A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

开始日期2014-11-01

申办/合作机构

Sumitomo Pharma Co., Ltd.

[+1]

100 项与 Boston Biomedical, Inc. 相关的临床结果

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0 项与 Boston Biomedical, Inc. 相关的专利（医药）

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项与 Boston Biomedical, Inc. 相关的文献（医药）

2019-12-01·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

Bioactivation of Napabucasin Triggers Reactive Oxygen Species–Mediated Cancer Cell Death

1区 · 医学

Article

作者: Park, Youngkyu ; Deschênes, Astrid ; Alagesan, Priya ; Watson, James D. ; Chang, An-Yun ; Rogoff, Harry A. ; Li, Juying ; Froeling, Fieke E.M. ; Yao, Melissa A. ; Belleau, Pascal ; Tuveson, David A. ; Swamynathan, Manojit Mosur ; Lucito, Matthew ; Trotman, Lloyd C. ; Chio, Iok In Christine ; Brosnan, Erin

Abstract:

Purpose::

Napabucasin (2-acetylfuro-1,4-naphthoquinone or BBI-608) is a small molecule currently being clinically evaluated in various cancer types. It has mostly been recognized for its ability to inhibit STAT3 signaling. However, based on its chemical structure, we hypothesized that napabucasin is a substrate for intracellular oxidoreductases and therefore may exert its anticancer effect through redox cycling, resulting in reactive oxygen species (ROS) production and cell death.

Experimental Design::

Binding of napabucasin to NAD(P)H:quinone oxidoreductase-1 (NQO1), and other oxidoreductases, was measured. Pancreatic cancer cell lines were treated with napabucasin, and cell survival, ROS generation, DNA damage, transcriptomic changes, and alterations in STAT3 activation were assayed in vitro and in vivo. Genetic knockout or pharmacologic inhibition with dicoumarol was used to evaluate the dependency on NQO1.

Results::

Napabucasin was found to bind with high affinity to NQO1 and to a lesser degree to cytochrome P450 oxidoreductase (POR). Treatment resulted in marked induction of ROS and DNA damage with an NQO1- and ROS-dependent decrease in STAT3 phosphorylation. Differential cytotoxic effects were observed, where NQO1-expressing cells generating cytotoxic levels of ROS at low napabucasin concentrations were more sensitive. Cells with low or no baseline NQO1 expression also produced ROS in response to napabucasin, albeit to a lesser extent, through the one-electron reductase POR.

Conclusions::

Napabucasin is bioactivated by NQO1, and to a lesser degree by POR, resulting in futile redox cycling and ROS generation. The increased ROS levels result in DNA damage and multiple intracellular changes, one of which is a reduction in STAT3 phosphorylation.

2019-07-01·Molecular cancer research : MCR2区 · 医学

Evaluation of Tumor Cell–Tumor Microenvironment Component Interactions as Potential Predictors of Patient Response to Napabucasin

2区 · 医学

Article

作者: Iguchi, Haruhisa ; Hsu, Eric ; Patel, Jaimin ; Chang, An-Yun ; Zhang, Minjie ; Rogoff, Harry A. ; Li, Yiqun

Abstract:

Napabucasin is an NAD(P)H:quinone oxidoreductase 1 (NQO1)-bioactivatable small molecule hypothesized to affect multiple oncogenic pathways. In a prespecified, retrospective analysis of the napabucasin phase III CO.23 study, overall survival was longer for napabucasin versus placebo in patients expressing phosphorylated STAT3 (pSTAT3) in tumor cells and cells of the tumor microenvironment (TME). We hypothesized that a connection may exist between NQO1 expression in cancer cells and pSTAT3 in tumor cells and the TME. In 3D spheroid cocultures of cancer cells and cancer-associated fibroblasts, the antitumor activity of napabucasin was NQO1 dependent. The levels of cytokines such as IL6, CXCL10, and GM-CSF were higher in NQO1-positive versus NQO1-deleted cocultures. These differentially secreted cytokines promoted STAT3 phosphorylation in tumor cells and the TME. NQO1-expressing, napabucasin-sensitive tumor cells can modify tumor cells and the TME to promote STAT3 phosphorylation, suggesting that pSTAT3 may be used to identify a subpopulation of patients who would likely respond to napabucasin.

