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FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma
Globenewswire· 2025-12-22 06:00
Core Viewpoint - Roche's Lunsumio VELO™ (mosunetuzumab) has received FDA approval as a subcutaneous treatment for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, based on the phase I/II GO29781 study results [1][3][4] Group 1: FDA Approval and Treatment Benefits - The FDA approval is based on the results from the GO29781 study, which demonstrated an objective response rate of 75% and a complete response rate of 59% in patients treated with Lunsumio VELO [3][7] - Lunsumio VELO significantly reduces treatment administration time to approximately one minute, compared to the previous 2-4 hour intravenous infusion, thus aligning treatment with patient needs [2][7] - The treatment can be administered in outpatient settings and is designed for a fixed duration, potentially as short as six months, contrasting with indefinite treatment options [2][3] Group 2: Clinical Study Insights - The GO29781 study evaluated the safety, efficacy, and pharmacokinetics of mosunetuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, establishing efficacy based on objective response rate and duration of response [6] - The median duration of response for Lunsumio VELO was reported as 22.4 months [3] - The most common adverse reactions (≥20%) included injection site reactions, fatigue, rash, and cytokine release syndrome (CRS), with a CRS rate of 30% primarily occurring during Cycle 1 [3][4] Group 3: Ongoing Research and Development - Roche is advancing its bispecific antibody program in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment [5] - The SUNMO study is investigating Lunsumio VELO in combination with Polivy® for second-line or later large B-cell lymphoma, while the MorningLyte study is exploring its use with lenalidomide in previously untreated follicular lymphoma [5] Group 4: Follicular Lymphoma Overview - Follicular lymphoma (FL) is the most common slow-growing form of non-Hodgkin lymphoma, accounting for about 20% of cases, and is characterized by periods of remission and relapse [8] - More than 110,000 people are diagnosed with FL each year worldwide, and the disease typically becomes harder to treat with each relapse [8]
Hungry IPOs Carve A Heft Slice Of Mutual Funds
Rediff· 2025-12-22 05:05
Core Insights - The ongoing surge in IPOs is significantly utilizing mutual fund liquidity, with six primary market issuances accounting for over ₹13,000 crore in net equity investments by mutual funds in November [3][4]. Group 1: Mutual Fund Activity - Groww led the inflows, attracting approximately ₹4,200 crore, while other companies like Lenskart Solutions, Pine Labs, and Physics Wallah each garnered over ₹1,000 crore in investments from mutual funds [4]. - Net equity investments by mutual funds reached ₹43,500 crore in November, indicating strong demand and liquidity in the market [4]. Group 2: IPO Market Dynamics - The robust appetite for IPOs from mutual funds, alongside strong demand from other investor segments, has facilitated record issuances, with over 100 mainboard IPOs launched this year, the highest in 25 years [5]. - The primary market activity is largely driven by retail inflows into mutual funds, as elevated valuations in the secondary market have redirected liquidity towards primary issuances [5]. Group 3: Sector Trends - Demand in the primary market is particularly strong for consumer technology and new-age businesses, which currently represent 20% of recent IPOs, a figure expected to rise above 30% in the next five years [7][8]. - At least 20 startups with private market valuations in the hundreds of millions of dollars are preparing to enter the market, indicating a growing trend in the consumertech sector [8]. Group 4: Secondary Market Activity - In the secondary market, Eternal topped the mutual fund buy list with ₹4,500 crore invested, followed by ICICI Bank, ITC, Mphasis, and HDFC Bank [9]. - Conversely, mutual funds reduced their exposure to public sector banks and pharmaceutical stocks, with State Bank of India and Reliance Industries among the most sold stocks [9].
A股午评 | 沪指强势收复3900点 海南持续火爆,超二十股涨停
智通财经网· 2025-12-22 03:53
跌幅方面,影视院线方向多股调整,博纳影业跌停;消费股陷入分化,南京商旅跌停;AI医疗概念震 荡回落,华人健康逼近跌停,漱玉平民、嘉应制药跌逾5%。 点评:消息面上,12月18日,海南自由贸易港全岛封关运作正式启动。据三亚市商务局统计,封关首 日,三亚全市免税销售额达1.18亿元。其中,三亚国际免税城进店客流超3.6万人次,同比增长逾60%。 2、智能驾驶概念反复活跃 智能驾驶概念反复活跃,浙江世宝5连板,万集科技涨超10%。 点评:消息面上,长安汽车官方消息称,12月20日,首块L3级自动驾驶专用正式号牌"渝AD0001Z"在 重庆诞生。平安证券称,智能驾驶的商业化进程有望在2026年加速。此次L3车型的准入获批意味着智 驾在技术、政策端的进步,为后续智驾的商业化进程奠定基础。 展望后市,中信建投认为,当前市场仍处于窄幅震荡格局当中,目前美股AI核心公司股价已经企稳, 日本央行加息落地后续影响有限,A股有望和全球股市一起共振上行。 热门板块 1、海南延续强势 海南板块短线拉升,海汽集团、海南发展涨停,凯撒旅业、海南高速等纷纷走高 12月22日,市场早盘三大指数放量上涨,截至午间收盘,沪指涨0.64%,一举收复 ...
