A Single Center, Non-Randomized, Phase 1b Study of Orca-T Following Escalated Dose of Total Marrow and Lymphoid Irradiation in Patients With Acute Leukemias and MDS

This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Total marrow and lymphoid irradiation is a targeted form of total body irradiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Giving chemotherapy with medications such as thiotepa, fludarabine, and melphalan before a treatment with stem cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Orca-T cells take cells from a donor and remove some of the T cells and replace them with partially engineered T cells in order to induce better tolerance in patients. Giving total marrow and lymphoid irradiation and chemotherapy followed by Orca -T cells may be an effective treatment for patients with AML, ALL or MDS.

开始日期2024-05-24

申办/合作机构

City of Hope National Medical Center

[+1]

NCT05013437

/ Withdrawn早期临床1期IIT

A Pilot Study to Assess Impact of Low Dose Melphalan on Disease Burden Measured by Next Generation Sequencing Before Autologous Hematopoietic Cell Transplant (AHCT) for Multiple Myeloma Patients

The purpose of this study is to see if Multiple Myeloma (MM) cells are sensitive to the chemotherapy used in transplant or not. The main chemotherapy agent utilized in stem cell transplant is melphalan. The study will utilize 1/10 of the dose used in transplant to study sensitivity of the tumor to melphalan. Melphalan is approved by the U.S. Food and Drug Administration (FDA) for transplant for MM patients.

开始日期2023-09-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT05438394

/ Recruiting临床1期IIT

Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for Injection in the Treatment of Relapsed or Relapsed and Refractory Multiple Myeloma

This study is an investigator-initiated clinical study to evaluate the safety and tolerability of melphalan hydrochloride for injection in patients with relapsed or relapsed refractory multiple myeloma. Using the "3 + 3" dose escalation principle, 3-6 subjects per dose were enrolled, depending on the dose limiting toxicity (DLT) observed in the first cycle of chemotherapy for each subject. After completing the 21-day assessment of the first cycle of chemotherapy, if there was no DLT, the study started for the next dose group.

开始日期2022-10-13

申办/合作机构

北京大学人民医院

[+1]

100 项与盐酸美法仑相关的临床结果

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100 项与盐酸美法仑相关的转化医学

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100 项与盐酸美法仑相关的专利（医药）

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1,126

项与盐酸美法仑相关的文献（医药）

2024-12-31·ACS Omega

Quantum Chemical Studies of Bendamustine and Melphalan in Water as Antiblood Cancer Agents

Article

作者: Štofko, Juraj ; Boča, Roman ; Ladická, Miriam ; Rajnák, Cyril

A hybrid B3LYP version of the Density Functional Theory was applied in full geometry optimization followed by vibrational analysis of mustard-type molecules acting as antiblood cancer agents: melphalan and bendamustine. All calculations were performed with water as a solvent. In addition to the ground-state properties (dipole moment, quadrupole moment, dipole polarizability, solvated surface and volume, zero-point vibration energy, total entropic term), properties that characterize adiabatic redox processes (ionization energy, electron affinity, molecular electronegativity, chemical hardness, electrophilicity index) together with the absolute oxidation and reduction potentials were evaluated. Vibrational frequencies were also calculated, and frontier orbitals were displayed and analyzed. Bendamustine and melphalan in their canonical (amino acid, A) forms were found to have very low ionization energies E _i = 4.85 eV and consequently low (in absolute value) oxidation potentials E _ox ^o̷ = -4.92 V based on the reaction Gibbs energies; this indicates considerable antioxidant capacity. The zwitterionic (Z) form of melphalan is more stable in water as opposite the bendamustine, for which the Z-form is less stable in water: ΔG _Z-A = -2.7 and 2.9 kcal mol^-1, respectively. The cationic residues of bendamustine-hydrochloride (bendamustinium) and melphalan-hydrochloride (melphalanium) have properties essentially analogous to those of the canonical forms, except for a very large dipole moment for the Bd-Z, p = 29.7 debye. All calculations were refined with the ab initio post-Hartree-Fock method DLPNO-CCSD(T), which is a variant of the "gold standard coupled cluster theory" CCSD(T) that accounts for the major part of the correlation energy (DLPNO-CCSD(T)-Domain Localized Pair Natural Orbitals-Coupled Cluster Singles + Doubles + Triples method). It is confirmed that (i) the canonical form of bendamustine is more stable in water compared to the zwitterionic form by ΔG _Z-A = 4.8 kcal mol^-1; (ii) low ionization energy E _i = 5.10 eV causes low absolute oxidation potential E _ox* = -5.10 V and increased antioxidant capacity; and (iii) the redox properties of bendamustinium are analogous to the zwitterionic form of bendamustine and are significantly different from the canonical form of bendamustine. The energy profile of electron-proton coupled transfer shows that the SET-PT mechanism proceeds over lower barriers than the concurrent SPLET mechanism.