Implications::

pSTAT3 is a potential biomarker for patient response to the anticancer drug napabucasin.Visual Overview: http://mcr.aacrjournals.org/content/molcanres/17/7/1429/F1.large.jpg.

2018-01-01·PDA journal of pharmaceutical science and technology

Data Integrity: History, Issues, and Remediation of Issues

Review

作者: Rattan, Anil K

Data integrity is critical to regulatory compliance, and the fundamental reason for 21 CFR Part 11 published by the U.S. Food and Drug Administration (FDA). FDA published the first guideline in 1963, and since then FDA and European Union (EU) have published numerous guidelines on various topics related to data integrity for the pharmaceutical industry. Regulators wanted to make certain that industry capture accurate data during the drug development lifecycle and through commercialization-consider the number of warning letters issued lately by inspectors across the globe on data integrity. This article discusses the history of regulations put forward by various regulatory bodies, the term ALCOA Plus adopted by regulators, the impact of not following regulations, and some prevention methods by using some simple checklists, self-audit, and self-inspection techniques. FDA uses the acronym ALCOA to define its expectations of electronic data. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. ALCOA was further expanded to ALCOA Plus, and the Plus means Enduring, Available and Accessible, Complete, Consistent, Credible, and Corroborated. If we do not follow the regulations as written, then there is a huge risk. This article covers some of the risk aspects. To prevent data integrity, various solutions can be implemented such as a simple checklist for various systems, self-audit, and self-inspections. To do that we have to develop strategy, people, implement better business processes, and gain a better understanding of data lifecycle as well as technology.LAY ABSTRACT: If one does a Google search on "What is data integrity?" the first page will give the definition of data integrity, how to learn more about data integrity, the history of data integrity, risk management of data integrity, and at the top about various U.S. Food and Drug Administration (FDA) and European Union (EU) regulations. Data integrity is nothing but about accuracy of data. When someone searches Google for some words, we expect accurate results that we can rely on. The same principle applies during the drug development lifecycle. Pharmaceutical industry ensures that data entered for various steps of drug development is accurate so that we can have confidence that the drugs produced by the industry are within some parameters. The regulations put forward by FDA and EU are not new. The first regulation was published in 1963, and after that regulators published multiple guidelines. Inspectors from both regulatory bodies inspected the industry, and they found that the data was not accurate. If pharmaceutical industry produces drugs within the stated parameters, then it is approved and available in the market for patients. If inspectors find that the data is modified, then the drug is not approved. That means revenue loss for industry and drugs not available for patients. In this article, I explain some of the remediation plans for the industry that can be applied during the drug development lifecycle pathway.

