Core Viewpoint - The collaboration between Tengsheng Bo Pharmaceutical and Health元 Group focuses on the exclusive licensing and commercialization of BRII-693 in Greater China, addressing the urgent need for new antibiotics in the face of rising antibiotic resistance [1] Company Summary - Tengsheng Bo Pharmaceutical's subsidiary, Brii Biosciences, has signed a technology transfer agreement with Health元 Group for the development and commercialization of BRII-693 in Greater China [1] - Health元 Group will be responsible for the development, regulatory approval, and commercialization of BRII-693 in the specified regions [1] - The agreement includes an upfront payment and additional milestone payments based on the achievement of specific development and commercialization milestones, along with a sales revenue sharing arrangement [1] Industry Summary - The increasing threat of antibiotic resistance in Greater China highlights the urgent need for new hospital antibiotics, making the development of BRII-693 particularly timely [1] - The collaboration is expected to leverage Health元 Group's proven capabilities in the production and commercialization of hospital antibiotics, enhancing the prospects for BRII-693 [1] - The project is anticipated to address significant unmet clinical needs, with potential to become a Best-in-Class drug based on its therapeutic potential and pharmacological characteristics [1]

Financial Performance - Total revenue for 2023 was RMB 617,000, a significant decrease from RMB 51,626,000 in 2022, indicating a decline of approximately 98.8%[12] - Other income for 2023 was RMB 163,728,000, down from RMB 107,857,000 in 2022, reflecting a decrease of about 51.8%[12] - The net loss for 2024 was RMB 512,381,000, which is an increase of 177.5% from the net loss of RMB 184,370,000 in 2023[12] - Other income decreased from RMB 163.7 million in 2023 to RMB 141.4 million in 2024, primarily due to a decline in bank interest income and government subsidies[43] - Other gains and losses shifted from a gain of RMB 252.4 million in 2023 to a loss of RMB 197.7 million in 2024, mainly due to non-cash losses from the fair value of financial assets and impairment of intangible assets[44] - The adjusted loss for the year was RMB 496.3 million for the year ended December 31, 2024, compared to RMB 120.1 million for the year ended December 31, 2023[50] - The company has faced significant net losses since its establishment and is expected to continue incurring losses in the foreseeable future[110] - The company has a history of significant losses and will require additional financing to fund its operations, which may not be secured under acceptable terms[110] Research and Development - Research and development expenses for 2024 were RMB 249,847,000, a reduction of 37.8% compared to RMB 402,705,000 in 2023[12] - The company is focusing on expanding its early research pipeline in new targets and platform technologies, enhancing its commitment to innovative solutions for global patients[6] - The company is focusing on infectious diseases, particularly its HBV projects and three core assets: BRII-179, elebsiran, and tobevibart, which are showing promising multi-modal approaches for higher functional cure rates in HBV patients[14] - The optimized recombinant vaccine BRII-179 has demonstrated strong HBsAg and broad T-cell responses, indicating its potential in enhancing immune responses against HBV[14] - The company expects to obtain key interim data between 2025 and 2026, which will guide further clinical actions towards achieving the highest functional cure rates for HBV[15] - The company plans to present data from ongoing combination studies involving BRII-179, elebsiran, and PEG-IFNα between 2025 and 2026, focusing on their effectiveness in treating chronic HBV[28] - The company plans to further evaluate its combination therapy programs to enhance functional cure rates for HBV infections, with a focus on initiating confirmatory clinical studies in the Greater China region[39] - The company is advancing multiple clinical trials for HBV treatments, with key data from the ENSURE study showing higher HBsAg seroclearance rates when combining siRNA with PEG-IFNα compared to monotherapy[24] Financial Position - Total assets as of December 31, 2024, were RMB 2,706,625,000, down from RMB 3,198,251,000 in 2023, representing a decrease of approximately 15.4%[12] - The company’s non-current liabilities increased to RMB 23,124,000 in 2024 from zero in 2023, indicating a shift in financial obligations[12] - The total liabilities decreased to RMB 100,545,000 in 2024 from RMB 125,869,000 in 2023, showing a reduction of approximately 20%[12] - Cash and cash equivalents decreased from RMB 2,661.4 million as of December 31, 2023, to RMB 2,413.4 million as of December 31, 2024, primarily due to operating expenses and third-party contract costs[48] - The current ratio increased to 3,118% as of December 31, 2024, from 2,211% as of December 31, 2023, due to the payment of most third-party contract costs and the amortization of deferred revenue[52] Strategic Focus - The