2024-06-01·Journal of NeuroInterventional Surgery

Efficacy of a prolonged stability melphalan formulation for intra-arterial treatment of retinoblastoma

Article

作者: Albuquerque, Felipe C ; Li, Amanda ; Abruzzo, Todd A ; Jubran, Jubran H ; Luong, Hanna ; Srinivasan, Visish M ; Feldman, Michael J ; Scherschinski, Lea ; Naik, Anant ; Ramasubramanian, Aparna

BackgroundMelphalan, which is poorly soluble at room temperature, is widely used for the treatment of retinoblastoma by selective ophthalmic artery infusion. Evomela, a propylene glycol-free formulation of melphalan with improved solubility and stability, has recently been used as an alternative.To compare the safety and efficacy of Evomela with standard-formulation melphalan (SFM) in the treatment of retinoblastoma by selective ophthalmic artery infusion.MethodsWe performed a retrospective case–control study of patients with retinoblastoma undergoing selective ophthalmic artery infusion with SFM or Evomela at a single institution. Cycle-specific percent tumor regression (CSPTR) was estimated by comparing photos obtained during pretreatment examination under anesthesia (EUA) with those obtained during post-treatment EUA 3–4 weeks later. CSPTR, ocular salvage rates, complication rates, operation times (unadjusted and adjusted for difficulty of ophthalmic artery catheterization), and intraprocedural dose expiration rates were compared between Evomela- and SFM-treated groups. Univariate and multivariate analyses were performed.ResultsNinety-seven operations (melphalan: 45; Evomela: 52) for 23 patients with 27 retinoblastomas were studied. The ocular salvage rate was 79% in the SFM-treated group and 69% in the Evomela-treated group. Multivariate regression controlling for tumor grade, patient age, and treatment history revealed no significant differences in ocular salvage rate, CSPTR, complication rates, or operation times. Although the dose expiration rate was higher for the SFM-treated group, the difference was not statistically significant. Notably, there were no ocular or cerebral ischemic complications.ConclusionEvomela has non-inferior safety and efficacy relative to SFM when used for the treatment of retinoblastoma by selective ophthalmic artery infusion.

2024-05-01·Ophthalmology and Therapy

Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment

Article

作者: González-García, María J ; Blanco-Vázquez, Marta ; Pinto-Fraga, José ; Calonge, Margarita ; Valencia-Nieto, Laura ; Fernández, Itziar ; García-Vázquez, Carmen ; Enríquez-de-Salamanca, Amalia ; López-Miguel, Alberto

INTRODUCTIONTo evaluate the short-term efficacy of cyclosporine A (CsA)-0.1% cationic emulsion (CE) in patients with dry eye disease (DED) and mitigation of the inflammatory flares triggered by desiccating stress environments.METHODSA single-center non-randomized clinical trial was performed at a tertiary care setting. Twenty patients with DED treated with CsA 0.1% CE were exposed to a normal controlled environment (NCE) (23 °C, 50% relative humidity) and an adverse controlled environment (ACE) (23 °C, 10% relative humidity, 0.43 m/s localized airflow) during baseline and the 1- and 3-month visits. Patients underwent the following evaluations: conjunctival hyperemia and staining, corneal fluorescein staining (CFS) using the Oxford and Cornea and Contact Lens Research Unit (CCLRU) scale, meibomian gland (MG) secretion quality, Dry Eye Questionnaire-5, Symptom Assessment in Dry Eye (SANDE II), and Change in Dry Eye Symptoms Questionnaire. Multivariate models were adjusted for statistical analysis.RESULTSNineteen women and one man (mean age, 58.9 ± 12.3 years) completed the study. All symptom questionnaires, CFS, conjunctival hyperemia and staining, and MG secretion quality improved (p ≤ 0.003) with 1 month of treatment; improvements were maintained after 3 months (p ≤ 0.02), except for SANDE II (p ≥ 0.07). The CFS worsening (total CCLRU) after baseline ACE exposure (from 8.6 to 10.1) was higher, although not significant (p = 0.64), compared with 1 month (from 5.4 to 5.8) and 3 months (from 5.0 to 5.9) after treatment.CONCLUSIONTopical CsA-0.1% CE improved DED signs and symptoms after 1 month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments.TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT04492878.

162

项与盐酸美法仑相关的新闻（医药）

2025-01-13

·Business Wire

Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2024 Financial Results

QUEENSBURY, N.Y.--( BUSINESS WIRE )--Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced preliminary financial results for the fourth quarter and year-ended December 31, 2024. Preliminary Fourth Quarter and Full-Year 2024 Financial Results (unaudited) Total fourth quarter and full year revenue expected to be approximately $15.1 million and $37.2 million, respectively HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $13.7 million and $32.3 million, respectively CHEMOSAT ® fourth quarter and full year revenue expected to be approximately $1.4 million and $4.9 million, respectively Gross margins expected to be in the 80%-85% range As of December 31, 2024, the Company had approximately $53.2 million of cash, cash equivalents and short-term investments and no debt Final financial results for the fourth quarter and full year 2024 and a detailed business update will be provided during Delcath’s annual financial results release and investor call scheduled for March 6, 2025. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT ® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information , including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Preliminary and Unaudited Nature of Reported Results The Company has not yet completed its financial close process for the fourth quarter and full year 2024 and, as a result, actual results may vary from the estimated preliminary results set forth in this press release due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full interim or annual audited financial statements. Safe Harbor / Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: changes to the estimated preliminary results set forth in this press release as a result of audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized; the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

上市批准财报

2025-01-06

·Insight数据库

10 家制药公司完成新一轮融资

Insight 投融资数据库显示，上周全球制药领域发生 10 起投融资事件（截至 1 月 5 日）。从药物类型来看，备受资本看好的领域有癌症疫苗、基因编辑疗法、ADC、双抗等。从地区分布来看，上周获得融资的 Biotech 主要来自中国，占比达到 70%，包括橙帆医药、普祺医药、瑞风生物等在内的多家公司获得了新一轮融资。下面，Insight 数据库将节选部分备受关注的融资案例做介绍，仅供读者参阅。中国新锐融资橙帆医药完成近 5000 万美元 Pre-A 轮融资橙帆医药宣布完成近 5000 万美元 Pre-A 轮融资。本轮由瑞伏医疗和上海生物医药基金领投，其它投资人还有弘晖基金、Everjoy Fortune、万物创投等。本次融资将用于橙帆医药创新药物管线推进，加速核心研发项目进入临床阶段。橙帆医药成立于 2021 年，专注于发现与开发多特异性抗体和抗体偶联药物（ADC）。目前，该公司已在肿瘤和自身免疫疾病等领域建立研发管线，涵盖十余个多特异性抗体和 ADC 分子，其核心研发管线预计将于 2025 年在美国和中国进入临床阶段。普祺医药完成超 3 亿元融资普祺医药宣布完成超 3 亿元 B 轮系列融资，投资人包括北京市医药健康产业投资基金、亦庄国投、首发展集团等。本轮融资将用于 JAK1/2 抑制剂 PG-011 治疗特应性皮炎的 Ⅲ 期临床及 NDA 申报，拓展该药在其它适应症的应用，以及推进其他创新管线的临床等。普祺医药成立于 2016 年，聚焦免疫/炎症性疾病的创新药研发。该公司的产品管线以皮肤科为主，其中核心产品 PG-011 已进入后期临床，另有多个产品处于临床前研发阶段。本轮融资完成后，该公司拟准备在北交所进行 IPO 申报。普祺医药融资历程截图来源：Insight 数据库高光制药完成 1.5 亿元 Pre-C 轮融资高光制药宣布完成由华金资本、康君资本、英飞尼迪资本共同认购的 1.5 亿元 Pre-C 轮融资。本轮融资将用于该公司后期管线的临床开发和早期管线的推进。高光制药致力于研发治疗危及人类生命或健康的重大疾病、亟待解决临床医疗需求的突破性创新药。其中，治疗自身免疫疾病和炎症的小分子药物已进入 Ⅲ 期注册临床。此外，该公司还有多个针对神经炎症/中枢神经系统疾病的早期管线产品。2023 年，该公司的 TYK2/JAK1 双抑制剂 TLL041 已以近 10 亿美元将海外权益授权给了 Biohaven 公司。高光制药研发管线截图来源：Insight 数据库瑞风生物完成数亿元融资瑞风生物宣布获得由广州产投领投的数亿元新一轮融资，其他投资人还有广州金控、科金控股、港粤资本等。本轮融资主要用于推动该公司基因编辑药物的临床试验、后续研发管线扩展及核心技术创新。瑞风生物成立于 2019 年，致力于为全球患者提供治愈性药物。其先导产品 β-地中海贫血项目 RM-001 早期试验疗效显著，确证性临床试验有望于近期开展；α-地中海贫血项目 RM-004 已成功治愈首位患者；视网膜疾病 Usher 综合征药物 RM-101 也在中美获批开展临床。迈科康完成 2 亿元融资迈科康生物宣布获得由深创投认购的 2 亿元可转债融资。本轮融资将主要用于支持其创新佐剂平台的持续研发，创新佐剂车间新产能落地，以及支持多款在研产品的临床开发，包括重组带状疱疹疫苗和重组呼吸道合胞病毒疫苗等。迈科康专注于创新疫苗和新型佐剂的研发、生产和商业化，目前已形成从佐剂原材料研发、生产到佐剂配方开发与应用的垂直化产业链。针对传染性、过敏性疾病及肿瘤领域，该公司布局了多样化的产品研发管线，包括多个预防性疫苗和治疗性疫苗，目前已有 3 项进入临床阶段。海外新锐融资 Delcath Systems 获得 1630 万美元融资 Delcath Systems 宣布获得 1630 万美元融资。该公司将继续推动 HEPZATO KIT 治疗葡萄膜黑色素瘤患者的商业化进程，并投资于新的临床试验。 Delcath Systems 专注于原发性和转移性肝癌治疗。其产品 HEPZATO KIT 是一种组合药物和器械产品，旨在向肝脏施用高剂量化疗，同时控制经皮肝脏灌注过程中的全身暴露和相关副作用。该产品已在美国被批准用于治疗转移性葡萄膜黑色素瘤的成人患者。 OS Therapies 完成 600 万美元融资 OS Therapies 宣布完成约 600 万美元的私募融资。本轮融资将用于支持该公司主要候选药物 OST-HER2（治疗复发性、切除性转移性骨肉瘤患者）在美国的商业化。 OS Therapes 专注于骨肉瘤和其他实体瘤疗法的开发和商业化。其中，OST-HER2 是一种免疫治疗性疫苗，利用李斯特菌的免疫刺激作用来启动针对 HER2 蛋白的强免疫应答。美国 FDA 已授予该产品罕见儿科疾病资格认定（RPDD）、快速通道资格和孤儿药资格。 Innocan Pharma 完成 63.54 万加元融资 Innocan Pharma 宣布完成非经纪私募发行融资，总收益约为 63.54 万加元。该公司打算将本次发行所得用于公司运营，包括进一步推进其创新脂质体大麻二酚平台 (LPT-CBD) 的开发。 Innocan 开发的 LPT-CBD 平台具有精确剂量，可延长和控制合成 CBD 的释放，用于非阿片类药物疼痛管理。该公司还在健康领域开发和销售一系列高性能的自我护理和美容产品，以促进更健康的生活方式。除了上述案例，上周还有一些其它公司也获得了融资，限于篇幅，此处不再一一介绍。欲了解上周更多融资信息，请点击「阅读原文」前往 Insight 数据库「新药投融资」模块查看。封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期IPO疫苗基因疗法抗体药物偶联物

