Peginterferon Alfacon-2(Beijing Kawin Technology)

BRII-179 (VBI-2601) as an add-on therapy to standard of care PEG-IFNα increases HBsAg loss rate at the end of treatment and 12 weeks follow up Significantly increased seroconversion rate is strongly associated with BRII-179 (VBI-2601) treatment and correlates with the increased rate of HBsAg loss Safety findings are similar to those of PEG-IFNα and BRII-179 (VBI-2601) as previously reported CAMBRIDGE, Mass.--(BUSINESS WIRE)-- VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”) today announced that its strategic hepatitis B (HBV) partner, Brii Biosciences (Brii Bio) (Stock code: 2137.HK), announced topline cohort-level unblinded Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in chronic hepatitis B virus (HBV) patients compared with PEG-IFNα only treatment. VBI and Brii Bio reported in previous studies that BRII-179 (VBI-2601) induced broad antibody and T-cell responses against Pre-S1, Pre-S2, and S epitopes in HBV patients. Brii Bio’s detailed press release can be found here: . “We share Brii Bio’s excitement about this data and congratulate them on their continued ability to move quickly and execute clinical programs as they seek to deliver higher hepatitis B functional cure rates,” said Jeff Baxter, President and CEO of VBI. “Brii Bio’s ongoing commitment, investments, and partnerships in this field continue to reinforce the strategic potential of our partnership and we look forward to seeing further data from this study and future studies of this first-in-class immunotherapeutic candidate.” In July 2023, VBI and Brii Bio announced an expansion of their HBV partnership to include an exclusive global license to develop and commercialize BRII-179 (VBI-2601), and an exclusive license to develop and commercialize PreHevbri®, VBI’s prophylactic 3-antigen adult HBV vaccine, in the Asia Pacific region, excluding Japan. About BRII-179 (VBI-2601) + PEG-IFNα Combination Study The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled, parallel study designed to evaluate the safety and efficacy of BRII-179 (VBI-2601) as an add-on therapy to PEG-IFNα and NrtI therapy for the treatment of chronic HBV infection. This study enrolled adult HBV patients in mainland China who had received 24 to 28 doses of PEG-IFNα per treatment guideline, at least 12 months of NrtI therapy, and met a pre-defined criteria for partial response. Subjects were randomized 1:1 to receive BRII-179 (VBI-2601) or placebo every three weeks for a total of 7 doses over 18 weeks while continuing PEG-IFNα treatment for 48 weeks. Subjects who met Nrtl discontinuation criteria would stop Nrtl