectiveness of organizational optimization - As of June 30, 2024, the company had **95** employees, with R&D personnel accounting for **66%**[54](index=54&type=chunk) - Total remuneration costs for H1 2024 were **RMB 96.2 million**, a significant decrease from **RMB 155 million** in the prior year[54](index=54&type=chunk) [Use of Proceeds from Global Offering](index=28&type=section&id=Use%20of%20Proceeds%20from%20Global%20Offering) The company listed in **July 2021**, with net proceeds of approximately **HKD 2.614 billion**. As of June 30, 2024, **HKD 1.422 billion** has been cumulatively utilized, with **HKD 1.192 billion** remaining unutilized. During the reporting period, **HKD 152 million** was utilized, primarily for HBV functional cure projects (**HKD 90.3 million**) and CNS projects (**HKD 40.4 million**), with remaining funds expected to be fully utilized by the end of **2027** Summary of Use of Proceeds (As of June 30, 2024) | Item | Net Allocated Amount (HKD in millions) | Cumulative Utilized (HKD in millions) | Unutilized Amount (HKD in millions) | | :--- | :--- | :--- | :--- | | **Total** | **2,613.8** | **1,422.3** | **1,191.5** | | For HBV Functional Cure Projects | 994.1 | 589.6 | 404.5 | | For CNS Projects | 496.3 | 276.9 | 219.4 | | For MDR/XDR Infection Projects | 294.0 | 60.8 | 233.2 | | For HIV Projects | 176.0 | 150.4 | 25.6 | [Corporate Governance and Compliance](index=29&type=section&id=Corporate%20Governance%20and%20Compliance) During the reporting period, the company complied with most corporate governance code provisions, with a deviation where the roles of Chairman and CEO are held by the same individual (Dr. Zhi Hong), which the Board believes benefits management and strategic execution; interim results were reviewed by external auditor Deloitte and the Audit and Risk Committee, and no interim dividend was declared - The company did not declare an interim dividend for the six months ended June 30, 2024[58](index=58&type=chunk) - The company deviated from the corporate governance code where the roles of Chairman and CEO are held by Dr. Zhi Hong, which the Board believes benefits the Group's management and strategic execution[58](index=58&type=chunk) - The interim financial statements have been reviewed by external auditor Deloitte Touche Tohmatsu and by the Board's Audit and Risk Committee[61](index=61&type=chunk)

HBV Product Development - In 2023, Brii Biosciences significantly expanded its HBV product portfolio and achieved notable clinical progress, moving closer to finding a functional cure for HBV[9]. - BRII-179 has shown promising data indicating its ability to induce a strong immune response in HBV patients, potentially identifying those most likely to achieve functional cure[10]. - The company plans to initiate late-stage clinical trials for its HBV functional cure project, focusing on scientific differentiation and expediting commercialization[4]. - BRII-179 received breakthrough therapy designation from CDE in November 2023, accelerating the provision of innovative therapies for HBV patients[16]. - Brii Biosciences is collaborating with Vir to advance multiple ongoing studies into late-stage development, including various combination therapies for HBV[13]. - The proprietary therapeutic vaccine BRII-179 aims to significantly improve the functional cure rate for HBV, with global rights expanded in July 2023 and further progress made through IP acquisition and technology transfer in February 2024[59]. - The company plans to initiate multiple combination therapy studies in the second half of 2024 to validate the potential of BRII-179 in enhancing HBV functional cure rates[80]. - The company has completed patient enrollment for the Phase 2 study of elebsiran combined with PEG-IFNα in the Asia-Pacific region, including mainland China, with preliminary topline results expected in Q4 2024[89]. - In 2023, the company gained significant insights from multiple Phase 2 combination studies, informing strategies to enhance innate immunity in HBV patients[41]. - BRII-179 demonstrated an increased HBsAg clearance rate and duration in chronic hepatitis B patients receiving PEG-IFNα treatment, potentially enhancing functional cure rates[29]. Antibiotic Development - The company acquired global exclusive rights for the development and commercialization of BRII-693, a novel antibiotic aimed at treating severe Gram-negative bacterial infections[19]. - The company is actively seeking strategic partnerships to accelerate the development of BRII-693, addressing the growing threat of antimicrobial resistance[19]. - BRII-693, a new synthetic lipopeptide for treating MDR/XDR Gram-negative bacterial infections, is being developed to address severe infections with enhanced efficacy and safety compared to currently available treatments[70]. - The company plans to initiate a large global Phase 3 registration trial for hospital-acquired bacterial pneumonia in 2025, following the pre-IND submission for BRII-693 in China[50]. - The FDA has granted QIDP designation to BRII-693, providing incentives for its development in the U.S., including eligibility for priority review[99]. Financial Performance - In 2023, the company reported total revenue of RMB 617,000, a significant decrease from RMB 51,626,000 in 2022, while other income increased to RMB 163,728,000 from RMB 107,857,000 in 2022[78]. - The net loss for 2023 was RMB 184,370,000, a reduction from RMB 489,781,000 in 2022, indicating improved financial performance[78]. - The total assets of the company as of December 31, 2023, were RMB 3,198,251,000, a decrease from RMB 3,391,849,000 in 2022[78]. - The company reported a loss before tax of RMB 184,370,000, significantly improved from a loss of RMB 489,781,000 in the previous year[171]. - Basic and diluted loss per share was RMB 0.24, an improvement from RMB 0.67 in the previous year[172]. - The total comprehensive loss for the year was RMB 159,687,000, down from RMB 238,456,000 in 2022[171]. - The company generated bank interest income of RMB 108.02 million, compared to RMB 37.20 million in the previous year[150]. - The company incurred research and development (R&D) expenses of RMB 402.7 million for the year ended December 31, 2023[134]. Corporate Governance and Management - The company has adopted a board diversity policy that considers multiple factors such as gender, skills, age, and professional experience when selecting board candidates[114]. - The board consists of eight members, including two executive directors, one non-executive director, and five independent non-executive directors, with 25.0% (2) being female[115]. - The senior management team has a gender distribution of 40.0% (4) female and 60.0% (6) male, while overall employees are 65.4% (89) female and 34.6% (47) male[117]. - The strategic committee is chaired by an executive director and includes independent non-executive directors, ensuring diverse oversight in strategic decisions[117]. - The company is committed to enhancing its corporate governance infrastructure, including systems across various business units and departments[124]. Research and Development - The company has established a pipeline of 10 innovative candidate products focusing on infectious diseases and CNS disorders, with a strong emphasis on HBV functional cure projects primarily conducted in China[64]. - The company is actively seeking collaboration opportunities for the further development of BRII-753[92]. - The Phase 1 clinical trial of BRII-297, a long-acting injectable for treating anxiety and depression, has completed patient dosing, with data expected in the second half of 2024[94]. - The company is exploring the potential of BRII-179 in selecting suitable patients for better efficacy outcomes in HBV treatment[89]. - The company plans to continue expanding its market presence and investing in new technologies and products[134].

