7月15日，中国国家药监局药品审评中心（CDE）在其官方网站上宣布，百济神州公司提交的1类新药注射用BG-C9074已获得临床试验批准，该药物旨在用于晚期实体瘤的治疗。这款药物是针对B7H4靶点的抗体偶联药物（ADC），目前正进行全球范围内的1期首次人体临床试验。据公开资料显示，百济神州于2023年7月与映恩生物签订了一项价值超过13亿美元的合作协议，据此获得了该ADC产品的全球开发和商业化权利。 截图来源：CDE官网 B7H4是B7家族的新成员，是一种在多种肿瘤细胞表面过度表达的蛋白，有助于肿瘤细胞逃避免疫系统的监视。研究发现，B7H4在三阴性乳腺癌、卵巢癌、子宫内膜癌和胆管癌中的表达率分别高达74%、77%、94%和89%，而在正常组织中的表达相对较少。此外，B7H4的表达与PD-L1独立，通常在PD-L1阴性的肿瘤中表达较高，表明它可能为PD-1/L1之外的另一种免疫逃逸机制。这为针对B7H4的疗法提供了治疗PD-L1阴性或难治性肿瘤患者的潜力。 百济神州已于今年6月启动了BG-C9074的1期临床研究，目的是评估该药物单独使用或与抗PD-1单抗替雷利珠单抗联合使用在治疗实体瘤

- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 - - Product has patent protection through 2043 - July 15, 2024 -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food an

ART26.12 seeks to address a critical need in painful neuropathies, including chemotherapy-induced peripheral neuropathy for which there is no FDA-approved treatment Phase 1 trial results expected in the first half of 2025 July 15, 2024 -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today announced that the U.S. F

July 15, 2024 -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that it has entered into a stock purchase agreement with Ridgeback Capital Investments L.P. (“Ridgeback Capital”) for a $30 million private investment in public equity (“PIPE”) common stock financing. “We appreciate the significant support a

Claudin 18.2是一种紧密连接分子，主要存在于非恶性胃上皮中，在恶性转化过程中可以在肿瘤细胞表面接近，从而为癌症治疗提供了一个有吸引力的靶点。两项测试抗claudin 18.2抗体zolbetuximab的III期试验数据表明，claudin 18.2阳性的晚期胃癌是一种独立的治疗亚群，可以从化疗中获益。这一进展大大提高了有资格接受靶向治疗的患者比例。此外，新的治疗方法，如高亲和力单克隆抗体、双特异性抗体、嵌合抗原受体T细胞和具有旁观者杀伤作用的抗体药物偶联物，在表达claudin 18.2的胃癌患者中显示出相当大的希望。这一新的发展是由于药物开发人员超越了传统的目标，如驱动基因改变或生长因子。在这篇综述中，我们强调了claudin 18.2靶向治疗晚期胃癌患者的生物学原理和临床活性，并探讨了claudin 18.2靶向治疗扩展到其他claudin 18.2阳性实体瘤患者的潜力。 ①Claudin 18.2几乎只在胃粘膜中表达，没有明确的证据表明这种紧密连接蛋白在胃癌发生和/或增殖中的作用。 ②针对claudin 18.2的单克隆抗体zolbetuximab的两项关键III期

7月16日，迈威生物宣布其自主研发的靶向 B7-H3 ADC 创新药（7MW3711）获FDA授予孤儿药资格认定，用于治疗小细胞肺癌。 7MW3711 基于迈威生物新一代 ADC 定点偶联技术平台 IDDC™ 开发，由创新抗体分子、新型连接子以及新型载荷 Mtoxin™（拓扑异构酶 I 抑制剂）构成，具有完全知识产权。7MW3711注射人体后，可与肿瘤细胞表面的抗原 B7-H3 结合内吞进入肿瘤细胞，通过特定酶解作用，定向释放小分子，从而实现对肿瘤的精准杀伤。 7MW3711 具有结构稳定，组分均一，纯度高，易于产业化放大等特点，相较国内外同类型药物，7MW3711 在多种动物肿瘤模型中均显示出更好的肿瘤杀伤作用。在食蟹猴等动物安全性评价模型中，7MW3711 显示具有良好的药物安全性及药代特性。上述研究结果表明 7MW3711 具有临床差异化特性以及广阔的临床开发前景。 IDDC™ 是迈威生物自主开发的新一代 ADC 定点偶联技术平台，由定点偶联工艺 DARfinity™，定点连接子接头 IDconnect™，新型载荷分子 Mtoxin™，以及条件释放结构 LysOnly™ 等

July 15, 2024 -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that enrollment has been completed and dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the sixth cohort are r

July 15, 2024 -- Amolyt Pharma, a global, clinical-stage biopharmaceutical company specializing in developing therapeutic peptides for rare endocrine and related diseases, today announced that its previously announced acquisition by the global pharmaceutical company, AstraZeneca, has closed. The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigat

Bexotegrast at 320 mg was well tolerated up to 40 weeks of treatment with no treatment-related severe or serious adverse events 320 mg cohort demonstrated improvement in liver stiffness by transient elastography at Week 24 compared to placebo Statistically significant improvement in alkaline phosphatase (ALP) levels over 24 weeks compared to placebo Continued improvement in hepatocyte function and bile flow by contrast MRI imaging observed from Week 12 to Week 24 FDA guidance provided clarity on

July 15, 2024 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI’s L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®. "The approval and launch of L-Glutamine Oral Powder, the first AA-rated approved generic to Endari®, continues to demonstrate the st