CHICAGO, Sept. 6, 2023 /PRNewswire/ -- In the near future, the precision medicine industry is poised to revolutionize healthcare by harnessing the power of genomic and personalized data. With advancements in technology, including high-throughput sequencing, AI-driven analytics, and targeted therapies, precision medicine will become increasingly accessible and tailored to individual patients. This transformative approach will not only lead to more accurate disease diagnosis and treatment selection but also enable proactive disease prevention strategies. As collaborations between pharmaceutical companies, research institutions, and healthcare providers continue to flourish, the precision medicine field will pave the way for more effective, personalized, and cost-efficient healthcare solutions, ultimately improving patient outcomes and reshaping the landscape of medicine as we know it. Precision Medicine Market in terms of revenue was estimated to be worth $29.1 billion in 2023 and is poised to reach $50.2 billion by 2028, growing at a CAGR of 11.5 % from 2023 to 2028 according to a new report by MarketsandMarkets™. The rising number of product approvals followed by growing focus on genetic testing, a prerequisite for precision medicine therapeutics, are the factors supporting market growth. Download an Illustrative overview: Browse in-depth TOC on "Precision Medicine Market" 189 - Tables 50 - Figures 240 - Pages Precision Medicine Market Scope: Hospitals and Clinics subsegment accounted is the fastest growing of the precision medicine market by product & service Among the end user, the market is segmented hospitals and clinics and home care setting. In 2022, the hospitals and clinics segment accounted for the highest growth rate of the precision medicine market by end user. Growth in this market segment can be attributed to factors such as availability of better facilities and assistance in hospitals and clinics, accessibility to advanced diagnostic tests along with precise therapeutic regime among others. Oncology is the fastest-growing segment of the precision medicine market by applications Among the applications, the precision medicine market is segmented into drug discovery, clinical diagnostics, soil microbiome applications, industrial applications, ecological & environmental applications, veterinary applications, and other applications. In 2023, the drug discovery segment accounted for the fastest-growing share of the usage segment of precision medicine market. Growth in this market segment can be attributed to one of the major factors which is the growing number of research activities for development of new drugs. Europe: The second-largest region in the precision medicine market. The European market is the second-largest precision medicine market globally, mainly due to factors such as presence of key market players in the region. Europe is considered a major hub for precision medicine players and organizations. Moreover, greater awareness among people about newly emerging area of precision medicine, especially compared to developing regions. Request Sample Pages: Precision Medicine Market Dynamics: Drivers: Growth in genetic testing and companion diagnostics Restraints: High costs of therapeutics Opportunities: Growing demand for cell and gene therapies Challenges: Challenges associated with adoption of precision medicine Key Market Players: The market for precision medicine is competitive, with key players strategizing to capture the market. Prominent players in the precision medicine market are F. Hoffmann-La Roche Ltd. (Switzerland), Novartis AG (Switzerland), Bristol Myers Squibb (US), Gilead Sciences, Inc. (US), AstraZeneca (UK), Pfizer Inc. (US), AbbVie Inc. (US), Eli Lilly and Company (US), , GlaxoSmithKline plc (UK), Sanofi (France), Johnson & Johnson (US), Merck KGaA (Germany), Amgen, Inc. (US), Takeda Pharmaceutical Company Limited (Japan) among others. Get 10% Free Customization on this Report: Precision Medicine Market Advantages: Personalized Treatment: Precision medicine tailors medical treatment and interventions to individual patients based on their genetic makeup, lifestyle, and specific health characteristics. This approach ensures that treatments are more effective, with fewer adverse effects, as they are customized to the patient's unique needs. Improved Diagnostic Accuracy: Precision medicine relies on advanced diagnostic tools and genomic sequencing to identify diseases and their underlying causes with unparalleled accuracy. This leads to earlier and more precise diagnoses, enabling timely and targeted interventions. Enhanced Drug Development: Pharmaceutical companies benefit from precision medicine by developing drugs that target specific genetic mutations or biomarkers associated with diseases. This approach streamlines drug development, reduces the likelihood of trial failures, and accelerates the availability of innovative treatments. Reduced Healthcare Costs: By avoiding trial-and-error approaches to treatment and focusing on therapies that are more likely to work for a given patient, precision medicine can potentially lower healthcare costs in the long run. Fewer unnecessary treatments, hospitalizations, and adverse reactions contribute to cost savings. Preventative Medicine: Precision medicine also emphasizes preventive strategies by identifying individuals at higher risk for certain diseases based on their genetic predispositions and lifestyle factors. This proactive approach allows for early interventions and lifestyle modifications to reduce disease risk. Data-Driven Insights: The collection and analysis of extensive patient data, including genomic and clinical information, enable researchers to uncover new insights into disease mechanisms and treatment responses. This data-driven approach accelerates medical research and innovation. Patient Empowerment: Precision medicine empowers patients by involving them in their healthcare decisions. Patients gain a better understanding of their health risks, treatment options, and potential outcomes, leading to more informed choices and improved overall healthcare experiences. Tailored Therapies for Rare Diseases: Precision medicine is particularly advantageous for rare and orphan diseases, where traditional treatment options may be limited. By identifying specific genetic abnormalities associated with these conditions, researchers can develop targeted therapies that offer hope to patients who previously had few treatment options. Global Health Impact: Precision medicine has the potential to address global health challenges by providing tailored solutions to diseases that affect diverse populations worldwide. It can facilitate the development of region-specific treatments and healthcare strategies. Long-Term Healthcare Sustainability: As precision medicine advances, it contributes to the sustainability of healthcare systems by focusing resources on treatments that are most likely to be effective, reducing unnecessary healthcare expenditures, and improving overall health outcomes. In summary, the precision medicine market holds the promise of revolutionizing healthcare by providing individualized, data-driven, and effective treatment options, ultimately benefiting patients, healthcare providers, pharmaceutical companies, and society at large. Recent Developments: In February 2023, Roche received EC approval for expansion of the Hemlibra (emicizumab) European Union (EU) marketing authorization. In January 2022, AstraZeneca (UK) collaborated with Scorpion Therapeutics to develop and commercialize precision medicines against hard-to-target cancer proteins, with an aim to transform oncology treatment. The size of this deal accounted for USD 75 billion. Related Reports: Plasma Fractionation Market - Global Forecasts to 2028 Biosimilars Market - Global Forecasts to 2028 Immunohistochemistry Market - Global Forecasts to 2028 Epigenetics Market - Global Forecasts to 2027 Research Antibodies & Reagents Market - Global Forecasts to 2027 About MarketsandMarkets™: MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients. The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry. To find out more, visit ™.com or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Aashish Mehra MarketsandMarkets™ INC. 630 Dundee Road Suite 430 Northbrook, IL 60062 USA: +1-888-600-6441 Email: [email protected] Research Insight: Visit Our Website: Content Source: Logo: SOURCE MarketsandMarkets

2023-08-18

·PRNewswire

Thrombotic AEs of Hemlibra (emicizumab) were 2.8 times more frequent than those of FVIII replacements.

Analyzed the FDA FAERS data…to compare the thrombotic AEs of Hemlibra vs. FVIII replacements. YONGIN, South Korea, Aug. 17, 2023 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced on August 17, 2023 that it has presented the results of analyzing and comparing thrombotic adverse events(AEs) of Hemlibra (emicizumab) and Factor FVIII replacements reported in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) at the Bleeding Disorder Conference (BDC) currently being held in Maryland, U.S. from August 17 to August 19, 2023. BDC, organized by National Hemophilia Foundation (NHF), is an international conference and is routinely attended by nearly 2,700 people, including researchers, physicians and other healthcare professionals, industry representatives, NHF chapters, patients, and families. This year's conference marks the 75th anniversary. The results of the study shared by GC Biopharma holds significance in that it is an outcome of research collaboration between industry, university, and hemophilia treatment center, represented respectively by BongKyoo Choi, ScD MPH RPh, Vice President of Department of Research and Development in GC Biopharma, Professor Ju-Young Shin from Sungkyunkwan University, and Ki Young Yoo M.D., Ph.D. of Korea Hemophilia Foundation. According to the study, which analyzed the FAERS data of the past 5 years (from 2018 to 2022), out of total 2,383 AEs associated with Hemlibra, 97 AEs (4.07%) were thrombotic AEs. By contrast, the proportion of thrombotic AEs for FVIII replacements was 1.44% (134 thrombotic AEs out of total 9,324 AEs associated with FVIII replacements) during the same period. That is, when compared, thrombotic AEs of Hemlibra were 2.83 times more frequent than those of FVIII replacements. In the early of this year, similar findings were reported in in a European pharmacovigilance study using the Eudravigilance database[i]. The study showed that thrombotic AEs were about 2.77 times more frequently reported for Hemlibra than for EHL FVIII replacements. It is also notable in the study shared by GC Biopharma that the thrombotic AEs of Hemlibra were still 1.84 times more frequently reported than those of FVIII replacements even after excluding the AEs of Hemlibra with bypassing agents (BPAs). In fact, it has been known in initial clinical trials that when used together with BPAs such as activated prothrombin complex concentrate (aPCC), Hemlibra increases the risk for thrombotic microangiopathy in some Hemophila A patients. Yet, in the study shared by GC Biopharma, out of total 97 thrombotic AEs of Hemlibra, 62 AEs were reported without BPAs which is higher than 35 AEs with BPAs as co-reported drugs . "This is the first study of analyzing and comparing thrombotic AEs of Hemlibra and FVIII replacements using the real-world data reported in FAERS" said Ki Young Yoo, M.D., Ph.D., Korea Hemophilia Foundation, "More future research and efforts are warranted for monitoring, elucidating, and preventing the potential greater risk of thrombotic AEs of Hemlibra." Details of the presentation are as follows: Title: Comparison of thrombotic adverse events in patients treated with factor VIII replacements and emicizumab using the 2018-2022 FAERS data. Poster Number: QOL4 Session Day and Time: Thursday, August 17, 2023 from 11:00 AM to 4:00 PM. Presenter: BongKyoo Choi, ScD MPH RPh, Vice President of Department of Research and Development in GC Biopharma The poster can be viewed here. About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Seunghyun Baek [email protected] Sohee Kim [email protected] Yelin Jun [email protected] SOURCE GC Biopharma