智通财经APP讯，腾盛博药-B(02137)公布2023年业绩，其他收入为人民币1.637亿元，同比增长51.7%。研发开支为人民币4.03亿元，同比减少8.6%。公司拥有人应占亏损1.75亿元，同比收窄63.9%;每股亏损0.24元。 公告称，其他收入增长主要是由于美元及港元定期存款利率上升导致银行利息收入增加人民币7080万元。该增加部分被中国政府补助确认的收入减少所抵销。研发开支减少主要是由于COVID-19项目终止。 截至本公告日期，集团的主要工作重点是打造候选药物管线。集团的大多数项目均在不同阶段的临床开发中，预计未来短期内不会实现其他候选药物的销售或商业化。该集团正在为PreHevbriTM寻求在亚太地区进行商业化的合作伙伴。随着管线逐渐成熟，集团将对商业化战略方案进行评估，确保最大限度地发挥其潜力，以解决尚未得到满足的关键需求。 于报告期间，腾盛博药在其多样化产品组合中取得了重大里程碑，尤其是推进了其领先的乙型肝炎病毒项目。通过持续进行联合研究及建立战略合作伙伴关系，集团正积极努力巩固我们专有的治疗性疫苗BRII-179在治疗HBV中的地位，旨在大幅提高HBV功能性治愈率。基于关键数据结果以及即 ...

Financial Performance - For the year ended December 31, 2023, administrative expenses were RMB 196.5 million, an increase of RMB 27.9 million or 16.5% compared to RMB 168.6 million for the year ended December 31, 2022, primarily due to increased employee costs [3]. - The group reported a pre-tax loss of RMB 184.4 million for the year ended December 31, 2023, compared to a loss of RMB 489.8 million for the previous year [5]. - The basic and diluted loss per share for the year ended December 31, 2023, was RMB 0.24, compared to RMB 0.67 for the previous year [26]. - The company reported a loss attributable to shareholders of RMB 174,829 thousand for the year ended December 31, 2023, compared to a loss of RMB 484,312 thousand for the year ended December 31, 2022, representing a significant improvement [64]. - The company reported a net loss of RMB 184.4 million for the year ended December 31, 2023, compared to a net loss of RMB 489.8 million for the year ended December 31, 2022 [110]. - Adjusted net loss for the year ended December 31, 2023, was RMB 120.1 million, significantly improved from RMB 411.9 million in the previous year [110]. - Other income for the year was RMB 163.7 million, an increase of RMB 55.8 million or 51.7% compared to RMB 107.9 million for the year ended December 31, 2022, mainly due to increased bank interest income from rising interest rates [22]. - The company reported a significant turnaround in other income and losses, moving from a loss of RMB 12.3 million in 2022 to a profit of RMB 252.4 million in 2023, driven by fair value gains on financial assets [105]. Revenue and Sales - The group generated revenue from pharmaceutical sales of RMB 617,000 for the year, a significant decrease from RMB 51.6 million in 2022 [17]. - Total revenue for the year ended December 31, 2023, was RMB 163.7 million, an increase from RMB 107.9 million in the previous year, driven by bank interest income rising to RMB 108.0 million [126]. Research and Development - R&D expenses for the year ending December 31, 2023, amounted to RMB 402.7 million, reflecting the company's commitment to drug development [98]. - Research and development expenses for the year ended December 31, 2023, were RMB 402.7 million, down from RMB 440.6 million in the previous year [129]. - The company has established a pipeline of over 10 innovative candidate products, focusing on infectious diseases and central nervous system diseases, with a key project aimed at functional cure for HBV primarily in China [71]. - The company is actively seeking partnerships to continue developing its CNS candidates and HIV projects, aiming for commercialization in China and other Asia-Pacific regions [123]. - The company plans to expand its pipeline through in-house R&D and licensing opportunities, focusing on therapies for HBV and other diseases [100]. Strategic Initiatives - The company is focused on advancing treatments for infectious diseases and other significant public health burdens in China and globally [28]. - The company plans to initiate additional combination therapy studies in the second half of 2024 to enhance HBV functional cure rates, focusing on BRII-179 and other therapies [42]. - The company is seeking strategic funding partners to accelerate the development of BRII-693, addressing the growing threat of antimicrobial resistance [53]. - The company aims to optimize its organizational structure to support sustainable long-term growth and address global public health challenges [100]. Acquisitions and Partnerships - The company has agreed to acquire all rights, title, and interest related to BRII-179 from VBI, including a technology transfer and a license for VBI-1901 in the Asia-Pacific region, excluding Japan [40]. - The company has entered into agreements with VBI for the acquisition of BRII-179 and related technologies, enhancing its product portfolio [101]. - The company is actively seeking commercial partners for the commercialization of PreHevbriTM, having submitted two IND applications for registration in China [80]. - The FDA granted QIDP designation to BRII-693, providing incentives for its development in the U.S., including eligibility for priority review [82]. Employee and Administrative Costs - Employee costs for the year ended December 31, 2023, were RMB 126.5 million, up from RMB 100.8 million in the previous year, attributed to an increase in average employee numbers and a one-time charge for share-based compensation [108]. - The company’s prepaid expenses rose to RMB 47,685 thousand in 2023 from RMB 19,589 thousand in 2022, indicating a 143% increase [65]. - Research and development payables decreased to RMB 20,539 thousand in 2023 from RMB 113,531 thousand in 2022, reflecting an 82% reduction [66]. - As of December 31, 2023, the total employee count was 128, with a compensation cost of RMB 302 million, up from RMB 294 million in 2022 [141][167]. Governance and Compliance - The board has established an audit and risk committee composed of three independent non-executive directors to oversee financial reporting and risk management [148]. - The board consists of two executive directors, one non-executive director, and five independent non-executive directors, ensuring a high level of independence [176]. - The company has adopted its own code of conduct for securities trading by directors, which is at least as stringent as the standards set out in the listing rules [177]. Future Outlook - The company plans to initiate a global Phase 3 registration trial for hospital-acquired bacterial pneumonia in 2025, following the submission of a pre-IND application for BRII-693 in April 2023 [90]. - The company expects to utilize the net proceeds from its fundraising by the end of 2026 [143]. - The company will hold its annual general meeting on June 25, 2024, with a share transfer registration suspension from June 20 to June 25, 2024 [174].

Pipeline Development - The company is developing a broad pipeline of candidate therapies focusing on infectious diseases and central nervous system disorders, with a particular emphasis on hepatitis B virus (HBV) and postpartum depression treatments [4]. - The company has a pipeline of over 10 innovative candidate products, focusing on infectious diseases and central nervous system disorders, with key projects in HBV and postpartum depression [13]. - The company is exploring a range of potential combination therapies to enhance the likelihood of achieving high functional cure rates for HBV patients [4]. - The company is advancing clinical development of BRII-296 for PPD/MDD and anxiety disorders, and BRII-297 for various anxiety disorders and depression [30]. - The company is actively pursuing other promising projects beyond HBV, including BRII-296 for PPD and MDD as a potential first-in-class treatment [54]. - The company is exploring external collaboration opportunities to continue the development of BRII-732 as a potential long-acting combination therapy for HIV patients [182]. - The company is actively working to expand the clinical indications for BRII-296, with plans to initiate further studies in the U.S. in 2024 [188]. Market Opportunities - China has approximately 87 million HBV infected individuals and 200 million susceptible individuals, representing a significant market opportunity for the company's preventive and therapeutic solutions [4]. - There is a high unmet demand for HBV vaccination among high-risk adult populations in China and other Asia-Pacific countries, with over 200 million individuals aged 19 to 64 lacking anti-HBs protection [27]. - The company is positioned as a leading participant in the pursuit of eliminating hepatitis B, leveraging its strong HBV assets and recent licensing agreements [11]. - The company aims to establish a patient-centered global strategy based on a strong cultural foundation to address public health challenges [30]. Strategic Partnerships and Collaborations - The company has established strategic licensing collaborations with Vir Biotechnology, Inc. and VBI Vaccines Inc., enhancing its product pipeline with differentiated preventive vaccines and assets aimed at improving functional cure rates for HBV patients [4]. - The company is actively seeking external strategic partnerships for its HIV program in the U.S. to continue developing long-acting treatment options for HIV patients [13]. - The company signed a final licensing agreement with VBI to develop and commercialize PreHevbri® in Greater China and several other Asia-Pacific countries [49]. - The company entered into a licensing agreement with VBI Vaccines, Inc. in July 2023, acquiring global exclusive development and commercialization rights for BRII-179 (VBI-2601) and exclusive rights for PreHevbri® in Greater China and several other Asia-Pacific countries, with an upfront licensing fee of USD 7 million [133]. Clinical Trials and Results - The company completed enrollment of approximately 120 patients in a Phase 2 trial for BRII-179 (VBI-2601) and BRII-835 (VIR-2218) combination therapy [39]. - 67% of participants in a study met criteria to stop NRTI treatment, indicating potential effectiveness of BRII-877 (VIR-3434) [45]. - The mid-term results presented at the 2023 APASL conference showed that the combination therapy of BRII-835 and BRII-179 induced a stronger anti-HBsAg antibody response compared to monotherapy [60]. - In June 2023, data from the Phase 2 MARCH trial A part indicated that HBsAg levels in participants decreased by 2.7-3.1 log10 IU/mL, with 90% of participants achieving HBsAg levels below 10 IU/mL by the end of treatment [94]. - The company plans to announce preliminary data from the ongoing Phase 2 MARCH trial B part in the second half of 2023 regarding the combination of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) with or without PEG-IFN-α [86]. Financial Performance - As of the report date, 26.3% of patients receiving BRII-179/PEG-IFNα treatment achieved HBsAg clearance at week 24, compared to 19.3% in the placebo group [62]. - The company reported a net loss of RMB 3,632,061 thousand for the first half of 2023, compared to a loss of RMB 2,433,742 thousand in the same period last year, indicating a worsening financial position [116]. - The company’s management compensation for the first half of 2023 