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].
腾盛博药-B(02137) - 2021 - 年度财报