Key Takeaways GSK said bepirovirsen met primary endpoints in two phase III studies in chronic hepatitis B patients.GSK reported a statistically significant functional cure versus SoC in patients with lower baseline HBsAg.GSK plans global regulatory filings in early 2026, positioning bepirovirsen as a finite six-month CHB therapy.GSK plc (GSK) announced positive results from two phase III studies, B-Well 1 and B-Well 2, which evaluated its investigational chronic hepatitis B (CHB) therapy called bepirovirsen ...

Core Viewpoint - Sanofi is set to acquire Dynavax for approximately $2.2 billion, enhancing its vaccine portfolio amid changing vaccine policies in the US [1][4] Group 1: Acquisition Details - The acquisition price is $15.50 per share in cash, with the deal expected to close in the first quarter of 2026 [1] - Sanofi will gain Dynavax's hepatitis B vaccine HEPLISAV-B, which was approved in the US in 2017 and in Europe in 2021 [2] - Sanofi currently lacks a hepatitis B vaccine in its portfolio, having previously partnered with MSD for a vaccine that is now solely commercialized by MSD [2] Group 2: Product and Market Insights - HEPLISAV-B is administered in a two-dose regimen within one month, contrasting with competitors GSK's Engerix-B and MSD's Recombivax HB, which require three doses over six months [3] - HEPLISAV-B generated sales of $268.4 million in 2024, with Dynavax projecting net product revenue of $305 million to $325 million for 2025 [3] - GlobalData forecasts that HEPLISAV-B will achieve annual sales of $677 million by 2031 [3] Group 3: Industry Context and Regulatory Changes - The acquisition comes amid significant regulatory changes, as the CDC has altered its guidance, no longer recommending hepatitis B vaccination for all US newborns, leading to volatility in the vaccine sector [4] - Analyst Matt Phipps noted that the deal value is slightly below the net present value for HEPLISAV-B, but the acquisition aligns with addressing regulatory concerns and investor expectations for value creation [4] Group 4: Future Prospects - Dynavax's pipeline includes a shingles vaccine candidate, Z-1018, currently in Phase I/II trials, which has shown comparable efficacy to GSK's Shingrix while having fewer adverse reactions [5] - The shingles market is significant, with Shingrix generating £3.4 billion globally for GSK in 2024, indicating the potential market size for Z-1018 [6]

瑞科生物-B(02179)发布公告，公司新佐剂重组带状疱疹疫苗REC610(REC610)的新药上市申请已于近日 获国家药品监督管理局药品审评中心正式受理，受理号：CXSS2500145。 带状疱疹是一种常见的由潜伏感染的病毒引起的疾病，患者可能并发带状疱疹后神经痛，这种剧烈的神 经疼痛严重损害患者健康，影响患者生活质量。据统计，中国每年约有600万人罹患带状疱疹，且近年 来其发病有逐步年轻化的趋势。根据全球已上市的带状疱疹疫苗研究数据，相比减毒活疫苗，新佐剂重 组带状疱疹疫苗能提供更强的细胞免疫、更高的保护效力和更长的保护时间。REC610搭载由公司自主 研发的BFA01新型佐剂，可促进机体产生高水平的VZV糖蛋白E(gE)特异性CD4+T细胞和抗体。目前， 全球范围内新佐剂重组带状疱疹疫苗仅有葛兰素史克Shingrix上市销售。 此前，REC610分别在菲律宾和中国开展了以Shingrix为阳性对照的探索性临床研究，均取得预期的结 果。数据显示，在40岁及以上健康受试者中，接种两剂REC610总体安全性良好，未观察到与研究用疫 苗接种相关的严重不良事件(SAE)、特别关注不良事件(AESI)或接种后发生的 ...

