Dexamethasone Sodium Phosphate

当地时间6月11日-14日，2026年第31届欧洲血液学会大会/年会（EHA）在瑞典斯德哥尔摩召开。中国生物制药（1177.HK）核心企业正大天晴公布了艾贝格司亭α注射液、泊马度胺胶囊的7项研究成果，涵盖从支持治疗到免疫调节联合方案的多个维度，为血液肿瘤患者带来更安全、更便捷、更长生存的希望。 完善肿瘤全周期管理，强化支持治疗根基 在非霍奇金淋巴瘤的常见治疗方案中，骨髓抑制是主要的不良反应之一，重症患者可能伴有发热性中性粒细胞减少症（FN）的发生。本次大会上，正大天晴发表了艾贝格司亭α在中性粒细胞减少症预防领域的重要研究成果，进一步夯实了公司在肿瘤支持治疗中的领先地位。 艾贝格司亭α在新诊断非霍奇金淋巴瘤患者使用类R-CHOP方案诱导治疗引起的中性粒细胞减少症的疗效和安全性：一项随机对照多中心临床研究 PB3733-Efficacy and safety of efbemalenograstim alfa in the treatment of neutropenia induced by r-chop-like regimens in newly diagnosed non-hodgkin's lymphoma patients clinical study 第一作者：哈尔滨市第一医院血液肿瘤研究中心 赵东陆 通讯作者：哈尔滨市第一医院血液肿瘤研究中心  马军 内容概要：本研究是一项多中心、开放标签、随机对照、两阶段临床研究，旨在评估长效G-CSF药物艾贝格司亭α用于预防非霍奇金淋巴瘤患者接受类R-CHOP方案化疗后中性粒细胞减少的有效性和安全性。第一阶段入组22例患者，接受艾贝格司亭α一级预防，19例可评估，未观察到特殊关注事件，进入第二阶段。第二阶段按2:1随机将70例患者分为试验组和对照组，主要终点为第一周期≥3级中性粒细胞减少（ANC <1.0×10⁹/L）的发生率。试验组和对照组主要终点发生率分别为38.3% vs 73.91%（p=0.0051）；FN发生率分别为2.13% vs 17.39%（p=0.0372）；ANC最低值中位数分别为1.91×10⁹/L vs 0.38×10⁹/L；恢复至ANC≥2.0×10⁹/L的中位时间分别为2天 vs 4天。≥3级治疗相关不良事件发生率为8.51%。研究表明，艾贝格司亭α用于初治非霍奇金淋巴瘤患者类R-CHOP方案化疗后中性粒细胞减少的一级预防是有效且安全的。 ▲ 上下滑动查看更多 拓宽免疫调节应用边界，优化血液肿瘤全程管理 外周T细胞淋巴瘤（PTCL）是一组异质性、侵袭性强的非霍奇金淋巴瘤，预后较差，尤其在复发或难治性状态下。泊马度胺联合戈利昔替尼的JACKPOT25研究是本次该领域值得关注的临床研究之一，以壁报形式在大会发表。 壁报展示 泊马度胺联合戈利昔替尼治疗复发或难治性外周T细胞淋巴瘤的安全性和初步疗效（JACKPOT25）：一项多中心I/II期研究 PS2158-Safety and preliminary efficacy of golidocitinib combined with pomalidomide in relapsed or refractory peripheral T-cell lymphoma (JACKPOT25): a multicenter, phase I/II study 第一作者：中山大学肿瘤防治中心  孙鹏 通讯作者：中山大学肿瘤防治中心 李志铭 内容概要：本研究是一项正在进行的开放标签、多中心I/II期剂量递增与扩展研究（JACKPOT25），旨在评估JAK1抑制剂戈利昔替尼联合泊马度胺在复发/难治性外周T细胞淋巴瘤（r/r PTCL）患者中的安全性、耐受性、推荐2期剂量（RP2D）以及初步疗效。截至2026年2月2日，共入组14例患者，64.3%为III/IV期，中位既往治疗线数2线（28.6%≥3线）。9例可评估疗效，ORR为44.4%，疾病控制率55.6%，最长治疗超过9个月。13例可评估安全性，治疗相关不良事件（TRAE）发生率46.2%，≥3级TRAE为30.8%（主要为淋巴细胞减少23.1%、中性粒细胞减少15.4%），严重不良事件15.4%（包括重症肺炎）。研究表明，尽管基线预后差且经多线治疗，该联合方案安全性可控且显示初步抗肿瘤活性，RP2D确定为泊马度胺(3 mg)+戈利昔替尼(150 mg)。 ▲ 上下滑动查看更多 此外，正大天晴的5项泊马度胺的研究成果以摘要收录的形式在大会上发表，集中展示了其在新诊断多发性骨髓瘤、POEMS综合征、套细胞淋巴瘤、复发/难治性多发性骨髓瘤等多种血液肿瘤和复杂临床情境中的应用潜能。 摘要收录 关于泊马度胺作为NDMM患者维持治疗的有效性和安全性的真实世界研究 PB3236-A real-world study on the efficacy and safety of pomalidomide as maintenance therapy for patients with newly diagnosed multiple myeloma 第一作者：河南科技大学附属第一医院 赵雨情 通讯作者：河南科技大学附属第一医院  秦玲 内容概要：本研究旨在评估泊马度胺作为长期维持治疗在新诊断多发性骨髓瘤（NDMM）患者中的临床疗效和安全性。截至2025年12月31日，共入组73例NDMM患者，中位年龄59岁，中位随访16.4个月。主要终点为无进展生存期（PFS），次要终点包括总生存期（OS）和安全性。中位PFS和OS均未达到，2年PFS率为65.1%，2年OS率为98.6%（标危组2年PFS 率为69.0%，高危组2年PFS 率为60.9%）。