临床结果疫苗

2023-05-24

·药研网

全球获批的10款双抗全梳理

近期，艾伯维/Genmab的CD3/CD20双抗获批上市，用于治疗复发难治性弥漫大B细胞淋巴瘤（R/R DLBCL）。截止目前，全球已获批上市10款双抗，其中FDA批准了7款，国内获批了3款（开坦尼、Hemlibra和Blincyto）。01Epcoritamab（Epkinly）一种CD3/CD20 IgG1双抗，使用Genmab专有的DuoBody技术创建，可同时结合T细胞上的CD3和B细胞上的CD20，并诱导T细胞靶向杀伤肿瘤细胞。DuoBody是Genmab许多双抗产品和企业合作的基础，是一种双抗生成技术，能够快速、稳定且规模化生产双抗。生产过程包括三个步骤：利用重组哺乳动物表达系统分别生产两种IgG1，并在CH3结构域引入K409R和F405L突变；两种抗体按照回收和纯化的标准流程进行纯化；纯化后，进行Controlled Fab-arm交换，获得高产量双抗。DuoBody优势在于具有大规模制造兼容,可以用于高通量双特异性抗体库的生成和筛选。此次获批是基于I/II期EPCORE NHL-1试验的研究结果，在148例DLBCL患者中ORR为61%，其中CR为38%，PR为23%；DOR为15.6个月。02Glofitamab（COLUMVI）Glofitamab是在加拿大获批，一款2:1型CD20/CD3双抗，同样是引导T细胞靶向杀伤肿瘤细胞。Glofitamab的Fc区域被设计为取消FcγRs和C1q的结合，同时保持FcRn的结合，这可能延长循环半衰期。Glofitamab有2个Fab臂用于结合B细胞上的CD20，以及1个Fab臂用于结合T细胞上的CD3，特异性更强。CD3结合臂通过一个短的柔性连接体以头到尾的方式直接与其中一个CD20结合臂融合。这种独特的结构允许与CD20的高活性结合，即使在效应物:目标物（E：T）细胞比例较低的情况下，也能产生对B细胞的活性。Glofitamab的获批是基于一项I/II期临床，针对复发或难治B细胞非霍奇金淋巴瘤（R/R B-NHL）患者，ORR为51.6% (n=80/155)，CR为40%(n=62/155)，中位随访时间为 13.4 个月。在达到 CR 的患者中，73.1% 的患者在 12 个月时继续经历缓解。基于这项临床数据，今年1月FDA已接受了罗氏递交的治疗R/R LBCL的BLA申请。03Mosunetuzumab（Lunsumio）Mosunetuzumab最早于2022年6月在欧盟获附条件上市批准，用于治疗此前接受过至少两次全身治疗的滤泡性淋巴瘤（FL）。它利用Knob-In-Hole防止重链错配，同时抗体的Fc端进行N297突变，去除该位点的糖基化，并去除了抗体的ADCC和CDC相关效应功能。批准主要基于 I/II 期临床试验 GO29781 研究，旨在评估该药在复发性或难治性 B 细胞非霍奇金淋巴瘤的疗效和安全性。中位随访 18.3 个月后，ORR为80% (n = 72/90)，CR为60%（n=54/90），中位反应持续时间（mDoR）为 22.8 个月（95% CI：9.7-不可估计）。04Teclistamab（Tecvayli）Teclistamab和Epcoritamab一样，也是通过DuoBody技术构建的，是1+1非对称IgG4双抗，可诱导T细胞重定向靶向杀伤BCMA阳性骨髓瘤细胞。最早于2022年8月获欧盟批准作为单一疗法治疗复发和难治性多发性骨髓瘤（RRMM）的成年患者，采用皮下注射给药。Teclistamab(B)Teclistamab作用机制获批是基于关键的2期MajesTEC-1临床试验（n=110），ORR为61.8%，CR为28.2%，6个月时DOR为90.6%（95%CI：80.3%，95.7%），9个月时为66.5%（95%CI：38.8%，83.9%）。安全信息包括对细胞因子释放综合征（CRS）和神经系统毒性的警告，包括免疫效应细胞相关的神经毒性综合征。05Faricimab（Vabysmo）Faricimab是首个专为眼睛设计的lgG1双抗，是用罗氏的CrossMAb技术开发，抗体的Fc端采用了Knob-in-Hole的设计，并进行Fc突变，以减少与FcγR和FcRn受体的结合。