Bevacizumab biosimilar(Hanwha Biologics)

单克隆抗体的主要优势之一是它们对目标分子的高度特异性。通过精心设计和选择，可以将 mAb 设计为与特定抗原或受体结合，从而能够精确靶向致病因子，如癌细胞或致病蛋白。这种特异性最大限度地减少了脱靶效应并增强了 mAb 的治疗效果。由于这一优势，单克隆抗体已成为一类具有治疗各种疾病潜力的革命性治疗药物。根据 Coherent Market Insights 的最新市场研究，全球单克隆抗体市场估计在 2023 年价值 2054 亿美元，预计在预测期间（2023-2031 年）的复合年增长率将达到 12.7%，在 2031 年增至 5336 亿美元。单克隆抗体在各种治疗领域都有应用。它们用于治疗癌症、自身免疫性疾病、传染病和炎症，产品包括治疗乳腺癌的曲妥珠单抗 (Herceptin)、治疗淋巴瘤的利妥昔单抗 (Rituxan) 和治疗炎症性肠病的英夫利昔单抗 (Remicade)。此外，一些单克隆抗体通过刺激或抑制免疫系统发挥作用。免疫检查点抑制剂，如 pembrolizumab (Keytruda) 和 nivolumab (Opdivo)，可增强人体对癌细胞的免疫反应。另一方面，像阿达木单抗（修美乐）这样的单克隆抗体靶向并中和与自身免疫性疾病有关的特定免疫蛋白。癌症，也称为恶性肿瘤，是指异常的细胞生长。单克隆抗体作为一种有效的癌症治疗方法在世界范围内越来越受欢迎。因此，各种制药公司、生物技术公司、大学和癌症中心都将重点投资于新型单克隆抗体的开发。根据 Coherent Market Insights 的分析，目前有 59 种单克隆抗体被 FDA 批准用于不同的癌症治疗，包括用于治疗淋巴瘤、多发性骨髓瘤、乳腺癌、肺癌和肉瘤。癌症患病率的增加预计会增加对单克隆抗体的需求，因为它们有助于治疗这种疾病。下图显示了 2022 年全球单克隆抗体市场的治疗领域市场份额（Coherent Market Insights）。仅在 2022 年，FDA 就批准了 16 种治疗性抗体，如下表所示。下表代表了针对不同癌症（预计将提交监管申请的适应症）的研究性单克隆抗体。市场参与者也在研究用于非肿瘤适应症的单克隆抗体。用于非肿瘤适应症的研究性单克隆抗体如下所示。根据 Coherent Market Insights 的分析，几种单克隆抗体已成为重磅炸弹，为制药公司带来了可观的销售额。下表代表了 2022 年最畅销的单克隆抗体药物。全球单克隆抗体市场的主要市场参与者包括默克、艾伯维、辉瑞、诺华、拜耳、赛诺菲、罗氏、礼来、葛兰素史克、百时美施贵宝和再生元制药。创新者的市场限制是生物仿制药开发者的市场机会尽管单克隆抗体市场在过去五年中增长有利可图，但与单克隆抗体疗法相关的高成本等因素限制了中低收入群体对单克隆抗体的采用，从而阻碍了市场增长。例如，Keytruda (pembrolizumab) 是一种用于治疗各种癌症类型的单克隆抗体，50 mg小瓶的成本约为 2,250 美元。同样，Bavencio（由辉瑞和默克生产）免疫疗法每月花费约 13,000 美元。生物制药产品的高成本是医疗保健系统中的一个主要问题（在报销政策不发达的地区）。因此，为了解决这个问题，制造商纷纷求助于生物仿制药产品的开发。由于开发成本相对较低，生物仿制药的成本远低于原研产品。大多数可用的单克隆抗体疗法，如 Humira、Keytruda、Stelara 和其它产品预计将在 2020 年后失去专利保护。几家制造商拥有针对现有单克隆抗体的生物仿制药。例如，总部位于新加坡的 Prestige Biopharma 的 HD204（Avastin 生物仿制药）处于实体瘤的 3 期临床，PBP1502（Humira 生物仿制药）处于类风湿性关节炎的 1 期临床。结论单克隆抗体彻底改变了治疗领域，为各种疾病提供靶向治疗。推动全球单克隆抗体市场增长的主要因素包括癌症等慢性病的高患病率、监管机构对产品批准的增加以及市场参与者对开发新单克隆抗体的关注度不断提高。随着持续的研究和开发，单克隆抗体有望塑造医疗保健行业的未来，从而改善患者的治疗效果并改变治疗格局。虽然这些抗体的高成本阻碍了市场增长，但低成本生物仿制药的开发有望帮助市场参与者扩大中低收入人群的客户群。原文：R.Shah, K.Hasan, A Look At The Growing Market Landscape For Monoclonal Antibodies. Bioprocess Online, 2023.