company is actively seeking partnerships to further develop its promising projects in the MDR/XDR and HIV fields[25] - The company aims to enhance functional cure rates for a broader patient population through targeted combination therapy designs[18] - The company is seeking collaborations for promising non-HBV projects, including long-acting treatments for HIV and multi-drug resistant Gram-negative infections[16] - The company is strategically increasing investments in its leading HBV candidates as they enter late-stage clinical development[22] - The company aims to expand its pipeline through strategic licensing opportunities and business development, aligning with its long-term vision and priorities[40] Corporate Governance - The company is focused on expanding its board with experienced professionals in finance, auditing, and pharmaceutical sectors to enhance governance and strategic direction[80] - The management team emphasizes the importance of strategic planning and risk management in navigating market challenges and opportunities[80] - The company has adopted a share incentive plan to provide incentives and rewards to its employees[61] - The board of directors includes Zhi Hong as the Chairman and CEO, and Li Ankang as an executive director[126] - The company has no significant transactions or contracts involving directors or related entities during the reporting period[131] Employee and Shareholder Information - The group employed a total of 98 full-time employees as of December 31, 2024, down from 128 in 2023[137] - Total compensation costs for the year ended December 31, 2024, amounted to RMB 194 million, a decrease of 36% from RMB 302 million for the year ended December 31, 2023[62] - Major shareholders include ARCH Venture Fund IX, L.P. with 45,205,210 shares, representing 6.18% of the total shares[145] - The company has established a unified, value-based corporate culture and brand globally, enhancing performance and employee engagement[96] Market and Competitive Landscape - The company has experienced intense competition, which may lead to other companies discovering or commercializing competitive drugs before it does[110] - Approximately 87 million people in China are affected by chronic HBV, making it the country with the highest prevalence of the virus, and the company is focusing on improving functional cure rates for these patients[26] Future Outlook - The company plans to allocate HKD 1,466.6 million (56%) of the net proceeds to the HBV functional cure project, with HKD 681.8 million already utilized[112] - The company expects to fully utilize the revised unutilized net proceeds by the end of 2027[112] - The company has not fully utilized the net proceeds from the global offering, indicating ongoing funding needs for operations[111]

Core Viewpoint - The company reported a net loss of 508 million yuan with no operating revenue, marking a year-on-year increase of 190.66% after the cessation of its COVID-19 neutralizing antibody drug production. The market capitalization has plummeted from over 36 billion HKD to less than 1.8 billion HKD [1]. Financial Performance - The company did not achieve operating revenue in 2024, only generating other income of 141 million yuan. This was impacted by a decrease in bank interest income by 20.8 million yuan due to lower deposit rates and a 13.6% reduction in government subsidy income [2]. - As of the end of 2024, the company's cash and cash equivalents decreased by 9.3% to 2.413 billion yuan due to operational and R&D expenditures [2]. - Administrative expenses were reduced by 22% to 153 million yuan, primarily due to pipeline focus and organizational optimization, resulting in a decrease in employee costs by 39.7 million yuan. The number of employees dropped from 146 in 2022 to 98 in 2024, marking the first time the workforce fell below 100 [2]. R&D Pipeline - R&D expenditures decreased by 38% to 250 million yuan, mainly due to prioritizing the hepatitis B virus (HBV) functional cure project and strategic organizational optimization, which led to a reduction in third-party contract costs by 80 million yuan and employee costs by 68 million yuan [3]. - The company initially established a pipeline of 10 innovative candidate products in 2022 but only reported progress on 7 major candidates in the 2024 annual report. Key products include BRII-179, Elebsiran, and Tobevibart, all currently in Phase II clinical trials [3]. Strategic Focus - The primary focus remains on infectious diseases, particularly the three core candidates in the hepatitis B pipeline. The company aims to enhance the functional cure rate for hepatitis B through combination therapies [4][5]. - The company has strategically acquired rights to BRII-179 to ensure a stable supply for future clinical development after the bankruptcy of VBI Vaccines, which previously held rights to the product [5]. - The company is seeking partners to advance other promising projects, such as long-acting HIV therapies and treatments for multi-drug resistant infections, while emphasizing that commercialization discussions are premature [6].