totaled RMB 44,829 thousand, down from RMB 59,565 thousand in the same period of 2022, indicating a reduction of about 24.7% [119]. - The company has recognized an impairment loss of RMB 5,432,000 related to a terminated R&D project, which was included in other income and loss items [176]. - Government subsidies received amounted to RMB 39,480,000, an increase from RMB 27,885,000 in the same period last year, representing a growth of approximately 41% [156]. Product Development and Commercialization - The company has expanded its global development and commercialization rights for BRII-179 and obtained rights for the new HBV preventive vaccine PreHevbri® in Greater China and several other Asia-Pacific regions [11]. - The company is advancing its product pipeline and business operations, particularly optimizing its HBV product portfolio based on strong research data, expanding global development and commercialization rights for BRII-179 and BRII-693 [57]. - The company has acquired global exclusive rights for the BRII-693 treatment for MDR/XDR Gram-negative bacterial infections, enhancing its product offerings [57]. - PreHevbri® is the only three-antigen adult HBV preventive vaccine on the market, showing a higher and more durable seroprotection rate compared to the single-antigen HBV vaccine Engerix-B, with antibody titers up to 5 to 8 times higher [70]. Research and Development Focus - The company is committed to a patient-centered approach, strengthening relationships with patients, caregivers, and advocacy organizations to ensure patient voices are heard throughout the development process [6]. - The company emphasizes the importance of patient needs in its research and development efforts, focusing on infectious and mental diseases [198]. - The company is focusing on enhancing its research and development capabilities to support the launch of new therapies and improve its competitive position in the market [108]. - The company plans to expand its R&D capabilities and may consider establishing more laboratories to support international goals, particularly in the U.S. [199]. Management and Governance - In July 2023, Dr. David Margolis was appointed as Chief Medical Officer, succeeding Dr. Li Yan [197].

Financial Performance - For the six months ended June 30, 2023, other income was RMB 859 million, an increase of RMB 477 million or 124.9% compared to RMB 382 million for the same period in 2022[19]. - Research and development expenses for the six months ended June 30, 2023, were RMB 202.2 million, a decrease of RMB 56.3 million or 21.8% from RMB 258.5 million for the same period in 2022[19]. - Administrative expenses for the six months ended June 30, 2023, were RMB 102.8 million, an increase of RMB 7.3 million or 7.6% compared to RMB 95.5 million for the same period in 2022[19]. - Total comprehensive expenses for the six months ended June 30, 2023, were RMB 104.0 million, a decrease of RMB 113.7 million or 52.2% from RMB 217.7 million for the same period in 2022[19]. - For the six months ended June 30, 2023, the company reported a loss of RMB 196.83 million compared to RMB 365.61 million for the same period in 2022[51]. - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.26, compared to RMB 0.48 for the same period in 2022[51]. - The company reported a significant increase in other income and losses, moving from a loss of RMB 34.0 million to a gain of RMB 23.3 million for the six months ended June 30, 2023[155]. - Adjusted loss for the six months ended June 30, 2023, was RMB 163.7 million, compared to an adjusted loss of RMB 311.6 million for the same period in 2022[163]. Assets and Liabilities - As of June 30, 2023, total assets minus current liabilities amounted to RMB 3,086,766 thousand, a decrease from RMB 3,162,736 thousand as of December 31, 2022, reflecting a decline of approximately 2.4%[52]. - Non-current assets totaled RMB 350,032 thousand, compared to RMB 314,950 thousand as of December 31, 2022, indicating an increase of about 11.1%[52]. - Current assets decreased to RMB 2,848,316 thousand from RMB 3,076,899 thousand, representing a decline of approximately 7.4%[52]. - The company's net asset value as of June 30, 2023, was RMB 3,086,766 thousand, down from RMB 3,157,497 thousand at the end of 2022, a decrease of about 2.2%[55]. - The total cash and cash equivalents as of June 30, 2023, were RMB 487,494 thousand, significantly lower than RMB 1,190,572 thousand as of December 31, 2022, indicating a decrease of approximately 59.1%[52]. - The company’s total liabilities decreased to RMB 111,582 thousand from RMB 229,113 thousand, a reduction of approximately 51.3%[52]. - The current ratio increased to 2,553% as of June 30, 2023, from 1,343% as of December 31, 2022, due to the payment of most third-party contract costs[167]. Research and Development - The company is focusing on the clinical development of a functional cure for hepatitis B in China and a potential first-in-class treatment for postpartum depression and major depressive disorder in the U.S.