Nov. 07, 2024 -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it dosed its first subject in its Phase 1 clinical study of PALI-2108, an orally administered PDE4 inhibitor prodrug that is locally bioactivated in the colon and is in development for patients affected by UC. The Phase 1

Both novel bifunctional (SON-1411) and monofunctional (SON-1400) fusion proteins exhibit wild-type binding to the IL-18 receptor (IL-18Rc), coupled with undetectable binding to the inhibitory IL-18 binding protein (IL-18BP) IL-18 has significant importance for cancer immune-oncology and combination with IL-12 on Sonnet’s FHAB platform which Sonnet believes could present an important oncology possibility The lock-and-load flexibility of the FHAB platform offers the bifunctional payload capability

11月15日，中国国家药监局药品审评中心（CDE）官网最新公示，信达生物1类新药IBI354拟纳入突破性治疗品种，针对适应症为铂耐药卵巢癌。公开资料显示，IBI354是一款抗HER2单克隆抗体-喜树碱衍生物偶联物（靶向HER2的ADC），信达生物在2024年欧洲肿瘤内科学会（ESMO）大会上公布了该产品治疗多种晚期实体瘤的临床数据，其中针对铂耐药卵巢癌患者的总体客观缓解率（ORR）为40.2%，疾病控制率（DCR）为81.6%。40例接受高剂量（12mg/kg）IBI354治疗的卵巢癌受试者中ORR达到52.5%，DCR达90.0%。 IBI354是一款抗HER2单克隆抗体-喜树碱衍生物偶联物，药物抗体比（DAR）值为8，能够携带更多的毒素载荷到达肿瘤细胞。IBI354不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在HER2靶向治疗耐药和转移模型中也表现出了突出的抑瘤效力。信达生物正在中国、美国、澳大利亚开展临床研究，探索IBI354在针对各种晚期恶性肿瘤的有效性和安全性。 信达生物在2024年ESMO大会上公布的数据来自一项临床1/2期研究，旨在评估IBI354治疗晚期实体瘤

11月14日晚，恒瑞医药发布公告，旗下子公司的SHR-2173注射液、HRS-5632注射液获得CDE批准，将于近期开展临床试验。 SHR-2173注射液适应症为：治疗原发免疫性血小板减少症（ITP）。 HRS-5632注射液适应症为：治疗脂蛋白紊乱。 SHR-2173注射液是恒瑞医药自主研发的治疗用生物制品，能够通过靶向异常激活的免疫细胞，发挥抗炎和抑制免疫的生物学效应，有望降低自身抗体水平，改善ITP患者的疾病活动状态。目前国内外尚无同类药物上市或在临床研发阶段。截至目前，SHR-2173注射液相关项目累计已投入研发费用约4503万元。 HRS-5632注射液是恒瑞医药自主研发的1类化学药物，临床前数据显示，HRS-5632给药后可有效改善脂蛋白紊乱，安全性良好。目前国内外暂无同类药物获批上市，截至目前，HRS-5632注射液相关项目累计已投入研发费用约为2938万元。 内容来源于网络，如有侵权，请联系删除。

2024年11月12日，国家药品监督管理局官网显示，药友制药的盐酸普萘洛尔注射液通过仿制药质量和疗效一致性评价（5ml:5mg、2ml:2mg），系国内该品种首家过评。 1966年在日本首次上市，是一种非选择性β-肾上腺素能受体阻断剂，与β-肾上腺素能受体刺激剂竞争受体位点。当β-肾上腺素能受体通路被阻断时，对β-肾上腺素能刺激的变时性、变力性和舒血管反应相应降低。当剂量大于阻滞β-肾上腺素受体所需剂量时，普萘洛尔会产生奎尼丁样或麻醉剂样的膜电位，从而影响心脏动作电位。 普萘洛尔选择性阻断β-肾上腺素能受体，对α-肾上腺素能反应没有影响。β受体有两种特征明显的亚型（β1和β2），普萘洛尔与这两种亚型具有同等的相互作用。β1-肾上腺素能受体主要存在于心脏。心脏β1-肾上腺素能受体阻断可致正常和异位起搏细胞活性降低及AV节点传导速度下降。心脏β1-肾上腺素能受体阻断也会降低心肌收缩力，并可能在心力储备极少的患者中发生心脏失代偿。β2-肾上腺素能受体主要存在于平滑肌-血管、支气管、胃肠道和泌尿生殖系统，这些受体的阻断可导致收缩。 普萘洛尔在国内获批多种剂型，其中注射液于1996年在中国

Phase 2b ACCESS study designed to evaluate multiple doses up to 120 mg of GSBR-1290 over 36 weeks Comprehensive development program also includes Phase 2 ACCESS II study to evaluate even higher doses of GSBR-1290 over 36 weeks; first patient expected to be dosed by end of 2024 Topline data from both ACCESS and ACCESS II studies expected in the fourth quarter of 2025 Company to host conference call today at 4:30 p.m. Eastern Time Nov. 13, 2024 -- Structure Therapeutics Inc. (NASDAQ: GPCR), a cli

– Results demonstrate statistically significant fibrosis reversal and protection against hepatocellular carcinoma in animal models of MASH – – Kriya plans to evaluate KRIYA-497, a one-time intramuscular gene therapy designed to enable continuous expression of native FGF21, in people with MASH – Nov. 13, 2024 -- Kriya Therapeutics, Inc., ("Kriya"), a biopharmaceutical company developing gene therapies to address common diseases affecting millions of people around the world, today announced the p

Nov. 13, 2024 -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) ("NurExone" or the "Company"), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the European Medicines Agency (the “EMA”) has granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this potential treatment available for acute spinal cord injury patients across Europe. This designation support

Nov. 12, 2024 -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in a pivotal randomized Phase 3 trial for the

Mavorixafor durably and meaningfully elevated participants’ mean absolute neutrophil counts (ANC) Mavorixafor enabled substantial reductions in G-CSF dosing while maintaining mean ANC at normal levels Phase 2 study results and new analysis confirming functionality of neutrophils in sub-study participants bolster confidence in achieving success in Phase 3 4WARD trial Company conference call and webcast today at 8:00 am ET Nov. 13, 2024 -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to im