智通财经APP讯，腾盛博药-B(02137)发布公告，在中国北京举行的第34届亚太肝病学会年会("2025亚肝 会")上，公司以最新突破口头报告的形式公佈了其正在进行的ENSURE 2期研究的最新数据。 ENSURE(NCT05970289)是一项多中心、开放性2期研究。队列1-3旨在评估elebsiran(一种研究性小干扰 核糖核酸(siRNA))在与聚乙二醇干扰素α ("PEG-IFNα")联合治疗慢性乙型肝炎病毒("HBV")感染者(基线 乙肝表面抗塬("HBsAg")水平为100-3,000 IU/mL)中的作用。在先前的亚太地区研究 BRII-179-835- 001(NCT04749368)中接受过9剂BRII-179(一种基于重组蛋白的治疗性疫苗)联合elebsiran(BRII-835)给药 的参与者被纳入该研究的第4队列，并接受elebsiran和PEG-IFNα联合治疗。本研究队列4的设计基于既往 研究的见解，即多数比例的慢性HBV患者在接受多剂次BRII-179后仍未能产生足够的免疫应答，因此不 太可能获得免疫支持以实现持久的功能性治愈。 • 第24周时，BRII-179应答者的HBsA ...

Financial Performance - As of December 31, 2024, the company's cash and cash equivalents amounted to RMB 2,413.4 million, a decrease of RMB 248.0 million or 9.3% compared to RMB 2,661.4 million as of December 31, 2023, primarily due to operational and R&D expenditures[4] - Other income for the year ended December 31, 2024, was RMB 141.4 million, down RMB 22.3 million or 13.6% from RMB 163.7 million for the year ended December 31, 2023, mainly due to a decrease in bank interest income[4] - The company reported a net loss of RMB 512.4 million for the year ended December 31, 2024, an increase of RMB 328.0 million or 177.9% compared to a net loss of RMB 184.4 million for the previous year, primarily due to investment-related losses[4] - The basic and diluted loss per share for the year ended December 31, 2024, was RMB 0.70, compared to RMB 0.24 for the previous year[9] - The company reported a pre-tax loss of RMB 508,162 thousand for 2024, compared to a loss of RMB 174,829 thousand in 2023[28] - The adjusted loss for the year was RMB 496.3 million in 2024 compared to RMB 120.1 million in 2023, indicating a significant increase in losses[68] Research and Development - R&D expenses for the year ended December 31, 2024, were RMB 249.8 million, a reduction of RMB 152.9 million or 38.0% from RMB 402.7 million for the previous year, attributed to pipeline focus and organizational optimization[4] - The company made significant progress in its HBV functional cure project, with ongoing Phase II trials providing valuable data[5] - Elebsiran, tobevivart, and BRII-179 have been granted breakthrough therapy designation by the CDE, recognizing their innovative potential in HBV treatment[7] - The company’s BRII-693 project for MDR/XDR infections received IND approval from the CDE for a Phase I PK bridging study in China[7] - The company plans to release further data sets from ongoing studies in 2025 and 2026, which will guide its later-stage development and registration strategies[6] - The company is focusing on its HBV functional cure program, which is expected to have significant therapeutic impact for patients in China and globally[34] - Key data results from ongoing HBV studies are planned to be announced between 2025 and 2026, guiding the company's late-stage development and registration strategy[35] - The company is advancing multiple combination studies for HBV treatment in China, aiming to improve the functional cure rate for chronic HBV patients, with approximately 87 million affected by the disease in the region[45] - The ENSURE study demonstrated a higher HBsAg clearance rate in patients receiving elebsiran combined with PEG-IFNα compared to those on PEG-IFNα monotherapy, marking a significant advancement in functional cure potential[49] - The company plans to present key data from the ENSURE, ENRICH, and ENHANCE studies between 2025 and 2026, focusing on identifying optimal functional cure methods for HBV[42] Assets and Liabilities - Non-current assets decreased from RMB 415,473,000 in 2023 to RMB 292,503,000 in 2024, a decline of approximately 29.5%[10] - Current assets decreased from RMB 2,782,778,000 in 2023 to RMB 2,414,122,000 in 2024, a decline of about 13.2%[10] - Total liabilities decreased from RMB 3,072,382,000 in 2023 to RMB 2,606,080,000 in 2024, a reduction of about 15.2%[11] - The company's net assets decreased from RMB 3,072,382,000 in 2023 to RMB 2,606,080,000 in 2024, a decline of approximately 15.2%[11] - The company reported a significant reduction in intangible assets from RMB 267,420,000 in 2023 to RMB 179,710,000 in 2024, a decrease of about 32.8%[10] - The company recognized lease liabilities of RMB 10.0 million as of December 31, 2024, under operating lease arrangements[76] Corporate Governance - The company emphasizes high standards of corporate governance to protect shareholder interests[92] - The board consists of two executive directors and five independent non-executive directors, ensuring a high level of independence[93] - The audit and