泊马度胺维持4个周期后，深度缓解率（CR/sCR）从63.0%显著升至83.6%（p=0.0034），微小残留病（MRD）阴性率从47.9%升至56.2%（p=0.320）；末次随访时MRD阴性率进一步升至68.5%（p=0.012），深度缓解率65.8%。不良事件发生率39.7%，1例5级不良事件（手术相关脓毒症），无患者因药物相关不良事件停药。研究表明，泊马度胺维持治疗可显著提高NDMM患者的缓解深度，安全性良好，可能带来生存获益。 泊马度胺联合地塞米松治疗不适合自体造血干细胞移植的POEMS综合征的临床观察 PB-3315-Clinical observation of pomalidomide combined with dexamethasone in the treatment of poems syndrome unsuitable for autologous hematopoietic stem cell transplantation 第一作者：甘肃省人民医院  魏小芳 通讯作者：甘肃省人民医院 张启科 内容概要：本研究旨在探讨泊马度胺联合地塞米松方案（Pd方案）治疗不适合自体造血干细胞移植（auto-HSCT）的POEMS综合征患者的有效性和安全性。研究回顾性分析了2021年1月至2025年8月的9例患者。所有患者接受至少6个周期泊马度胺联合地塞米松治疗，中位随访26个月（8-50个月）。2年无进展生存（PFS）率和总生存（OS）率均为100%。血液学总缓解率77.8%（7/9），完全缓解率55.6%（5/9）。所有患者均达到神经功能缓解，中位总体神经病变严重程度评分（ONLS）从5分降至1分。血清血管内皮生长因子（VEGF）缓解率100%，77.8%的患者VEGF水平恢复正常。治疗方案耐受性良好，无治疗相关死亡，未出现3级或4级血液学及非血液学毒性。研究表明，泊马度胺联合地塞米松方案用于治疗不适合自体造血干细胞移植的POEMS综合征患者是安全且有效的。 MRD驱动的泊马度胺和奥布替尼联合泽贝妥单抗三药方案治疗新诊断中/高危套细胞淋巴瘤 PB3606-MRD-driven triplet therapy with orelabrutinib, pomalidomide, and zuberitamab for newly diagnosed intermediate/high-risk Mantle cell lymphoma 第一作者：北京大学第三医院血液科 杨萍 通讯作者：北京大学第三医院血液科 景红梅 内容概要：本研究（NCT07257510）初步评估了无化疗的POZ方案（泊马度胺+奥布替尼+泽贝妥单抗）在新诊断中/高危套细胞淋巴瘤（MCL）中的疗效和安全性，并探索基于诱导后MRD状态指导后续降阶梯治疗的可行性。截至2026年3月26日，共入组10例患者，进行6个周期POZ方案诱导治疗，诱导后达到MRD阴性者继续奥布替尼联合泽贝妥单抗维持治疗18个周期，MRD阳性者停止研究治疗。中位随访4.1个月，10例可评估疗效，ORR为100%（CR率90%）。无疾病进展或死亡报告。安全性可控，无因不良事件停药，仅1例延迟给药。最常见不良事件为1级皮疹（n=4）和瘙痒（n=1），其他包括2级肺部感染（1例）、3级白细胞减少（2例）、4级中性粒细胞减少（1例），未发生5级不良事件。研究表明，POZ方案在新诊断中/高危MCL（包括TP53突变等高危患者）中可显示出较高的早期缓解率，安全性良好，需继续随访以评估主要终点uMRD及缓解持久性。 泊马度胺联合艾沙妥昔单抗和地塞米松治疗中国复发/难治性多发性骨髓瘤患者：一项前瞻性真实世界研究的2年随访结果更新 PB3328-Updated results of isatuximab plus pomalidomide and dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: 2-year follow-up of a real-world prospective study 第一作者：上海交通大学医学院附属瑞金医院海南医院 游建华 通讯作者：上海交通大学医学院附属瑞金医院 赵维莅 内容概要：本研究为IsaFiRsT研究（ChiCTR2200062878）的2年随访分析，旨在提供泊马度胺联合艾沙妥昔单抗和地塞米松（Isa-Pd）方案在中国复发/难治性多发性骨髓瘤（RRMM）患者中的真实世界长期有效性和安全性证据。共入组24例患者，中位随访23.8个月。主要终点ORR为82.6%，60.9% 的患者达到完全缓解或更佳疗效；中位首次缓解时间1.18个月。中位PFS和缓解持续时间均未达到，12个月PFS率为82.6%，12个月OS率为87.0%。所有患者均发生≥1级治疗期间出现的不良事件（TEAE）和≥1次的3级及以上TEAE，91.7%发生严重TEAE。研究表明，Isa-Pd方案在中国多线治疗RRMM患者中可诱导深度快速且持续的缓解，真实世界长期安全性可接受。 埃普奈明联合基于泊马度胺的方案在复发/难治性多发性骨髓瘤中的疗效和安全性 PB3325-Efficacy and safety of aponermin combined with pomalidomide-based regimens in relapsed/refractory multiple myeloma 第一作者：中南大学湘雅三医院 李昕 通讯作者：首都医科大学附属北京朝阳医院 陈文明 内容概要：本研究是一项多中心回顾性研究，旨在评估埃普奈明（Apo）联合泊马度胺为基础的治疗方案在复发/难治性多发性骨髓瘤（RRMM）患者中的有效性和安全性。研究共纳入40例RRMM患者，疾病分期以晚期为主。32例可评估疗效患者中，主要终点ORR为56.3%，次要终点≥VGPR率为21.9%；完成≥4周期治疗患者的ORR升至70.0%。