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]

Financial Performance - Total revenue for 2021 reached RMB 99,032 thousand, a 17.1% increase from RMB 84,625 thousand in 2020[20]. - The company reported a net loss of RMB 4,191,084 thousand for 2021, compared to a net loss of RMB 1,283,510 thousand in 2020, reflecting a significant increase in losses[20]. - The adjusted annual loss for 2021 was RMB 480.7 million, compared to RMB 888.7 million in 2020, reflecting a significant improvement[131]. - Research and development expenses for the year ended December 31, 2021, amounted to RMB 494.6 million, reflecting the company's commitment to expanding its life sciences research and candidate product portfolio[115]. - R&D expenses decreased from RMB 875.8 million in 2020 to RMB 494.6 million in 2021, a reduction of RMB 381.2 million, primarily due to a decrease in third-party contract costs[124]. - Administrative expenses increased from RMB 103.4 million in 2020 to RMB 208.4 million in 2021, an increase of RMB 105.0 million, mainly driven by a rise in employee costs[125]. - The company recorded listing expenses of RMB 32.1 million in 2021, compared to RMB 14.9 million in 2020[127]. - The company reported a significant increase in other income due to the fair value increase of private equity investments in the U.S., contributing RMB 61.6 million to other income[121]. - The fair value loss on financial liabilities measured at fair value through profit or loss increased from RMB 350.4 million for the year ended December 31, 2020, to RMB 3,598.8 million for the year ended December 31, 2021[122]. - The company had a total of 113 employees as of December 31, 2021, with 63% in R&D and 37% in administration[136]. Clinical Development and R&D - The company has over 10 innovative candidates in clinical development targeting major infectious diseases and mental health disorders[3]. - The HIV treatment candidates BRII-778 and BRII-732 are currently in Phase 1 clinical trials, with data expected to be presented in the second half of 2022[7]. - The CNS project includes BRII-296, which is in Phase 1 clinical trials and aims to provide better treatment options for PPD and MDD patients[7]. - The company is leading the search for functional cure therapies for chronic HBV, with multiple studies currently in phase 2 clinical trials[23]. - The company is developing a functional cure for chronic HBV infection, which significantly impacts public health in China[30]. - The company is focusing on addressing unmet treatment needs in the rapidly growing depression market with its PPD/MDD projects[33]. - The Phase 2 study for the combination therapy of BRII-179 (VBI-2601) and BRII-835 (VIR-2218) has enrolled a total of 90 patients across multiple countries[44]. - The mid-term data for the Phase 2 study is expected to be released by the end of 2022[45]. - The Phase 2a/2b study for BRII-179 (VBI-2601) in HBV patients is set to include approximately 600 patients, with the first part expected to complete enrollment in the second half of 2022[49]. - The company is actively negotiating with governments for the commercialization of its antibody therapy for COVID-19[31]. Regulatory Approvals and Partnerships - The company became the first in China to receive BLA approval for its COVID-19 antibody combination therapy in December 2021[23]. - The company has established a partnership with China National Pharmaceutical Group to enhance distribution and regional access for its COVID-19 therapy[5]. - The company has submitted an EUA application for its neutralizing antibody therapy to the U.S. FDA in December 2021[37]. - The company is awaiting FDA's decision on the EUA application while collaborating with CDMO for production site inspections[66]. - The company is committed to ensuring sufficient commercial supply of its monoclonal antibodies in the U.S. and obtaining authorization for use in other countries[116]. - The company is actively discussing the commercialization of its COVID-19 antibody combination therapy, which was approved for use in China in December 2021[117]. Market Presence and Recognition - Brii Biosciences Limited raised approximately HKD 27.88 billion (around RMB 2.325 billion) from its successful listing on the Hong Kong Stock Exchange in July 2021[7]. - The company was included in the Hong Kong Stock Connect program in December 2021, increasing its market recognition and stock liquidity[7]. - The company has been included in the Hong Kong Stock Connect and eight Hang Seng Indexes, enhancing its visibility and liquidity[26]. - The company received multiple awards in 2021, including "2021 R&D Achievement" from BioCentury-BayHelix and "Best New Economy Listed Company" from Sina Finance[8]. - The company has a total of 113 employees globally as of December 31, 2021, with over half holding advanced degrees such as MDs or PhDs, indicating a strong talent pool for R&D[109]. Governance and Leadership - The leadership team includes industry veterans with extensive experience in drug discovery and commercialization, enhancing the company's competitive edge in the biopharmaceutical sector[111]. - The board of directors comprises experienced professionals with expertise in various scientific and corporate disciplines, guiding the company's R&D processes and candidate selection[113]. - The company has a diverse board with expertise across various sectors, including pharmaceuticals, biotechnology, and finance, which supports comprehensive strategic planning[159]. - The presence of independent directors ensures robust governance and oversight, aligning with best practices in corporate governance[161][164]. - The strategic committee, which includes Bouchon, focuses on long-term growth strategies, indicating a commitment to innovation and market leadership[159]. Challenges and Risks - The company reported significant net losses since its inception and anticipates continued losses in the foreseeable future, with no assurance of achieving or maintaining profitability[197]. - The company relies heavily on the success of candidate drugs currently in preclinical or clinical development, facing potential delays in development, regulatory approval, and commercialization[197]. - The company has faced intense competition, which may lead to other companies discovering, developing, or commercializing competitive drugs before it does[197]. - The business and operations of the company may be adversely affected by health epidemics or infectious diseases, including the COVID-19 outbreak[198]. - The company has not established, protected, or exercised its intellectual property rights sufficiently[199].

Financial Performance - Total revenue for the six months ended June 30, 2021, was RMB 46,280,000, compared to RMB 22,855,000 for the same period in 2020, representing an increase of 102.1%[171] - The company reported a loss before tax of RMB (2,953,579,000) for the six months ended June 30, 2021, compared to a loss of RMB (308,228,000) for the same period in 2020, indicating a significant increase in losses[171] - The total comprehensive expenses for the six months ended June 30, 2021, amounted to RMB (2,921,456,000), compared to RMB (293,483,000) for the same period in 2020[173] - The basic and diluted loss per share for the six months ended June 30, 2021, was RMB (14.86), compared to RMB (1.63) for the same period in 2020[173] - The net loss for the first half of 2021 was RMB 4,636,767 thousand, compared to a net loss of RMB 1,742,702 thousand for the same period in 2020, indicating an increase in losses of about 166%[179] - The total comprehensive income for the first half of 2021 was RMB (2,921,456) thousand, compared to RMB (1,742,702) thousand for the same period in 2020, indicating a worsening financial performance[179] Government Subsidies and Other Income - Total other income increased from RMB 22.9 million in the six months ended June 30, 2020, to RMB 46.3 million in the six months ended June 30, 2021, primarily due to an increase in government subsidy income of RMB 24.6 million[9] - Government subsidies accounted for RMB 45.66 million in the six months ended June 30, 2021, compared to RMB 21.1 million in the same period of 2020, reflecting a significant increase in support for R&D activities[9] - Government subsidies received during the six months ended June 30, 2021, totaled RMB 45,660,000, significantly higher than RMB 21,105,000 in the same period of 2020, indicating a year-over-year increase of approximately 116.5%[191] Research and Development - The company is developing a functional cure for chronic HBV infection, addressing a significant health impact in China[5] - A long-acting single-tablet regimen for HIV patients is under development, with initial focus on the U.S. market[5] - The company is also working on broad-spectrum antibiotics to treat MDR/XDR Gram-negative bacterial infections, which have a substantial health impact in China[5] - A neutralizing antibody cocktail therapy for COVID-19 treatment is being developed as part of the company's commitment to public health[5] - The global incidence of postpartum depression (PPD) reached 18.9 million cases in 2019, indicating a significant unmet need for new therapies targeting CNS disorders[5] - The company aims to address the substantial demand for innovative therapies that provide rapid relief and sustained treatment effects for emotional disorders exacerbated by the COVID-19 pandemic[5] - The company has established a pipeline of over 10 innovative candidates targeting infectious diseases and CNS diseases[36] - The company is leveraging both internal R&D capabilities and strategic partnerships to develop its product pipeline[40] - The company has over 10 candidate products in preclinical and clinical stages, including licensed and self-discovered drug combinations[42] Clinical Trials and Product Development - The company is conducting a Phase 3 trial for a COVID-19 neutralizing antibody cocktail therapy, showing a significant reduction of 78% in combined hospitalization and death events compared to a placebo[37] - The company plans to initiate patient enrollment for BRII-179's phase 2 study by Q1 2022 after receiving IND approval from the Chinese National Medical Products Administration[51] - The combination therapy of BRII-179 and BRII-835 may represent a new functional cure for HBV, utilizing dual mechanisms of action[55] - The company has initiated a phase 2 MRCT study for BRII-179/BRII-835 in New Zealand, Australia, Singapore, and Hong Kong[56] - The company plans to report more comprehensive key results from the ACTIV-2 trial in Q3 2021 and intends to submit an EUA later in the year[69] - The company initiated a Phase 1 study of BRII-778 in the US in March 2021, with key results expected in Q4 2021[72] - The company is collaborating with Qpex to develop therapies for MDR/XDR Gram-negative bacterial infections, with ongoing Phase 1 studies for BRII-636 in Australia[78] Financial Position and Cash Flow - Cash and cash equivalents increased from RMB 1,058.7 million as of December 31, 2020, to RMB 1,445.1 million as of June 30, 2021, primarily due to proceeds from the issuance of C series preferred shares[16] - The current ratio increased to 972% as of June 30, 2021, compared to 190% as of December 31, 2020, mainly due to increased cash reserves from C series preferred shares financing[22] - The company had no outstanding secured or unsecured borrowings as of June 30, 2021[24] - The company raised RMB 1,002,455 thousand from the issuance of C series preferred shares during the first half of 2021, which significantly contributed to financing activities[181] - The company's cash and cash equivalents at the end of June 2021 were RMB 1,444,816 thousand, up from RMB 552,446 thousand at the end of June 2020, representing an increase of approximately 161%[181] Equity and Shareholder Information - As of the report date, Robert Taylor Nelsen holds a 12.56% equity interest in the company, amounting to 90,410,418 shares[127] - Booming Passion Limited and associated entities collectively hold a 14.70% equity interest, totaling 105,821,112 shares[134] - The total number of shares issued as of the report date is 719,953,926[137] - The company has adopted three equity incentive plans to enhance shareholder interests[149] - The pre-IPO equity incentive plan was approved on October 30, 2018, and aims to attract and retain key personnel[150] Corporate Governance - The company has complied with all corporate governance codes since its listing date, except for the separation of the roles of Chairman and CEO[111] - The audit committee, consisting of three independent non-executive directors, has reviewed the financial reporting procedures and internal controls of the company[164]