2025-01-06

·access wire

CASI Announces First Patient Dosed in Phase 1/2 Clinical Trial of CID-103 in Immune Thrombocytopenia

BEIJING, CHINA / ACCESSWIRE / January 6, 2025 / CASI Pharmaceuticals, Inc. (Nasdaq:CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China.\"Dosing the first patient in our phase 1/2 study marks a significant milestone for both CID-103 program and chronic ITP patients who have limited treatment options,\" said Dr. Wei-Wu He, Chairman and CEO of CASI, \"The rapid execution underscores our commitment to accelerating clinical development. This phase 1/2 study is designed to deliver important safety and dose-response data, providing valuable insights to guide the future development of CID-103 for additional autoimmune indications with significant unmet medical needs.\"CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.About CASI PharmaceuticalsCASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its focus on hematology oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease, as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company\'s China-based regulatory and commercial competencies and its global drug development expertise. The Company\'s operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.CASI Forward-Looking StatementsThis announcement contains forward-looking statements. These statements are made under the \"safe harbor\" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as \"will,\" \"expects,\" \"anticipates,\" \"future,\" \"intends,\" \"plans,\" \"believes,\" \"estimates,\" \"confident\" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company\'s strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the \"SEC\"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company\'s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: uncertainties related to the non-binding proposal to acquire the Company\'s certain business operations in China; the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; the risk related to the Company\'s ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company\'s filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. We caution readers not to place undue reliance on any forward-looking statements contained herein.EVOMELA® is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN® is proprietary to Acrotech Biopharma Inc and its affiliates. Please refer to the Company\'s earlier SEC filing with respect to Evomela® for further information.Contact InformationRui Zhang [email protected]240.864.2643SOURCE: CASI PharmaceuticalsRelated Documents:

免疫疗法临床研究

100 项与盐酸美法仑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08173	盐酸美法仑	L01AA03	DB01042

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性淋巴细胞白血病	冰岛	Adienne SRL	2020-11-16
急性淋巴细胞白血病	列支敦士登	Adienne SRL	2020-11-16
急性淋巴细胞白血病	挪威	Adienne SRL	2020-11-16
急性淋巴细胞白血病	欧盟	Adienne SRL	2020-11-16
霍奇金淋巴瘤	欧盟	Adienne SRL	2020-11-16
霍奇金淋巴瘤	挪威	Adienne SRL	2020-11-16
霍奇金淋巴瘤	列支敦士登	Adienne SRL	2020-11-16
霍奇金淋巴瘤	冰岛	Adienne SRL	2020-11-16
神经母细胞瘤	挪威	Adienne SRL	2020-11-16
神经母细胞瘤	欧盟	Adienne SRL	2020-11-16
神经母细胞瘤	列支敦士登	Adienne SRL	2020-11-16
神经母细胞瘤	冰岛	Adienne SRL	2020-11-16
非霍奇金淋巴瘤	挪威	Adienne SRL	2020-11-16
非霍奇金淋巴瘤	列支敦士登	Adienne SRL	2020-11-16
非霍奇金淋巴瘤	欧盟	Adienne SRL	2020-11-16
卵巢癌	列支敦士登	Adienne SRL	2020-11-16
卵巢癌	冰岛	Adienne SRL	2020-11-16
卵巢癌	挪威	Adienne SRL	2020-11-16
卵巢癌	欧盟	Adienne SRL	2020-11-16
多发性骨髓瘤	加拿大	-	1963-09-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
眼部黑色素瘤	申请上市	美国	Delcath Systems, Inc.	2023-03-27
免疫球蛋白轻链淀粉样变性	临床3期	美国	Spectrum Pharmaceuticals, Inc.	2018-01-08
系统性淀粉样变性	临床3期	美国	Spectrum Pharmaceuticals, Inc.	2018-01-08
难治性多发性骨髓瘤	临床1期	中国	CASI Pharmaceuticals, Inc.	2022-10-13
转移性结直肠癌	临床申请批准	美国	Delcath Systems, Inc.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2024	N/A	急性淋巴细胞白血病 \| 肿瘤	-	Inotuzumab ozogamicin	選鹽顧製製觸網糧襯遞(選齋觸積憲鹹糧鏇齋鑰) = Two patients experienced a relapse: 1 with initial primary induction failure withTP53mutation and 1 withKMT2Amutation who had extramedullary sarcoma at relapse after HCT 齋齋齋網築顧積淵製夢 (構遞艱齋積範積憲鹹鬱 ) 更多	-	2024-12-07
				Melphalan
BusinessWire 人工标引	N/A	葡萄膜黑色素瘤二线 \| 一线	30	HEPZATO KIT as first-line therapy	(選願鹽鹹夢鹽餘鏇願構) = 淵齋鑰繭願構鹽顧鬱膚醖憲夢網構膚蓋壓餘壓 (顧艱鹽觸廠糧範夢齋築 ) 更多	积极	2024-08-27
				HEPZATO KIT as second-line therapy	(選願鹽鹹夢鹽餘鏇願構) = 淵簾壓壓選糧襯鬱膚鏇醖憲夢網構膚蓋壓餘壓 (顧艱鹽觸廠糧範夢齋築 ) 更多
NCT03417284 (EHA 12024 \| EHA 22024) 人工标引	临床1/2期	多发性骨髓瘤一线	60	EVOMELA (short infusion)	(餘網顧積獵窪衊鹹壓鹹) = 鏇憲構遞鑰醖鑰顧顧願範鹹構蓋簾鑰遞鑰願廠 (積艱艱積鹹窪鏇襯膚鬱 ) 更多	积极	2024-05-14
				EVOMELA (extend infusion)	(餘網顧積獵窪衊鹹壓鹹) = 網鬱夢窪齋鏇鏇襯憲艱範鹹構蓋簾鑰遞鑰願廠 (積艱艱積鹹窪鏇襯膚鬱 ) 更多
