Arthropathy, Progressive Pseudorheumatoid, of Childhood

Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY, March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed by Lipocine for the treatment of postpartum depression (PPD). The pivotal PK study is an open label, randomized, crossover study in 24 healthy postmenopausal women utilizing the "to be marketed" formulation of LPCN 1154 and dosing regimen. The primary objective of the study is to compare the pharmacokinetics of a multi-dose regimen of oral LPCN 1154 to IV infusion brexanolone administered per label instructions. During the two treatment visits, each participant will receive the oral and IV brexanolone regimens in a randomized, crossover manner. Safety and tolerability of the multidose regimen of LPCN 1154 will also be evaluated. Consistent with the goal of NDA submission by the end of the fourth quarter of 2024, the company anticipates topline results from this crossover pivotal study late in the second quarter of 2024. PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting for up to 12 months after childbirth. There is an unmet need for an oral fast-acting product with an improved efficacy and safety pro treat PPD. Oral LPCN 1154, comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing, is being developed to provide rapid relief with robust efficacy. Recent reports suggest that the market size for PPD is larger than previously estimated. Approximately 500,000 women are affected by PPD annually in the United States and, according to the CDC, an estimated 175,000 women suffer from moderate to severe PPD. Increasing awareness of PPD among physicians and patients is expected to result in higher diagnosis rates and greater numbers of patients seeking treatment. Lipocine has confirmed with the U.S. Food and Drug Administration (FDA) acceptance of a proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. "It is encouraging to see that awareness of this serious condition is growing," said Dr. Mahesh Patel, President and CEO of Lipocine. "LPCN 1154 is targeted to be a highly effective, oral, fast-acting and short duration treatment option for PPD, a serious and potentially life-threatening condition. We believe a 48-hour oral dosing duration will be important for patients and caregivers. If approved, LPCN 1154 has the potential to be a differentiated preferred treatment option for PPD." About LPCN 1154 LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of postpartum depression (PPD). Brexanolone is a bioidentical to naturally occurring neuro active steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone. About Postpartum Depression and Unmet Needs: PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as sexual dysfunction and weight gain, and do not demonstrate adequate remission post-acute treatment. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnering. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk pro target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the timing and outcome of product studies, our development of and filing of a NDA with the FDA for LPCN 1154, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. Company Codes: NASDAQ-SMALL:LPCN

