董事会欣然宣布，其自主研发的地舒单抗注射液(60mg)(代号BA6101)已获玻利维亚国家药品和卫生技术 局(AGEMED)批准上市。 BA6101为原研参照药Prolia的生物类似药，在全球范围内Prolia广泛应用于骨质疏松症的治疗。BA6101 的适应症与原研参照药相同。BA6101基于本公司全球研发策略开发，并计划在全球多个国家及地区开 展商业化。2022年，BA6101(博优倍)作为首个国产地舒单抗注射液在中国率先获批上市。当前， BA6101在英国的上市许可申请正处于审批阶段，本公司计划在欧洲、美国、日本等国家和地区提交上 市许可申请。 BA6101的研发过程严格遵循中国、美国、欧盟、日本的生物类似药相关指导原则，通过一系列分析、 非临床、人体药代动力学及临床研究，确证其与原研参照药的整体相似性。具体而言，BA6101在质 量、安全性和有效性方面均证实与原研参照药高度相似，无临床意义上的差异。此外，BA6101的生产 亦遵循国际最高标准，为其海外拓展提供品质保障。 博安生物(06955)发布公告，本公司董事会注意到本公司股份(H股)于2026年1月9日的成交量有所上升。 经就本公司作出在有关情况下 ...

Stacks of gold coins forming an upward arrow beside a lab beaker and heart-rate icon. Key Points Stryker, Amgen, and Eli Lilly have all raised their dividends, signaling increased capital returns to shareholders despite varied stock performance in 2025. Amgen now offers an industry-leading 3.2% dividend yield, one of the few large-cap healthcare stocks with a yield above 3%. Wall Street maintains a positive outlook across all three names, with Stryker offering the highest implied upside at over 20%, fo ...

Core Insights - Amgen reported strong Q3 2025 earnings, with adjusted earnings of $5.64 per share, surpassing the Zacks Consensus Estimate of $5.00, and total revenues of $9.6 billion, exceeding the estimate of $8.9 billion, reflecting a 12% year-over-year increase [2][3] Financial Performance - Total product revenues increased by 12% year-over-year to $9.17 billion, driven by a 14% rise in volume, although partially offset by a 4% decline in pricing [3] - Other revenues rose by 19.3% year-over-year to $420 million, primarily due to higher royalty income [3] - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with operating expenses increasing by 18% to $5.25 billion [22] Key Product Performance - Prolia revenues reached $1.14 billion, up 9% year-over-year, significantly exceeding the Zacks Consensus Estimate of $911 million [6] - Evenity sales grew by 36% year-over-year to $541 million, surpassing the Zacks Consensus Estimate of $519 million [7] - Repatha generated revenues of $794 million, a 40% increase year-over-year, beating the Zacks Consensus Estimate of $720 million [7] - Biosimilar portfolio sales surged by 52% year-over-year to $775 million [5] Guidance and Outlook - Amgen raised its 2025 revenue and earnings outlook, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [24] - Adjusted operating margin is anticipated to be around 45%, with R&D expenses expected to grow at a mid-20s percentage rate year-over-year [25] Pipeline Developments - Enrollment has been completed in two phase III studies for MariTide, with approximately 5,000 adults enrolled [27] - Ongoing enrollment in two other phase III studies for atherosclerotic cardiovascular disease and heart failure [28]

Core Insights - Amgen's mission focuses on discovering, developing, manufacturing, and delivering innovative medicines for serious illnesses globally [2] - The company is experiencing strong momentum with a positive long-term growth outlook driven by its diverse therapeutic areas [3] Financial Performance - Amgen reported a 10% revenue growth for the first nine months ending in September, with product sales growing by 11% [4] - The growth was primarily driven by a 14% increase in volume, with 12 products achieving double-digit growth and 14 products annualizing over $1 billion [4] - In the third quarter, 16 products exhibited double-digit growth compared to the previous year, indicating robust business momentum [4] Strategic Outlook - The company is preparing for full-year competition related to its products Prolia and XGEVA, indicating a proactive approach to market challenges [5]

INCHEON, Korea--(BUSINESS WIRE)-- #Biosimilar--Samsung Bioepis Co., Ltd. today announced the launch of OBODENCEâ"¢ (60 mg pre-filled syringe) and XBRYKâ"¢ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively. "We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability ch ...

Core Viewpoint - The company, 博安生物, has seen a stock increase of over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities [1] Group 1: Product Development - 博安生物's BA6101 (60mg) and BA1102 (120mg) are key products in its global development strategy, targeting orthopedic and oncology fields respectively [1] - The company plans to submit marketing applications for these products to major international regulatory bodies including EMA, FDA, and PMDA [1] Group 2: Market Potential - There is a significant global market potential for 地舒单抗, with projected combined sales of Prolia and Xgeva reaching approximately $6.6 billion in 2024 [1] - The company has established a comprehensive quality management system that meets international standards to support the global commercialization of its products [1]

Core Viewpoint - The company, Boan Biotech (06955), has seen its stock rise over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities in the orthopedic and oncology sectors [1] Group 1: Product Development - Boan Biotech announced that its self-developed monoclonal antibody injections, BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology, have received acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorization [1] - The company considers BA6101 and BA1102 as core products in its global development strategy and plans to submit applications to other international regulatory bodies, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [1] Group 2: Market Potential - There is a broad market outlook for the monoclonal antibody, denosumab, due to extensive clinical demand and significant clinical value, with global sales for Prolia and Xgeva projected to reach approximately $6.6 billion in 2024 [1] - To support its global commercialization goals, the company has established a comprehensive quality management system that meets international standards in China, Europe, the United States, and Japan, ensuring quality assurance for denosumab and future biopharmaceuticals [1]