treatment and would be followed up for additional 48 weeks. About BRII-179 (VBI-2601) BRII-179 (VBI-2601) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate and is designed to target enhanced and broad B-cell and T-cell immunity. BRII-179 (VBI-2601) has been licensed to Brii Biosciences (Brii Bio) under an exclusive global development and licensing agreement. BRII-179 (VBI-2601) is currently being investigated in two Phase 2 clinical trials in combination with BRII-835 (VIR-2218) and PEG-IFNα as part of a potential functional cure regimen for the treatment of chronic HBV infection. About PreHevbri® PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – Pre-S1, Pre-S2, and S. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel). Please visit for U.S. Important Safety Information for PreHevbrio® [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information. U.S. Indication PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older. U.S. Important Safety Information (ISI) Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio. Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio. PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or . Please see Full Prescribing Information. About VBI Vaccines Inc. VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. Website Home: News and Resources: Investors: Cautionary Statement on Forward-looking Information Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the COVID-19 pandemic and the continuing effects of the COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the Canadian security authorities at sedar.com on March 13, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

本周，反腐再升级，中纪委部署整治全国医药领域腐败问题，指出各级纪检监察机关要深入开展医药行业全领域、全链条、全覆盖的系统治理，加大执纪执法力度，紧盯领导干部和关键岗位人员，坚持受贿行贿一起查，集中力量查处一批医药领域腐败案件，形成声势震慑。与此同时，CDE官网连发3项“以患者为中心”的指导原则。以患者为中心”的药物研发是基于患者角度开展的药物开发、设计、实施和决策的过程，旨在高效研发更符合患者需求的有临床价值的药物，是当前各国药品监管机构积极探索的领域，受到业内广泛关注。此外，本周的大型交易也频频发生，备受关注的是关于罕见病的两起交易，一是渤健约73亿美元收购了一家神经系统罕见病疗法公司Reata Pharmaceuticals；二是阿斯利康旗下罕见病公司Alexion与辉瑞就其临床前基因治疗项目和专有技术组合达成明确购买和许可协议，该协议将进一步协助Alexion和阿斯利康推进新一代基因组药物，增加互补管线资产和开发创新技术。一起看看本周医药行业有哪些亮点值得关注？政策动态中纪委部署整治全国医药领域腐败问题7月28日，纪检监察机关配合开展全国医药领域腐败问题集中整治工作动员部署视频会议在北京召开，中央纪委副书记、国家监委副主任喻红秋出席会议并讲话。会议指出，集中整治医药领域腐败问题是推动健康中国战略实施、净化医药行业生态、维护群众切身利益的必然要求。各级纪检监察机关要深入开展医药行业全领域、全链条、全覆盖的系统治理。加大执纪执法力度，紧盯领导干部和关键岗位人员，坚持受贿行贿一起查，集中力量查处一批医药领域腐败案件，形成声势震慑。湖南省医保局下发《关于开展2023年省际药品价格联动挂网工作的通知》7月28日，湖南省医保局下发《关于开展2023年省际药品价格联动挂网工作的通知》（湘医保函〔2023〕58号），该《通知》的下发，意味着湖南省新一轮的药品价格联动、挂网工作方式正式确立。《通知》显示，除了定点供应、国谈、集采药品之外的所有合法合规上市的药品，可按规定在湖南申请挂网，并进行相应的价格联动。本次挂网联动药品价格、采购交易信息采集时间均为2022年8月1日至2023年7月31日。药品价格采集范围原则上不包含外省明确的集采中选价格、医保支付限价、企业自主报价。