REC610于2023年10月获得国家药品监督管理局签发的药物临床试验批准通知书(通知书编号： 2023LP02151)，于2024年12月完成III期临床全部受试者的入组，目前正遵循临床方案进行后续访视观察 工作。该项临床研究采用随机、双盲、安慰剂对照设计，旨在评估REC610疫苗对40岁及以上健康受试 者的保护效力、安全性及免疫原性。 格隆汇12月29日丨瑞科生物-B(02179.HK)公告，公司新佐剂重组带状疱疹疫苗REC610("REC610")的新 药上市申请已于近日获国家药品监督管理局药品审评中心正式受理，受理号：CXSS2500145。 带状疱疹是一种常见的由潜伏感染的病毒引起的疾病，患者可能并发带状疱疹后神经痛，这种剧烈的神 经疼痛严重损害患者健康，影响患者生活质量。据统计，中国每年约有600万人罹患带状疱疹，且近年 来其发病有逐步年轻化的趋势。根据全球已上市的带状疱疹疫苗研究数据，相比减毒活疫苗，新佐剂重 组带状疱疹疫苗能提供更强的细胞免疫、更高的保护效力和更长的保护时间。REC610搭载由本公司自 主研发的BFA01新型佐剂，可促进机体产生高水平的VZV糖蛋白E(gE)特异性CD4+T细胞 ...

一款曾被寄予厚望的疫苗，上市两年多后价格腰斩再打折，甚至让公司季度财报上出现负收入和负销量，股价随之跌跌不休。 12月23日，江西省疾控预防中心网站显示，长春百克生物科技股份公司（下称"百克生物"，证券代码：688276）递交调价函，将带状疱疹减毒活疫苗（规 格：0.5ml）价格从原采购价（含配送费）1375元/支降至464元/支，即一针降价911元，价格下调约66.25%。 | 序号 | 疫苗名称 | 规格 | 剂型 | 包装 | 最小包 | 生产企业 | 原采购价格含配送 | 调整后采购价含配 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | 装单位 | | 费(元/支) | 送费(元/支) | | | 带状疱疹减毒 | 0.5m1 | 注射 | 预填 | ত তেওঁ | 长春百克生物 | 1375.00 | 464.00 | | | 活疫苗 | | 쥐 | 车 | | 科技股份公司 | | | 目前，中国共有两款带状疱疹疫苗获批，一款是 葛兰素史克 ( GSK )研发生产的Shingrix，该疫苗于2020年6月 ...

Core Insights - GSK's stock has increased by 18.6% over the past three months, driven by strong Q3 results that exceeded earnings and sales estimates, along with raised sales and profit guidance for the year [1][9] - The drug and biotech sector has seen a recovery, with major companies like Pfizer and AstraZeneca entering drug pricing agreements with the Trump administration [2] - GSK's Specialty Medicines unit is a key growth driver, with sales rising 16% in the first nine months of 2025, supported by successful launches in Oncology and long-acting HIV medicines [4][6] Specialty Medicines Growth - The Specialty Medicines unit's sales growth is attributed to strong demand for new long-acting HIV medicines and oncology drugs, with key products like Nucala and Dovato contributing significantly [5][6] - GSK expects Specialty Medicines sales to grow at a mid-teens compound annual growth rate (CAGR) in 2025, up from previous low-teens expectations, and anticipates this segment will account for over 50% of total revenues by 2031 [6][26] Promising Pipeline - GSK is increasing R&D investments in long-acting and specialty medicines, with several recent drug approvals, including Penmenvy and Blujepa, expected to drive growth in the coming years [7][8] - The company plans to launch five new products/line extensions in 2025, with several already approved in the U.S. [12] Vaccine Sales Decline - GSK's vaccine sales in the U.S. have declined by 11% at constant exchange rates (CER) in 2025, primarily due to lower demand for its shingles and RSV vaccines [13][15] - Despite the decline in the U.S., sales of these vaccines have risen in Europe, indicating a mixed performance across regions [15] Stock Performance and Valuation - GSK's stock has outperformed the industry and the S&P 500, rising 43.1% year-to-date compared to an industry increase of 11.7% [17] - The stock is trading at a price/earnings ratio of 10.02, which is lower than the industry average of 16.31, indicating an attractive valuation [20] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings has increased from $4.38 to $4.49 per share for 2025, reflecting analysts' optimism about profit growth [23][24] - GSK expects to achieve over 7% sales growth and more than 11% core operating profit growth on a CAGR basis through 2026 [27]