risk committee, composed of three independent non-executive directors, oversees the financial reporting process and risk management[96] - The company will continue to review the effectiveness of its corporate governance structure, including the potential separation of the roles of chairman and CEO[93] - All directors confirmed compliance with the company's securities trading code during the reporting period[94] Strategic Focus and Partnerships - The company has paused low-priority projects to focus on advanced HBV cure initiatives, with MDR/XDR and HIV project developments contingent on external partnerships[49] - The company is actively seeking partnerships to further develop its promising projects in the MDR/XDR and HIV fields[44] - The company plans to seek partnerships for its non-HBV clinical projects and will not allocate further internal resources to these projects[81] Market Presence and Future Plans - The company is listed on the NASDAQ under the ticker symbol VBIV, indicating its presence in the global market[107] - The company is headquartered in Cambridge, USA, positioning it strategically within a major biotech hub[107] - The annual general meeting is scheduled for June 17, 2025, where further strategic directions may be discussed[103] Employee and Compensation - As of December 31, 2024, the total employee count is 98, with 67 in R&D (68%) and 31 in administration (32%)[80] - Total compensation costs for the year ending December 31, 2024, amounted to RMB 194 million, a decrease of 36% from RMB 302 million for the year ending December 31, 2023[81] - The company has adopted a share incentive plan to provide incentives and rewards to employees[81] Financial Management - The company emphasizes capital preservation and liquidity in its treasury policy, primarily investing in low-risk instruments[82] - The company has made sufficient provisions for employee benefits according to applicable regulations[81] - The company has no foreign currency hedging policy currently in place but will consider hedging significant foreign exchange risks as needed[79]

[Company Overview](index=2&type=section&id=Company%20Overview) [Company Profile](index=2&type=section&id=Company%20Profile) Brii Biosciences is a biotechnology company focused on developing functional cures for Hepatitis B (HBV) by combining surface antigen reduction and immunomodulation therapies, while seeking collaborations for non-HBV projects - The company's core mission is to develop functional cures for Hepatitis B (HBV), believing this will have a profound impact on patients in China and globally[3](index=3&type=chunk) - The company's HBV product portfolio includes three differentiated candidates: elebsiran (siRNA), tobevibart (monoclonal antibody), and BRII-179 (therapeutic vaccine), all of which have received Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE)[3](index=3&type=chunk) - While focusing on HBV projects, the company is actively seeking external collaborations for its HIV, Multi-drug Resistant/Extensively Drug-Resistant (MDR/XDR), and Central Nervous System (CNS) projects[3](index=3&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) [Company Information](index=3&type=section&id=Company%20Information) This section provides essential legal and administrative details, including board members, company secretary, legal advisors, auditors, registered office, and stock code - The Chairman and Chief Executive Officer of the company is **Dr. Zhi Hong**[4](index=4&type=chunk) - The company's auditor is **Deloitte Touche Tohmatsu**[5](index=5&type=chunk) - The company was listed on the Hong Kong Stock Exchange on July 13, 2021, with stock code **2137**[5](index=5&type=chunk) [Management Discussion and Analysis (MD&A)](index=5&type=section&id=Management%20Discussion%20and%20Analysis%20%28MD%26A%29) [Business Overview](index=5&type=section&id=Business%20Overview) The company's strategy focuses on developing HBV functional cures, leveraging its US-China presence to advance late-stage combination therapies, with three core candidates receiving CDE breakthrough designations - The company's strategic focus is on the HBV functional cure program, believing it can bring meaningful therapeutic impact to patients in China and globally[6](index=6&type=chunk) - The company's three leading HBV candidates (elebsiran, tobevibart, and BRII-179) have all received Breakthrough Therapy Designation from China's NMPA CDE, which will accelerate their clinical development and regulatory review[6](index=6&type=chunk) - The