New PDUFA Target Action Date of January 14, 2026 set by FDAMIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission a ...

A target discovery agreement to identify disease-specific T-cell receptors (TCRs) in rheumatoid arthritis A data licensing agreement to access Adaptive’s proprietary TCR-antigen datasets for research and development in multiple immunology applications SEATTLE, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, tod ...

CLEVELAND, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Mohamad Tabrizi, M.S., M.B.A., as Senior Vice President, Chief Business Officer (CBO). In this role, Mr. Tabrizi will lead the Company’s corporate strategy and business development functions, as well as drive operating efficiency for the Company. “Mohamad brings a wealth of experience in strategic planning and business development,” said Vish Seshadri, Chief Executive Officer of Abeona. “W ...

BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the withdrawal of the proposed public offering of common shares due to market conditions. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there ...

Company is on track to file the Phase 3 protocol in the fourth quarter of 2025 SAN FRANCISCO, Dec. 15, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS). “The Orphan Drug Designation granted to roxadustat for MDS underscores the significant treatment gap in this indication, and highlights patient ...

92% of evaluable patients at interim analysis treated with RAD 101 achieved concordance¹ with MRI imaging (the primary endpoint) with significant and selective tumor uptake in suspected or recurrent brain metastases Company to host webinar on Tuesday, December 16 at 10:00 am AEDT (Australia) / Monday, December 15 at 6:00 pm EST (U.S.) SYDNEY, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing in ...

5 1 ®®Resistance to venetoclax (Venclexta and Venclyxto, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CLL) therapy, is emerging as a therapeutic challenge, with leukemic cells persisting over time, even with combination therapy 2,3Studies show that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cancer cells and that SPHK2 inhibition may reduce T-cell-induced activation and proliferation of venetoclax-resistant CLL cancer cells and resensitize previou ...

公司里程碑与产品管线 - 公司宣布已向美国FDA提交了imsidolimab的生物制品许可申请，用于治疗泛发性脓疱型银屑病[1] - imsidolimab是一种新型IgG4 IL-36受体拮抗剂，通过抑制IL-36受体信号通路发挥作用，针对GPP患者常见的IL36RN基因突变导致的内源性IL-36RA调节因子缺乏[1] - 公司已为该BLA申请优先审评，若获准将建立为期六个月的审评周期，imsidolimab有望最早于2026年中获得FDA批准用于治疗GPP[3] 临床数据与疗效 - BLA提交得到全球III期GEMINI-1和GEMINI-2研究的积极结果支持[2] - 在GEMINI-1试验中，第4周时，接受任一剂量imsidolimab治疗的患者中有53%达到了GPPGA评分为0/1，而安慰剂组为13%[4] - 在GEMINI-2维持研究中，所有接受活性维持治疗的患者均维持了皮损清除或几乎清除且无复发，而安慰剂组的维持率为25%，复发率为63%[5] - 单次静脉输注imsidolimab即可实现快速疾病清除，且每月给药一次的疗效在大约2年的维持研究期内持续保持[2] - 在所有研究中，imsidolimab均显示出良好的安全性，未出现具有临床意义的安全信号、治疗相关严重不良事件或因不良事件导致的停药[2][5] 目标疾病与市场 - GPP是一种罕见、慢性、危及生命的自身炎症性皮肤病，以突发性广泛脓疱、红斑以及发热和疲劳等全身症状为特征[2] - 该病主要由IL36RN基因的功能缺失性突变驱动，存在显著的未满足医疗需求[2] - 全球患病率估计差异很大，大约在每百万人2至124例之间[2] - imsidolimab针对的是罕见孤儿适应症，其监管和专利独占期预计将持续到2030年代末[8] 公司战略与背景 - 公司正在其日益增长的罕见孤儿病专业知识和抗炎产品组合基础上进行拓展，其产品组合包括已获批治疗复发型多发性硬化症的Ponvory，该药也正处于治疗银屑病和溃疡性结肠炎的临床开发中[3] - 公司计划利用其商业基础设施来应对GPP这一致残性疾病[3] - 公司拥有来自AnaptysBio的imsidolimab全球独家开发和商业化许可[8]

市场趋势 - 生物仿制药市场预计到2035年将增长6倍，达到超过1800亿欧元[19] - 预计到2030年，全球生物仿制药市场将达到99亿欧元[49] - 全球生物仿制药市场的年节省预计将从300亿欧元增长到超过1000亿欧元[21] - 2023年，生物仿制药在欧盟的采用率超过90%，美国市场也在加速增长[51] 业绩总结 - 2022年生物制药收入为0.4亿欧元，预计2025年将达到0.8亿欧元[23][34] - Fresenius Kabi的EBITDA在2024年实现盈亏平衡目标，2025年收入目标已提前达成[33] - 生物仿制药在2023年贡献了Fresenius Kabi显著的EBIT增长，EBIT利润率从8.5%提升至15.2%[38] - 预计到2030年，生物制药的收入将实现约2倍增长，EBIT利润率达到20%[42][44] 产品与研发 - 公司在生物仿制药领域拥有超过15年的开发经验，开发周期比竞争对手快40%[112] - 预计每年将有2个以上的分子进入开发阶段，目标是到2030年代将产品组合翻倍[82] - 公司在2022至2025年间获得8项美国FDA生物制剂许可申请（BLA）批准，领先于竞争对手[99] - 目前的生物仿制药管道覆盖了2000亿欧元的原研药销售[89] 产能扩展 - 公司计划在未来5年内投资超过3亿欧元以扩展产能并推动增长[122] - 在Graz新增的生产线将使小瓶和注射器的产能增加超过一倍[125] - León的新建筑将增加双倍的药物活性成分(DS)产能[125] - 公司预计到2025年，内部药物成分(DS)的产能将超过60%[130] 成本与效率 - 通过内部化和产品及流程优化，预计将进一步降低成本[122] - 制药成本中，75%来自于与mAbxience的垂直整合，15%为药物产品成本，10%为成品成本[64] - 供应链的灵活性和可靠性将提高，预计交货时间将减少33%[142] - 公司目标是通过产品和流程优化进一步降低成本[147] 市场份额与竞争 - Fresenius在全球生物仿制药收入中增长最快，2025年LTM净销售额为5亿欧元[54] - 公司在全球生物仿制药市场的份额预计将持续增长，特别是在美国市场[161] - 在法国，生物仿制药的招标成功率为95%，德国的法定病假基金合同覆盖率为100%[68] 未来展望 - 预计到2029年，生物制剂的全球销售将达到65亿欧元[109] - 预计到2030年，内部药物产品(DP)的产能将超过55%[130] - 生物类似药组合中，adalimumab的全球峰值品牌销售额为210亿欧元，预计在2019年和2023年分别在美国和欧洲上市[180] - pegfilgrastim的全球峰值品牌销售额为40亿欧元，预计在2022年和2023年分别在美国和欧洲上市[186]

 IND submitted for ABP-102/CT-P72, a HER2 × CD3 T cell engager, with preclinical studies demonstrating enhanced HER2-high tumor selectivity and a favorable safety profile ABP-102/CT-P72 represents Abpro’s first IND submission for a phase 1 trial in a solid tumor indication, and is being co-developed by Abpro and Celltrion, Inc. BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Abpro Holdings, Inc. (Nasdaq: ABP, “Abpro”), a biotechnology company developing novel breakthrough therapeutics for solid tumors, ...