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创新药周报:全球首个口服HAE急性发作按需治疗药物获批上市-20250713
Huachuang Securities· 2025-07-13 14:22
创新药周报20250713: 证券研究报告 证券分析师刘浩 执业编号:S0360520120002 邮箱:liuhao@hcyjs.com 联系人段江瑶 邮箱:duanjiangyao@hcyjs.com @2021 华创版权所有 第一部分 本周创新药重点关注 国内创新药回顾 02 全球首个口服HAE急性发作按需治疗药物获批上市 本报告由华创证券有限责任公司编制 卖的出价或询价。本报告所载信息均为个人观点,并不构成对所涉及证券的个人投资建议。 请仔细阅读PPT后部分的分析师声明及免责声明。 2025-07-13 全球新药速递 03 01 遗传性血管性水肿(HAE) 证券研究报告 致。 ┃ HAE诊断流程 ┃ HAE分型及特征 | HAE 分型 | 发病机制 | C1-INH 浓度 | CI-INH 功能 | | --- | --- | --- | --- | | HAE-C1-INH 1 型 | C1-INH 基因突变 | 降低 | 降低 | | HAE-C1-INH2 型 | C1-INH 基因突变 | 正常或增高 | 障低 | | HAE-nC1-INH | FXII、 ANGPTI、PLG 基因突变 | ...
失事客机双发一秒内被关闭,调查显示大概率人为因素引发印航空难
Hua Xia Shi Bao· 2025-07-12 11:37
Core Insights - The preliminary report from the Indian Aircraft Accident Investigation Bureau (AAIB) regarding the Air India 787-8 crash on June 12 reveals critical operational failures during takeoff, specifically the simultaneous shutdown of both fuel control switches within one second, leading to engine power loss [2][5][6] Investigation Findings - The report includes background information, personnel casualties, weather data, flight recorder details, and the current status of the investigation [2] - The aircraft was carrying 230 passengers and 12 crew members, and the crash resulted in 12 crew members, 229 passengers, and 19 ground personnel fatalities, marking it as one of the deadliest aviation disasters in a decade [7] - The flight data indicates that the fuel control switches were switched from "RUN" to "OFF" in a critical phase of flight, which is unusual and raises questions about operational protocols [3][5] Technical Analysis - The design of the fuel control switches on the Boeing 787 requires a specific action to change states, making accidental simultaneous operation unlikely [3][4] - The aircraft was equipped with two enhanced flight data recorders, which provided valuable data despite some damage [3][5] - The investigation has ruled out bird strikes as a cause, as there were no signs of bird activity in the flight path [5] Industry Impact - The crash has significant implications for Boeing, which has faced challenges in rebuilding its reputation following previous incidents, including the 737 MAX crisis [8][9] - The incident occurred just before the 2025 Paris Air Show, leading to cancellations of Boeing's planned activities at the event, which typically serves as a platform for showcasing new products and technologies [7][8] - Air India, under Tata Group's ownership, has ambitious plans to modernize its fleet, including a substantial order for 470 aircraft, which aims to enhance its competitive position in the market [9][10] Market Context - Air India is currently the largest airline in India by fleet size, with a total of 191 aircraft, including 33 Boeing 787s, positioning it favorably for long-haul operations [9][10] - The Indian aviation market has significant growth potential, but local airlines have historically struggled against foreign competitors, highlighting the need for improved competitiveness and brand image [10]
南航开通首条第五航权定期货运航线
Zhong Guo Xin Wen Wang· 2025-07-10 02:18
中新网广州7月10日电(记者郭军)记者9日从中国南方航空公司获悉,南方航空物流股份有限公司(以下简 称"南航物流")近日正式开通广州-奥克兰-悉尼国际货运航线。这是国内航司首条从中国大陆直飞新西兰 定期全货机正班航线,也是南航首条第五航权货运航线,拥有澳大利亚、新西兰之间双向第五航权。 目前,南航物流共运营19架波音777全货机,每周执飞定期国际航班超80班,形成国内辐射全球的全货 机货运航线网络。(完) 南航开通 近年来,中新两国在农产品、电子产品、消费品等领域的贸易合作不断深化。据报道,中新自贸协定生 效以来,中新双边货物贸易额增长近300亿新元,2025年一季度,中新贸易总额105.1亿新元,同比增长 8.9%。为满足日益旺盛的澳新货运需求,南航物流新开新西兰货机航线,进一步开拓新兴市场,打通 国际空中运输大动脉。 新航线由波音777全货机定期执飞,将有效弥补大洋洲方向运力缺口,大幅缩短大湾区与澳新地区货物 运输时间,为大湾区300余家跨境电商和高端制造企业出海提供更高效的物流解决方案。 据悉,第五航权也称第三国准入权,是指一个国家的航空公司在经营某条国际航线的同时,获得在中途 第三国经停并载运客货的权 ...