Transitioning HBV cure programs into multiple late-stage combination studies with interim results throughout 2024 and 2025 informing Company's registrational strategyIntegrating R&D, manufacturing and commercial upsides by acquiring full intellectual property rights of BRII-179 and expanding its manufacturing footprintPrioritizing company resources with a robust cash balance of US$376 million supporting operations until 2027Company to host a conference call (English session) on March 25 at 8:30 AM ET / 8:30 PM HKT DURHAM, N.C. and BEIJING, March 22, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today provided a corporate update and reported its financial results for the year ended December 31, 2023. Continue Reading Throughout 2023, the Company delivered significant milestones in its leading HBV program, driving the development of novel combination treatment regimens for an HBV functional cure while also expanding its portfolio. Following formative data readouts from ongoing trials with multiple HBV candidates and the acquisition of full intellectual property rights for BRII-179 and its technology transfer, Brii Bio is poised to launch multiple combination studies in 2024. "2023 was a pivotal year for Brii Bio, with key insights received from multiple Phase 2 combination studies," stated Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "Through vigorous clinical investigations over the past 5 years, we have a deep understanding of what is required to maximally reduce and sustain HBsAg loss. With BRII-179 we have a strategy to assess and enhance HBV patients' intrinsic immunity, targeting therapies to those most likely to respond, while sparing others from poorly tolerated regimens. These are important breakthroughs informing our late-stage clinical combination trials." Full Year 2023 and Recent Corporate Updates In February 2024, Brii Bio finalized agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV) to acquire full intellectual property rights for BRII-179 and manufacturing technology, to expand its future global manufacturing and supply capabilities. This move also eliminates future payments to VBI related to BRII-179 and PreHevbriTM. BRII-179 received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in November 2023, expediting innovative treatments for HBV patients. Brii Bio secured exclusive development and commercialization rights for PreHevbriTM in Greater China and Asia Pacific (excluding Japan) in July 2023 and has submitted two pre-INDs to the CDE for PreHevbriTM's registration plan in China. A Market Authorization Application has also been filed in Hong Kong. Brii Bio has prioritized resources to focus on the clinical and commercial development of its advanced HBV portfolio. The Company is actively seeking partnership opportunities for further development of its CNS, HIV, and MDR/XDR global assets. Brii Bio has appointed Dr. Brian A. Johns as Chief Scientific Officer (CSO) to oversee Brii Bio's discovery programs and shape the Company's future pipeline strategy. Our new organizational strategy is underpinned by highly experienced leaders in infectious diseases who are committed to clear deliverables across the Company's pipeline. Full Year 2023 Core Clinical Pipeline Highlights and Upcoming Milestones Hepatitis B Virus (HBV) Program Key data were generated in 2023 confirming that BRII-179, our proprietary therapeutic vaccine, can trigger a potent and specific immune response in chronic Hepatitis B (CHB) patients and linking that response to improved clinical outcomes. Brii Bio, with our strategic partners, is conducting a series of confirmatory combination studies in 2024, to establish BRII-179 as a core component of future curative regimens in Hepatitis B. In furthering our commitment to BRII-179, Brii Bio negotiated full IP and manufacturing rights with VBI. We are working closely with our partners to initiate late-stage clinical studies to definitively address the contribution of BRII-179 and BRII-835 (elebsiran) towards achieving a higher functional cure rate of HBV infection. More importantly, BRII-179 holds the potential