This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Radiopharmaceutical drug developer Aktis Oncology on Thursday said it raised $318 million from an initial public offering, the first for a biotechnology company in 2026. Aktis priced 17.65 million shares at $18 each, more than what it planned to sell, according to an updated securities filing earlier this week. It upsized the round after Eli Lilly, which previ ...

二、在研药品的基本信息及研究情况 证券代码：600196 股票简称：复星医药 编号：临2025-206 上海复星医药（集团）股份有限公司 关于控股子公司药品临床试验进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 一、概况 近日，上海复星医药（集团）股份有限公司（以下简称"本公司"）控股子公司成都星睿菁烜生物科技有 限公司就诊疗一体化核药项目SRT-007于中国境内（不包括港澳台地区，下同）启动Ⅰ期临床试验，适 应症为用于PSMA阳性的转移性去势抵抗性前列腺癌的诊断和治疗。 药品研发及至上市是一项长期工作，存在诸多不确定因素，敬请广大投资者注意投资风险。 特此公告。 上海复星医药（集团）股份有限公司 董事会 二零二五年十二月三十日 诊疗一体化核药项目SRT-007包括镓[68Ga]PSMA-0057（诊断）和镥[177Lu]PSMA-0057（治疗）两个注 射液；其中，镓[68Ga]PSMA-0057注射液为诊断用放射性药物、镥[177Lu]PSMA-0057注射液为治疗用 放射性药物。 截至2025年11月，本集团 ...

格隆汇12月30日丨复星医药(02196.HK)公告，近日，上海复星医药(集团)股份有限公司(以下简称"本公 司")控股子公司成都星睿菁烜生物科技有限公司就诊疗一体化核药项目SRT-007于中国境内(不包括港澳 台地区，下同)启动Ⅰ期临床试验，适应症为用于PSMA阳性的转移性去势抵抗性前列腺癌的诊断和治 疗。 截至本公告日期(即2025年12月30日)，全球范围内已获批上市的同靶点放射性药物为NOVARTISAG的 Pluvicto。根据公开信息显示1，2024年Pluvicto全球的销售额为13.92亿美元。 诊疗一体化核药项目SRT-007包括镓[68Ga]PSMA-0057(诊断)和镥[177Lu]PSMA-0057(治疗)两个注射 液；其中，镓[68Ga]PSMA-0057注射液为诊断用放射性药物、镥[177Lu]PSMA-0057注射液为治疗用放 射性药物。截至2025年11月，本集团(即本公司及控股子公司/单位)现阶段针对SRT-007的累计研发投入 约为人民币3,219万元(未经审计；包含许可费)。 ...

当前，全球核药抗肿瘤诊疗领域正以前所未有的速度迈向"诊疗一体化"时代。 作为全球仅有的四家成功实现创新核药全球商业化应用的制药企业之一，远大医药（00512）近期在核药抗肿瘤诊疗 板块接连取得里程碑式进展，标志着其全球化商业布局进一步加速： 公司自主研发的重磅全球创新放射性核素偶联药物GPN01530，近日获得美国FDA批准开展用于诊断实体瘤的I/II期临 床研究，实现了自研产品的"硬核出海"；同时，用于前列腺癌诊断的TLX591-CDx中国III期临床试验也取得了积极的 顶线结果，并成功达到了主要临床终点。 除核药领域的绝对优势外，远大医药在多个优势领域的差异化创新发展同样捷报频传： 公司近期布局的全球首款用于紧急治疗I型过敏反应的肾上腺素鼻喷雾剂Neffy®（优敏速®）近期在国内获批上市，填 补了国内院外急救市场的空白；此外，公司1.1类中药创新药GPN01360国内II期临床研究成功达到临床终点，在抑郁 症治疗中展现出显著的疗效与安全性优势，为抑郁症治疗提供了"中国方案"。 这一系列突破，不仅验证了远大医药在多赛道上的先发优势，更揭示了其以核药板块为代表的"Go Global"全球化创新 发展下更深层的 ...

Clinical Trial Results of MRT-2359 - MRT-2359 combined with enzalutamide demonstrated a 100% PSA response rate in heavily pre-treated mCRPC patients with AR mutations[5, 38, 59] - Among the 4 patients with AR mutations, 2 patients showed PSA90 responses and 2 patients showed PSA50 responses[5, 38] - Two patients with AR mutations achieved RECIST partial responses (1 confirmed, 1 unconfirmed), and two had stable disease, resulting in a 100% disease control rate in the AR mutant population[5] - An overall disease control rate (DCR) of 64% was observed in 14 evaluable patients, including 5 patients without AR mutations who had stable disease[5, 59] Safety and Tolerability - The combination of MRT-2359 and enzalutamide was well-tolerated, with the most frequent adverse events (AEs) being mild or moderate manageable GI symptoms[5, 33, 59] - Treatment-related AEs occurring in >15% patients included fatigue (50%), diarrhea (45%), nausea (35%), arthralgia (30%), decreased appetite (30%), vomiting (30%), neutropenia (25%), and muscular weakness (20%)[31, 32] Future Plans - The company plans to initiate a signal-confirming 2-stage Phase 2 study (MODeFIRe-1) of MRT-2359 in combination with a 2nd generation AR inhibitor in 2026, targeting AR-mutated mCRPC[2, 56, 59] - Updated data from the Phase 1/2 study is expected to be presented at the ASCO Genitourinary Cancers Symposium in February 2026[59]

Core Insights - The article highlights the performance and outlook of several stocks, including Microsoft, Novartis, RTX, and Air T, as analyzed by Zacks Equity Research [1][2]. Microsoft - Microsoft's shares have outperformed the Zacks Computer - Software industry over the past year, with a growth of 6.8% compared to the industry's 2.3% [4]. - The company holds a 25% market share in the cloud sector through Azure and integrates AI strategically via OpenAI, generating over $100 billion in annual operating cash flows with margins exceeding 40% [4]. - Fiscal 2026 net sales are expected to grow by 15.1% from fiscal 2025, but the company faces competition from AWS and Google Cloud, regulatory scrutiny, and rising capital expenditures for AI infrastructure [5]. Novartis - Novartis has outperformed the Zacks Large Cap Pharmaceuticals industry over the past year, with a growth of 38.8% compared to 14.9% for the industry [6]. - The company has a diverse portfolio, including drugs like Kisqali and Pluvicto, with projected compound annual growth rates (CAGR) of 37.9% and 43.3% over the next three years [7]. - New drug approvals and label expansions are expected to mitigate the impact of generic competition for key drugs, supported by recent acquisitions and collaborations [8]. RTX - RTX's shares have outperformed the Zacks Aerospace - Defense industry over the past year, with a growth of 54.1% compared to 28.1% for the industry [9]. - The company has a backlog of $251 billion as of September 30, 2025, driven by strong demand for defense products and improving global commercial air traffic [10]. - However, uncertainties from U.S. government import tariffs and ongoing supply-chain challenges pose risks to RTX's performance [11]. Air T - Air T has outperformed the Zacks Transportation - Air Freight and Cargo industry over the past year, with a growth of 0.8% compared to a decline of 8.4% for the industry [12]. - The company shows operational strength with margin expansion in Commercial Aircraft & Engines and stable cash flow from FedEx feeder operations [12]. - Elevated leverage, rising interest costs, and execution risks across segments constrain earnings durability, with liquidity pressured by volatile working-capital needs [13].

Summary of Vir Biotechnology FY Conference Call - December 03, 2025 Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Focus**: Development of innovative therapies for infectious diseases and cancer, particularly through T cell engagers and hepatitis programs Key Accomplishments in 2025 - **Clinical Programs**: Significant advancements in three clinical-stage T cell engagers and a registration program for hepatitis delta [2][4] - **Data Reporting**: First-time reporting of data on Vir-5500 (PSMA CD3 T cell engager) and Vir-5818 (HER2 CD3 T cell engager) with promising early results [2][3] - **Hepatitis Delta Program**: Achieved transformative data with 66% of patients achieving undetectable virus levels after 48 weeks of treatment [4] Clinical Development Highlights - **Vir-5500**: - Unique dual masking technology enhances safety and efficacy by preventing toxicity associated with naked PSMA T cell engagers [8][10] - Extended half-life of 8-10 days allows for less frequent dosing [10] - Early clinical data showed 58% of patients achieving a PSA reduction of 50, with only 25% experiencing any CRS (cytokine release syndrome) [15][16] - **Hepatitis Delta**: - Phase two Solstice trial demonstrated significant efficacy, with 66% of patients achieving target not detected status [4][30] - Enrollment for phase three trials (Eclipse) completed ahead of schedule, indicating strong demand for therapy [32] Differentiation and Competitive Landscape - **Masking Technology**: - Vir-5500 utilizes a dual masking approach that is distinct from single mask competitors, providing a better therapeutic index [21][22] - The Xtend mask technology has been validated in other marketed drugs, enhancing confidence in safety and efficacy [11][22] - **Market Positioning**: - Potential to position Vir-5500 in both pre- and post-Pluvicto treatment settings, aiming for a balance of efficacy and safety [26][27] Future Expectations - **Upcoming Data**: - Next data cut expected in January will focus on early readouts such as PSA levels and safety data, with a meaningful dataset anticipated [24] - **Product Presentation**: - Anticipated to be two subcutaneous injections, allowing for at-home administration or by healthcare professionals [33] Industry Insights - **Feedback from Medical Community**: - Positive reception from KOLs regarding the unmet medical need in hepatitis delta, with enthusiasm for the efficacy demonstrated in clinical trials [29][30] - **Enrollment Trends**: - Rapid enrollment in Eclipse trials reflects strong demand and interest in the hepatitis delta treatment [32] Conclusion - Vir Biotechnology has made significant strides in its clinical programs, particularly with its innovative masking technology for T cell engagers and promising results in its hepatitis delta program. The company is well-positioned to address unmet medical needs in both oncology and infectious diseases, with strong support from the medical community and a clear path forward for upcoming data releases and product development.