SINGAPORE--(BUSINESS WIRE)-- Prestige Biopharma Limited (KRX: 950210, hereafter referred to as “Prestige”) and Intas Pharmaceuticals Limited (hereafter referred to as “Intas”) today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma’s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan. Prestige’s bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin®, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development (SAMSON-II) and the US and EU filing is planned next year. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin®. The partnership arrangement includes the exclusive rights for Intas and its affiliate Accord Healthcare that will commercialize the bevacizumab biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan, leveraging their strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. As one of the key players in the global biosimilar market, Accord has a longstanding commitment to oncology with proven commercial capabilities and it currently supplies around one in three injectable oncology medicines in Europe. This collaboration represents the successful execution of the company’s strategy to expand its market reach in Europe and Canada leveraging Accord’s strong global footprint and deep commercial expertise. The global sales of bevacizumab including its biosimilars were recorded at USD 6.4 billion1) last year and the market is expected to continue growing. Prestige’s HD204 with excellent cost competitiveness based on the company’s proprietary bevacizumab production technology will be providing affordable access to more patients in need. Lisa S. Park, CEO of Prestige Biopharma, commented: “We are delighted to establish a partnership with Intas for the key markets, the US and Europe. Accord is the ideal partner to commercialize our bevacizumab biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets.” Binish Chudgar, Vice Chairman & Managing Director of Intas Pharmaceuticals, commented: “We are pleased to announce the collaboration with Prestige Biopharma. This collaboration is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar drugs for cancer patients globally.” About Prestige Biopharma Limited: Prestige Biopharma Ltd. is a Singapore-based biopharmaceutical company with operations in USA and Korea, specialising in the discovery and development of biosimilars, novel antibodies and vaccines. The company strives to become a global innovator through the development of first-in-class mAbs including PBP1510 (INN: Ulenistamab) anti-PAUF mAb for pancreatic cancer that recently obtained FDA approval for Phase 1/2a IND and orphan designation from FDA, EMA and MFDS. Prestige's rich portfolio of biosimilars in various stages including HD201 trastuzumab under marketing authorisation review, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. Prestige’s business also includes alliance vaccine development and production, starting with the partnered commercial production of COVID-19 vaccines. For more information, please visit . About Intas Pharmaceuticals Limited: Intas Pharmaceuticals Ltd. is a leading vertically integrated pharmaceutical company based in Ahmedabad, India, having end-to-end capabilities of formulation development, manufacturing and marketing along with backward integration of APIs. The organisation has more than 18,000 employees and 14 manufacturing sites worldwide and sells products in more than 85 countries. The Intas Group's revenue amounted to USD 2.3 bn in FY 2020-21 and the compounded annual growth rate of revenue has been 19% in the past 5 years. For more information, please visit . 1) Source: IQVIA View source version on businesswire.com: Contacts Media inquiries: Global Communication Team Prestige Biopharma Ltd. Tel: +65-6924-6535 info@prestigebio.com Source: Prestige Biopharma Limited View this news release online at: