Pembrolizumab

Teva-engineered TEV-56278 is an anti-PD1-IL2 ATTENUKINE™ therapy in Phase 1 for the treatment of various forms of cancer, including melanoma Fosun Pharma-Teva collaboration agreement established with goal of accelerating clinical data generation for TEV-56278 Partnership leverages strategic relationships to enable research and development of innovative treatments to advance Teva's Pivot to Growth strategy TEL AVIV, Israel and SHANGHAI, June 16, 2025 /PRNewswire/ -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", SSE: 600196, HKEX: 02196) today announced that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. Teva's internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications. Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies. "This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva's innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients." Anti-PD1-IL2 fusion proteins like TEV-56278 represent a novel approach to cancer immunotherapy. TEV-56278 is designed to deliver IL-2 selectively to PD-1+ T cells, thus amplifying anti-tumor T-cell activity while minimizing off-target systemic toxicities. The targeted approach holds promise for improving outcomes for patients with a variety of oncology diseases. "We are pleased to partner with Teva on the development of TEV-56278," said Xingli WANG, MD, PhD, Executive President of Fosun Pharma and CEO of the Global R&D Center, "This collaboration brings together Teva's expertise in innovative drug development with Fosun Pharma's strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally." About TEV-56278 TEV-56278 is an anti-PD-1 antibody-cytokine fusion protein designed to selectively deliver an interleukin-2 (IL-2), i.e., ATTENUKINE, to PD-1-expressing T cells within the tumor microenvironment. This targeted approach aims to amplify anti-tumor T-cell activity while minimizing systemic toxicities. TEV-56278 is being evaluated as a monotherapy and in combination with pembrolizumab. Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit . About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy - Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide. For more information, please visit our official website: Teva Cautionary Note Regarding Forward-Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as "should," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to effectively execute our collaboration with Fosun for the development of Anti-PD1-IL2 Therapy (TEV-56278) for the treatment of various forms of cancer, including melanoma; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned "Risk Factors and "Forward Looking Statements." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Forward-looking Statements of Fosun Pharma This press release contains "forward-looking statements" of Fosun Pharma. These forward-looking statements may include, but may not be limited to, the acceleration of global clinical development and commercialization of TEV-56278 through the strategic collaboration, TEV-56278's potential to become an "efficacious and low-toxicity" therapy for multiple cancers with its novel mechanism of action, Fosun Pharma's plans and prospects for the exclusive development, manufacture and commercialization of the therapy in China and Southeast Asia, and the synergies arising from integrating both parties' strengths through this collaboration. Any forward-looking statements in this press release are based on Fosun Pharma's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet the predefined endpoints in clinical trials, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data, and the risk that efficacy, safety and tolerability observed in future larger and more diverse populations may differ from current data; risks inherent in collaborations; production and supply chain risks; and changes in market competition. Forward-looking statements speak only as of the date on which they are made, Fosun Pharma assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. 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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。任何文章转载需要得到授权。6月13日，默沙东（MSD）宣布其明星产品PD-1抑制剂帕博利珠单抗（商品名：可瑞达®）已正式获得中国国家药品监督管理局（NMPA）的批准，与仑伐替尼联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌患者。肝癌，作为中国第四大高发和第二大死亡癌种，其治疗难度之大、预后之差，一直是医学界亟待攻克的难题。据摩熵医药数据显示，2022年中国肝癌新发病例高达36.77万，死亡病例达31.65万，更为严峻的是，肝癌预后极差，发病率与死亡率之比达到1:0.9。截图来源：摩熵咨询《肝癌药物——市场研究专题报告》在此背景下，默沙东公司凭借其深厚的研发实力和前瞻性的战略布局，成功推出了帕博利珠单抗与仑伐替尼联合TACE的创新治疗方案。这一方案的获批，是基于III期临床试验LEAP-012研究的积极数据。该研究纳入了全球33个国家的480例Child-Pugh A级肝癌患者，结果显示，相比于使用TACE+双联安慰剂的患者，采用TACE+帕博利珠单抗+仑伐替尼方案的患者，无进展生存期显著延长至14.6个月，疾病进展和死亡风险降低了34%；24个月总生存率提升至75%，死亡风险降低了20%。帕博利珠单抗作为PD-1抑制剂的佼佼者，通过阻断PD-1/PD-L1信号通路，恢复T细胞的免疫功能，从而杀伤肿瘤细胞。据摩熵医药数据库显示，帕博利珠单抗近几年在全国医院（全终端）的销售额一直保持着增长态势，市场潜力也在持续攀升中。此前（6月7日），默沙东也递交了PD-1抑制剂帕博利珠单抗注射液（皮下注射）的上市申请，并成功获得受理。（点击跳转阅读原文：300亿药王，国内首款K药皮下注射版申报上市！）截图来源：摩熵医药全国医院（全终端）销售数据库仑伐替尼（lenvatinib）是一种口服多种激酶抑制剂，可以选择性抑制多种激酶的活性，包括血管内皮生长因子受体（VEGFR1、VEGFR2和VEGFR3），以及成纤维细胞生长因子受体（FGFR1、FGFR2、FGFR3和FGFR4），此外还有致病性血管生成、肿瘤生长和癌症进展相关受体酪氨酸激酶，如血小板衍生生长因子受体α（PDGFRα）、KIT和RET。该药由卫材药业研发，2018年获FDA批准用于晚期HCC系统治疗，是继索拉非尼之后十多年来首次获批用于晚期HCC一线治疗的新药，同年也在中国获批上市。仑伐替尼作为单药，已经在日本、美国、欧洲、中国等国家和地区获批用于一线治疗甲状腺癌和肝细胞癌，仑伐替尼与抗PD-1单抗帕博利珠单抗组成的联合疗法也已经在多地获批用于一线治疗肾细胞癌、既往经过全身治疗的子宫内膜癌等。截图来源：摩熵医药全球药物研发数据库仑伐替尼作为一种多靶点酪氨酸激酶抑制剂，能够抑制肿瘤血管生成和肿瘤细胞增殖。两者联合TACE，形成了优势互补、协同增效的治疗模式，为肝癌患者带来了新希望。在安全性方面，虽然TACE+仑伐替尼+帕博利珠单抗组和TACE+双联安慰剂组分别有71%和76%的患者发生3级及以上不良事件，但大多数不良事件均可通过有效的管理和支持治疗得到控制。这一方案不仅延长了患者生存期，也可以提升患者的生活质量。LEAP-012研究的主要研究者、复旦大学附属中山医院肝胆肿瘤内科主任医师任正刚教授表示：“我国大多数的肝细胞癌患者初诊时已经失去手术治疗机会，此次帕博利珠单抗与仑伐替尼联合TACE新适应症的获批，为对抗肝细胞癌这一难治癌种提供了又一新方案，也为患者带来了新的治疗选择与希望。”默沙东全球高级副总裁、默沙东中国研发中心总裁李正卿也强调：“默沙东始终积极探寻能够改变癌症治疗的方式与可能，向前探索科学的边界。此次联合用药获批是基于国际多中心临床试验LEAP-012研究数据，其中入组中国患者占比43.3%，这也是该适应症的全球首次获批，将为中国肝细胞癌的临床治疗带来新的选择。”小结随着帕博利珠单抗与仑伐替尼联合TACE方案的获批，肝癌治疗领域迎来了新的曙光。这一创新联合方案不仅为患者提供了更为有效的治疗手段，也为临床医生提供了更多的治疗选择。未来，随着研究的不断深入和临床应用的不断拓展，我们有理由相信，肝癌的治疗效果将得到进一步提升，更多患者将从中受益。END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！