免疫性血小板减少症 （ Immune thrombocytopenia， ITP） 是一种自身免疫疾病，其特征为自身抗体介导的血小板破坏。使用 抗 CD38 单克隆抗体 ，有望通 过 对 CD38 阳性细胞 （包括浆细胞） 的靶向清除来治疗该疾病。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 2024 年 6 月 20 日， 中国医学科学院血液病医院 张磊 教授团队在国际顶尖医学期刊《 新英格兰医学杂志 》 （NEJM） 发表临床研究论文 【1】 ，这项 1/2 期临床研究显示，国产新药—— 抗 CD38 单克隆抗体 （CM313，由 康诺亚 开发） 治疗免疫性血小板减少症的安全性良好，显示出持久的疗效反应。在 研究纳 入的 22 例患者中，21 例 （95%） 在治疗期间连续两次血小板计数至少达到50× 10 9 /L，出血患者比例从基线的 68% 分别下降到第 8 周的 5% 和第 24 周 的 10%，而且长期缓解率高达 60% 以上。 值得一提的是，这是《 新英格兰医学杂志 》 （NEJM） 首次发表 中国原创新药 的 1/2 期临床试验结果。 2025 年 5 月 29 日， 张磊 教授团队 （ 孙婷 ...

Core Insights - The FDA Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® for treating high-risk smoldering multiple myeloma (HR-SMM), marking a significant step in the treatment landscape for this condition [1][2][3] Company Insights - Johnson & Johnson aims to transform oncology care by advocating for early intervention in high-risk smoldering multiple myeloma, potentially delaying or preventing progression to active multiple myeloma [4][6] - The company emphasizes its commitment to evolving treatment paradigms for multiple myeloma, aligning with its vision for a future where early diagnosis and treatment are standard [4][5] Industry Insights - Currently, there are no approved treatments specifically for HR-SMM, with an estimated 35,000 new multiple myeloma cases expected in the U.S. in 2024, of which approximately 15% are classified as smoldering [3][7] - The standard of care for smoldering multiple myeloma is active monitoring, which may delay therapeutic intervention until significant disease progression occurs [3][8] - The AQUILA study, a Phase 3 trial, demonstrated that early intervention with DARZALEX FASPRO® could reduce the risk of progression or death in patients with HR-SMM [4][6]

Halozyme Therapeutics (HALO) reported first-quarter 2025 adjusted earnings of $1.11 per share, which comprehensively beat the Zacks Consensus Estimate of 95 cents. Earnings rose 41% year over year.Total revenues in the first quarter increased 35% year over year to $264.9 million. Revenues too surpassed the Zacks Consensus Estimate of $239 million. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The top-line growth was primarily driven by higher royalty payments from Roche (RHHBY) fo ...

TARPON SPRINGS, Fla., April 25, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP®) patient selection technology today announced the presentation of a poster containing data on a new DRP for the monoclonal antibody drug daratumumab. The post ...

Company Announcement Net sales of DARZALEX® in the first quarter of 2025 totaled USD 3,237 millionGenmab receives royalties on worldwide net sales from Johnson & Johnson (J&J, legal entity Janssen Biotech, Inc.) COPENHAGEN, Denmark; April 15, 2025 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by J&J ...