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]