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	多发性骨髓瘤一线	60	Evomela (Short Infusion (S-IV))	(網蓋夢鬱鹹蓋觸選顧糧) = 繭遞淵鑰壓選獵觸鏇衊製齋構積廠夢築願遞壓 (鹽鑰憲顧夢襯艱壓窪觸 ) 更多	积极	2024-02-01
				Evomela (Long Infusion (L-IV))	(網蓋夢鬱鹹蓋觸選顧糧) = 築窪鬱淵鹹製夢壓鹽糧製齋構積廠夢築願遞壓 (鹽鑰憲顧夢襯艱壓窪觸 ) 更多
ASH2023	临床1/2期	多发性骨髓瘤	60	Evomela (Short infusion)	(糧鏇繭壓廠襯獵構鹽醖): HR = 9.5 (95% CI, 1 ~ 91.2), P-Value = 0.022	-	2023-12-11
				Evomela (Extended infusion)
FDA 人工标引	N/A	多发性骨髓瘤	295	Melphalan hydrochloride (Oral)	(膚鹽鏇衊鹹範膚鏇廠艱) = 鬱顧齋襯膚糧觸鑰網淵觸願糧構範網糧窪廠蓋 (淵願鏇構淵夢窪繭鑰艱 ) 更多	积极	2023-08-18
				Melphalan hydrochloride + Melphalan hydrochloride	(膚鹽鏇衊鹹範膚鏇廠艱) = 範鬱選鏇獵鬱糧繭鹹獵觸願糧構範網糧窪廠蓋 (淵願鏇構淵夢窪繭鑰艱 ) 更多
NCT03128359 (CTgov)	临床2期	复发性浆细胞骨髓瘤 \| 霍奇金淋巴瘤 \| 慢性淋巴细胞白血病 \| 弥漫性大B细胞淋巴瘤 \| 急性白血病 \| 伴有骨髓发育不良相关变化的急性髓系白血病 \| 移植物抗宿主病 \| 套细胞淋巴瘤 \| 继发性骨髓增生异常综合征 \| 滤泡性淋巴瘤 \| 费城染色体阳性慢性粒细胞白血病 \| 难治性多发性骨髓瘤 \| 边缘区B细胞淋巴瘤	38	Peripheral Blood Stem Cell Transplantation+Fludarabine Phosphate+cyclophosphamide+Tacrolimus+Mycophenolate Mofetil+Melphalan Hydrochloride (Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis))	製淵觸鬱膚壓廠襯艱鹹(鏇鹹鑰構鑰餘網衊醖網) = 淵製蓋鹹獵壓壓鬱遞製鏇窪繭餘鹹簾廠蓋衊糧 (顧鹽醖鹹願選艱糧積壓, 壓願範構廠鹽鬱網醖獵 ~ 餘憲廠獵壓醖衊廠鑰齋) 更多	-	2023-06-09
				Peripheral Blood Stem Cell Transplantation+Fludarabine Phosphate+cyclophosphamide+Tacrolimus+Mycophenolate Mofetil (Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis))	製淵觸鬱膚壓廠襯艱鹹(鏇鹹鑰構鑰餘網衊醖網) = 鹽顧築網獵窪鏇艱醖製鏇窪繭餘鹹簾廠蓋衊糧 (顧鹽醖鹹願選艱糧積壓, 範獵顧醖蓋積壓製鏇簾 ~ 顧築窪鏇齋選築網淵鑰) 更多
NCT02994784 (CTgov)	临床2期	免疫球蛋白轻链淀粉样变性 \| 系统性淀粉样变性	27	Propylene Glycol-Free Melphalan Hydrochloride	鹽餘鹽壓窪構窪窪網鹹(繭廠簾淵餘艱廠鏇艱淵) = 窪窪網簾觸鹹夢範遞鑰壓鑰鏇蓋憲衊鑰選網鑰 (顧鏇範觸鏇鏇膚糧願製, 鑰遞齋淵窪構鏇顧顧製 ~ 醖積積壓糧鹽鏇壓構選) 更多	-	2023-05-24
P125 (EBMT2021)	N/A	巩固	59	High-dose melphalan	(願醖製廠鏇願夢鏇窪觸) = 廠膚廠夢簾願鏇選齋觸壓廠範構壓餘顧壓鹹蓋 (壓選蓋襯襯網糧網鹽醖, 59 ~ 112) 更多	积极	2021-03-14
Tandem Meetings ASTCT and CIBMTR2021	N/A	造血干细胞移植	-	Alkeran	(顧齋網壓艱蓋鏇遞製淵) = 觸鑰廠鹹獵廠醖憲憲構蓋獵網構願構顧醖鹽淵 (鏇憲憲鏇壓襯蓋憲壓鹽, 85.2 ~ 97.6) 更多	-	2021-03-01
				Evomela	(顧齋網壓艱蓋鏇遞製淵) = 鑰壓範製壓鹹簾獵範襯蓋獵網構願構顧醖鹽淵 (鏇憲憲鏇壓襯蓋憲壓鹽, 86.7 ~ 100) 更多