company presented the first direct evidence that immune responses induced by the HBV therapeutic vaccine (BRII-179) are associated with HBsAg reduction and viral control, providing key support for late-stage combination trials[7](index=7&type=chunk) [Product Pipeline Summary](index=7&type=section&id=Product%20Pipeline%20Summary) The company has a pipeline of 10 innovative candidates primarily for infectious and CNS diseases, with core HBV projects (Elebsiran, Tobevibart, BRII-179) in Phase 2 development Product Pipeline Overview | Indication | Project | Phase | Rights Scope | | :--- | :--- | :--- | :--- | | Hepatitis B (HBV) | Elebsiran (BRII-835) | Phase 2 | Greater China | | Hepatitis B (HBV) | Tobevibart (BRII-877) | Phase 2 | Greater China | | Hepatitis B (HBV) | BRII-179 | Phase 2 | Global | | MDR Infection | Epetraborole (BRII-658) | Phase 2/3 | Greater China | | Postpartum Depression (PPD) | BRII-296 | Phase 2 | Global | | Anxiety/Depression | BRII-297 | Phase 1 | Global | [Business Review](index=8&type=section&id=Business%20Review) During the reporting period, the company strategically increased investment in core HBV assets, advanced clinical trials, presented key data at EASL, and is actively seeking collaborations for non-HBV projects - The company presented key data at the 2024 European Association for the Study of the Liver (EASL) conference, providing the first direct evidence that immune responses induced by the HBV therapeutic vaccine (BRII-179) are associated with HBsAg reduction and viral control[10](index=10&type=chunk) - With increased strategic focus on HBV, the company is actively seeking collaborations for projects in the MDR/XDR, HIV, and CNS fields[10](index=10&type=chunk) [HBV Program Updates](index=8&type=section&id=HBV%20Program%20Updates) The company is advancing multiple HBV combination therapies to increase functional cure rates for approximately 87 million infected individuals in China, with key Phase 2 data expected in Q4 2024 - Elebsiran and Tobevibart received Breakthrough Therapy Designation from China's NMPA CDE in May 2024[11](index=11&type=chunk) - Multiple key clinical study results are expected to be announced in the fourth quarter of 2024, including Part B of the MARCH study, preliminary results from the ENSURE study, and additional data from the SOLSTICE Hepatitis D trial[11](index=11&type=chunk) - In February 2024, the company entered into an agreement with VBI to acquire the intellectual property rights and related manufacturing facilities for BRII-179 to ensure supply for clinical studies[12](index=12&type=chunk) [Other Clinical and Pre-clinical Program Updates](index=10&type=section&id=Other%20Clinical%20and%20Pre-clinical%20Program%20Updates) The company is seeking partnerships for non-core projects, including commercialization of PreHevbriTM in APAC, advancing BRII-693 for MDR/XDR infections, and seeking external collaborations for HIV and CNS programs - For BRII-693, targeting MDR/XDR Gram-negative bacterial infections, an IND application for a Phase 1 PK bridging study has been submitted in China to support global Phase 3 registration trials[13](index=13&type=chunk) - BRII-296, for the treatment of postpartum depression (PPD), has completed a Phase 2 study, and the company is actively seeking partners[17](index=17&type=chunk) - Partner AN2 reported unfavorable Phase 2/3 clinical trial results for Epetraborole (BRII-658) for the treatment of Mycobacterium avium complex (MAC) lung disease and has decided to terminate the trial[17](index=17&type=chunk) [Research and Development](index=11&type=section&id=Research%20and%20Development) R&D is the company's cornerstone, led by experienced professionals with cross-border capabilities to accelerate clinical development in China and participate in global research, with R&D expenses of RMB 126.2 million in H1 2024 H1 2024 R&D Expenses | Project | Amount (RMB) | | :--- | :--- | | H1 2024 R&D Expenses | 126.2 million yuan | - The company's R&D execution team comprises several industry veterans, including CEO **Dr. Zhi Hong** and Chief Medical Officer **Dr. David Margolis**[19](index=19&type=chunk) [Future Outlook and Strategy](index=12&type=section&id=Future%20Outlook%20and%20Strategy) The long-term strategy is to lead in HBV functional cures by improving cure rates with combination therapies and initiating confirmatory studies, while expanding the pipeline through in-licensing and out-licensing opportunities - As a leading company in HBV functional cures, the company will continue to