[21]. - The company has expanded its licensing agreement with VBI to strengthen its core HBV assets, holding global exclusive rights to BRII-179 (VBI-2601) as part of a functional cure strategy[22]. - The company is developing new combination therapies for specific subpopulations of HBV patients to enhance functional cure rates and improve treatment decision adoption[23]. - Data presented at the 2023 European Association for the Study of the Liver conference highlighted the potential for achieving best-in-class functional cure in a broad HBV patient population[23]. - The company initiated an additional Phase 2 study of BRII-835 combined with PEG-IFN-α after receiving regulatory approvals from multiple Asia-Pacific authorities, including IND approval from the National Medical Products Administration in July 2023, with the first patient dosed in August 2023[25]. - The company is actively exploring collaboration opportunities to further develop a long-acting combination therapy for HIV patients, aiming for dosing intervals of once a week to once every six months[25]. - The company is focusing on central nervous system projects, with plans to initiate a Phase 2 trial for BRII-296 in the treatment of postpartum depression (PPD) in the United States in Q3 2023[25]. - The company is developing a series of novel HBV therapeutic candidates aimed at improving functional cure rates for chronic HBV patients[95]. - The pipeline includes candidates for postpartum depression and anxiety disorders, with BRII-296 and BRII-297 being developed globally[93]. Clinical Trials and Approvals - The company reported that in the Phase 2 VIR-2218 (BRII-835) trial, 16% of subjects maintained HBsAg clearance 24 weeks post-treatment, with a significant correlation between anti-HBs titers greater than 500 mIU/mL at the end of treatment and sustained HBsAg clearance[29]. - The company completed the acquisition of global exclusive rights to BRII-693 (formerly QPX9003) for the treatment of MDR/XDR infections, receiving approximately $24 million post-acquisition[25]. - The company received IND approval for BRII-877 (VIR-3434) Phase 1 clinical study in China, expected to start by the end of 2023[44]. - The company has received regulatory approvals for BRII-835 (VIR-2218) and PEG-IFN-α combination therapy in multiple Asia-Pacific regions, including China[103]. - The company plans to announce preliminary data from the ongoing Phase 2 MARCH trial B section in the second half of 2023[108]. - The company has initiated a Phase 1 clinical trial for BRII-297, aimed at treating various anxiety disorders and depression[116]. - The company has launched a Phase 1 study for BRII-732, an oral drug for potential HIV treatment, with lower dose weekly administration[119]. Market and Commercialization - PreHevbri®, a differentiated adult HBV preventive vaccine, has recently been approved for use in the U.S., EU/EEA, UK, Canada, and Israel, with market registration applications submitted in Hong Kong[22]. - The company is planning the market authorization pathway for PreHevbri® in the Asia-Pacific region, prioritizing areas that may not require additional trials, with a market authorization application submitted in Hong Kong[27]. - The company aims to optimize its organizational structure in China and the U.S. to support business development and address global public health challenges[85]. - The company is actively pursuing market registration for PreHevbri® in the Asia-Pacific region, with an application submitted for Hong Kong[113]. - The company plans to commercialize PreHevbri® in China and other Asia-Pacific regions while further developing BRII-296 and BRII-297 for various anxiety and depression disorders[85]. Governance and Corporate Structure - The company is committed to enhancing its governance strategy and optimizing its executive team to effectively guide public health-oriented projects through clinical development[27]. - The board consists of two executive directors, one non-executive director, and five independent non-executive directors, ensuring a high level of independence[193]. - The company’s governance practices adhere to the corporate governance code, with a commitment to maintaining high standards to protect shareholder interests[192]. - The external auditor, Deloitte, reviewed the unaudited consolidated financial statements for the six months ending June 30, 2023[197]. - The Audit and Risk Committee consists of three independent non-executive directors, ensuring compliance with listing rules and financial expertise[197]. Employee and Operational Insights - The total number of employees was 133, with 69% in R&D and 31% in administration[177]. - The company has implemented a share incentive plan to motivate and reward employees[178]. - The company has made sufficient provisions for employee benefits in accordance with applicable regulations, including retirement and medical insurance plans[184]. - The company confirmed lease liabilities of RMB 8.0 million as of June 30, 2023, related to operating lease arrangements[172]. - The company’s cash primarily comes from equity financing, with investments focused on low-risk instruments to generate financial income above current bank deposit rates[186].

(b) 根據首次公開發售後購股權計劃（包括已授出但尚未行使的購股權及可供日 後授出的購股權）可供發行的股份總數為69,792,092股股份，相當於2022年年 報日期已發行股份約9.59%；及 有關截至2022年12月31日止年度之年報的 補充公告 除2022年年報所載董事會報告「股份激勵計劃」一節及綜合財務報表附註25的披露 外，本公司謹此根據上市規則第17.09(3)條提供以下與股份激勵計劃有關的額外 資料： (c) 根據首次公開發售後股份獎勵計劃（包括已授出但尚未歸屬的股份獎勵及可 供日後授出的股份獎勵）可供發行的股份總數為34,384,784股股份，相當於 2022年年報日期已發行股份約4.73%。 承董事會命 騰盛博藥生物科技有限公司 主席 Zhi Hong博士 於本公告日期，董事會包括執行董事Zhi Hong博士及李安康博士；非執行董事 Robert Taylor Nelsen先生；以及獨立非執行董事Martin J Murphy Jr博士、Grace Hui Tang女士、徐耀華先生、Gregg Huber Alton先生及楊台瑩博士。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的 ...