项与 Boston Biomedical, Inc. 相关的新闻（医药）

2024-04-08

·BioSpace

IBEX Completes Sale of the Company

MONTRÉAL, April 08, 2024 (GLOBE NEWSWIRE) -- IBEX Technologies Inc. (“IBEX” or the “Company”) (TSX Venture: IBT) announces that it has completed the sale of the company by amalgamating with 15720273 Canada Inc., a newly-incorporated wholly-owned subsidiary of BBI Solutions OEM Limited (“BBI”). In the amalgamation, BBI acquired all of the issued and outstanding shares of IBEX at a price of $1.45 per share in cash. The total consideration for the sale of IBEX was approximately $37.9 million. As previously announced, the amalgamation was approved by IBEX shareholders at an annual and special meeting held on April 3, 2024 with a positive vote of approximately 99.83% of the shares voted. In connection with the sale, IBEX has applied for delisting from the TSX Venture Exchange, which is expected to occur on or about Thursday, April 11, 2024. Trading in IBEX’s shares on the TSX Venture Exchange has been halted and will remain halted until delisting. IBEX will also apply to the provincial securities commissions for revocation of its status as a “reporting issuer”. ABOUT IBEX IBEX manufactures and markets proteins for biomedical use through its wholly-owned subsidiary IBEX Pharmaceuticals Inc. (Montréal, QC). For more information, please visit the Company’s website at . ABOUT BBI BBI is an international provider of immunoassay products and services to the global diagnostics and life sciences industries. The company offers high-performance recombinant and native reagents across the entire immunodiagnostic workflow, including antigens, antibodies, enzymes and complementary reagents. It also offers a one-stop service for lateral flow assay development and lateral flow point of care manufacturing. Our core purpose is serving the science of diagnostics and in doing so we supply the majority of the main IVD players globally. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Safe Harbor Statement All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, as they are based on the current assessment or expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which IBEX does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. IBEX disclaims any intention or obligation to update these statements, except if required by applicable laws. Contact: Paul Baehr Chairman, President & CEO IBEX Technologies Inc. 514-344-4004 x 143