focus on improving functional cure rates through different combination therapies[21](index=21&type=chunk) - The company plans to explore global business development opportunities through in-licensing and out-licensing, and refine its early-stage development strategy to align with long-term pipeline interests[21](index=21&type=chunk) [Financial Review](index=13&type=section&id=Financial%20Review) For the six months ended June 30, 2024, revenue dropped to zero due to COVID-19 project termination, total loss expanded to RMB 283.2 million primarily from fair value losses on financial assets, while R&D and administrative expenses significantly decreased H1 2024 Key Financial Data (vs. H1 2023) | Indicator (RMB thousand) | H1 2024 (Unaudited) | H1 2023 (Unaudited) | Reason for Change | | :--- | :--- | :--- | :--- | | Revenue | 0 | 617 | Termination of COVID-19 project | | Other income | 70,879 | 85,863 | Decrease in government grants | | Other gains and losses | (115,374) | 23,326 | Fair value loss on financial assets | | Research and development expenses | (126,169) | (202,175) | Focus on HBV projects and organizational optimization | | Administrative expenses | (78,629) | (102,823) | Organizational optimization leading to lower employee costs | | Loss for the period | (283,238) | (196,826) | Primarily impacted by fair value loss on financial assets | | Adjusted loss for the period (Non-IFRS) | (280,099) | (163,700) | - | - As of June 30, 2024, total bank and cash balances were **RMB 2.4778 billion**, a decrease from **RMB 2.6614 billion** at the end of 2023, primarily used for daily operations and R&D activities[27](index=27&type=chunk) - The current ratio significantly increased from **2,211%** at the end of 2023 to **3,781%** as of June 30, 2024, mainly due to the payment of most third-party contract costs, leading to a decrease in other payables[31](index=31&type=chunk) [Debt and Liabilities](index=17&type=section&id=Debt%20and%20Liabilities) As of June 30, 2024, the company had no significant bank borrowings or financing, with main liabilities including RMB 17.8 million in bills payable and RMB 1.9 million in lease liabilities, and no contingent liabilities or asset pledges - As of June 30, 2024, the Group had no significant borrowings, pledges, or similar debts, except for **RMB 17.8 million** in bills payable[33](index=33&type=chunk) - The Group has no contingent liabilities or asset pledges[33](index=33&type=chunk)[36](index=36&type=chunk) [Employees and Remuneration](index=18&type=section&id=Employees%20and%20Remuneration) As of June 30, 2024, the company had 95 employees, with 66% (63 people) in R&D, and total remuneration costs for H1 2024 significantly decreased to RMB 96.2 million, reflecting organizational optimization and strategic focus Employee Distribution | Function | Number of Employees | Percentage of Total | | :--- | :--- | :--- | | R&D | 63 | 66% | | Administrative | 32 | 34% | | **Total** | **95** | **100%** | - For the six months ended June 30, 2024, the Group's total remuneration costs amounted to **RMB 96.2 million**, a significant decrease from **RMB 155.0 million** in the same period of 2023[38](index=38&type=chunk) [Corporate Governance and Other Information](index=18&type=section&id=Corporate%20Governance%20and%20Other%20Information) [Use of Proceeds from Global Offering](index=19&type=section&id=Use%20of%20Proceeds%20from%20Global%20Offering) The company's 2021 IPO raised approximately HKD 2.614 billion, with HKD 1.422 billion utilized by June 30, 2024, primarily for HBV and CNS projects, and remaining funds expected to be fully used by end of 2027 Use of Proceeds from Global Offering (as of June 30, 2024) | Category of Use | Net Allocated (HKD million) | Amount Utilized (HKD million) | Amount Unutilized (HKD million) | | :--- | :--- | :--- | :--- | | HBV Functional Cure Projects | 994.1 | 589.6 | 404.5 | | HIV Projects | 176.0 | 150.4 | 25.6 | | MDR/XDR Infection Projects | 294.0 | 60.8 | 233.2 | | CNS Projects | 496.3 | 276.9 | 219.4 | | Pipeline Expansion | 392.0 | 83.2 | 308.8 | | Working Capital and General Corporate Purposes | 261.4 | 261.4 | 0 | | **Total** | **2,613.8** | **1,422.3** | **1,191.5** | [Corporate Governance Practices](index=20&type=section&id=Corporate%20Governance%20Practices) The company complied with corporate governance code provisions during the period, except for the combined roles of Chairman and CEO, which the board believes enhances management efficiency and strategic execution - The company deviated from Corporate