Emicizumab

BOSTON, July 28, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the appointments of Jeremy Bender, Ph.D., MBA and Christy Oliger to its Board of Directors. Dr. Bender, who most recently served as Chief Executive Officer at Day One Biopharmaceuticals through its acquisition by Servier in 2026, brings more than 20 years of corporate strategy and operating experience in biotechnology to Bicara. Ms. Oliger brings more than 30 years of commercial and operating experience in global biopharmaceutical organizations, having most recently served as Senior Vice President of the Oncology Business Unit at Genentech. "We are delighted to welcome Jeremy and Christy to our Board of Directors at this pivotal time for Bicara. Together, they bring deep commercial, strategic, and operational expertise that will be invaluable as we continue our evolution from a clinical-stage organization to one focused on successfully delivering ficerafusp alfa to patients,” said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. “Each of these distinguished professionals has an established track record of guiding innovative biopharmaceutical companies through critical stages of growth, including pipeline development, corporate strategy, and commercialization. Their perspectives will strengthen our Board as we advance our portfolio, execute on our long-term vision, and continue building Bicara into a mature biopharmaceutical organization.” In addition, Kiran Mazumdar-Shaw has retired from Bicara’s Board of Directors. "As one of our founding Board members, Kiran has been instrumental in shaping Bicara from its earliest days. Her impact extends beyond the initial seed capital that helped launch the company, but also the strategic guidance and steadfast support that has enabled Bicara to advance ficerafusp alfa into the clinic and reach the important milestone of a registration-enabling clinical study,” said Mike Powell, PhD, Chairman of Board of Bicara Therapeutics. “On behalf of the Board, management team, and Bicara employees, I want to thank Kiran for her vision, leadership, and indelible contributions to Bicara.” About Jeremy Bender, Ph.D., MBADr. Bender most recently served as Chief Executive Officer, President and a member of the Board of Directors of Day One Biopharmaceuticals, Inc. from September 2020 to April 2026, where he led the company through its evolution into a commercial-stage oncology company, including the approval and launch of OJEMDA® for pediatric low-grade glioma and the company's approximately $2.5 billion acquisition by Servier in 2026. Prior to joining Day One, Dr. Bender was Vice President of Corporate Development at Gilead Sciences, Inc., a pharmaceutical company, from March 2018 to September 2020. Prior to that, he was Chief Operating Officer of Tizona Therapeutics, Inc. from July 2015 to March 2018 and Chief Business Officer of Sutro Biopharma, a biotechnology company specializing in cancer and autoimmune therapeutics, from October 2012 to July 2015. Prior to joining Sutro Biopharma, Inc., he was Vice President of Corporate Development at Allos Therapeutics Inc., a biotechnology company focused on cancer treatments, from January 2006 to September 2012. Dr. Bender began his career in the life sciences practice at Boston Consulting Group, a management consulting company. Dr. Bender also sits on the boards of Mereo BioPharma Group plc and Aura Biosciences, Inc. From October 2023 to June 2024, Dr. Bender also served as a director of