并购

2024-04-01

·药融圈

日本TOP药企：住友制药的成功之道，与转折破局中

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。不断开拓新产品，体系内研发与外延合作并购，加深护城河，才是创新药企长久之道。从药融云数据库获悉，日本住友制药的支柱产品抗精神分裂症药品Latuda的在美独家销售权终止（美国化合物专利2024年2月到期），而这势必会造成公司销售额大幅下滑。早在2019年底，住友制药就与英国Roivant Science制药公司达成协议，向Roivant总公司出资30亿美元，获得Roivant一定比例的股份以及收购旗下几家子公司的选择权。此次合作住友制药不仅可以获得子宫肌瘤治疗药Relugolix，以及泌尿系统疾病治疗药Bevegron的全球销售权，还从Roivant公司获得其在制药及健康管理相关领域的平台和技术支持。2020年底，FDA批准Relugolix用于治疗前列腺癌（商品名Orgovyx），2022年度该产品销售额达到1.82亿美元，成为公司在北美的主要畅销药物之一，而这一未雨绸缪的做法无疑缓解了公司的“专利到期焦虑”。住友制药是有400年商业历史的住友集团的一员，在2005年由大日本制药株式会社和日本住友制药株式会社合并，主要通过医疗药品、再生医学/细胞疗法和非医疗解决方案来为人类生活做出贡献，重点关注精神病学和神经病学、肿瘤学领域。而合并的两个公司历史可追溯到一百多年前。1897年，21位制药行业的杰出领导者在大阪道商町创立了Osaka Pharmaceuticals，第二年在大阪惠边市设立制药工厂，收购了东京的公私合营公司大日本制药株式会社，并将公司名称变更为大日本制药株式会社。日本住友制药株式会社成立于1984年，由住友化学株式会社（成立于1913年）制药业务的研究、开发和制造部门以及住友化学株式会社药品的独家经销商稻畑产业株式会社的药品销售部门组成。住友制药自合并后就接连收购了美国的Sepracor、Boston Biomedical、Elevation Pharmaceuticals和Tolero Pharmaceuticals等公司，并在海外成立子公司。20世纪90年代，公司逐步在中国开展事业，2005年底，住友制药（苏州）有限公司在苏州成立，中国也成为住友集团在除日本和北美外的全球第三大重要市场。此前住友制药在中国有近800名员工，2021年的销售额约20亿人民币。PART1主要产品住友制药的优先研究领域是精神病学、神经病学和肿瘤学，同时，还致力于通过再生医学/细胞疗法和非医疗解决方案为改善医疗保健和人类生活作出贡献。以下是公司各领域的主要上市产品：分地区来看，在日本，除了精神病学和神经病学领域，还重点关注糖尿病和罕见疾病领域，上年度畅销产品有TRERIEF（zonisamide，唑尼沙胺）、LATUDA（lurasidone，鲁拉西酮）和TWYMEEG（imeglimin）；北美地区的畅销产品有ORGOVYX（relugolix）、MYFEMBREE（relugolix + 雌二醇 + norethindrone acetate）和GEMTESA（vibegron）；在中国地区专注于传染病，以及精神病学和神经病学领域，主要畅销产品有MEROPEN（美罗培南）。图：各地区畅销药物PART2研发管线（图片信息截至2023年10月31日）1、精神病和神经病学（1）小分子Ulotaront（SEP-363856）是一种 TAAR1（痕量胺相关受体1）激动剂，具有5-羟色胺（血清素）5-HT1A激动剂活性，不与多巴胺D2或5-羟色胺5-HT2A受体结合。前Sunovion公司（2009年收购的美国制药商，现为住友制药子公司）与Psychogenics公司合作，利用其体内表型分析平台SmartCube和相关AI算法发现。目前针对精神分裂症的研究在美国进行到临床试验3期，在日本和中国进行到临床试验2/3期；在美国针对aMDD（辅助性重性抑郁障碍）的研究处于临床试验2/3期；在美国和日本针对GAD（广泛性焦虑障碍）的研究进行到临床试验2/3期；在美国针对帕金森病精神病的研究进行到临床试验2期。Ulotaront于2019年5月被FDA授予治疗精神分裂症的突破性疗法称号，是第一个也是唯一一个进入精神分裂症患者临床试验3期研究的TAAR1激动剂，也是第一个进入GAD的临床试验2/3期研究的TAAR1激动剂，并作为MDD的辅助治疗。