Key Takeaways from China Biopharma Trip Industry Overview - The trip focused on the Chinese biopharmaceutical industry, highlighting the rapid development of local biotech companies and their competitive landscape in drug discovery and clinical R&D [3][5][9]. Core Insights 1. **Rapid Development of Biotech Companies**: Local Chinese biotech firms have shown a remarkable pace of development, with examples like Pyrotech achieving clinical proof-of-concept in 4 years and Hengrui progressing from preclinical studies to IND acceptance in 6 months [3]. 2. **Factors Driving Speed**: Key factors contributing to this accelerated development include streamlined decision-making, a concentrated ecosystem of contract research organizations (CROs), strong fundamental research, and experienced clinical investigators [3]. 3. **Licensing and Partnerships**: Chinese biotech companies generally prefer licensing out their products, but more mature firms are increasingly seeking co-development and co-commercialization agreements, as seen with Innovent's partnership with Takeda [4]. 4. **Pipeline Diversity**: Companies visited exhibited broad pipelines across multiple disease areas, with a notable focus on antibody-drug conjugates (ADCs) and a competitive landscape characterized by intense pressure [5]. 5. **Obesity Market Developments**: Eccogene is optimistic about its obesity drug ECC5004, while Innovent noted rapid uptake of mazdutide, indicating strong competition in the obesity segment [7]. 6. **Vaccine Market Challenges**: Zhifei highlighted ongoing challenges in the vaccine market due to vaccine hesitancy and pricing pressures, complicating commercialization efforts [8]. Competitive Landscape 1. **ADC Focus**: Nearly half of the companies visited are engaged in ADC research, particularly in oncology, indicating China's emergence as an ADC hub [5]. 2. **Emerging Therapies**: Companies are exploring bispecific/trispecific antibodies and new-generation cell therapies, with a focus on innovative approaches to cancer treatment [5][31]. 3. **Market Dynamics**: The Chinese pharmaceutical market is valued at $160-180 billion, with the innovative market growing at 20-30% annually, expected to reach $50-60 billion in five years [23]. Company-Specific Highlights 1. **3SBio and Pfizer**: 3SBio expressed optimism regarding its PD-1xVEGF bispecific antibody program, with plans for multiple trials to establish the compound as a backbone therapy [9]. 2. **Kelun Biotech**: Kelun is advancing its TROP2 targeting ADC, sac-TMT, with expectations of significant peak sales based on recent clinical data [10]. 3. **Hengrui's Lp(a) Program**: Hengrui is encouraged by Phase 2 data for its Lp(a) targeted oral small molecule drug, which could transform cardiovascular disease treatment [10]. 4. **Zhifei's Gardasil Challenges**: Zhifei reported difficulties in the vaccine market, particularly with Gardasil, due to pricing pressures and vaccine hesitancy [10]. Additional Observations - **Regulatory Environment**: Sanofi noted that early-stage R&D in China is 50% cheaper and 60% faster than in the US, with plans to invest more in local partnerships [23]. - **Pricing Dynamics**: The conversation with obesity experts revealed insights into pricing dynamics and the competitive landscape for obesity treatments [7]. Conclusion The trip underscored the dynamic nature of the Chinese biopharma industry, characterized by rapid innovation, strategic partnerships, and a competitive landscape that poses both opportunities and challenges for local and multinational companies [3][5][23].