CDE官网连发3项指导原则7月27日，CDE官网发布3项指导原则，分别是《以患者为中心的药物临床试验设计技术指导原则（试行）》、《以患者为中心的药物临床试验实施技术指导原则（试行）》、《以患者为中心的药物获益-风险评估技术指导原则（试行）》，以推动“以患者为中心”理念在药物研发的实践应用。根据CDE公告，“以患者为中心”的药物研发是指基于患者角度开展的药物开发、设计、实施和决策的过程，旨在高效研发更符合患者需求的有临床价值的药物，是当前各国药品监管机构积极探索的领域。文件强调，从以患者为中心的角度出发，应重点关注以下原则：一是将患者需求贯穿药物研发全过程；二是体现患者需求的临床试验设计；三是改善受试者体验、减轻受试者负担；四是加强早期和全过程沟通交流。大型制药默沙东21价肺炎球菌结合疫苗两项III期试验获得积极结果7月27日，默沙东宣布，21价肺炎球菌结合疫苗V116的两项III期试验获得积极结果。与辉瑞的20价肺炎球菌结合疫苗PCV20相比，在初治肺炎球菌疫苗成人中，V116对于两种疫苗中共有常见的血清型产生了统计学意义上显著的免疫反应。礼来Tirzepatide用于减重的2项Ⅲ期临床试验成功7月27日，礼来宣布，Tirzepatide用于减重的2项Ⅲ期临床试验成功。试验结果显示，与安慰剂相比，接受Tirzepatide治疗的患者体重平均减轻了21.1%；加上为期12周的干预期，患者体重平均减轻了26.6%；Tirzepatide组体重减轻≥5%的患者比例达94.4%，安慰剂组仅为10.7%。阿斯利康/第一三共德曲妥珠单抗Ⅱ期临床获积极结果7月27日，阿斯利康和第一三共联合宣布，Enhertu（德曲妥珠单抗）治疗既往接受过治疗的多种HER2表达晚期实体瘤患者，Ⅱ期临床试验中，患者无进展生存期（PFS）和总生存期（OS）改善。恒瑞医药两款新药获批临床7月25日，恒瑞医药宣布，子公司上海盛迪医药有限公司和苏州盛迪亚生物医药有限公司收到国家药监局核准签发关于阿得贝利单抗注射液、注射用 SHR-A2009 的《药物临床试验批准通知书》，将于近期开展临床试验。阿得贝利单抗是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。国外有同类产品 Atezolizumab（商品名：Tecentriq）、Avelumab(商品名：Bavencio)和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中Atezolizumab 和 Durvalumab 已在中国获批上市。多家MNC发布财报本周，阿斯利康、罗氏、葛兰素史克、渤健等MNC接连发布2023年H1财报。7月25日，渤健发布2023H1财报，上半年营收49.19亿美元，同比下滑4%，净利润为9.81亿美元，同比下滑23.2%，研发投入11.55亿美元，同比增长6.9%。多发性硬化症产品销售额继续下滑，上半年总收入23.35亿美元。同时，渤健还宣布了一项新的“Fit for Growth”计划，预计将节省约10亿美元的运营费用，其中约3亿美元将用于产品推出和研发，到2025年将节省约7亿美元的净运营费用，该计划包括裁员约1000人。7月27日，罗氏公布2023H1业绩，营收297.79亿瑞士法郎（约为328.4亿美元），同比下降2%；净利润为75.63亿瑞士法郎（83.4亿美元），同比下降9%；研发投入64.49亿瑞士法郎，同比增加8%。7月27日，葛兰素史克发布2023年第二季度财报，总营收为71.8亿英镑，同比增长4%。主要增长来源于疫苗，收入约20亿英镑，同比增长18%；而特殊药品销售同比下降7%，收入25亿英镑；普通药品收入约26亿英镑，同比增长8%。7月28日，阿斯利康公布2023H1业绩。公司总营收222.95亿美元，其中产品收入214.48亿美元；扣除新冠产品后，上半年收入219.61亿美元，同比增长12%；研发投入52.78亿美元，同比增长13%。生物科技康希诺吸附破伤风疫苗获得药物获批临床7月28日，康希诺发布公告，收到NMPA核准签发的关于吸附破伤风疫苗的《药物临床试验批准通知书》。破伤风是由破伤风梭状芽孢杆菌(破伤风杆菌)感染机体导致的一种急性感 染性疾病，破伤风杆菌产生的一种外毒素即破伤风痉挛毒素，是破伤风的致病因 子，可引起全身骨骼肌强直性收缩和阵发性痉挛。重症破伤风患者可并发喉痉挛、 窒息、肺部感染和器官功能衰竭，病死率高达 30%-50%，在无医疗干预的情况 下病死率接近 100%，是一种极为严重的潜在致命性疾病。贝达药业EYP-1901玻璃体内植入剂药品获批临床7月27日，贝达药业发布公告称，收到国家药品监督管理局签发的《药物临床试验批准通知书》，公司由EyePoint引进的EYP-1901玻璃体内植入剂病理性近视脉络膜新生血管适应证药品临床试验申请已获得NMPA批准开展。伏罗尼布是具有全新化学结构的新一代多靶点酪氨酸激酶血管内皮生长因子受体(VEGFR)/血小板衍化生长因子受体(PDGFR)抑制剂，可抑制肿瘤血管生成及生长，可用于治疗病理性血管生成性疾病。伏罗尼布片用于治疗肾癌的适应症已于2023年6月获批上市。博瑞生物：BGM0504注射液获得II期临床试验伦理批件7月27日，博瑞生物发布公告称，控股子公司博瑞新创自主研发的BGM0504注射液治疗减重和2型糖尿病的II期临床研究方案通过了牵头医院中南大学湘雅三医院伦理委员会的审批，分别获得了《中南大学湘雅三医院伦理委员会审批件》。BGM0504注射液是公司自主研发的GLP-1(胰高血糖素样肽1)和GIP(葡萄糖依赖性促胰岛素多肽)受体双重激动剂，属于境内外均未上市化学药品1类创新药。欧林生物：疫苗产品获批临床7月26日，欧林生物发布公告称，近日，公司收到国家药品监督管理局核准签发的关于冻干b型流感嗜血杆菌结合疫苗的《药物临床试验批准通知书》，符合药品注册的有关要求，同意开展用于预防由 b 型流感嗜血杆菌引起的侵袭性感染（包括脑膜炎、肺炎、败血症、蜂窝组织炎、关节炎、会厌炎等）的临床试验。凯因科技培集成干扰素新增适应证获批临床7月24日，凯因科技公告，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，培集成干扰素α-2注射液新增适应症临床试验申请获得批准。