2023年7月，住友制药与大冢制药宣布了临床试验3期的DIAMOND 1和DIAMOND 2研究的顶线结果，在患有精神分裂症的剂型精神病成人患者中，每日一次给药未达到其主要终点，在两项研究中，都观察到了较大的安慰剂效应，这可能掩盖了该分子的治疗效果，总体来说该药物是安全的，耐受性良好。药融云数据库：药物基本信息EPI-589有望通过消除线粒体功能降低过度产生的氧化应激而显示出功效，它有望被开发用于由氧化还原应激引起的神经退行性适应症。在美国地区针对帕金森病的研究进行到临床试验2期；针对肌萎缩侧索硬化症（ALS）的研究在美国和日本均进行到临床试验2期（在日本的研究由德岛大学主导）。注：氧化应激(OS) 是指体内氧化与抗氧化作用失衡的一种状态，倾向于氧化，导致中性粒细胞炎性浸润，蛋白酶分泌增加，产生大量氧化中间产物。氧化应激是由自由基在体内产生的一种负面作用，并被认为是导致衰老和疾病的一个重要因素。Sep-378614和SEP-380135是新型的中枢神经系统活性分子，均由Sunovion公司与Psychogenics公司合作，利用其体内表型分析平台SmartCube和相关AI算法发现。Sep-378614的临床前研究表明，它可能具有快速起效的抗抑郁活性。当前在美国研究进行到临床试验1期。SEP-380135的临床前研究显示了广泛的体内活性，表明对痴呆的许多行为和心理症状有效，包括激越/攻击性、精神运动性多动症和抑郁症，当前针对相关适应症的研究在美国进行到临床试验1期。DSP-0038是5-羟色胺5-HT2A受体拮抗剂和5-羟色胺5-HT1A受体激动剂。是住友制药利用Exscientia的人工智能技术发现的一种新型化合物。基于5-HT2A受体拮抗剂和5-HT1A受体激动剂的叠加效应，预期DSP-0038表现出更强的抗精神病作用。该化合物在治疗痴呆（BPSD）的行为和心理症状（包括激越、攻击性、焦虑和抑郁）方面也可能具有更广泛的功效。此外，DSP-0038对多巴胺受体D2的亲和力可忽略不计，因此与现有的抗精神病药物相比，它可以显示出更高的安全性和耐受性。目前在美国针对阿尔兹海默症精神病的研究进行到临床试验1期。DSP-9632P是5-羟色胺5-HT1A受体部分激动剂。可能通过抑制左旋多巴衍生的多巴胺的过度释放，对左旋多巴给药后表达的运动障碍发挥作用。临床前研究表明，DSP-9632P可抑制左旋多巴引起的运动障碍症状。通过稳定的血药浓度，DSP-9632P的透皮贴剂制剂可能成为治疗帕金森病中左旋多巴诱导的运动障碍的有效选择，并且还可能提高患者给药的便利性。在日本针对左旋多巴诱导的帕金森病运动障碍的研究进行到临床试验1期。DSP-0187是一种食欲素2受体激动剂，有望改善由食欲素缺乏引起的发作性睡病的白天过度嗜睡（EDS）和猝倒，也有望证明对除发作性睡病以外的EDS的疗效。在日本针对发作性睡病的研究进行到临床试验1期。住友制药于2022年4月授予Jazz Pharmaceuticals PLC在除日本、中国和某些其他亚太市场以外的地区的独家开发和商业化权利。DSP-3456是一种mGluR2/3 NAM（代谢型谷氨酸受体2/3负变构调节剂）。DSP-3456 有望通过增强谷氨酸释放来选择性激活前额叶皮层，同时避免副作用（精神病症状、认知功能障碍），从而表现出类似氯胺酮的抗抑郁作用。在美国针对难治性抑郁症的研究进行到临床试验1期。DSP-0378是一种γ-氨基丁酸A型受体（GABAA受体）正向变构调节剂，它作用于突触和突触外区域表达的各种GABAA受体亚型，其方式不同于常见的GABAA受体增强剂，例如苯二氮䓬类药物和神经类固醇，预计该药物具有广泛的抗癫痫作用，包括Dravet综合征和Lennox-Gastaut综合征（LGS）等难治性罕见疾病。在日本针对Dravet综合征和Lennox-Gastaut综合征的研究进行到临床试验1期。DSP-2342是一种5-羟色胺5-HT2A和5-HT7受体拮抗剂。基于5-HT2A和5-HT7受体拮抗剂的累加效应，该药物有望显示出更广泛的抗精神病作用，包括精神病、焦虑和抑郁，此外，还对5-HT2A和 5-HT7受体具有高选择性，有望显示出高水平的安全性和耐受性。DSP-2342是住友制药利用Exscientia的AI技术发现的一种新型化合物，当前在美国研究进行到临床试验1期。（2）再生医学/细胞疗法住友制药与合作伙伴合作，开发了针对帕金森病和视网膜色素上皮撕裂的再生医学/细胞疗法，分别是CT1-DAP001/DSP-1083和HLCR011，这两种均是同种异体iPS细胞衍生产品。其中，CT1-DAP001/DSP-1083针对帕金森的研究在日本进行到临床试验1/2期，在美国准备开始临床研究；HLCR011在日本针对视网膜色素上皮撕裂的研究进行到临床试验1/2期。