营收情况 - 瑞士制药巨头Roche Holding AG的2024年第一季度营收因瑞士法郎升值和COVID-19相关销售下降而减少6%[1] - 在恒定汇率下，销售额增长2%，主要受到对新药物和诊断产品的需求增加的推动，包括免疫诊断、临床化学检测和先进染色溶液[2] - 制药部门的销售额在第一季度增长2%，达到109亿瑞士法郎，主要受到关键药物需求增长的推动，但COVID-19药物Ronapreve的销售下降[4] - 诊断部门的销售额增长2%，达到35亿瑞士法郎，主要受到免疫诊断产品、临床化学检测和先进染色溶液需求增加的推动[5] 产品表现 - Vabysmo是销售增长的最大推动因素，其他重要贡献者包括Phesgo、Ocrevus、Polivy和Hemlibra[7] - FDA批准Alecensa作为ALK阳性早期肺癌患者的第一线辅助治疗[17] - Xolair获得FDA批准，成为首个也是唯一一个用于治疗一种或多种食物过敏的药物[18] - Elecsys pTau217试剂获得FDA突破性设备认定，以支持更早的阿尔茨海默病诊断[20] - Roche和Lilly期待该测试在获批后在改善早期和准确阿尔茨海默病诊断方面发挥重要作用[21] 公司展望 - Roche管理层表示COVID-19相关销售下降的影响基本结束，未来集团销售不会再受到重大影响[6] - Roche预计总销售额将以中单位数增长（在恒定汇率下），核心每股收益预计与销售增长大致同步，预计将进一步增加瑞士法郎的股息[16] - Roche的表现受到汇率汇率贬值和COVID-19相关销售下降的影响，但眼科药物Vabysmo持续增长[22] - Roche正在努力在肥胖市场取得进展，以弥补传统药物销售下降的影响[25] - Roche在2024年1月收购了Carmot Therapeutics，获得了三种具有潜在最佳类别的临床阶段资产，涉及肥胖和糖尿病[26]

销售额表现 - 罗氏控股AG在第一季度报告中表示，销售额在恒定汇率下增长2%，主要受到新药品和诊断产品需求的增强推动[2] - 在不包括COVID-19产品的情况下，销售额增长了7%[2] - 由于瑞士法郎走强，销售额在本地货币报告时收窄了6%[3] - 公司预测，在调整货币波动的情况下，年度集团销售额将以中单位数百分比增长[6] - Schinecker在周三表示，公司对今年的集团销售额在中单位数百分比范围内增长的展望感到自信，并因此确认了2024年的展望[7] 展望和预测 - CEO Thomas Schinecker确认了公司2024年的展望，表示COVID-19对销售的影响在本季度基本上已经结束[4] - 罗氏在2月份发布了一个比预期更为温和的2024年增长展望，因为公司继续面临COVID-19产品需求下降以及一些癌症药物的问题[5]

Roche (RHHBY) announced that the FDA has approved a label expansion of its lung cancer drug, Alecensa. The drug is now approved for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node-positive), as detected by an FDA-approved test. Alecensa is a kinase inhibitor, already approved as the first and second-line treatment for ALK-positive metastatic NSCLC, in various countries like the United States, E ...

罗氏控股新药研究 - 罗氏控股宣布其市场药物Columvi（glofitamab）与吉西他滨和奥沙利铂（GemOx）联合治疗复发性或难治性弥漫性大B细胞淋巴瘤（DLBCL）的晚期研究达到了总生存期的主要终点[1] - Columvi是罗氏的固定疗程和CD20xCD3 T细胞结合的双特异性抗体，目前已获得FDA批准作为单药治疗R/R DLBCL的药物，该药物还获得了欧盟对同一适应症的有条件上市授权[2] - STARGLO阶段III研究结果表明，早期R/R DLBCL患者接受Columvi/GemOx联合疗法的生存期比接受MabThera/Rituxan（利妥昔单抗）联合GemOx治疗的患者更长[3]

Elecsys pTau217血浆生物标志物测试 - 罗氏公司宣布新的Elecsys pTau217血浆生物标志物测试获得FDA的“突破性设备认定”[3] - 该测试并非治愈阿尔茨海默病，而是用于告知患者根据检测到的淀粉样斑块水平是否有患病风险[4] - 临床试验必须首先建立并进行，即使结果积极，测试仍需获得FDA批准才能投放市场[5] 市场前景 - 全球阿尔茨海默病患者数量庞大，罗氏公司有望在这一市场中获得收益[6] - Elecsys pTau217能否带来罗氏公司的增长仍有待观察，目前股票价格合理，且具有丰厚的股息[7]

Roche (RHHBY) has unveiled its latest innovation in diabetes care, paving its way into the continuous glucose monitoring (CGM) market, at the 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy. The new Accu-Chek SmartGuide solution for real-time CGM promises to revolutionize diabetes management with its predictive artificial intelligence (AI) capabilities, addressing critical unmet needs faced by individuals with diabetes. Roche is currently working toward ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from Stage 1 of the National Institutes of Health (NIH)- sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair® (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine (NEJM) and featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthm ...

Roche (RHHBY) announced that the FDA has approved a label expansion of the asthma drug Xolair (omalizumab). The regulatory body approved the drug for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged one year and older with IgE-mediated food allergy. The FDA approval is based on positive data from the late-stage OUtMATCH study, which evaluated Xolair in patients aged between one and 55 years who are a ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE- mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are al ...

Cristina Arias/Cover via Getty Images Description The Swiss company Roche (OTCQX:RHHBY) (OTCQX:RHHBF) (OTCPK:RHHVF) is one of the most well- recognized brands in the pharmaceutical sector. It has a CHF 187 billion market capitalization and annual revenues of CHF 58.7 billion (2023 data). With a 2.7% weight, it is the tenth largest company by weight within the MSCI world healthcare index. msci world health care sector weight (MSCI World) The company has a strong international presence, as it generates 48% of ...