to identify immune-responsive CHB patients with a higher chance of achieving a functional cure. Key Data and Development Plans: BRII-179 Related Studies and Plans Brii Bio presented two late-breaking posters on BRII-179 at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in November 2023, showing an important connection between HBsAg loss and anti-HBs antibody response. These data enable a clear direction in further improving the functional cure rate and identifying patients likely to respond to curative treatments. - BRII-179 induced functional immune responses that improve the rate and duration of HBsAg loss in CHB patients who receive PEG-IFNα treatment, thereby increasing the CHB functional cure rate.- Translational research data from Brii Bio's Phase 1b/2a studies on BRII-179 and BRII-179 in combination with BRII-835 (elebsiran) suggests that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBV-specific immune responses hence achieving higher functional cure rate in the selected patients while sparing others from unnecessary treatments. Brii Bio plans to initiate additional combination studies in the second half of 2024 to confirm the ability of BRII-179 to enhance HBV functional cure rates in combination with other modalities. Brii Bio will present data on patients meeting NRTI discontinuation criteria from its ongoing Phase 2 study of BRII-179 in combination with PEG-IFNα in CHB patients as an oral late-breaking presentation at the 33rd Conference of Asian Pacific Association for the Study of the Liver (APASL 2024), being held from March 27 – 31, 2024 in Kyoto, Japan. BRII-835 (Elebsiran) & BRII-877 (Tobevibart) Related Studies and Plans Completed enrollment in the Phase 2 study of BRII-835 (elebsiran) in combination with PEG-IFNα in the APAC region including mainland China. The primary objectives of this study are to gain deeper insights into the contribution of BRII-835 (elebsiran) towards improving HBV cure rates relative to PEG-IFNα alone and to explore the role of BRII-179 in enriching patients to achieve better curative outcomes. Early topline result is expected in the fourth quarter of 2024. Brii Bio's development partner, Vir Biotechnology, Inc. ("Vir", Nasdaq: VIR), presented new MARCH Part B data at the AASLD The Liver Meeting in November 2023. The data demonstrated an approximately three-fold higher response rate when adding BRII-877 (tobevibart) to a regimen of BRII-835 (elebsiran) with or without PEG-IFNα after 24 weeks of treatment: 15.0% for BRII-877 (tobevibart) + BRII-835 (elebsiran) + PEG-IFNα and 14.3% for BRII-877 (tobevibart) + BRII-835 (elebsiran). The data from cohorts undergoing 48 weeks of treatment will be available in the fourth quarter of 2024. In a late-breaker presentation at the AASLD The Liver Meeting in November 2023 with an update at the 42nd Annual J.P. Morgan Healthcare Conference in January 2024, Vir shared initial SOLSTICE data from a small subset of chronic hepatitis D (CHD) participants. After 12 weeks of combination treatment with BRII-877 (tobevibart) and BRII-835 (elebsiran), 5 of 6 participants achieved undetectable HDV RNA and 6 out of 6 were below the lower limit of quantitation. Additional data will be presented in the second quarter of 2024 and complete 24-week treatment data are expected in the fourth quarter of 2024. A Phase 1 study of BRII-877 (tobevibart) is ongoing in China. Human pharmacokinetics (PK) in mainland Chinese subjects will be compared to subjects from the APAC region and Europe. Additional Clinical and Pre-Clinical Development Updates Based on the Company's strategy to focus on its advanced HBV programs, Brii Bio is pursuing