Governance Code Provision C.2.1, where the roles of Chairman and Chief Executive Officer are held by the same person (**Dr. Zhi Hong**)[44](index=44&type=chunk) - The Board believes this arrangement facilitates management efficiency and strategic execution, and its effectiveness will be continuously reviewed[44](index=44&type=chunk) [Share Schemes](index=25&type=section&id=Share%20Schemes) This section details the company's share incentive plans, including pre- and post-IPO option and award schemes, and the new 2023 plans, outlining their purpose, eligibility, share limits, and changes in outstanding options and restricted share units [Pre-IPO Share Incentive Scheme](index=25&type=section&id=Pre-IPO%20Share%20Incentive%20Scheme) Adopted in October 2018 to attract and incentivize key personnel, this scheme ceased new grants post-IPO, with 19,127,468 outstanding options as of June 30, 2024, representing approximately 2.6% of issued share capital - After listing, the company no longer grants any share options or awards under this scheme[62](index=62&type=chunk) - As of June 30, 2024, there were **19,127,468** outstanding share options under this scheme, involving directors **Dr. Zhi Hong**, **Dr. Ankang Li**, and other employees and consultants[62](index=62&type=chunk) [Post-IPO Share Option Scheme](index=29&type=section&id=Post-IPO%20Share%20Option%20Scheme) Adopted in June 2021 and terminated on September 1, 2023, by the new 2023 scheme, this plan no longer grants new options but has 34,120,333 outstanding options as of June 30, 2024, representing approximately 4.7% of issued share capital - This scheme was terminated on September 1, 2023, and no new share options will be granted, but previously granted options remain valid[64](index=64&type=chunk) - As of June 30, 2024, there were **34,120,333** outstanding share options under this scheme[71](index=71&type=chunk) [Post-IPO Share Award Scheme](index=32&type=section&id=Post-IPO%20Share%20Award%20Scheme) Adopted in June 2021 and terminated on September 1, 2023, by the new 2023 scheme, this plan no longer grants new awards but has 8,048,817 unvested restricted share units as of June 30, 2024, representing approximately 1.1% of issued share capital - This scheme was terminated on September 1, 2023, and no new share awards will be granted[73](index=73&type=chunk) - As of June 30, 2024, there were **8,048,817** unvested restricted share units under this scheme[79](index=79&type=chunk)[80](index=80&type=chunk) [2023 Share Option Scheme](index=37&type=section&id=2023%20Share%20Option%20Scheme) Adopted on September 1, 2023, with a 10-year validity and a shared authorization limit of 72,813,078 shares, the company granted 5,752,500 options on March 28, 2024, with 5,752,500 unexercised options as of June 30, 2024 - On March 28, 2024, the company granted **5,752,500** share options to employees under this scheme, with an exercise price of **HKD 0.964**[92](index=92&type=chunk) - As of June 30, 2024, the total number of share options available for future grant under this scheme was **66,239,078**[91](index=91&type=chunk) [2023 Share Award Scheme](index=39&type=section&id=2023%20Share%20Award%20Scheme) Adopted on September 1, 2023, with a 10-year validity and a shared authorization limit, the company granted 821,500 restricted share units on March 28, 2024, with 821,500 unvested units as of June 30, 2024 - On March 28, 2024, the company granted **821,500** restricted share units to employees under this scheme[102](index=102&type=chunk) - As of June 30, 2024, the total number of share awards available for future grant under this scheme was **66,239,078** (shared with the Share Option Scheme)[100](index=100&type=chunk) [Condensed Consolidated Financial Statements](index=42&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Review Report](index=42&type=section&id=Review%20Report) Deloitte Touche Tohmatsu reviewed the condensed consolidated financial statements for the six months ended June 30, 2024, concluding that no matters indicated non-compliance with IAS 34 - Auditor Deloitte issued a review conclusion, not an audit opinion, on the interim financial statements[107](index=107&type=chunk) - The review concluded that no matters indicated non-compliance with International Accounting Standard 34[108](index=108&type=chunk) [Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=44&type=section&id=Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2024, the company reported a loss of RMB 283.2 million, an increase from RMB 196.8 