Ang-2和VEGF-A通过使血管不稳定，导致形成新的渗漏血管并增加炎症进而导致视力丧失，通过同时阻断Ang-2和VEGF-A这两个通路，Faricimab可稳定血管，阻止nAMD等眼部疾病的发展。给药方式采用玻璃体注射，其优势在于，像Eylea、雷珠单抗等药物基本都是1个月给药一次直至病情稳定后再2-3个月给药，而Faricimab可以做到4个月给药一次且保证疗效。06Amivantamab（Rybrevant）Amivantamab也是通过DuoBody平台开发的，2021年获批用于含铂化疗失败后病情进展、EGFR 20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC），是全球首个获批用于实体瘤治疗的双抗，并且解决了EGFR-TKI耐药和EGFR 20ins无药可用的问题。有两种作用机制：一是与受体结合，促进受体-抗体复合物内吞和降解；二是诱导巨噬细胞的Fc依赖性胞啃作用和自然杀伤细胞的ADCC。获批是基于CHRYSALIS临床研究，评估了81位化疗后进展、具有EGFR 20ins突变的晚期NSCLC患者。BICR评估的ORR为40%，（95%CI：29%，51%），中位反应时间为11.1个月（95%CI：6.9，无法评估）。最常见的不良反应（≥20%）是皮疹、输液相关反应、副睾丸炎、肌肉骨骼疼痛、呼吸困难、恶心、疲劳、水肿、口腔炎、咳嗽、便秘和呕吐。07Emicizumab（Hemlibra）Emicizumab是一款FIXa/FX 非对称lgG4双抗，由罗氏和中外合作开发，于2017年获批治疗血友病A，自获批以后，Emicizumab销量逐年增长，2022销额45.19亿美元，为全球58亿美元的双抗市场贡献了近80%的份额。血友病A是由于FVIII的基因缺陷引起的，Emicizumab能够结合酶因子IXa和底物因子X，从而恢复FVIII的功能，但其具有与 FVIII 分子完全不同的结构或抗原性，不会诱导FVIII抑制剂的生成。https://doi.org/10.1182/blood-2017-08-801662此外，罗氏与中外正在开发新一代非共同轻链的NXT007，活性显著高于Emicizumab。NXT007基于FAST-Ig技术，采用三重正负电荷避免错配。08卡度尼利单抗（开坦尼）开坦尼为康方生物通过Tetrabody技术开发的全球首款肿瘤免疫双抗，将靶向CTLA-4的抗体以scFv的形式融合于PD-1抗体的C末端。获批是基于一项在中国开展的II期临床，评估了100位化疗后复发或转移的宫颈癌患者，ORR为33%，CR为12%。09Blinatumomab（Blincyto）Blinatumomab一种含有两个串联scFv的无糖基化的鼠源性抗体，这两个scFv片段的连接体来源于鼠抗人CD16 mAb HD37与CD3 mAb OKT3，是首个BiTE技术药物，BiTE是Micromet公司开发，后2012年被Amgen收购。Blinatumomab通过静脉滴注给药，由于没有长效化设计，给药不方便，虽然于2014年就获批上市，但直至2022年其年销额仅为5.83亿美元。10Ozoralizumab（Nanozora）Ozoralizumab由Ablynx通过NANOBODY技术开发，是全球首款获批的纳米双抗，分子量38kDa，它含有3个人源化纳米抗体结构域，其中2个靶向人TNF-α，1个与人HSA结合可将半衰期由数小时延长至3周以上。2015年，Ablynx将Ozoralizumab在日本的开发和商业化权益授权给Taisho。2018年，Ablynx被赛诺菲收购。细胞系产品查询投稿丨商务合作加入交流群往期推荐双抗ADC全球在研格局2023年美国最昂贵药物TOP102023，Biotech的下半场——现金为王，产品为金点击下方“药研网”，关注更多精彩内容参考：1. 《2022年全球双抗药物市场格局》2. 《盘点：2022获批的6款“双功能抗体”》3. 企业官网及相关论文

上市批准临床1期临床2期临床结果免疫疗法

100 项与艾美赛珠单抗生物类似药（正大天晴）相关的药物交易

登录后查看更多信息