Core Viewpoint - Amgen Inc. needs to broaden its portfolio and improve its narrative around its products despite having a strong quarter [1] Company Overview - Amgen Inc. manufactures human therapeutics targeting cancer, cardiovascular, inflammatory, and bone disorders [1] - Key products include Enbrel, Prolia, Repatha, Otezla, and Kyprolis [1] Product Comparison - Amgen's MariTide requires only one injection per month, contrasting with competitors like Mounjaro and Ozempic, which require weekly injections [1] Market Reaction - Following Amgen's presentation, the market reacted negatively, resulting in a significant sell-off of the stock [1] - New information was presented regarding a Phase 1 trial, indicating lower starting doses of MariTide with different escalation schedules resulted in far less vomiting [1]

Core Viewpoint - Amgen reported strong Q3 earnings, exceeding expectations with a revenue of $9.6 billion, a 12% year-over-year increase, and raised its full-year guidance for 2025 [1][12][30] Financial Performance - Total revenue for Q3 reached $9.6 billion, up 12% year-over-year, driven by a 14% increase in sales volume [11][15] - Non-GAAP operating margin was 47%, with free cash flow of $4.2 billion [15][28] - The company raised its 2025 revenue guidance to between $35.8 billion and $36.6 billion, and adjusted non-GAAP EPS guidance to $20.60–$21.40 [3][30] Product Highlights - Repatha sales reached $794 million, a 40% increase year-over-year, significantly exceeding analyst expectations [3][32] - Tezspire sales grew by 40% to $377 million, benefiting from recent approvals for chronic rhinosinusitis [5][37] - Uplizna generated $155 million in sales, a 46% increase, with upcoming FDA approval for generalized myasthenia gravis [6][35] - Prolia sales were $1.1 billion, a 9% increase, surpassing analyst forecasts [7][16] Research and Development - The VESALIUS-CV trial showed that Repatha significantly reduces major adverse cardiovascular events (MACE) in high-risk patients, with results to be presented at the AHA meeting [4][43] - MariTide, a weight management drug, is in six Phase III trials, showing promising results in cardiovascular risk factors [8][41] Market Strategy - Amgen launched AmgenNow, a direct-to-consumer platform for Repatha, priced at $239 per month, enhancing patient accessibility [5][33] - The company plans to invest over $3 billion in U.S. manufacturing in 2025, continuing its commitment to expand production capabilities [12][22] Future Outlook - Amgen is optimistic about the growth potential of its pipeline, particularly in obesity and cardiovascular disease with MariTide and Olpasiran [10][24] - The company expects continued investment in R&D, with a projected 20% increase in non-GAAP R&D expenses for 2025 [14][30]

Core Insights - Amgen reported third-quarter 2025 adjusted earnings of $5.64 per share, exceeding the Zacks Consensus Estimate of $5.00 per share, with a year-over-year earnings increase of 1% driven by higher revenues despite increased operating costs and taxes [1] - Total revenues reached $9.6 billion, surpassing the Zacks Consensus Estimate of $8.9 billion, marking a 12% year-over-year increase [1] Revenue Breakdown - Total product revenues increased by 12% year-over-year to $9.17 billion, with volume growth of 14% offset by a 4% negative impact from pricing [2] - Other revenues amounted to $420 million, reflecting a 19.3% year-over-year increase [2] Key Drug Performance - Evenity sales reached $541 million, up 36% year-over-year, exceeding both the Zacks Consensus Estimate of $519 million and the model estimate of $463.9 million [3] - Repatha generated revenues of $794 million, a 40% year-over-year increase, beating the Zacks Consensus Estimate of $720 million and the model estimate of $672.2 million [3] - Prolia revenues were $1.14 billion, up 9% year-over-year, significantly surpassing the Zacks Consensus Estimate of $911 million and the model estimate of $812.8 million [4] - Xgeva delivered revenues of $539 million, flat year-over-year, but exceeded the Zacks Consensus Estimate of $428 million and the model estimate of $408.6 million [5] - Blincyto sales were $392 million, a 20% increase year-over-year, but missed the Zacks Consensus Estimate of $413 million [7] - Otezla sales were $585 million, up 4% year-over-year, beating the Zacks Consensus Estimate of $582 million but missing the model estimate of $648.2 million [8] - Enbrel revenues declined by 30% year-over-year to $580 million, missing the Zacks Consensus Estimate of $645 million but beating the model estimate of $530.4 million [9] - Tezspire recorded sales of $377 million, a 40% year-over-year increase, exceeding both the Zacks Consensus Estimate of $364 million and the model estimate of $270.6 million [10] Cost and Margin Analysis - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with adjusted operating expenses rising by 18% to $5.25 billion [14] - R&D expenses increased by 31% year-over-year to $1.89 billion, reflecting ongoing investment in the late-stage pipeline [14] Future Outlook - Amgen raised its 2025 revenue and earnings guidance, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [15] - The company anticipates continued growth from key drugs like Repatha, Evenity, Tezspire, and its biosimilar portfolio, although erosion from biosimilars of Prolia and Xgeva may offset some growth [21] Pipeline Developments - Amgen is advancing its obesity drug MariTide, which has shown strong efficacy in clinical studies, with six global phase III studies currently underway [16][17] - Enrollment has been completed in two phase III studies for MariTide, with ongoing studies for cardiovascular disease and heart failure [18]