5 Global Dividend Stocks to Add Stability to Your Singapore Portfolio
The Smart Investor· 2025-12-22 03:30
Group 1: Johnson & Johnson (J&J) - J&J's revenue for Q3 2025 increased by 6.8% YoY to US$24 billion, with adjusted earnings growing 15.7% to US$6.8 billion due to strong performance across its segments [2][3] - The company has paid US$9.3 billion in dividends and repurchased US$4.0 billion in shares YTD, reflecting its commitment to shareholder returns [3] - J&J plans to spin off its Orthopaedics unit, DePuy Synthes, within the next 18-24 months to focus on higher-margin segments [3][4] Group 2: PepsiCo - PepsiCo's revenue for Q3 2025 rose by 3% YoY to US$23.9 billion, but operating earnings decreased by 8% to US$3.57 billion due to rising costs and M&A charges [5] - The company increased its annual dividend by 5% to US$5.69 per share, maintaining its status as a dividend aristocrat with a payout ratio of 75% [6][7] - PepsiCo plans US$1.0 billion in share repurchases for 2025, with total shareholder returns expected to reach US$8.6 billion for the year [7][8] Group 3: NextEra Energy - NextEra's operating revenue for Q3 2025 grew by 5.3% to US$8.0 billion, with adjusted earnings per share increasing by 9.7% YoY to US$1.13 [9][10] - Dividends for the first nine months of 2025 climbed 10.2% YoY to US$3.5 billion, with a payout ratio of 51.5% [10] - The company has a significant backlog of 29.6 gigawatts in renewables and storage, and is collaborating with Google on a nuclear plant project [11] Group 4: Microsoft - Microsoft's revenue for Q1 FY2026 increased by 18.4% YoY to US$77.7 billion, with net income rising 12% to US$27.7 billion despite increased expenses [13] - The company raised its dividend by 9.6% YoY to US$0.91 per share and has a favorable payout ratio of 24.4% [14] - Microsoft is investing heavily in AI and plans to expand its data center footprint by 80% in FY2026, with significant share repurchases planned [15] Group 5: Nestle - Nestle's sales for the first nine months of 2025 dropped by 1.9% YoY to CHF 65.9 billion, but organic sales growth was 3.3% without currency effects [16][17] - The company has not yet announced its 2025 dividend, but it increased its dividend by 1.7% in 2024 to CHF3.05 per share [17] - Nestle's growth strategy includes focusing on "Cold Coffee" products and "Maggi Air Fryer seasonings" to capitalize on market trends [18][19] Group 6: Global Dividend Stocks - Investing in global dividend stocks can enhance portfolio diversification, providing exposure to sectors like healthcare, consumer staples, and utilities [20] - The combination of local investments in Singapore banks and REITs with global dividend stocks can improve resilience and long-term compounding [21]
Fennec Pharmaceuticals: A Compelling Single-Asset Growth Story For 2026 (NASDAQ:FENC)
Seeking Alpha· 2025-12-22 03:01
Company Overview - Fennec Pharmaceuticals Inc. is a commercial-stage specialty pharmaceutical company focused on producing a drug to reduce cisplatin-induced ototoxicity (CIO) [1] - The drug is known as Pedmark in the US and Pedmarqsi in Europe, which is a sodium thiosulfate injection [1] Product Details - Cisplatin is a widely used chemotherapy drug that can cause hearing loss as a side effect, making the development of Pedmark/Pedmarqsi significant for patients undergoing treatment [1]
Fennec Pharmaceuticals: A Compelling Single-Asset Growth Story For 2026
Seeking Alpha· 2025-12-22 03:01
Company Overview - Fennec Pharmaceuticals Inc. is a commercial-stage specialty pharmaceutical company focused on producing a drug aimed at reducing cisplatin-induced ototoxicity (CIO) [1] - The drug is marketed as Pedmark in the US and Pedmarqsi in Europe, which is a sodium thiosulfate injection [1] Product Details - Cisplatin is recognized as a highly effective chemotherapy agent, but it is associated with significant side effects, including ototoxicity [1]
中国每周前瞻-MXCN 与沪深 300 指数下跌 1.6%;11 月经济数据普遍不及预期-China Weekly Kickstart_ MXCN_CSI300 lost 1.6; November economic data broadly missed expectation
2025-12-22 02:31
22 December 2025 | 2:53AM HKT Portfolio Strategy Research CHINA WEEKLY KICKSTART MXCN/CSI300 lost 1.6%/0.3%; November economic data broadlymissed expectation; emphasized expanding domestic demand MXCN/CSI300 lost 1.6%/0.3% this week. President Xi published an article titled "Expanding Domestic Demand is a Strategic Move" in Qiushi magazine. The Hainan Free Trade Port officially launched its island-wide customs clearance operation on December 18, broadening duty-free items to 6000+. NDRC noted a slowing inve ...