2、肿瘤学TP-3654通过抑制 PIM（Moloney白血病病毒的前病毒整合位点）激酶来抑制炎症信号通路，PIM激酶经常在各种血液系统恶性肿瘤和实体瘤中过表达，使癌细胞逃避细胞凋亡并促进肿瘤生长。FDA于2022年5月授予TP-3654 孤儿药资格，用于治疗骨髓纤维化。在美国和日本针对骨髓纤维化的研究进行到临床试验1/2期。DSP-5336是一种小分子抑制剂，可抵抗Menin（一种肿瘤抑制蛋白）和混合谱系白血病（MLL）蛋白的结合，伴有MLL重排或核磷蛋白1（NPM1）突变的急性白血病主要通过menin-MLL相互作用来上调促白血病发生的基因。DSP-5336 在临床前研究中已被证明具有抗癌活性，通过抑制 meninMLL 相互作用来下调基因。FDA于2022年6月授予DSP-5336孤儿药资格，用于治疗急性髓系白血病，目前在美国和日本的研究进行到临床试验1/2期。DSP-0390是EBP（依莫帕米结合蛋白）抑制剂， EBP是一种参与胆固醇生物合成的内质网膜蛋白，大多数癌细胞的特征是负责其生物合成的各种通路上调，并且对支持细胞增殖的胆固醇需求很高，因此，DSP-0390对EBP的抑制预计会导致胆固醇稳态的破坏并诱导癌细胞死亡。FDA于2022年5月授予DSP-0390孤儿药资格，用于治疗脑癌，目前在美国和日本针对胶质母细胞癌的研究进行到临床试验1/2期。TP-1287是一种小分子口服药物，可抑制CDK9（细胞周期蛋白依赖性激酶9）。TP-1287在临床前研究中显示出良好的口服生物利用度可以产生一种有效的CDK9抑制剂。FDA分别于2023年2月和3月授予了TP-1287儿科罕见病资格认定和孤儿药认定，用于治疗尤文肉瘤（也称尤因肉瘤）。TP-1454通过酶的四聚化诱导PKM2（丙酮酸激酶M2）的活性，该酶主要以酶活性较低的二聚体状态存在于癌细胞中，PKM2 的四聚化导致癌细胞中有氧糖酵解的减少并恢复免疫抑制微环境，TP-1454有望与免疫检查点抑制剂显示出协同作用。目前TP-1287和TP-1454在美国针对实体瘤的研究均进行到临床试验1期。3、其他Lefamulin是一种截短侧耳素类抗菌剂，可通过静脉注射或者口服给药，其作用机制为抑制细菌生长所必须的蛋白质的合成。Lefamulin最初由Nabriva Therapeutics开发，在美国，FDA于2019年8月批准了XENLETA（Lefamulin，来法莫林）用于治疗CAP（社区获得性细菌性肺炎）成年患者，由Nabriva Therapeutics在美国地区销售。2018年3月，仑胜医药获得在大中华区（包括中国大陆、香港、澳门、台湾省）开发和商业化lefamulin的权利。2021年5月7日，住友制药与仑胜医药签订资产转让协议，住友制药（苏州）获得仑胜医药持有的包括lefamulin在内的多个在研新药在大中华区的独家研发和销售权。2021年10月，住友制药在中国提交了Lefamulin的新药上市申请，2023年11月14日，国家药品监督管理局（NMPA）批准了XENLETA（Lefamulin，醋酸来法莫林注射剂和片剂）用于治疗成人社区获得性肺炎。图片来源：国家药品监督管理局Vibegron是一种口服小分子β3肾上腺素能受体激动剂，选择性作用于膀胱中的β3肾上腺素能受体，使膀胱松弛，增强尿液储存，并改善膀胱过度活动症（OAB）患者的尿急、尿频和急迫性尿失禁症状。2020年12月，Urovant Sciences（2019年12月住友制药从Roivant公司收购）的Gemtesa（vibegron，维贝格龙）在美国获得了膀胱过度活动症的批准。目前在中国针对膀胱过度活动症的研究进行到临床试验3期；在美国针对BPH（良性前列腺增生）男性膀胱过度活动症的研究也进行到临床试验3期。SP-101是一种新型的腺相关病毒（AAV）载体，可有效地从顶端（管腔）表面转导人气道上皮细胞，它旨在将缩短但功能齐全的CFTR（囊性纤维化跨膜传导调节因子）基因传递给CF（囊性纤维化）患者的气道。基于临床前数据，阿霉素的加入显著改善了SP-101转导和随后CFTR基因的表达，目前正在开发SP-101和阿霉素通过喷雾器给药的联合产品，SP-101有望恢复CFTR功能并改善CF患者肺部的疾病，在美国针对囊性纤维化的研究进行到临床试验1/2期。KSP-1007可抑制β-内酰胺酶，该酶由可降解碳青霉烯类抗生素的细菌产生。KSP-1007与美罗培南水合物（一种全球通用的碳青霉烯类抗生素，住友制药在国内市场的产品名称为Meropen）联合用药，有望成为治疗耐碳青霉烯类细菌感染的有效选择。