Financial Performance - The company achieved a revenue of RMB 51,626 thousand in 2022, with other income increasing to RMB 107,857 thousand, representing a growth of approximately 8.5% from the previous year[4]. - The company reported a net loss of RMB 489,781 thousand for 2022, a significant reduction compared to the net loss of RMB 4,191,084 thousand in 2021, indicating improved financial performance[4]. - The adjusted loss for 2022 was RMB 411,853 thousand, a decrease from RMB 480,730 thousand in 2021[154]. - The company’s research and development expenses for the year ended December 31, 2022, were RMB (440,634) thousand, compared to RMB (494,615) thousand in 2021[166]. - The total administrative expenses for the year ended December 31, 2022, were RMB (168,629) thousand, down from RMB (208,404) thousand in 2021[166]. - The total employee compensation cost for the year ended December 31, 2022, was RMB 294 million, an increase from RMB 264 million for the year ended December 31, 2021[190]. Pipeline and Product Development - The company has a diverse pipeline with over 10 therapeutic candidates for infectious and CNS diseases, showcasing its commitment to innovation and addressing public health challenges[12]. - The company is focusing on developing a functional cure for chronic hepatitis B virus (HBV) in China, targeting a market with approximately 87 million infected individuals[13]. - The company plans to expand its pipeline through internal research and licensing agreements, aiming to accelerate global regulatory approvals and business development opportunities[14]. - The company has established over 10 innovative drug candidates, with key projects targeting HBV in China and PPD/MDD in the United States[20]. - The company is focusing on the development of a functional cure for chronic HBV infection, which has significant health impacts in China, leveraging partnerships with Vir and VBI for innovative drug candidates[25]. - The company is actively exploring the expansion of its therapeutic indications for major depressive disorder (MDD) and postpartum depression (PPD) in the United States[10]. - The company aims to establish external strategic partnerships for its HIV program, focusing on long-acting single-tablet regimens for patients[14]. - The company is committed to addressing unmet medical needs through innovative therapies for infectious diseases and CNS disorders[48]. - The candidate drug pipeline is primarily in various stages of clinical development, with no expected sales or commercialization in the short term due to ongoing trials[140]. Clinical Trials and Studies - The BRII-296 project for treating postpartum depression and anxiety disorders is set to expand its clinical indications in 2023, with positive early feedback from doctors and patients[26]. - The company plans to initiate the first human PK, safety, and tolerability studies for BRII-297, aimed at treating various anxiety disorders and depression[26]. - The company has completed the first part of a Phase 2 trial involving approximately 120 patients to evaluate the administration of BRII-179 (VBI-2601) in chronic HBV patients[62]. - The company presented initial data from the ongoing Phase 2 MARCH study, showing that the combination therapy of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) significantly reduced HBsAg levels in chronic HBV patients compared to monotherapy, with no safety signals reported[83]. - More data from the Phase 2 MARCH study is expected in the first half of 2023, with preliminary results from the B part of the trial anticipated in the second half of 2023[84]. - The company plans to initiate additional Phase 2 studies for BRII-296 in the U.S. by the end of 2023, expanding its clinical indications[90]. Strategic Partnerships and Collaborations - The company is actively pursuing a business model that combines in-house research and licensing to accelerate clinical projects and capitalize on commercialization opportunities[24]. - The company is exploring collaboration opportunities for the development of long-acting HIV treatment options, including the candidate drug BRII-732[26]. - The company has established strategic partnerships with global pharmaceutical and biotechnology companies, enhancing its research and development capabilities[136]. - The company is maintaining close collaboration with partners in the U.S. to advance clinical development projects for MDR/XDR candidates, with plans to begin subsequent development in China later this year[27]. - The company is leveraging clinical data from partners in China to accelerate clinical development and participate in late-stage global studies[134]. Market Presence and Recognition - The company received an "A" rating in the MSCI ESG Rating, reflecting its effective management of long-term ESG risks[2]. - The company was included in the MSCI China Small Cap Index in 2022, enhancing its visibility and liquidity in the capital markets[2]. - The company has received over 10 awards and recognitions in 2022, reflecting its progress and commitment to creating sustainable value for stakeholders[18]. - The company received multiple industry recognitions, including the "Top 10 Biotech Companies with ESG Investment Value" award from E药经理人 in 2022[58]. Financial Position and Assets - As of December 31, 2022, the company's total assets amounted to RMB 3,391.8 million, while total liabilities were RMB 234.4 million, resulting in a net asset value of RMB 3,157.5 million[56]. - The current ratio as of December 31, 2022, was 1,343%, an increase from 1,215% as of December 31, 2021[175]. - The company has no interest-bearing borrowings, rendering the debt-to-equity ratio meaningless[171]. - As of December 31, 2022, the company had no secured, unsecured, or collateralized unused bank financing, significant pledges, or similar debts[176]. - The company has no assets pledged to any person or financial institution as of December 31, 2022[185]. Leadership and Governance - The board of directors comprises industry experts with extensive experience in drug development and commercialization processes[137]. - Nelsen served on the boards of multiple publicly listed companies, including Renovation Healthcare Acquisition Corp. (REVH) and Sienna Biopharmaceuticals, Inc. (SNNA) from 2021 to 2022[196]. - Dr. Martin J. Murphy Jr. was appointed as an independent non-executive director on June 22, 2021, and serves as the chairman of the compensation committee[197]. - Grace Hui Tang has been an independent non-executive director since June 22, 2021, and is currently the co-chair of the audit and risk committee[198]. - Mr. Xu Yaohua was appointed as an independent non-executive director on June 22, 2021, and is a member of the audit and risk committee[200].