亚组分析显示，伴或不伴高危细胞遗传学异常（61.1% vs 50.0%）、伴或不伴髓外病变（45.5% vs 61.9%）、三类药物暴露与非暴露（55.6% vs 53.8%）患者的ORR均无显著差异，提示联合方案在各难治亚组中均能带来临床获益。最常见的治疗期间出现的不良事件为恶心（5%）、血小板减少（5%）、白细胞减少（5%）、淋巴细胞减少（5%），均可通过支持治疗控制。研究表明，该方案治疗RRMM患者具有较好的总缓解率，即使对于伴高危细胞遗传学异常、髓外病变或既往多线治疗失败的患者，亦能带来临床获益。 ▲ 上下滑动查看更多 声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● EAACI口头报告 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PALO ALTO, Calif., June 16, 2026 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing, and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced Dream Bowl I Meme Coin tokens (“Dream Bowl Tokens”) to list on Biconomy Exchange as early as June 23, 2026. Scilex believes that such listing may deliver liquidity and allow for broad distribution of such tokens for the Participating Holders (as defined below). Biconomy serves more than 10 million users and institutions across 180+ countries and consistently ranks among the top 40 global exchanges by trading volume, with average daily volume of approximately $2.0 billion. The platform offers hundreds of trading pairs and maintains industry-leading security, with 98% of assets held in cold storage. Participating Holders can also open digital wallets with Biconomy (www.biconomy.com). As previously announced, stockholders and certain other eligible equityholders of Scilex (collectively, the “Participating Holders”) as of record date of April 30, 2026 became entitled to receive five (5) Dream Bowl Tokens for each share of Scilex common stock held (or for each share of common stock issuable or deemed issuable upon exercise or conversion of such other eligible securities). The payment date for such distribution began on May 26, 2026, subject to the holder’s satisfaction of certain payment conditions previously disclosed by Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur Pharmaceuticals, Inc. (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur is headquartered in Palo Alto, California Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, including Scilex’s belief that the potential listing of the Dream Bowl Tokens on Biconomy Exchange may deliver liquidity to the holders thereof and allow broad distribution of such tokens. These statements are based on management’s current expectations and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. Scilex Bio™ is a trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2026 Scilex Holding Company All Rights Reserved.