FDA于2022年8月授予KSP-1007合格传染病产品（QIDP）资格和快速通道指定，用于复杂性尿路感染、复杂性腹腔内感染、医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎的适应症。目前在美国针对复杂性尿路感染和复杂性腹腔内感染的研究进行到临床试验1期。自合并后，住友制药一直致力于实现业务全球化，当前在日本、北美、中国和亚洲设有本地总部、销售和开发职能部门，并从事地区特色的销售营销活动。以下是研究开发机构全球分布图：PART3财务状况2022财年（2022.04~2023.03）住友制药的收入为5555亿日元（38.5亿美元，均以1.00美元=144.34日元计算），与上年同期相比降低了0.8%。核心营业利润164亿日元（1.14亿美元）；营业利润为（亏损）770亿日元（5.34亿美元）；税前利润（亏损）479亿日元（3.32亿美元），净利润（亏损）967亿日元（6.70亿美元）。2023前两个季度收入1526亿日元（10.8亿美元），与上年同期相比下降52.2%，收入下降的主要原因是LATUDA（鲁拉西酮）在美国的独家经营权丧失，住友制药食品化学株式会社转让。尽管销售、一般和行政费用比预期减少，但集团公司在北美的合并，以及住友制药动物保健株式会社股份转让产生的其他收入，由于收入下降导致毛利大幅下降，截至2023年9月30日止六个月的核心营业利润为（亏损）658亿日元（4.56亿美元）。尽管前六个月确认的减值亏损主要为专利权，但由于核心经营亏损及北美业务结构改善的开支，营业利润（亏损）为865亿日元（5.99亿美元），较去年同季有所增加。由于日元贬值导致的外汇收益被营业利润的下降所抵消，公司税前利润（亏损）为561亿日元（3.89亿美元）。由于税前亏损，净亏损较去年同期有所增加，净利润（亏损）为677亿日元（4.69亿美元），而截至2022年9月30日的六个月为152亿日元（1.05亿美元）。分地区来看，日本地区销售额为585亿日元（4.05亿美元），与上年同期相比下降了40.3%；北美地区销售额733亿日元（5.08亿美元），同比下降62.5%；亚洲地区销售额为208亿日元（1.44亿美元），同比下降19.5%。PART4中期破局经营计划（2023~2027）2019年，住友制药制定了新的愿景，并励志成为一家能够满足日益多样化的医疗保健需求的公司，公司的目标是到2033年将自己打造成全球化专业企业。短期来看，公司制定了2027年中期经营计划，该计划从2023年开始实施，在中期经营计划的第一年，住友制药预计核心营业亏损为620亿日元（4.30亿美元），因为LATUDA（鲁拉西酮）在美国的独家销售期结束，销售额将几乎归零。在这种情况下，住友制药将努力建立支持持续增长的收入基础，主要是通过最大限度地提高三个主要产品（ORGOVYX、MYFEMBRE、GEMTESA）的业务，并通过研发改变其业务结构，以业务形式将公司的创新付诸实践。同时，将以美国集团公司合并为契机，重新设计集团运营结构，努力向灵活高效的业务基础转变。在北美，公司的目标是到2024财年实现4600亿日元（31.9亿美元）的收入和400亿日元（2.77亿美元）的核心营业利润。同时还设定了从2023财年开始，到2027财年的收入复合年增长率至少为12%的目标，以及从2024财年到2027财年的累计核心营业利润至少为1920亿日元（13.3亿美元）的目标。以下是公司中期经营计划财政目标：参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）；https://www.sumitomo-pharma.com/；https://www.sumitomo-pharma.co.jp/；https://www.vbdata.cn/newsDetail/f04332a4f4d45697e3814b64f1a8367c；https://xueqiu.com/5603603160/138434661；https://www.jiemian.com/article/3494847.html；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 8月 • NDC2024生物医药创新博览会关键词：抗体、多肽、核酸、核药，XDC、小分子、注册、临床、CMC（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