Financial Performance - The company reported a loss attributable to shareholders of RMB 484.3 million for the year, compared to a loss of RMB 4.16 billion in the previous year[2]. - The average weighted number of ordinary shares for basic and diluted loss per share was 723,478 thousand shares, up from 439,047 thousand shares[2]. - For the year ended December 31, 2022, revenue increased from zero to RMB 516 million, primarily due to the commercialization of long-acting amubarvimab/romlusevimab combination therapy for COVID-19 in China[35]. - Other income for the year ended December 31, 2022, was RMB 107.9 million, an increase of RMB 8.9 million or 9.0% compared to RMB 99.0 million for the year ended December 31, 2021, mainly due to increased bank interest income from higher cash balances[35]. - Research and development expenses for the year ended December 31, 2022, were RMB 440.6 million, a decrease of RMB 54.0 million or 10.9% from RMB 494.6 million for the year ended December 31, 2021, primarily due to reduced third-party contracting costs related to COVID-19 projects[35]. - Administrative expenses for the year ended December 31, 2022, were RMB 168.6 million, a decrease of RMB 39.8 million or 19.1% from RMB 208.4 million for the year ended December 31, 2021, mainly due to reduced employee costs[35]. - Total comprehensive expenses for the year ended December 31, 2022, were RMB 238.5 million, a decrease of RMB 4,010.5 million or 94.4% from RMB 4,249.0 million for the year ended December 31, 2021, primarily due to reduced fair value losses on financial liabilities[36]. - The company reported total revenue of RMB 51,626,000 for the year ended December 31, 2022, compared to zero in 2021, indicating a significant growth in sales[107]. - The company incurred a net loss of RMB 489,781,000 for the year ended December 31, 2022, a decrease from a net loss of RMB 4,191,084,000 in 2021, reflecting improved financial performance[100]. - The company reported other comprehensive income of RMB 251,325,000 for the year ended December 31, 2022, compared to a loss of RMB 57,867,000 in 2021, indicating a positive shift in overall financial health[100]. Product Development and Pipeline - The company is advancing its HBV treatment pipeline, including BRII-877 (VIR-3434), which is a promising monoclonal antibody with significant potential[7]. - The company has over 10 candidate products in its pipeline, including BRII-732 and BRII-753 for HIV treatment, and BRII-179, BRII-835, and BRII-877 for HBV functional cure[11]. - The company plans to initiate more Phase 2 studies for BRII-296 in the U.S. by the end of 2023, targeting additional clinical indications[19]. - The company is exploring external collaboration opportunities to continue developing BRII-732 as a potential weekly oral treatment for HIV patients[21]. - The company has received positive early feedback for BRII-296 as a pioneering single-injection treatment for postpartum depression in the U.S.[28]. - The company is collaborating with Qpex to develop MDR/XDR therapies, holding exclusive rights for BRII-636, BRII-672, and BRII-693 in the Greater China region[33]. - BRII-693 is a new synthetic lipopeptide under development for treating MDR/XDR Gram-negative bacterial infections, showing enhanced efficacy and improved safety compared to currently available treatments[34]. - The company has established a diverse product pipeline with over 10 candidate products, primarily in clinical development, focusing on innovative treatments for infectious diseases and central nervous system disorders[37]. - The company plans to advance its product portfolio development to address significant unmet medical needs and alleviate public health burdens[42]. - The company is preparing to launch a Phase 2 validation trial for BRII-296 in patients with postpartum depression in the United States[39]. - The company received notification in December 2022 that the FDA lifted the clinical trial hold on its Phase 1 study of BRII-732, allowing for a lower dose weekly oral administration study[51]. - The company is exploring collaboration opportunities to continue the development of BRII-732 as a potential long-acting combination therapy for HIV patients[51]. - The company has selected a new clinical candidate drug BRII-753 for long-acting subcutaneous therapy, aiming to extend the dosing interval to once a month, once a quarter, or once every six months[71]. - The company is developing BRII-179 (VBI-2601), a novel HBV immunotherapy candidate, with expected Phase 2 study data in the second half of 2023[125]. - BRII-877 (VIR-3434) is being developed as a subcutaneous monoclonal neutralizing antibody for HBV, aiming to block all ten genotypes of HBV[128]. - The company is focusing on developing long-acting therapies for mental health disorders, addressing the unmet treatment needs in the industry[129]. - The company is actively exploring collaboration opportunities to continue developing its internally developed candidate drug BRII-732 as a long-acting therapy for HIV patients[138]. - BRII-732 is a proprietary prodrug NCE that rapidly metabolizes into EFdA and is being evaluated as a potential HIV treatment or prevention option[165]. - The company has advanced the commercialization of a long-acting neutralizing antibody cocktail therapy for COVID-19 in China since July 2022[119]. Strategic Partnerships and Collaborations - The company aims to establish external strategic partnerships for its HIV project in the U.S. to develop a long-acting single tablet regimen for HIV patients[9]. - The company aims to become a leader in achieving functional cure for HBV, leveraging strategic partnerships to develop new combination therapies[62]. - The company is seeking partners to co-develop a weekly oral formulation BRII-732 for the treatment or prevention of HIV, and a new low-volume subcutaneous injection therapy BRII-753, which may allow for administration once a month or every six months[132][138]. - The company is closely discussing with the FDA to reach consensus on the PPD treatment plan in preparation for a Phase 2 POC study[163]. Governance and Organizational Structure - The company expanded its executive leadership team and strengthened its board structure, appointing Dr. Li Ankang as Executive Director and Chairman of the Strategy Committee, and Dr. Yang Taiying as Independent Non-Executive Director and Co-Chair of the Audit and Risk Committee[54]. - The company was included in the MSCI China Small Cap Index in May 2022, enhancing its visibility and recognition among global investors[54]. - The company has received an MSCI ESG rating of "A," indicating its capability to address long-term ESG risks[74]. - The company has adopted corporate governance practices to enhance accountability and shareholder value[187]. - The roles of the Chairman and CEO are held by Dr. Zhi Hong, which deviates from the corporate governance code but is believed to benefit the group's management[189]. Financial Management and Resources - The company’s cash and bank balances were less than 9% held in SVB as of February 28, 2023, ensuring liquidity and risk management following the bank's closure[91]. - The company has no assets pledged to any individuals or financial institutions as of December 31, 2022[190]. - The company faces foreign exchange risks, with 40% of its restricted bank deposits and cash denominated in USD, 36% in HKD, and 24% in RMB as of December 31, 2022[191]. - The company emphasizes maintaining liquidity and capital preservation in its treasury policy, primarily investing in low-risk instruments[195]. - The company has adopted a share incentive plan to provide incentives and rewards to its employees[194]. - The total salary cost for the year ended December 31, 2022, was RMB 294 million, an increase from RMB 264 million for the year ended December 31, 2021[194]. - The company has adjusted its R&D resource allocation to focus on core pipeline products, reducing investment in non-core pipeline products[198]. Research and Development Focus - The company plans to expand the clinical indications for BRII-296 and initiate the first human PK, safety, and tolerability study for BRII-297 in 2023, indicating ongoing investment in R&D[93]. - The company has initiated IND pre-preparation studies for BRII-297 targeting various anxiety disorders and depression, showcasing its commitment to addressing mental health challenges[94]. - Significant progress has been made in CNS projects, with the company preparing for its Phase 2 POC study and expanding clinical indications for BRII-296[176]. - The company plans to initiate a Phase 1 study for BRII-297 in 2023, targeting various anxiety disorders and depression[176]. - The company has updated its funding allocation for CNS projects to reflect strategic focus and anticipated increases in CNS R&D activities[176].