partnership opportunities for the continued development of these programs. Multidrug- and Extensively Drug-Resistant (MDR/XDR) Gram-Negative Bacteria Infections Program BRII-693 Brii Bio gained exclusive global rights in June 2023 to develop and commercialize BRII-693, a novel polymyxin for the treatment of serious gram-negative infections. The Company is seeking strategic funding partners to expedite development of BRII-693, a novel antibiotic intended to help tackle the growing worldwide threat of antimicrobial resistance. In April 2023, Brii Bio submitted a pre-IND to the NMPA of China for the development of BRII-693, with plans to initiate one Phase 1 PK bridging study in China. Additional clinical PK studies to enable the initiation of a Phase 3 trial are in planning. These studies are crucial to support global development efforts. A large, global Phase 3 registrational trial in hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), is expected to begin in 2025. Human Immunodeficiency Virus (HIV) Infection Program BRII-753 is an internally discovered new chemical entity currently in the preclinical stage of development. BRII-753 is being developed as a long-acting subcutaneous injection with the potential for dosing once monthly, once quarterly, or twice yearly and can be used in combination therapy for HIV treatment and as monotherapy for pre-exposure prophylaxis (PrEP). BRII-732 has completed Phase 1 studies with the potential for development as part of an oral, once-weekly, long-acting combination treatment option for HIV patients. Non-Tuberculous Mycobacterial (NTM) Lung Disease Program BRII-658 (Epetraborole): In February 2024, Brii Bio's partner, AN2 Therapeutics, Inc. (NASDAQ: ANTX) announced a voluntary pause of its Phase 3 enrollment in a Phase 2/3 clinical trial for epetraborole (BRII-658) for the treatment-refractory Mycobacterium avium complex (MAC) lung disease, pending further data review. Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS Disorder s BRII-296: In September 2023, the first patient was dosed in the Phase 2 study evaluating BRII-296, a long-acting injectable (LAI) therapy in development for PPD. The Company expects data readouts from the Phase 2 trial by the second quarter of 2024. BRII-297: Dosing has been completed in a Phase 1 clinical trial for BRII-297, a long-acting injectable (LAI) being developed to treat anxiety and depressive disorders. The study aims to evaluate the safety, tolerability, and PK of BRII-297 in healthy volunteers with data expected by the second half of 2024. Full Year 2023 Financial Results Our bank deposits and cash and cash equivalents were RMB2,661.4 million as of December 31, 2023, representing a decrease of 337.9 million or 11.3%, compared with RMB2,999.3 million as of December 31, 2022. The decrease was primarily due to payout of daily operations and research and development activities. Other income was RMB163.7 million for the year ended December 31, 2023, representing an increase of RMB55.8 million or 51.7%, compared with RMB107.9 million for the year ended December 31, 2022. This was mainly due to the increased bank interest income of RMB70.8 million attributable to the rising interest rates on USD and HKD time deposits. The increase was partially offset by the decrease in income recognized from PRC government grants. Research and development expenses were RMB402.7 million for the year ended December 31, 2023, representing a decrease of RMB37.9 million or 8.6%, compared with RMB440.6 million for the year ended December 31, 2022. The decrease was primarily due to the decrease in discontinuation of COVID-19 program. Administrative