年内券商系LP出资超90亿元支持科技创新;ETF总规模突破5.8万亿元,创历史新高 | 券商基金早参
Mei Ri Jing Ji Xin Wen· 2025-12-22 01:40
Group 1 - The total investment from brokerage firms as limited partners (LPs) in private equity funds has exceeded 9.19 billion yuan this year, marking a year-on-year increase of 52.1% [1] - This investment supports technological innovation and industrial upgrading, reflecting the brokerage firms' commitment to serving the real economy [1] - The influx of capital from brokerage firms is expected to boost investor confidence in the technology sector, particularly in hard technology fields such as semiconductors and new energy [1] Group 2 - Public funds have adjusted their strategy towards hard technology and emerging industries, resulting in a floating profit exceeding 10.742 billion yuan from their investments [2] - A total of 39 public fund institutions participated in 85 A-share companies' private placements this year, with a total allocation amounting to 34.088 billion yuan, a year-on-year increase of 13.85% [2] - The shift in public fund investment strategies is expected to further attract market capital towards the technology sector, accelerating industry differentiation and promoting a transition to innovation-driven growth in the stock market [2] Group 3 - The total scale of the ETF market has surpassed 5.8 trillion yuan, achieving a historical high and increasing by over 2 trillion yuan within a year, representing a growth rate of over 50% [3] - Stock ETFs remain the mainstream in the market, accounting for more than 60% of the total scale, indicating a preference for core assets among investors [3] - The significant scale advantage of leading products and companies highlights the ongoing Matthew effect, which may accelerate industry consolidation and enhance market resource allocation efficiency [3]
流感特效药怎么吃才有效
Xin Lang Cai Jing· 2025-12-21 22:46
Group 1 - The flu season is currently at a high epidemic level in China, with a significant increase in the purchase of cold and flu medications across various regions, particularly in East China where orders for antiviral drugs have surged over 80% [1] - In central regions like Wuhan, the order volume for flu medications has increased by over 95%, with the specific antiviral drug, Marbofloxacin, seeing a 120% increase in orders [1] - The Chinese Center for Disease Control and Prevention has reported that the current flu epidemic is at a high level, prompting discussions on the appropriate use of medications to avoid excessive or inappropriate use [1] Group 2 - Common antiviral medications for flu include neuraminidase inhibitors such as Oseltamivir and Peramivir, as well as RNA polymerase inhibitors like Marbofloxacin, with different drugs having varying indications and treatment durations [2] - Oseltamivir is suitable for a wide range of patients, including those over 2 weeks old, with a standard treatment course of 5 days, extendable for severe or immunocompromised patients [2] - Marbofloxacin is indicated for patients aged 5 and above, requiring only a single dose for treatment [2] Group 3 - Specific groups of children may be considered for preventive antiviral treatment during flu outbreaks, including those with compromised immune systems or those who have not developed sufficient immunity after vaccination [3] - It is recommended that preventive medication be administered within 48 hours of exposure and continued for 7 days after the last exposure, although treatment is still advised even if started later [3] - Light symptom patients are advised to stay home and manage symptoms, while severe cases should receive early empirical antiviral treatment [3]
湖南方盛制药股份有限公司关于投资者接待日活动召开情况的公告
Zheng Quan Shi Bao· 2025-12-21 18:10
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。 近日,养血祛风止痛颗粒通过国家医保谈判,首次纳入《国家基本医疗保险、生育保险和工伤保险药品 目录(2025年)》。为使广大客户、投资者与行业分析师更深入了解该产品及公司发展动态,湖南方盛 制药股份有限公司(以下简称"公司")于2025年12月21日(周日)举办"养血祛风止痛颗粒新品上市发 布会暨投资者接待日"活动。现将有关情况公告如下: 一、活动基本情况 1、召开时间:2025年12月21日(周日),9:00-12:00; 2、召开地点:公司研发大楼一楼大礼堂(长沙市国家高新技术产业开发区嘉运路299号); 3、参会人员:董事长兼总经理周晓莉女士、党委书记兼董事长助理张庆华先生、董事兼副总经理陈波 先生、董事萧钺先生、董事会秘书何仕先生等公司领导及相关行业专家代表; 4、来访人员:天风证券、中泰证券、华源证券、华泰证券、国联民生证券、开源证券、中邮证券、东 北证券、东吴证券、西部证券、华创证券、财信证券、鑫巢资本、金石投资、创富启航及个人投资者与 部分媒体。(排名不分先后) 二、 ...