Boeing to Ride on Delivery Momentum With Strong Q2 Commercial Shipments
ZACKS· 2025-07-09 14:46
Key Takeaways BA delivered 150 commercial jets in Q2 2025, a 63% jump from the year-ago quarter, led by strong 737 demand. Sequential growth from Q1 was driven by higher wide-body 777 and 787 aircraft deliveries. Higher deliveries may lift BCA's revenues and margins, aiding BA's cash flow and financial recovery.The Boeing Company ((BA) is witnessing strong momentum in its commercial airplane business, backed by solid delivery numbers, making a significant rebound in terms of shipments to what were witness ...
Gold Falls 1%; ProKidney Shares Spike Higher
Benzinga· 2025-07-08 17:25
Market Overview - U.S. stocks showed mixed performance with the Dow Jones index declining by 0.35% to 44,249.09, while the NASDAQ increased by 0.07% to 20,427.63 and the S&P 500 fell by 0.03% to 6,228.39 [1] - Energy shares experienced a notable increase of 2.1%, while utilities stocks decreased by 1.9% [1] Used Vehicle Market - The US Manheim Used Vehicle Value Index rose by 1.6% month-over-month for June, following a 1.4% decline in May [2][11] Commodity Market - Oil prices increased by 0.3% to $68.14, while gold prices decreased by 1.1% to $3,306.90. Silver fell by 0.8% to $36.625, and copper dropped by 0.5% to $5.0000 [5] European Market - European shares showed positive movement with the eurozone's STOXX 600 rising by 0.40%, Spain's IBEX 35 Index up by 0.10%, London's FTSE 100 gaining 0.46%, Germany's DAX 40 increasing by 0.68%, and France's CAC 40 rising by 0.46% [6] Asian Market - Asian markets closed higher, with Japan's Nikkei gaining 0.26%, Hong Kong's Hang Seng climbing 1.09%, China's Shanghai Composite increasing by 0.70%, and India's BSE Sensex rising by 0.32% [7] Company News - ENDRA Life Sciences Inc. saw its shares surge by 134% to $8.10 after announcing a US patent for a "Radio Frequency Applicator" [9] - ProKidney Corp. shares surged by 218% to $1.95 following positive topline results from its Phase 2 REGEN-007 trial for chronic kidney disease and diabetes [9] - Humacyte, Inc. shares increased by 20% to $2.5750 after receiving Electronic Catalog Listing approval from the US Defense Logistics Agency [9] - Blue Gold Limited shares dropped by 21% to $58.75 after announcing the formation of its inaugural Advisory Board for Blockchain Evolution [9] - Sunrun Inc. shares fell by 11% to $9.84 after President Trump signed an executive order to end clean-energy tax credits [9] - Apogee Therapeutics, Inc. shares decreased by 8% to $36.24 following the release of data from its Phase 2 APEX clinical trial for atopic dermatitis [9]
Boeing Announces Second Quarter Deliveries
Prnewswire· 2025-07-08 15:00
ARLINGTON, Va., July 8, 2025 /PRNewswire/ -- The Boeing Company [NYSE: BA] announced today major program deliveries across its commercial and defense operations for the second quarter of 2025.The company will provide detailed second quarter financial results on July 29. Major program deliveries during the second quarter were as follows: Major Programs 2nd Quarter2025 Year-to-Date2025 Commercial Airplanes Programs 737 104 209 767 9 14 777 13</b ...
DoubleDown Interactive Enters into Agreement to Acquire German Social Casino Operator WHOW Games
Globenewswire· 2025-07-08 12:00
SEOUL, South Korea, July 08, 2025 (GLOBE NEWSWIRE) -- DoubleDown Interactive Co., Ltd. (NASDAQ: DDI) ("DoubleDown" or the "Company"), a leading gaming company delivering exceptional player experiences across multiple genres, announced today that the Company entered into a Share Purchase and Transfer Agreement with Azerion Tech Holding B.V. to acquire WHOW Games GmbH, a social casino developer headquartered in Hamburg, Germany. The initial consideration for 100% ownership interest in WHOW Games is €55 millio ...
