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罕见病创新药在北京投入临床使用
Cai Jing Wang· 2025-07-08 06:55
Core Viewpoint - Fosun Pharma's self-developed drug, Luwo Meitini tablets, has been officially launched for clinical use, marking it as China's first and only targeted drug approved for both adult Langerhans cell histiocytosis (LCH) and neurofibromatosis type 1 (NF1) in children aged 2 and above, providing new treatment options for rare disease patients [1][2]. Group 1: Drug Approval and Clinical Use - Luwo Meitini tablets received approval from the National Medical Products Administration (NMPA) on May 29 and were put into clinical use in Beijing and other cities within a month, addressing the dual challenges of "no available drugs" and "difficult access to drugs" for rare disease patients [1]. - The drug is expected to significantly improve drug accessibility for patients suffering from rare diseases, filling a treatment gap in the domestic market [1]. Group 2: Impact on NF1 Patients - NF1 is a rare genetic disorder that can severely impact patients' quality of life, with surgical interventions often limited in effectiveness [2]. - Luwo Meitini tablets are the first targeted drug approved for NF1 in China, showing promising clinical data with good efficacy and controllable safety, offering new hope for patients who cannot undergo surgery or have unsatisfactory surgical outcomes [2][3]. Group 3: Clinical Data and Efficacy - Luwo Meitini is a novel small molecule targeted drug that inhibits MEK1/2 protein activity, blocking the abnormal activation of the MAPK signaling pathway, thus suppressing tumor cell proliferation and inducing apoptosis [3]. - Phase II clinical trials showed a median follow-up of 15.1 months, with an objective response rate (ORR) of 60.5% and a median time to response (TTR) of 4.7 months, indicating rapid efficacy and good tolerability [3]. Group 4: Broader Implications for Rare Tumors - The drug also addresses a significant unmet need in the treatment of adult LCH and other histiocytic tumors, with an ORR of 82.8% in a Phase II trial for 29 patients, and a median time to response of only 2.9 months [4]. - Future clinical trials are planned for additional conditions, including low-grade gliomas and pediatric LCH, indicating the potential for broader applications of Luwo Meitini [4].
复星医药自研创新药芦沃美替尼片(复迈宁®)全国首批发货
Huan Qiu Wang· 2025-06-16 10:52
Core Viewpoint - Fosun Pharma has successfully completed the first batch shipment of its self-developed drug, Luwo Meitini Tablets (Fumainin®), marking its imminent clinical use and addressing patient medication needs [1][5]. Group 1: Product Launch and Approval - Fumainin® is the first and only targeted drug in China approved for dual indications: adult Langerhans cell histiocytosis (LCH) and tissue tumors, as well as type I neurofibromatosis for children aged 2 and above [1][6]. - The drug received approval from the National Medical Products Administration through a priority review and approval process by the end of May 2025 [5]. Group 2: Logistics and Distribution - The first batch of Fumainin® was successfully shipped from the production base of the entrusted manufacturer, Kelaiying Pharmaceutical Group, located in Tianjin [3]. - The logistics team completed a series of complex tasks within 10 working days after obtaining the approval, demonstrating efficient execution and a strong commitment to patient needs [5]. Group 3: Industry Impact and Responsibility - The rapid approval of Fumainin® fills a treatment gap in the rare disease oncology field in China, representing a significant breakthrough in domestic original innovation [6]. - The company emphasizes its responsibility to ensure that Fumainin® reaches patients in need as quickly as possible, reflecting a strong sense of social responsibility [6].