Product Development and Pipeline - The company has a diverse product pipeline with over 10 candidates primarily in clinical development, focusing on major infectious diseases and CNS disorders[3] - The company is advancing its HBV treatment candidates, with BRII-835 and BRII-179 currently in Phase 2 trials in China, and new data expected by the end of 2022[5] - The company plans to initiate Phase 2 studies for BRII-296 (postpartum depression) and Phase 1 studies for BRII-297 (anxiety and depression) in Q4 2022[7] - The company is focusing on a functional cure for chronic HBV infection, leveraging partnerships with Vir and VBI, and has introduced BRII-877, a promising HBV neutralizing monoclonal antibody[31] - The company is actively pursuing a combination therapy for HBV and plans to advance clinical development for CNS-related treatments under new leadership[35] - The company has established over 10 innovative candidate products focusing on infectious diseases and mental health, with options to license two additional innovative projects from partners[37] - The company is developing a long-acting, once-weekly oral treatment for HIV patients, with preliminary feedback from the FDA regarding the lifting of a clinical trial hold[34] - The company is focusing on developing BRII-179 (VBI-2601) and BRII-835 (VIR-2218) as a potential functional cure for HBV[47] - The company is conducting a Phase 1 study for BRII-296, a novel single-dose therapy for postpartum depression, with preliminary safety and pharmacokinetic data expected in the second half of 2022[74] - BRII-297, a new chemical entity for treating various anxiety disorders and depression, is in the IND preparation stage, with plans to initiate Phase 1 clinical studies in Q4 2022[78] Clinical Trials and Regulatory Approvals - The FDA has provided guidance for resuming clinical trials for BRII-732, which is currently on hold due to safety signals, with plans to advance the combination therapy with BRII-778[7] - The Phase 2 multi-regional clinical trial for the combination therapy of BRII-179 (VBI-2601) and BRII-835 (VIR-2218) has completed enrollment of 90 patients in the Asia-Pacific region[48] - The company plans to initiate discussions with CDE for pivotal studies in 2023 if the Phase 2 trial results are positive[50] - The Phase 2a study for BRII-179 (VBI-2601) and PEG-IFN-α combination therapy aims to enroll approximately 120 patients, with the first part expected to complete enrollment in Q4 2022[53] - The Phase 2b study for BRII-179 (VBI-2601) and PEG-IFN-α combination therapy will expand to 480 patients to evaluate the proportion achieving functional cure[53] - The company aims to resume clinical trials for BRII-732 by the end of 2022, following discussions with the FDA regarding safety signals[85] Financial Performance and Expenses - R&D expenses for the first half of 2022 amounted to RMB 258.5 million, reflecting the company's commitment to expanding its life sciences research and product pipeline[118] - R&D expenses increased from RMB 157.6 million in the six months ended June 30, 2021, to RMB 258.5 million in the six months ended June 30, 2022, representing a growth of 64.1%[132] - The increase in R&D expenses was primarily due to a rise in third-party contract costs by RMB 68.7 million, mainly related to drug production quality management activities in China[132] - Administrative expenses rose from RMB 67.99 million in the six months ended June 30, 2021, to RMB 95.47 million in the six months ended June 30, 2022, an increase of 40.5%[134] - The total salary cost incurred for the six months ended June 30, 2022, is RMB 157.4 million, compared to RMB 94.6 million for the same period in 2021, representing a 66.4% increase[155] - The adjusted loss for the period was RMB 311.6 million for the six months ended June 30, 2022, compared to an adjusted loss of RMB 152.8 million for the same period in 2021[140] Leadership and Organizational Changes - The leadership team has expanded with the addition of four new executives to enhance public health project guidance[4] - The company has expanded its leadership team with key appointments, including Karen D. Neuendorff as Chief Human Resources Officer and Susannah Cantrell as Chief Business Officer, to enhance its human-centric initiatives and global product pipeline strategy[29] - The company has made significant progress in expanding its executive leadership team during the reporting period[46] - The company appointed four new executives to enhance its global leadership team, including Dr. Susannah Cantrell as Chief Business Officer and Dr. Eleanor de Groot as Chief Technology Officer, all with extensive industry experience[113] Strategic Collaborations and Partnerships - The company is collaborating with partners like Vir and VBI to lead research in functional cures for HBV[5] - The company announced strategic collaborations with China National Pharmaceutical Group and China Resources Pharmaceutical to advance the commercialization of COVID-19 therapies in China[69] - The company is collaborating with Qpex to develop MDR/XDR therapies, with BRII-636, BRII-672, and BRII-693 candidates receiving QIDP designation from the FDA[88] Shareholder and Governance Information - The board consists of one executive director, two non-executive directors, and five independent non-executive directors, ensuring a high level of independence[164] - The company has made changes in the board composition, including the appointment of new directors and the resignation of others[170] - The shareholding structure indicates significant control by various investment entities, including Boyu Capital and ARCH Venture Partners[187][188] - The report highlights the importance of compliance with securities regulations regarding share ownership disclosures[183] Commitment to Sustainability and Patient Advocacy - The company launched its first ESG report in April 2022, emphasizing its commitment to innovative drug accessibility and patient advocacy[107] - The company is committed to patient-centered programs, ensuring that patient voices are integrated into its drug discovery and development processes[108] - The company emphasizes a green business approach and environmental sustainability in its operations[107]