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].
腾盛博药-B(02137) - 2023 - 中期业绩