Fusion Pharmaceuticals, Inc., a biopharmaceutical company. Dr. Bender holds a B.S. in Biological Sciences from Stanford University, a Ph.D. in Microbiology and Immunology from the University of Colorado, and an MBA from the MIT Sloan School of Management. About Christy OligerMs. Oliger is recognized for building industry leading capabilities and teams and was the Senior Vice President, Business Unit Head for Oncology and Genentech from 2017-2020, managing a portfolio of 15 products, contributing U.S. revenue exceeding $13 billion, delivering launches in lung cancer, breast cancer, chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), melanoma and leading an organization of more than 800 people. Prior to this role, Ms. Oliger served as Senior Vice President and Business Unit Head, Neurology, Rare Disease, Infectious disease where she was responsible for building the teams and driving successful launches in multiple sclerosis (MS) (Ocrevus®), hemophilia (Hemlibra®) and spinal muscular atrophy (SMA) (Evrysdi®), together the most significant growth drivers in the U.S. business. Prior to these roles, she spent three years as Global Head of Portfolio and Project Management where her team was responsible for the Late-Stage Portfolio Committee comprised of a late-stage development portfolio of greater than 300 projects across multiple therapeutic areas. Christy began her career in life sciences at Schering Plough, a pharmaceutical company. In addition to Bicara, Christy also currently sits on the boards of Vera Therapeutics, Karyopharm Therapeutics, and Replimune Inc. She previously served as a director at Nuvalent Inc. prior to acquisition by GSK, Sierra Oncology prior to acquisition by GSK, Reata Pharmaceuticals prior to acquisition by Biogen, Rayze Bio prior to acquisition by BMS, and Lava Oncology prior to acquisition by Xoma Therapeutics. She holds a B.A. in Economics from University of California, Santa Barbara. About Bicara Therapeutics Bicara is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara has built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This approach was deployed in the development of Bicara’s lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor (EGFR) directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment (TME). Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which Bicara believes will lead to deep and durable responses and an increase in overall survival, while reducing the potential adverse effects previously associated with systemic TGF-β inhibition. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding Bicara’s strategy, business plans and focus; the clinical development of ficerafusp alfa, including planned and ongoing clinical trials; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability; Bicara’s ability to scale and prepare for potential commercialization of ficerafusp alfa; the potential for U.S. regulatory approval and launch of ficerafusp alfa; and anticipated contributions of members of Bicara’s Board of Directors. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks relating to Bicara’s research and development activities; Bicara’s ability to execute on its business plans and strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to the clinical development of ficerafusp alfa; the Company’s dependence on third parties; risks related to the Company’s financial condition and need for additional funds in order to commercialize ficerafusp alfa, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Bicara’s intellectual property protections; and risks related to the competitive landscape for ficerafusp alfa; as well as other risks described in “Risk Factors,” in Bicara’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Bicara’s subsequent filings with the U.S. Securities and Exchange Commission (SEC). In addition, any forward-looking statements represent Bicara’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Bicara intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Contacts InvestorsRachel Frank IR@bicara.com MediaTim PalmerTim.Palmer@bicara.com

文章来源｜《医药经济报》 当下，生物医药行业不断涌现出有望挽救生命或改善生活质量的创新药物，但这些创新疗法的高昂价格对患者个人、家庭、社会、医保支付方也产生了巨大的经济和财政压力，影响药品的公平可及性。 有时药品的高昂定价与其治疗价值未必相符，特别是在专利垄断、缺乏竞争和不透明折扣的复杂市场环境中，创新药的价格制定若单靠价格谈判来降价只能解决一部分问题。 如何从源头保证创新药的合理公平定价，促进创新性和可负担性的平衡是当前创新药高质量发展中遇到的瓶颈，解决这一问题将有利于缓解药品价格给国家医疗系统带来的压力。 复旦大学公共卫生学院卫生经济学胡善联教授，在本文中系统梳理了创新药定价模型的演进路径，并深入剖析AIM模型，探索创新药公平定价新思路。 胡善联 复旦大学公共卫生学院卫生经济学教授、上海创奇健康发展研究院名誉院长 01 创新药定价模式演进 根据文献报道，目前常用的创新药定价模型共有六种： 基于成本加成定价； 基于价值的定价； 由国际互惠协会（International Association of Mutual Benefit Societies）开发的 AIM 模型； 贴现现金流模型（努伊藤斯 Nuijtens discounted cash flow）； 实物期权回报率法（real-option rate of return method）； 抗癌药物定价模型。 成本加成定价方法（cost-based pricing,CBP）常用于创新药的初期定价，尤其是肿瘤药的公平定价，也可称为基于成本加成定价的乌伊尔－德格鲁特模型 (Uyl-de Groot)，将总投入成本分摊到预期患者人数，再加成利润。主要参数有：C-rd 研发成本（含失败项目风险调整）、C-man 制造成本、M-p 利润率、N-p 累计患者人数。其定价公式为：P=(C−rd/N−p+C−man)×(1+M−p)。以 Keytruda（K 药）为例，2014 年时适应症较少，成本加成定价为 885 欧元 / 瓶，到 2021 年适应症扩大后，定价降低到 143 欧元 / 瓶。 获取可负担药物是公平医疗的基石。基于成本加成定价可以成为基于价值定价的有用补充。除了基于成本加成定价和标准增量成本效果比 (ICER) 的价值定价外，所有模型都会考虑符合条件的患者数量和剩余专利期。只有 AIM 模型和努伊藤斯贴现现金流模型使用一次性付款，将资本成本作为主要的成本组成部分。每个模型需要根据每种药物的特点和治疗领域制定更具差异化和动态化的定价。其中，成本的透明度是关键。 AIM 模型是欧洲计算公平价格的透明定价框架，采用更透明、更基于成本的定价方法，旨在计算覆盖全球研发、生产、销售及医学信息成本，同时反映治疗价值，允许药企获得合理利润的一种公平定价方法。该模型可从公开网络（https://fairpricingcalculator.eu）获得在线的 “公平定价计算器”。 该计算器的内容包括两个部分。第一部分是基本情况，包括药品治疗的疾病，根据发病率或患病率估算总发病人数、目标治疗率、目标治疗人数、药品研发成本、市场竞争产品数量，平均治疗月份、基本利润（按 8% 计算）、销售信息。 第二部分反映基于治疗价值创新程度的加分项目（属于创新奖励），如新药有助于治疗危重患者或无替代药物者可加价 5%、能治愈疾病或对病程带来重要影响的可加价 30%、能够明显改善生活质量者可加价 10%。如为抗肿瘤药物，与参照药物相比，能延长 PFS（无进展生存期）至少 6 个月或增加 50% 的新药可加价 5%、能延长 OS（总生存期）少于 6 个月且对病情有轻度改善影响者加价 5%、如能延长 OS 大于 6 个月对病情有中度影响者加价 10%。 02 AIM 模型实证研究 2026 年 4 月，PharmacoEconomics杂志报道了 Jocalijn 等研究人员在六个欧洲国家（比利时、爱沙尼亚、德国、荷兰、斯洛文尼亚、瑞士）开展的跨国实证分析，他们对在 2015—2018 年间获得欧洲药品管理局 (EMA) 授权的十种市场独占性药物的公平价格与实际中位价格差异进行测试。 这些药物包括达拉图单抗（Darzalex）、曲氟尿嘧啶联合替匹替尔（Lonsurf）、帕博西尼（Ibrance）3 种抗癌药，艾米昔单抗 (Hemlibra)、赛洛昔帕 (Uptravi)、美泊利单抗 (Nucala) 3 种用于治疗 (超) 罕见疾病的药物，还包括奥克雷珠单抗 (Ocrevus)、格雷帕韦 / 匹布瑞韦 (Maviret)、多替拉韦 / 阿巴卡韦 / 拉米夫定 (Triumeq) 以及司美格鲁肽（Ozempic）4 种治疗慢性疾病的药物。 研究人员采用全面的搜索策略，包括逆向滚雪球方法进行系统文献综述；使用 Web of Science 和谷歌学术作为数据库；检索重点是药品的定价模型；在计算公平价格时，使用每种药品 8 亿欧元的标准化平均研发成本，并进行了 2.5 亿欧元和 25 亿欧元的敏感性分析，将计算出来的公平价格与 2020 年的挂牌价格进行比较；潜在的国家支出预算节约，通过实际价格和公平价格之间的支出差距得出加权降幅百分比，并将其应用于新上市药品的国家支出来估算。 结果发现，仅美泊利单抗和赛洛昔帕两个药的公平价格高于实际价格，其他 8 个药物（10 个适应症）的公平价格均低于实际药品上市的价格。分析结果表明，AIM 合理价格比标价平均低 53%，最多可达 97%。在考虑保密折扣后，合理价格仍比净价平均低 33%。若将合理价格应用于十种选定药品，可使六个参与国家的总支出平均加权减少 77%，净支出减少 73%。若推算至欧洲层面，相当于新药每年潜在净节省 270 亿欧元。 基于上述结论，研究人员指出，采用一种更透明、更基于成本公平的定价方法与新药的市场价格进行比较，有望重塑公正、可持续的药品定价体系，确保医药创新惠及更广泛人群。 总结 单一的定价模式并不适用于所有药品。一般来讲，基于成本加成的定价适用于仿制药，而成本效果比 (ICER) 计算适用于常见药品，混合模式更适合精准医疗和针对小患者群体的药物。高度创新和重新利用的药物，考虑资本成本的模式更合适。创新药物建议采用综合差异化药品定价框架。然而，准确的成本数据和透明度至关重要。AIM 的模型为创新药物和再利用药物提供了有用的定价框架，提高了定价的透明度和公平性。 总之，不同的药品定价模式各有其优点，适用于不同类型的药品，因此药品定价需采用综合模式，以考虑药品特性、治疗领域和经济背景等各种因素。 推荐阅读 陈怡：创新药如何定义，医保怎样支持真创新 顶层文件呼之欲出，创新药发展如何做好“全链条”衔接 上海创奇健康发展研究院 创奇健康研究院是一个帮助健康行业价值创新和领导者持续成长的平台。通过连接政策制度、技术发展、商业模式，推动产业、学术、政府、投资和媒体的深度交流学习。研究院受上海市卫生健康委员会指导。 ▲ 点击观看创奇健康研究院宣传片