expenses were RMB196.5 million for the year ended December 31, 2023, representing an increase of RMB27.9 million or 16.5%, compared with RMB168.6 million for the year ended December 31, 2022. The increase was primarily attributable to the increase in employee cost. Total comprehensive expense for the year ended December 31, 2023, was RMB159.7 million, representing a decrease of RMB78.8 million or 33.0 %, compared with RMB238.5 million for the year ended December 31, 2022. The decrease was primarily attributable to the increase in other gain and loss, which was partially offset by the decrease in gain arising from the exchange difference on translation from functional currency to presentation currency. Conference Call Information A live conference call (English session) will be hosted on March 25, 2024 at 8:30 AM U.S. Eastern Time (8:30 PM Hong Kong Time). All participants are required to register in advance of the call. For the registration link, please click here. All participants shall use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive an email with important details for this call, including the call date, time and access link. This link is to be kept confidential and not shared with other participants. Additionally, a replay of the conference call will be available after the call and can be accessed by visiting the Company's website at under the Investor Relations section. *** This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B viral infection (HBV), postpartum depression (PPD), and major depressive disorder (MDD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . Forward Looking Statement The information communicated in this press release contains certain statements that are or may be forward looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company are unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments. SOURCE Brii Biosciences Limited

将乙肝治愈项目推进至多项后期临床联合研究， 2024 年和 2025 年取得的中期结果将为公司的注册战略提供依据 通过收购 BRII-179 的全球知识产权并拓展生产布局，以整合研发、生产和商业优势 优化公司资源， 3.76 亿美元的充足现金将支持公司运营至 2027 年 公司将于 3 月 25 日上午 8:30 （香港时间） / 3 月 24 日晚间 8:30 （美东时间）召开电话会议（中文场） 中国北京和美国北卡罗莱纳州达勒姆市 2024年3月22日 /美通社/ -- 腾盛博药生物科技有限公司 （"腾盛博药"或"公司"，股票代码：2137.HK），一家致力于针对患者未被满足的需求以及重大公共卫生性疾病开发创新疗法的跨国企业，今日发布了最新公司进展和截至2023年12月31日的全年业绩报告。 2023年，公司在其重点的乙型肝炎病毒（HBV）项目中取得了重要里程碑，推动了HBV功能性治愈新型联合疗法的开发，同时拓展了产品组合。随着正在进行的多个HBV候选药物临床试验产生形成性数据，以及获得了BRII-179的全球知识产权和生产技术，公司将在2024年启动多项联合疗法的研究。 腾盛博药董事长兼首席执行官洪志博士表示："2023年对腾盛博药来说是关键的一年，我们从多项2期联合研究中获得了重要洞见。通过过去5年的积极临床研究，我们深入了解了最大限度减少和维持乙肝表面抗原（HBsAg）清除所需的条件。基于BRII-179，我们制定了评估和增强乙肝患者内在免疫力的策略，针对最有可能产生应答的患者进行治疗，同时避免其他患者接受不必要的治疗。这些重要突破为我们的后期临床联合研究提供了依据。" 2023 财年及近期公司进展 2024年2月，腾盛博药与VBI Vaccines, Inc.（"VBI"，纳斯达克股票代码：VBIV）达成协议，收购 BRII-179的全球知识产权和生产技术，以扩大其未来的全球生产和供应能力。同时还取消了未来向VBI支付的与BRII-179和PreHevbri TM 相关的费用。 BRII-179于2023年11月获得中国国家药品监督管理局（NMPA）药品审评中心（CDE）颁发的突破性疗法认定（BTD），加快为HBV患者提供创新疗法。 腾盛博药于2023年7月获得PreHevbri TM 在大中华区和亚太地区（日本除外）的独家开发和商业化权益，并已就PreHevbri TM 在中国的注册计划向CDE 提交了两项 临床前申请（pre-IND）。香港的上市注册申请也已提交。 腾盛博药已优化其资源，重点投入其领先的HBV产品组合的临床和商业开发中。公司正积极寻求合作机会，以进一步开发其中枢神经系统（CNS）、人类免疫缺陷病毒（HIV）和多重耐药和广泛耐药（MDR/XDR）领域拥有全球权益的管线。 腾盛博药任命Brian A. Johns博士为首席科学官，负责腾盛博药的早期发现项目，并制定公司未来的管线战略。我们的新组织战略由在感染性疾病领域拥有丰富经验的领导者所引领，以确保公司管线目标的达成。 2023 财年临床管线亮点和未来里程碑 乙型肝炎病毒（ HBV ）项目 2023年获得的关键数据证明，我们拥有所有权的治疗性疫苗BRII-179可在慢性乙型肝炎患者引发强效的特异性免疫应答，其与临床疗效的改善密切相关。腾盛博药与其战略合作伙伴将于2024年开展一系列确证性联合研究，旨在建立以BRII-179为核心的未来乙肝治疗方案。为了进一步履行我们在BRII-179上的承诺，腾盛博药与VBI就全球知识产权和生产权益达成交易。我们正与合作伙伴密切合作，以启动后期临床研究，来明确BRII-179和BRII-835（elebsiran）对提高HBV功能性治愈率的贡献。此外，BRII-179有可能识别出能产生良好抗体应答并获得更高功能性治愈机会的慢乙肝患者。 关键数据及开发计划 BRII-179 相关研究和计划 在 2023 年 11 月举行的美国肝病研究协会年会（AASLD）上，腾盛博药展示了两份关于BRII-179的突破性壁报，揭示了HBsAg清除率与乙肝表面抗体反应之间的重要联系。这些数据为进一步提高功能性治愈率和识别最有可能对治愈性疗法产生应答的患者指明了方向。 