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].
腾盛博药-B(02137) - 2023 - 年度财报