培集成干扰素α-2注射液（商品名：派益生）是公司拥有自主知识产权的抗病毒、免疫调节药物，属于治疗用生物制品。本次临床试验申请为增加肝上皮样血管内皮瘤临床适应症（KW-059）。资本市场渤健约73亿美元收购Reata Pharmaceuticals7月28日，渤健和Reata Pharmaceuticals宣布，两家公司已经达成了一个明确的协议，根据该协议，渤健将以约73亿美元收购后者。Reata Pharmaceuticals在严重神经系统疾病中开发调节细胞代谢和炎症的治疗药物方面取得了显著进展。该公司的Skyclarys（omaveloxolone）是美国首个获批用于治疗弗里德赖希共济失调症的药物，欧洲监管审评正在进行中。此外，该公司还在开发一系列神经疾病的创新产品组合。阿斯利康和辉瑞达成10亿美元授权协议7月28日，阿斯利康收购的罕见病公司Alexion宣布已就辉瑞公司的一系列临床前基因治疗计划和技术达成最终购买和许可协议。该协议进一步推动了Alexion和阿斯利康通过增加补充管线资产和创新技术来推进下一代基因药物的承诺。Alexion将以高达10亿美元的总对价购买并许可辉瑞早期罕见病基因治疗组合的资产。Alexion计划在满足成交条件的情况下，于2023年第三季度完成交易。一家biotech合并失败，裁员78%7月25日，在与MEI Pharma的合并失败后，为了在寻求“战略交易以最大限度地发挥eganelisib的潜力”的同时继续存活，Infinity Pharmaceuticals宣布，裁掉78%的员工以及3名董事会成员，以降低公司烧钱的速度，确保其能够发挥PI3Kγ抑制剂eganelisib的最大化价值。艾伯维与Calibr达成战略合作7月26日，艾伯维与Calibr宣布扩大战略合作，在艾伯维的核心治疗增长领域推进多项创新的临床前和早期临床资产。这一合作关系是艾伯维与Scripps Research于2019年建立的合作关系的扩展。除了从临床前开发阶段到IND开发阶段的合作项目外，Calibr还将向艾伯维提交一定数量的新发现靶点和临床前资产，供艾伯维考虑选择。安斯泰来与PeptiDream合作开发蛋白降解剂7月25日，安斯泰来宣布，与PeptiDream达成一项研究合作与许可协议，针对安斯泰来选定的两个靶点发现新型蛋白质降解剂，安斯泰来还有权选择另外三个靶点纳入合作范围。两家公司计划将PeptiDream的PDPS技术与安斯泰来的药物发现能力相结合，以发现针对多个不同靶点的下一代蛋白质降解剂。根据协议，安斯泰来将向PeptiDream公司支付30亿日元的预付款。阿斯利康与艾德生物达成伴随诊断新合作7月24日，艾德生物公告，与阿斯利康达成靶向药物伴随诊断合作。根据协议，艾德生物自主研发的人类同源重组修复缺陷检测产品将作为PARP抑制剂利普卓®（奥拉帕利）卵巢癌适应症在中国的伴随诊断，并将积极推进HRD检测产品在国家药监局的注册审批。CXO动态赛默飞2023年第二季度营收下滑3%7月26日，赛默飞世尔发布2023年Q2业绩，第二季度营收为106.9亿美元，同比下降3%，上年同期为109.7亿美元；净利润为13.62亿美元，同比下降18%，上年同期为16.68亿美元。7月26日，赛默飞世尔发布2023年Q2业绩，第二季度营收为106.9亿美元，同比下降3%，上年同期为109.7亿美元；净利润为13.62亿美元，同比下降18%，上年同期为16.68亿美元。丹纳赫2023年Q2营收下滑约7.66%7月24日，丹纳赫公布了2023年第二季度和上半年的业绩。丹纳赫2023年第二季度实现营收71.57亿美元，同比减少约7.66%；第二季度净利润为11.06亿美元，同比减少约33.29%。丹纳赫2023年上半年实现营收143.24亿美元，同比减少约7.22%；上半年净利润为25.35亿美元，同比减少约24.15%。风险提示财务报表合并范围不完整、业绩预告披露不准确，宝莱特公司及高管收警示函广东宝莱特医用科技股份有限公司7月24日公开信息显示，董事长燕金元、副总经理杨永兴、副总裁廖伟、财务总监许薇因信息披露违规,业绩预测结果不准确或不及时,未依法履行其他职责被中国证券监督管理委员会广东监管局出具警示函（〔2023〕85号）。具体违规行为：一、财务报表合并范围不完整。2018年6月至2022年12月期间,宝莱特子公司天津市挚信鸿达医疗器械开发有限公司间接拥有天津新成就供应链管理有限公司(以下简称新成就公司)的控股权,且委派人员担任新成就公司监事,实际负责新成就公司财务工作,构成对新成就公司的实际控制。宝莱特在上述期间未将新成就公司纳入财务报表合并范围并予以披露,违反了《企业会计准则第33号——合并财务报表》第七条、《上市公司信息披露管理办法》(证监会令第40号)第二条、《上市公司信息披露管理办法》(证监会令第182号)第三条等相关规定。二、2022年业绩预告披露不准确。2023年1月30日,宝莱特披露《2022年年度业绩预告》,预计2022年度归属于上市公司股东的净利润为盈利1,700万元至2,500万元,扣除非经常性损益后的净利润为盈利170万元至250万元。2023年4月13日,宝莱特披露《2022年年度业绩预告修正公告》,因会计核算不准确等原因,将扣除非经常性损益后的净利润修正为亏损500万元至750万元,与此前的业绩预告存在重大差异。上述情形违反了《上市公司信息披露管理办法》(证监会令第182号)第三条、第十七条等相关规定。据上海证券报记者不完全统计，截至7月26日，本月已有47家公司因业绩预告披露存在问题收到交易所的监管函件，其中大部分是向2022年度业绩预告“不靠谱”公司发出的，有2家公司是因2023年半年报业绩预告相关问题被交易所问询。此外，已有11家公司及相关负责人被监管部门给予行政处罚。全面注册制是以信息披露为核心，上市公司必须真实、准确、完整、及时、公平地披露信息，业绩预告没有经过审计，但业绩预告也应在合理、客观的范围内，上市公司切勿要高估盈利，以免给投资者造成误解和投资损失。登记邮箱信息订阅E药经理人信息服务扫描二维码精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 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