BRII-179可诱导功能性免疫应答，提高接受联合聚乙二醇干扰素α（PEG-IFNα）治疗的慢乙肝患者的HBsAg清除率和清除持续时间，进而可能提高慢乙肝患者功能性治愈率。 腾盛博药对BRII-179和BRII-179联合BRII-835（elebsiran）开展的1b/2a期研究的转化研究数据表明，BRII-179可能有助于识别出能够产生必要HBV特异性免疫应答的慢乙肝患者，从而在这些被筛选出的患者中实现更高的功能性治愈率，同时避免了其他患者接受不必要的治疗。 腾盛博药计划在2024年下半年启动多项联合研究，以验证BRII-179与其他疗法联合使用时提高HBV功能性治愈率的能力。 腾盛博药将在2024年3月27日至31日于日本京都举行的第33届亚太肝脏研究学会（APASL）会议上，以突破性口头报告的形式公布其正在进行的BRII-179联合PEG-IFNα治疗慢乙肝患者的 2 期研究中，符合核苷酸逆转录酶抑制剂（NRTI）停药标准的患者数据。 BRII-835（E lebsiran ） & BRII-877（T obevibart ） 相关研究 和 计划 已完成在包括中国大陆在内的亚太地区开展的BRII-835（elebsiran）联合PEG-IFNα的2期研究患者入组工作。该研究旨在进一步了解BRII-835（elebsiran）相较单用PEG-IFNα对提高HBV治愈率方面的效果，并探索BRII-179在筛选出合适的患者以获得更佳疗效方面的潜力。该研究的初步顶线结果预计将于2024年第四季度公布。 腾盛博药的合作伙伴Vir Biotechnology, Inc.（"Vir"，纳斯达克股票代码：VIR）在2023年11月的AASLD会议上展示了MARCH研究B部分的新数据。数据显示，在将BRII-877（tobevibart）加入联合或不联合PEG-IFNα的BRII-835（elebsiran）方案中治疗24周后，应答率提高了约三倍： BRII-877（tobevibart）+ BRII-835（elebsiran）+ PEG-IFNα的应答率为15.0%，BRII-877（tobevibart）+ BRII-835（elebsiran）的应答率为14.3%。治疗48周的队列数据将于2024年第四季度公布。 Vir在2023年11月AASLD会议的突破性报告中，以及在2024年1月第42届摩根大通医疗健康年会上，分享了SOLSTICE研究中一小部分慢性丁型肝炎（CHD）参与者的初步数据。经过12周的BRII-877（tobevibart）和BRII-835（elebsiran）联合治疗后，6名参与者中有5人无法检测到丁型肝炎病毒核糖核酸（HDV RNA），6名参与者中有6人的HDV RNA低于定量下限。其他数据将于2024年第二季度公布，完整的24周治疗数据预计将于2024年第四季度公布。 BRII-877（tobevibart）的一项1期研究正在中国开展。中国大陆受试者的人体药代动力学（PK）数据将与亚太地区和欧洲的受试者进行比较。 其他临床和临床前开发更新 基于公司所专注的HBV项目战略，腾盛博药正寻求以下项目后续开发的合作机会。 多重耐药和广泛耐药（ MDR/XDR）革兰氏阴性菌感染项目 BRII-693 腾盛博药于2023年6月获得了开发和商业化BRII-693的全球独家权益，BRII-693是一种新型多粘菌素，用于治疗严重的革兰氏阴性感染。公司正寻求战略资金合作伙伴，以加快BRII-693的开发，这种新型抗生素旨在帮助应对全球日益严峻的抗菌药耐药威胁。 2023年4月，腾盛博药向NMPA提交了BRII-693的pre-IND申请，计划在中国启动1期临床PK桥接研究。公司正计划开展更多PK临床研究，以支持3期临床试验的启动。这些研究对支持全球开发工作至关重要。针对医院获得性细菌性肺炎（HABP）/呼吸机相关细菌性肺炎（VABP）的大型全球3期注册性临床试验预计将于2025年开展。 人类免疫缺陷病毒（ HIV）项目 BRII-753 是公司内部研发的新化学实体，目前正处于临床前开发阶段。BRII-753是一种长效皮下注射剂，可每月一次、每季度一次或每年两次给药，可用于治疗HIV的联合疗法和暴露前预防的单药疗法。 BRII-732 已完成1期研究，有潜力开发为HIV患者每周口服一次的长效联合治疗方案的一部分。 非结核分枝杆菌（ NTM）肺病项目 BRII-658（Epetraborole）： 2024年2月，腾盛博药的合作伙伴AN2 Therapeutics, Inc.（纳斯达克股票代码：ANTX）宣布自愿暂停其epetraborole（BRII-658）治疗难治性复合分枝杆菌（MAC）肺病的2/3 期临床试验患者招募，以待进一步的数据审查。 产后抑郁症（ PPD）和重度抑郁症（MDD）项目 BRII-296： 2023年9 月，评估BRII-296的2期研究完成首例患者给药。BRII-296是一种长效注射剂，正在开发用于治疗PPD。公司预计将于2024年第二季度公布2期试验数据。 BRII-297 是一种长效注射剂，正在开发用于治疗焦虑症和抑郁症，该药的1期临床试验已完成患者给药。该研究旨在评估BRII-297在健康志愿者中的安全性、耐受性和药代动力学，预计将于2024年下半年获得数据。 2023年全年财务业绩 截至2023年12月31日，银行存款以及现金及现金等价物为人民币26.614亿元，与截至2022 年12月31日的人民币29.993亿元相比，减少人民币3.379亿元或11.3%。该减少主要是由于日常营运及研发活动支出。 截至2023年12月31日止年度，其他收入为人民币1.637亿元，与截至2022 年12月31日止年度的人民币1.079亿元相比，增加人民币5,580万元或51.7%。这主要是由于美元及港元定期存款利率上升导致银行利息收入增加人民币7,080万元。该增加部分被确认的中国政府补助收入减少所抵销。 截至2023年12月31日止年度，研发开支为人民币4.027亿元，与截至 2022年12月31日止年度的人民币4.406亿元相比，减少人民币3,790万元或8.6%。该减少主要是由于COVID-19项目终止。 截至2023年12月31日止年度，行政开支为人民币1.965亿元，与截至 2022年12月31日止年度的人民币1.686亿元相比，增加人民币2,790万元或16.5%。该增加主要归因于雇员成本增加。 截至2023年12月31日止年度，综合开支总额为人民币1.597亿元，与截至2022年12月31日止年度的人民币2.385亿元相比，减少人民币7,880万元或 33.0% 。该减少主要归因于其他收益及亏损增加，部分被由功能货币换算至呈列货币的汇兑差额所产生的收益减少所抵销。 电话会议信息 公司将于2024年3月25日，香港时间上午8:30（美国东部时间3月24日晚间8:30）举行电话会议（中文场）。在参加电话会议之前，参会者须完成会议注册。注册链接请点击 这里 。 所有参会者须在电话会议之前通过上述链接完成在线注册。此外，此电话会议的回放将在会议后提供，并可通过访问公司网站 www.briibio.com 的投资者关系版块获取。 *** 本新闻稿涉及第三方信息的引用。此类信息不应被视为参考信息纳入本新闻稿中。腾盛博药对此类第三方信息的不负任何责任。 关于腾盛博药 腾盛博药（股票代码：2137.HK）是一家生物技术公司，致力于针对存在巨大未被满足的患者需求、治疗手段有限，以及给患者带来严重社会歧视的重大公共卫生挑战开发创新疗法。公司专注于感染性疾病和中枢神经系统疾病，正在推进一条涵盖多种独特候选药物的产品管线，并通过领先的项目开发针对乙型肝炎病毒（HBV）感染的新型功能性治愈方案，和针对产后抑郁症（PPD）以及重度抑郁症（MDD）的首创治疗方案。在富有远见卓识和经验丰富的领导团队带领下，公司在位于罗利-达勒姆、旧金山湾区、北京和上海的主要生物技术中心开展业务。欲了解更多信息，请访问 www.briibio.com 。 前瞻性声明 本新闻稿中传达的信息包含某些具有或可能具有前瞻性的陈述。这些陈述通常包含诸如"将"、"期望"、"相信"、"计划"和"预期"等词语以及类似含义的词语。就其性质而言，前瞻性陈述涉及风险和不确定性，因为它们与事件相关并取决于未来将发生的情况。可能存在目前被认为不重要或公司未意识到的其他重大风险。这些前瞻性陈述并非对未来业绩的保证。在这些不确定性的背景下，读者不应依赖这些前瞻性陈述。前瞻性陈述可能更新或根据未来的事件或发展进行相应修改，对此公司不承担任何责任。 媒体问询： media@briibio.com 投资者问询： ir@briibio.com