Dow Dips 1%; Mustang Bio Shares Spike Higher
Benzinga· 2025-07-07 16:30
Market Overview - U.S. stocks experienced a decline, with the Dow Jones index falling over 400 points, down 1% to 44,379.69, NASDAQ down 0.85% to 20,426.99, and S&P 500 down 0.39% to 6,255.16 [1] - In commodities, oil increased by 0.7% to $67.44, while gold decreased by 0.5% to $3,325.80, silver fell 0.8% to $36.795, and copper dropped 2.7% to $5.0025 [5] Company News - Cogent Biosciences, Inc. announced positive topline results from Part 2 of the SUMMIT trial for bezuclastinib, showing significant improvements across primary and key secondary endpoints [2] - Mustang Bio, Inc. shares surged 319% to $4.99 after receiving FDA Orphan Drug Designation for MB-101 in astrocytomas and glioblastoma [9] - Artelo Biosciences, Inc. saw a 79% increase in shares to $17.98 following preclinical efficacy results with ART12.11 in a stress-induced depression model [9] - LogProstyle Inc. shares rose 155% to $2.08 after reporting year-over-year financial growth for FY25 [9] - Core Scientific, Inc. shares dropped 21% to $14.21 after CoreWeave announced plans to acquire the company in an all-stock deal [9] - Jasper Therapeutics, Inc. shares fell 51% to $3.2964 after reporting an 89% response rate in its Urticaria study and the decision to halt the program [9] - Apogee Therapeutics, Inc. shares decreased by 16% to $40.03 following the release of 16-week data from Part A of the Phase 2 APEX clinical trial for APG777 [9] Regional Market Performance - European shares showed positive movement, with the eurozone's STOXX 600 rising 0.43%, Spain's IBEX 35 Index up 0.43%, London's FTSE 100 gaining 0.01%, Germany's DAX 40 increasing by 1%, and France's CAC 40 up 0.39% [6] - Asian markets closed mixed, with Japan's Nikkei down 0.56%, Hong Kong's Hang Seng down 0.12%, while China's Shanghai Composite gained 0.02% and India's BSE Sensex increased by 0.01% [7]
Airbus to Deliver 20 A330-900 Jets to Malaysia Aviation Group
ZACKS· 2025-07-07 13:25
Key Takeaways Airbus won a firm order from Malaysia Aviation Group for 20 A330-900 widebody aircraft. A330-900 jet, powered with Rolls-Royce Trent 7000 engines, offers reduced CO2 emissions. The global passenger fleet is expected to nearly double from 2025 to 2044, boosting Airbus' long-term outlook.Airbus SE (EADSY) recently secured a firm order from the Malaysia Aviation Group to deliver 20 of its A330-900 widebody commercial aircraft. This should bolster EADSY’s commercial aircraft backlog and future r ...
Apogee Therapeutics (APGE) Update / Briefing Transcript
2025-07-07 13:00
Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics - **Focus**: Development of APG-777 for atopic dermatitis Key Industry Insights - **Market Potential**: The atopic dermatitis market is projected to be worth $50 billion, with APG-777 positioned to potentially transform treatment paradigms [doc id='9'][doc id='33']. Core Points and Arguments 1. **Phase II APeX Study Results**: - APG-777 met or exceeded all key objectives in the Phase II APeX study for atopic dermatitis, demonstrating significant efficacy and a favorable safety profile [doc id='4'][doc id='15]. - 66.9% of patients achieved an EZ-75 response by week sixteen, surpassing results from existing treatments like Dupixent [doc id='15'][doc id='72']. 2. **Dosing and Administration**: - APG-777's induction regimen requires only four dosing days compared to nine for competitors, representing over a 50% reduction in injection days [doc id='14']. - The potential for maintenance dosing every three to six months could lead to 70-90% fewer injections compared to current standards [doc id='26']. 3. **Efficacy Metrics**: - The study showed a greater than 70% absolute percent change from baseline in EASI scores, with rapid lesion reduction observed as early as week two [doc id='15']. - Statistically significant improvements in itch relief were noted, with over 50% decrease from baseline at week sixteen [doc id='17']. 4. **Safety Profile**: - APG-777 demonstrated a promising safety profile, with lower rates of treatment-emergent adverse events compared to placebo [doc id='21']. - No injection site reactions were reported, enhancing the drug's appeal for patients [doc id='23']. 5. **Future Development Plans**: - Multiple data readouts are expected in the coming quarters, including maintenance data and results from the accelerated Part B of the APeX study [doc id='5'][doc id='29']. - Plans to initiate Phase III studies next year, contingent on regulatory alignment [doc id='32']. 6. **Market Positioning**: - APG-777 is expected to be a market leader, with 94% of patients preferring it over existing options if efficacy is equal [doc id='71']. - The company aims to establish APG-777 as a first-line biologic treatment for atopic dermatitis [doc id='73']. Additional Important Insights - **Combination Studies**: Ongoing studies are testing APG-777 in combination with IL-13 and OX40 ligand against Dupixent, which could further differentiate the product in the market [doc id='11'][doc id='44']. - **Regulatory Considerations**: The company is preparing for potential regulatory filings in early 2029, following Phase III trials [doc id='98']. - **Patient and Physician Preferences**: There is a strong demand for fewer injections and improved efficacy, which APG-777 aims to address [doc id='26'][doc id='72']. This summary encapsulates the key points discussed during the conference call, highlighting the promising results of APG-777 and its potential impact on the atopic dermatitis market.