Core Insights - The clinical trial results for Annamycin in combination with Cytarabine (AnnAraC) show significant improvements in overall survival (OS) for patients with relapsed acute myeloid leukemia (AML), exceeding industry expectations by over 30% [2][4] - The median OS for subjects achieving complete remission (CR) is reported at 15 months, while the median OS for the intent-to-treat (ITT) population is 9 months [5][3] - The company is progressing with the pivotal MIRACLE Phase 3 trial and anticipates the final clinical study report (CSR) for the MB-106 trial to be published in early Q1 2026 [1][6] Clinical Trial Results - A total of 22 subjects were enrolled in the MB-106 trial, with 8 subjects (36%) achieving complete remission [3][5] - The median OS for the 2nd line efficacy evaluable population is 12 months [5] - The durability of CR for the 8 subjects ranged from 2 to 22 months, with a median of 10 months [3] Safety and Tolerability - No clinically significant signs of cardiotoxicity were observed in any subjects, which is a critical aspect of Annamycin's profile [7][4] - The combination treatment was well tolerated, with myelosuppression and infections being the main adverse events [7] Future Developments - The company aims to recruit the first 45 patients for the MIRACLE trial by the end of the year, with safety and efficacy data expected to be unblinded thereafter [6] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, indicating its potential significance in addressing unmet medical needs [8][11]

葵花药业公告，2025年上半年营业收入13.1亿元，同比下降48.17%。净利润8130.99万元，同比下降 83.28%。 ...

Core Insights - MannKind Corporation has announced that United Therapeutics Corporation has exercised its option to develop a second dry powder inhalation therapy under their 2018 collaboration agreement [1][2] Group 1: Collaboration and Agreement Details - The original agreement led to the FDA approval of Tyvaso DPI in May 2022 and included an option for United Therapeutics to expand the license to additional active ingredients [2] - Under the expanded agreement, MannKind will formulate a second investigational molecule using its proprietary Technosphere platform, while United Therapeutics will handle preclinical and clinical development [2] - MannKind will receive an upfront payment of $5 million, with potential development milestone payments of up to $35 million and 10% royalties on net sales of any resulting product [3] Group 2: Development Activities - Formulation and development activities for the new investigational molecule will commence immediately [4] Group 3: Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices to address serious unmet medical needs, particularly in endocrine and orphan lung diseases [5] - The company aims to utilize its formulation capabilities and device engineering to alleviate the burden of diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension [6]

Company Overview - Belite Bio, Inc is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease type 1 and Geographic Atrophy in advanced dry age-related macular degeneration [2] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye, currently undergoing Phase 3 and Phase 2/3 studies [2] Upcoming Events - The executive management team will participate in three investor conferences: - Cantor Global Healthcare Conference on September 5, 2025, at 8:00 am ET - Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 5:35 pm ET - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 8:00 am ET [3] - Webcasts of the presentations will be available on the investor relations section of the Belite Bio website, with replays archived for 90 days [1]

® BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com Agitation Associated with Bipolar Disorders or Schizophrenia in the At-Home Setting SERENITY At-Home Pivotal Phase 3 Safety Trial Topline Results August 27, 2025 Nasdaq: BTAI Forward-Looking Statements This presentation includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe ...

NEWARK, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL; NYSE American: RFL-WT) announced today that its subsidiary Cyclo Therapeutics has had two abstracts selected for presentation from its programs evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 at the upcoming 15th International Congress of Inborn Errors of Metabolism (ICIEM) being held September 2-6, 2025 in Kyoto, Japan. Details for the presentations are as follows: Session: Oral PresentationTitle ...

Treatment with Verzenio plus endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy aloneIn the seven-year landmark analysis of monarchE, treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefitResults reinforce two years of Verzenio plus endocrine therapy as the standard of care in HR+, HER2-, node-positive, early breast cancer at a high risk of recu ...

这是一项多中心、随机、双盲、安慰剂对照临床试验，纳入了318例接受过标准治疗的IgAN成人患者， 泰它西普的使用剂量为240mg，皮下注射，每周1次。A阶段分析结果显示：与对照组相比，泰它西普组 患者在治疗39周时的24小时尿蛋白肌酐比值(UPCR)降低了55%(P<0.0001)，且表现出良好的耐受性和安 全性。详细数据将在国际重大学术会议上公布。 荣昌生物(09995)发布公告，公司自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普(商品 名：泰爱)用于治疗IgA肾病(IgAN)的中国III期临床研究，达到A阶段的主要研究终点。集团将尽快向中 国国家药品监督管理局(NMPA)药品审评中心(CDE)递交上市申请(BLA)。 研究表明，B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)是促进Gd-IgA1及其抗体产生的重要细胞 因子。泰它西普是由公司自主研发的重组BLyS/APRIL双靶点融合蛋白，通过同时抑制BLyS和APRIL与 B细胞表面受体结合，阻止B细胞异常分化和成熟，有效减轻机体的病理性免疫反应。目前在中国已获 批治疗重症肌无力(MG)、系统性红斑狼疮(SLE)和类风湿关节 ...

Core Insights - Hengdian Group's pharmaceutical arm Apeloa is leveraging Flow Chemistry to enhance sustainability in the pharmaceutical industry [1][2] - Apeloa has invested over USD 20 million in its flow chemistry platform over the past decade, emphasizing energy efficiency and reduced emissions [2] - The flow chemistry market is projected to grow at a 10% CAGR, reaching USD 2.9 billion by 2028, driven by regulatory support and scientific advancements [4] Group 1: Flow Chemistry Advantages - Flow chemistry allows for continuous chemical reactions, improving process safety and sustainability compared to traditional batch processing [3][6] - The method utilizes compact tubular reactors, providing better control over temperature, pressure, and time, resulting in less waste and higher yields [6] - Apeloa's flow chemistry platform supports the entire drug development lifecycle, from early development to commercial manufacturing [9] Group 2: Technological Developments - Apeloa has refined its flow chemistry platform technologically and commercially over the last ten years, with expertise in various high-value reactions [7][8] - The company’s Boston site specializes in early-stage flow chemistry, while its Shanghai and Hengdian locations handle larger scale samples [7] - A recent white paper published by Apeloa showcases its capabilities in high-risk reactions, demonstrating significant improvements in yield and safety [8][10] Group 3: Specific Reaction Improvements - Azide and Hydrogenation processes have been optimized to achieve 10-minute cycle times compared to 12 hours in batch processing [10] - Nitration with Acetyle Nitrate has shown an 80% yield in just 3 minutes, significantly faster than the traditional method [10] - Fluorination processes can handle a capacity of 12,000 tons/year with yields exceeding 90%, surpassing commercial standards [10]

Group 1 - A-share market sees a decline in several innovative drug concept stocks, with Yuekang Pharmaceutical dropping over 10% [1] - Guangshengtang falls by 8%, while Lifang Pharmaceutical and Haishike decrease by over 7% [1] - Saili Medical declines by over 6%, and Huiyu Pharmaceutical drops by over 5% [1] - Jingxin Pharmaceutical experiences a decline of over 4%, with Shutaishen, Haiteshengwu, and Xinlitai all falling by over 3% [1]