Core Viewpoint - Janux Therapeutics experienced a nearly 50% drop in stock price following the release of limited data on its prostate cancer treatment drug, JANX007, leading to negative investor sentiment [1][4]. Group 1: Company Overview - Janux Therapeutics is developing JANX007 for metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that continues to progress despite standard treatment aimed at maintaining very low testosterone levels [1][4]. - As of October 15, the company has treated 109 patients in two early studies, including many who had undergone multiple prior treatments [5]. Group 2: Clinical Data - The latest interim data revealed that patients treated with JANX007 had a maximum progression-free survival of up to 9 months, with 8 out of 27 evaluable patients showing tumor reduction [1][4]. - Among all patients receiving a target dose of 2 mg or more, 73% experienced at least a 50% reduction in prostate-specific antigen (PSA) levels [5]. Group 3: Market Reaction and Analyst Commentary - The stock price of Janux Therapeutics fell by 49.9%, closing at $17.04, marking the potential largest single-day drop in the company's history [1][4]. - Analysts, including Cantor's Josh Schimmer, noted that while the announcement addressed some key questions, there remain multiple variables and information gaps, with unclear timelines for the next clinical or regulatory updates [2][5].

Group 1 - Novartis AG is recognized as a strong slow growth stock, with a projected sales CAGR of 6% from 2024 to 2029, supported by recent meetings with TD Cowen [1][2] - Key growth contributors include existing medicines such as Cosentyx, Pluvicto, Kisqali, Leqvio, Kesimpta, and Scemblix, which are expected to mitigate the impact of generic erosion, particularly for Entresto [2] - The company has a robust position in immunology with products like Rhapsido and ianalumab, which are considered "substantially de-risked" and likely to contribute to growth before 2030 [2] Group 2 - Novartis revised its mid-term sales target for 2025-2030 to a CAGR of 5-6% in constant currencies and aims to achieve margins above 40% by 2029, despite a projected 1-2 percentage points dilution from the acquisition of Avidity Biosciences [3] - The company is focused on discovering, developing, and manufacturing innovative treatments aimed at improving and extending lives while addressing serious diseases [4]

Group 1: Market Overview - Pluvicto has become a major topic in the nuclear medicine field, with sales projected to reach $1.392 billion in 2024, a 42% increase year-over-year [1] - The sales of Pluvicto for the first three quarters of this year reached $1.389 billion, reflecting a 33% year-over-year growth [1] - Novartis predicts that Pluvicto's peak sales will exceed $5 billion [1] Group 2: Competitive Landscape - Major pharmaceutical companies such as Eli Lilly, BMS, AstraZeneca, and Roche are actively entering the nuclear medicine market [2][5] - Domestic companies like Heng Rui and Chengdu Nuyret are also making significant strides in nuclear medicine research and development [2][6] - The market is experiencing a new wave of growth, particularly in radiolabeled drug conjugates (RDC) [2][5] Group 3: Clinical Developments - Novartis leads the nuclear medicine sector with multiple products, including Lutathera and Pluvicto, and is developing additional candidates like 177Lu-NeoB and 225Ac-PSMA-617 [5][6] - Several domestic companies have products in late-stage clinical trials, such as ITM-11 and NRT6003, targeting various cancers [6][11] - The clinical pipeline for 177Lu-based products is expanding, with 17 innovative drug products currently in clinical stages in China [9] Group 4: Supply Chain and Production - The supply chain for Lu-177 has seen significant improvements, with domestic production capabilities being established to meet market demand [13][14] - The launch of the core product Lu-177 by Hefu One on June 25, 2025, marks a major breakthrough in the domestic production of medical isotopes [13] - The integration of nuclear medicine production and supply chains is becoming more evident, particularly in regions like Sichuan and Haiyan [23] Group 5: Future Trends - Research is expanding into new alpha-emitting isotopes, with a focus on Ac-225, which has shown promise in treating various cancers [15][17] - The supply chain challenges for Ac-225 are more severe than those for Lu-177, with a significant gap between production and clinical demand [22] - The nuclear medicine sector is entering a new phase of rapid growth, driven by advancements in both research and production capabilities [24]