REYKJAVIK, ICELAND (November 2, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab). The CRL noted that certain deficiencies, which were ...

公司临床数据发布安排 - 公司将于2025年11月3日东部时间上午8:00举行网络直播，报告ANTLER 1期临床试验的新数据，该试验评估vispa-cel在复发或难治性B细胞非霍奇金淋巴瘤患者中的应用 [1] - 网络直播将首次报告CaMMouflage 1期临床试验的初步临床数据，该试验评估CB-011在复发或难治性多发性骨髓瘤患者中的应用 [1] - 公司将报告vispa-cel预期的关键性3期试验设计以及CB-011后续临床开发计划 [1] 核心产品管线vispa-cel - vispacabtagene regedleucel是一种用于治疗复发或难治性B细胞非霍奇金淋巴瘤的同种异体抗CD19 CAR-T细胞疗法 [3] - 据公司所知，vispa-cel是临床中首个带有PD-1敲除的同种异体CAR-T细胞疗法，该基因组编辑策略旨在通过限制CAR-T细胞过早耗竭来增强其活性 [3] - 美国FDA已授予vispa-cel用于B-NHL的再生医学先进疗法、孤儿药和快速通道资格认定 [3] 核心产品管线CB-011 - CB-011是一种用于治疗复发或难治性多发性骨髓瘤的同种异体抗BCMA CAR-T细胞疗法，正在CaMMouflage 1期试验中进行评估 [4] - 据公司所知，CB-011是临床中首个通过B2M敲除并插入B2M–HLA-E融合蛋白的免疫伪装策略来避免免疫介导的排斥的同种异体CAR-T细胞疗法 [4] - CB-011已获得美国FDA的快速通道和孤儿药资格认定 [4] 公司技术平台与战略重点 - 公司是一家临床阶段的CRISPR基因组编辑生物制药公司，专注于为患有严重疾病的患者开发变革性疗法 [5] - 公司的基因组编辑平台，包括其Cas12a chRDNA技术，能够以卓越的精确度开发经过“装甲”改造的细胞疗法，从而可能改善对疾病的活性 [5] - 公司专注于将vispa-cel和CB-011作为现成CAR-T细胞疗法进行开发，这些疗法有潜力为血液恶性肿瘤患者提供广泛的治疗可及性和快速治疗 [5]

LUXEMBOURG, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE and Mexico: TS and EXM Italy: TEN) (“Tenaris”) announced today that pursuant to its USD 1.2 billion Share Buyback Program (the “Program”) announced on May 27, 2025, it has entered into a non-discretionary buyback agreement with a primary financial institution (the “Bank”) for the execution of its second tranche, covering up to the remainder USD 600 million of the Program (excluding customary transaction fees). This second tranche shall start o ...

MHRA response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization appl ...

SHENZHEN, China, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leader in AI-driven Internet healthcare solutions, was presented with a Generative AI Service Filing Certificate at the first Guangdong Provincial LLM Filing Conference in Shenzhen. At the event, Dr. Xie Fangmin, Founder, Chairman, and CEO of Fangzhou, remarked: “The successful launch of the ‘XingJie’ Large Language Model (‘XJ LLM’) marks another milestone in Fangzhou’s advancement of AI-driven ch ...

HTVRONT Black Friday sales will kick off on November 1st with exclusive dealsSACRAMENTO, Calif., Nov. 01, 2025 (GLOBE NEWSWIRE) -- As Black Friday approaches, HTVRONT, a global innovator in heat press and crafting technology, is set to launch its largest promotion of 2025, running from November 1st to December 1st across Amazon and its official website. This exciting event features steep discounts on best-selling machines, alongside exclusive chances to win free orders and limited-edition mystery machines, ...

文章核心观点 - 公司发布关于HERA框架协议和公共准备业务的澄清说明，确认了来自欧洲卫生应急准备与响应管理局的75万剂MVA-BN天花/猴痘疫苗订单，该订单将于2026年交付，并与早前美国生物医学高级研究与发展管理局的订单共同为2026年构建15-20亿丹麦克朗的基础准备业务奠定基础 [1][2] 新订单详情 - 欧洲委员会通过HERA下达了75万剂MVA-BN天花/猴痘疫苗的初始订单，将于2026年交付 [2] - 这是公司为2026年获得的第二份订单，第一份是2024年5月宣布的美国BARDA的合同选项 [2] - 公司预期在接下来一年内将获得额外的MVA-BN订单 [2] 财务影响与业务展望 - BARDA和HERA的订单是构建2026年基础准备业务的良好开端，规模预计在15-20亿丹麦克朗，与此前指引一致 [2] - HERA协议的授予不影响2025年的业绩指引 [2] 公司业务定位 - 公司是一家全球疫苗公司，致力于通过创新疫苗改善健康并拯救生命 [3] - 公司是政府加强公共卫生准备的首选天花和猴痘疫苗供应商，并拥有领先的旅行疫苗组合 [3]

GUANGZHOU, China, Nov. 01, 2025 (GLOBE NEWSWIRE) -- EQU Asset Management is enthusiastic to announce its revised commitment to playing a fuller role in the transition towards a lower-carbon economy and to achieving net-zero greenhouse gas emissions. As a leading wealth management and investment firm, we are accelerating our efforts by deploying innovative solutions that help to combat climate change. Making Tangible Progress Towards a Greener Future At EQU Asset Management, ensuring we make tangible progre ...

月度交付业绩 - 2025年10月交付量达40,397辆，创下月度交付新纪录，同比增长92.6% [2][6] - 2025年年初至今累计交付241,618辆，同比增长41.9% [6] - 截至2025年10月31日，累计总交付量达到913,182辆 [2][6] 分品牌交付构成 - 高端品牌NIO交付17,143辆 [2] - 家庭导向品牌ONVO交付17,342辆 [2] - 小型高端品牌FIREFLY交付5,912辆 [2] 重点车型表现 - ONVO L90旗舰SUV自2025年7月下旬正式上市后，连续三个月月交付量超过10,000辆 [3] - ONVO L90凭借在大型SUV细分市场的行业领先地位和卓越产品竞争力，有望加速大型三排座SUV向全面电动化转型 [3] 公司业务定位 - 公司是全球智能电动汽车市场的先驱和领先企业 [1][4] - 公司通过NIO、ONVO和FIREFLY三大品牌，分别提供高端智能电动汽车、家庭导向智能电动汽车以及小型智能高端电动汽车 [4]

SHANGHAI and NEW YORK, Oct. 31, 2025 (GLOBE NEWSWIRE) -- TH International Limited (Nasdaq: THCH), the exclusive master franchisee of Tim Hortons restaurants in China (“Tims China” or the “Company”), today announced that it has entered into a definitive agreement for the issuance of Senior Secured Convertible Notes. Additionally, THCH announced amendments to its existing 2024 unsecured convertible notes. Transaction Overview Tims China has entered into agreements providing for the issuance of senior secured ...