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].
腾盛博药-B(02137) - 2022 - 年度业绩