Core Insights - GSK plc reported third-quarter 2025 core earnings of $1.48 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.26, with core earnings increasing 11% year over year on a reported basis and 14% at a constant exchange rate (CER) [1][10] - Quarterly revenues rose 7% on a reported basis and 8% at CER to $11.52 billion (£8.55 billion), driven by rising sales across all business segments, particularly in HIV, oncology, and respiratory medicines, surpassing the Zacks Consensus Estimate of $11.16 billion [2][10] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 16%, General Medicines rose by 4%, and Vaccine sales were up by 2% [3] - HIV sales rose 12% during the quarter, driven by increased demand for Dovato and long-acting medications like Apretude and Cabenuva, with Dovato sales increasing by 24% [4][5] - Oncology sales surged by 39%, led by strong demand for Jemperli, which saw a 79% increase due to expanded treatment indications [6][7] - Respiratory drug Nucala sales increased by 14%, while Benlysta sales rose by 17%, reflecting strong demand across markets [9] Financial Guidance - GSK raised its 2025 guidance, now expecting sales growth of 6-7%, up from a previous forecast of 3-5%, and core EPS growth of 10-12% [10][17][19] - Specialty Medicines are now expected to grow at a mid-teens percentage at CER, while General Medicines are anticipated to remain stable [18] - The company reiterated its guidance for R&D and SG&A expenses, with R&D expected to grow slightly faster than sales [20] Long-term Strategy - GSK is focusing on HIV, immunology/respiratory, and oncology therapeutic areas, with 80 assets in clinical development, including 16 in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions this year, with four already approved by the FDA [25] - GSK aims to launch 15 new drugs between 2025 and 2031, each with peak sales potential exceeding £2 billion [26]

Core Insights - GSK raised its 2025 sales and earnings forecasts due to strong performance in its specialty HIV and cancer drugs, resulting in a nearly 7% increase in shares to their highest level since May 2024 [1][2] Group 1: Financial Performance - GSK's global vaccine sales reached £2.68 billion in the quarter ending September 30, surpassing analyst expectations, although U.S. sales of the shingles vaccine, Shingrix, fell by 15% [3][5] - The company expects annual revenue growth of 6% to 7% and core earnings per share to rise by 10% to 12%, factoring in current tariffs and potential impacts from 15% tariffs on Europe [7] Group 2: Leadership Transition - CEO Emma Walmsley is set to hand over to Luke Miels early next year, with analysts expressing confidence in Miels to achieve the annual revenue target of over £40 billion ($54 billion) by 2031 [2][6] - Miels acknowledged the target is achievable but did not provide specific details on his strategy for the upcoming year [6] Group 3: Challenges in Vaccine Sales - GSK's U.S. vaccine business faced challenges, with a noted decline in sales of influenza vaccines due to competition and a cautious outlook on the U.S. vaccine environment [3][4][5] - The company maintained its forecast for a low-single-digit decrease to stable revenues for vaccines, which accounted for over a third of third-quarter revenues [5]

Core Insights - GSK reported strong third-quarter results with sales of $11.53 billion, an 8% increase at constant currency, surpassing analyst expectations of $11.16 billion [1] - Core earnings rose 15% at constant currency to $1.48 per share, exceeding the consensus forecast of $1.26 [1] Sales Performance - Vaccine sales increased by 1% to 2.68 billion pounds, driven by strong demand for Shingrix and Arexvy, despite lower sales in Established and Influenza vaccines [2] - Arexvy sales reached 251 million pounds, up 34%, while Meningitis vaccine sales increased 4% to 541 million pounds [3] - Shingrix sales were 830 million pounds, up 12%, and Specialty Medicines sales grew by 15% to 3.41 billion pounds, reflecting strong performance across various therapeutic areas [3] Guidance Update - GSK raised its full-year 2025 guidance, expecting sales growth of 6% to 7%, up from the previous 3% to 5% range [6] - Core operating profit is anticipated to grow between 9% to 11%, and core earnings per share are expected to increase by 10% to 12% [6] - Specialty Medicine sales are projected to increase at a mid-teens percentage, an upgrade from the prior low teens guidance [6] Market Response - Following the positive earnings report and upgraded guidance, GSK stock rose by 2.56% to $44.82 in premarket trading [7] Tariff Considerations - GSK acknowledged the ongoing U.S. investigation regarding the impact of pharmaceutical imports on national security and indicated potential European tariffs of 15% [5] - The company is prepared to address the financial implications of these tariffs with identified mitigation options [5]