异动盘点0530| 宜明昂科月内股价翻倍,英伟达业绩强劲涨近6%,理想汽车交付预期推动涨超7%
贝塔投资智库· 2025-05-30 04:19
Group 1 - Kingsoft Software (03888) saw a nearly 5% drop in stock price, with Q1 revenue increasing by 9% year-on-year to 2.338 billion yuan, but net profit attributable to the parent company slightly decreased by 0.24% to 284 million yuan. Office software and services revenue grew by 6% year-on-year but fell by 13% quarter-on-quarter, while online gaming and other revenue increased by 14% year-on-year but decreased by 20% quarter-on-quarter [1] - Li Auto-W (02015) rose over 7%, reporting a 1.1% year-on-year revenue increase and a 9.4% rise in net profit for Q1. The company expects Q2 delivery volume to increase by 13.3%-17.9% year-on-year, with revenue projected to grow by 2.5%-6.7%. CEO Li Xiang expressed confidence in restoring monthly sales to 50,000 units and plans to launch the pure electric SUV i8 in July [1] - Hand Return Group (02621) debuted on the market but fell over 7% on its first day. The company is an internet-based life insurance intermediary with platforms like Xiaoyusan, Kachaba, and Niubao100, raising approximately 134 million HKD from its listing [1] - Yiming Anke-B (01541) surged over 13%, with its stock price doubling within the month. The company announced preliminary efficacy and safety data for its core product IMM2510 in treating non-small cell lung cancer (NSCLC) during I/II phase clinical trials [1] Group 2 - Meizhong Jiahe (02453) increased by over 7%, having developed a proprietary proton therapy language model successfully deployed in a Guangzhou hospital. The company plans to raise approximately 93.94 million HKD through a discounted share placement for equipment procurement, loan repayment, and working capital [2] - Gome Retail (06808) rose over 6%, with reports indicating that after a major shareholder change, the company is on track to transform its business, focusing on sales scale and absolute gross profit by FY2026. The company turned profitable in the second half of the last fiscal year, reporting a net profit of 199 million yuan, and plans to distribute 1.5 billion yuan in dividends for FY2025 [2] - Sany International (00631) saw a rise of over 4%, reporting a 14.6% year-on-year revenue increase to 5.876 billion yuan and a 23.2% rise in net profit to 635 million yuan for Q1. Growth was attributed to global expansion, digitalization, and low-carbon strategies [2] Group 3 - Dekang Agriculture (02419) surged over 8%, with analysts noting that April pig prices remained strong despite the seasonal downturn, and May's supply-demand dynamics are expected to support rising pig prices. The company is recognized for its leading breeding costs, projected to be below 13 yuan per kilogram, with an estimated 30% growth in pig output over the next three years [3] - Fubo Group (03738) increased by over 13%, completing an oversubscribed financing of over 500 million HKD for AI research and financial optimization. The company reported a total revenue increase of approximately 23% year-on-year, with mainland China revenue growing by about 21% and monthly recurring revenue (MRR) increasing by around 30% [3] - Gako Si-B (01167) rose over 8%, with a cumulative increase of over 25% this week. The company received domestic approval for its KRAS G12C inhibitor, used in specific non-small cell lung cancer treatments [3] - Fosun Pharma (02196) increased by over 6%, announcing that its self-developed new drug, Luwo Meitini tablets, has been approved for market release by the National Medical Products Administration [3] Group 4 - The smartphone supply chain stocks collectively fell, with companies like Hillstone Technology dropping over 5% and Sunny Optical, BYD Electronics, and GoerTek all declining over 3%. This decline was attributed to market concerns following the reinstatement of tariffs from the Trump administration [4] - Xiansheng Pharmaceutical (02096) rose over 8%, with five of its drugs selected for the 2025 ASCO annual meeting. The company's innovative drug BD's international expansion has garnered attention, including a deal with AbbVie worth over 1 billion USD [4] - Yika (09923) surged over 10%, following a 27% increase the previous day. The company recently obtained a payment license in Arizona, USA, with a projected nearly 5-fold increase in overseas transaction volume in 2024 [4] - Stone Pharmaceutical Group (01093) rose over 7%, with ongoing negotiations for three potential transactions involving products like EGFR-ADC, with total potential payments reaching approximately 5 billion USD, one of which is expected to be completed in June [4]
毕井泉被查;默沙东中国换帅丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-05-29 23:57
每经记者|甄素静 每经编辑|张益铭 丨2025年5月30日 星期五丨 NO.1 毕井泉被查 中央纪委国家监委网站5月29日晚消息,十四届全国政协常委、经济委员会副主任毕井泉涉嫌严重违纪 违法,目前正接受中央纪委国家监委纪律审查和监察调查。公开简历显示,毕井泉于2015年任国家食品 药品监督管理总局局长、党组书记,2018年任国家市场监督管理总局党组书记、副局长,同年因吉林长 春长生公司问题疫苗案件引咎辞职。 NO.2 默沙东中国换帅:日本总裁Kyle Tattle接棒 5月29日,默沙东全球高级副总裁、中国总裁田安娜(Anna Van Acker)将从中国总裁的角色转型,担 任人类健康事业部战略项目的重要管理职位,日本总裁Kyle Tattle接棒中国总裁。 点评:田安娜任职期间,推动默沙东中国战略更新,在创新药引入、HPV疫苗推广等方面成果显著。 Kyle Tattle接棒,其丰富经验有望助力默沙东进一步深耕中国市场,优化布局,或在市场拓展、研发合 作等方面有新动作。 NO.3 舒泰神:"注射用STSP-0601"正处于公示期内 舒泰神5月29日晚间发布公告称,公司股票交易连续十个交易日收盘价格涨幅偏离值累 ...