并购专利到期细胞疗法

2024-03-27

·BioSpace

IDRx Appoints David P. Kerstein, M.D., as Chief Medical Officer

Dr. Kerstein brings significant experience in the development of small molecule oncology therapeutics including in gastrointestinal stromal tumors (GIST) as IDRx advances IDRX-42 into mid-stage clinical development PLYMOUTH, Mass.--(BUSINESS WIRE)-- IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision therapies, today announced the appointment of David P. Kerstein, M.D., as Chief Medical Officer. Dr. Kerstein brings to IDRx deep experience in early- and late-stage oncology drug development, including multiple precision oncology medicines. He joins the founding IDRx R&D leadership team of Jessica Christo, Chief Development Operations Officer, and Vivek (Vic) Kadambi, Ph.D., Chief Product Development Officer. “We are thrilled to have Dr. Kerstein join the outstanding IDRx R&D team as we continue to advance our lead program, IDRX-42, with the goal of improving the lives of patients with GIST,” said Tim Clackson, Ph.D., Chief Executive Officer. “His expertise and proven track record in advancing multiple small molecule oncology therapeutics from development to approval will be invaluable as we approach the potential initiation of pivotal studies for IDRX-42 in 2025.” “This is a unique opportunity to be a part of an exciting company that has the potential to have a meaningful impact on the treatment of GIST patients with IDRX-42, including in early lines of therapy to prevent the emergence of resistance mutations,” said Dr. Kerstein. “IDRx’s progress since its inception is remarkable, and I look forward to working with this exceptional team as we prepare for important upcoming clinical milestones.” Prior to joining IDRx, Dr. Kerstein served as Chief Medical Officer of Theseus Pharmaceuticals, Inc., where he led the clinical development of the Company’s lead program for GIST. Before Theseus, Dr. Kerstein served as Chief Medical Officer of Anchiano Therapeutics Ltd. Prior to these roles, Dr. Kerstein served as Senior Medical Director in Oncology Clinical Research and Lung Cancer Clinical Portfolio Strategy Lead at Takeda Pharmaceutical Company Limited and Senior Medical Director of Clinical Research at ARIAD Pharmaceuticals, Inc. (acquired by Takeda in 2017) where he led the clinical development of ALUNBRIG®. Earlier in his career, Dr. Kerstein served as Director of Clinical Development and Regulatory Affairs at Boston Biomedical, Inc., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd. Dr. Kerstein holds an M.D. from Tufts University School of Medicine and received a B.S. in Biology from Tufts University. About GIST Gastrointestinal stromal tumors (GIST) are the most common subtype of soft tissue sarcoma. Approximately 80% of cases arise from gain of function mutations in the KIT receptor tyrosine kinase, driving the malignancy through constitutive activation of aberrant signaling. Resistance mutations in KIT emerge in ~90% of patients treated with imatinib, the current standard of care for GIST. In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. About IDRx IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRx’s lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). IDRx's pipeline also includes a second KIT inhibitor, IDRX-73. Founded in 2021, IDRx’s leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved medicines. To learn more, please visit and follow us on LinkedIn. View source version on businesswire.com: Contacts 1AB Katie Engleman katie@1abmedia.com Source: IDRx, Inc. View this news release online at:

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药物(靶点)	适应症	全球最高研发状态

Napabucasin ( STAT3 )	胃食管交界处腺癌更多	临床3期
DSP-0692 ( SCD1 )	结直肠癌更多	临床前
DSR-6434 ( TLR7 )	肿瘤更多	临床前
BB-15600	肿瘤更多	无进展
BBI-5006 ( PDGFRα )	肿瘤更多	无进展