million last year, primarily due to a significant shift in net other gains and losses from gain to loss, while R&D and administrative expenses decreased Profit or Loss Statement Core Data (RMB thousand) | Item | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Revenue | – | 617 | | Research and development expenses | (126,169) | (202,175) | | Administrative expenses | (78,629) | (102,823) | | Net other gains and losses | (115,374) | 23,326 | | **Loss for the period** | **(283,238)** | **(196,826)** | | **Loss per share (RMB)** | **(0.38)** | **(0.26)** | [Condensed Consolidated Statement of Financial Position](index=45&type=section&id=Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, total assets were RMB 2.897 billion and net assets RMB 2.810 billion, both decreased from year-end 2023 mainly due to a reduction in time deposits, while current liabilities significantly decreased, maintaining a robust financial position Balance Sheet Core Data (RMB thousand) | Item | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | **Non-current assets** | **337,255** | **415,473** | | **Current assets** | **2,559,350** | **2,782,778** | | *Including: Cash and cash equivalents* | *656,256* | *489,650* | | *Including: Time deposits* | *1,730,517* | *2,171,011* | | **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** | [Condensed Consolidated Statement of Cash Flows](index=48&type=section&id=Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) For the six months ended June 30, 2024, net cash used in operating activities decreased to RMB 226 million, indicating improved cost control, while investing activities generated a net inflow of RMB 394 million, primarily from withdrawal of time deposits, increasing period-end cash to RMB 656 million Cash Flow Statement Core Data (RMB thousand) | Item | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Net cash used in operating activities | (225,788) | (353,761) | | Net cash from (used in) investing activities | 393,908 | (353,409) | | Net cash used in financing activities | (4,422) | (4,782) | | **Net increase (decrease) in cash and cash equivalents** | **163,698** | **(711,952)** | | **Cash and cash equivalents at end of period** | **656,256** | **487,494** | [Notes to the Condensed Consolidated Financial Statements](index=49&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of financial statement items, including segment reporting, sources of other income and losses, significant transactions with VBI Vaccines and related impairment, and detailed changes in share-based payment schemes [Note 19: Significant Transactions (with VBI Vaccines)](index=64&type=section&id=Note%2019%3A%20Significant%20Transactions%20%28with%20VBI%20Vaccines%29) The company entered into significant transactions with VBI Vaccines Inc. (VBI) to acquire BRII-179 IP and other assets; however, VBI's July 2024 restructuring and delisting raised recoverability concerns, leading to a full impairment provision for the USD 4.6 million prepayment - The company entered into multiple significant transactions with VBI to acquire BRII-179 intellectual property, VBI-1901 license, and related assets[164](index=164&type=chunk)[165](index=165&type=chunk) - VBI initiated restructuring procedures in July 2024 and delisted from Nasdaq in August, introducing significant uncertainty to the transactions[165](index=165&type=chunk) - Due to VBI's financial risks, the company has fully provided for an expected credit loss allowance on the **USD 4.6 million** (approximately **RMB 33 million**) prepayment[165](index=165&type=chunk) [Note 18: Share-based Payment Transactions](index=58&type=section&id=Note%2018%3A%20Share-based%20Payment%20Transactions) This note details changes in the company's equity-settled share option and award schemes, including new grants under the 2023 plans and forfeiture of some milestone-based awards, with total share-based payment expenses of RMB 1.41 million for options and RMB 1.73 million for awards in H1 2024 - In September 2023, the company adopted new "2023 Share Award Scheme" and "2023 Share Option Scheme," replacing previous post-listing schemes[156](index=156&type=chunk) - As of June 30, 2024, the total number of outstanding share options under all schemes was **59,000,301**[159](index=159&type=chunk) - As of June 30, 2024, the total number of unvested restricted share units under all schemes was **8,870,317** (**8,048,817** + **821,500**)[152](index=152&type=chunk)[154](index=154&type=chunk)

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].