SystImmune and Bristol Myers Squibb to co-develop and co-commercialize BL-B01D1 in the United States; SystImmune to retain exclusive rights in Mainland China and Bristol Myers Squibb to gain an exclusive license in the rest of the world
百时美施贵宝和 SystImmune将在美国联合开发并商业化 BL-B01D1；SystImmune将保留其在中国大陆的独家权益，而百时美施贵宝将获得在全球其他市场的独家许可
BL-B01D1 is a potentially first-in-class bispecific EGFRxHER3 ADC with potential to treat patients with lung and breast cancer, with opportunities to expand into additional tumor types
BL-B01D1是一款潜在的同类首创EGFRxHER3双特异性抗体偶联药物（ADC），具有治疗肺癌和乳腺癌以及其他肿瘤患者的潜力
This collaboration combines SystImmune’s ADC expertise with Bristol Myers Squibb’s clinical development and oncology leadership to further advance the potential of BL-B01D1, and further diversifies Bristol Myers Squibb’s oncology portfolio and enhances the company’s presence in the ADC space
这项合作联合了SystImmune在ADC药物领域的专业能力和百时美施贵宝在临床开发及肿瘤学的领导力，将进一步推动BL-B01D1的发展潜力，并能丰富百时美施贵宝的肿瘤学产品组合，强化公司在ADC药物领域的影响力
REDMOND, WA & PRINCETON, N.J. — December 11, 2023—SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb (NYSE: BMY) today announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world.
华盛顿雷德蒙德和新泽西普林斯顿，2023年12月11日 - 处于临床阶段的生物制药公司SystImmune和百时美施贵宝（纽交所代码：BMY）于2023年12月11日宣布就SystImmune的BL-B01D1达成独家许可与合作协议。BL-B01D1是一款潜在的同类首创EGFR/HER3双特异性抗体药物偶联物（ADC）。根据协议，双方将合作推动BL-B01D1在美国的开发和商业化。SystImmune将通过其关联公司独家负责BL-B01D1在中国大陆的开发、商业化以及在中国大陆的生产，并负责生产部分供中国大陆以外地区使用的药品。百时美施贵宝将独家负责BL-B01D1在全球其他地区的开发和商业化。
BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global multi-center Phase 1 study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical studies of BL-B01D1 were presented in 2023 at ASCO, ESMO and the San Antonio Breast Cancer Symposium; these data demonstrate promising anti-tumor activity in patients with a range of solid tumors that had progressed after standard of care treatments, including NSCLC and breast cancer.
BL-B01D1是一种基于双特异性拓扑异构酶抑制剂的ADC，可同时靶向作用于表皮生长因子受体和人表皮生长因子受体3（EGFR X HER3）。目前正在开展全球多中心I期临床研究（BL-B01D1-LUNG101），以评估其在转移性或不可切除的非小细胞肺癌（NSCLC）患者中的安全性和有效性。BL-B01D1的早期临床研究数据已在2023年的美国临床肿瘤学会年会（ASCO）、欧洲医学肿瘤学会年会（ESMO）以及圣安东尼奥乳腺癌研讨会（SABCS）上被公布。这些数据显示，BL-B01D1在经标准治疗后疾病进展的非小细胞肺癌、乳腺癌患者中，表现出具有开发前景的抗肿瘤活性。
“Recent BL-B01D1 trials have shown broad potential across different solid tumors as well as a manageable safety profile,” said Dr. Yi Zhu, Chief Ｅxecutive Officer at SystImmune. “We have long admired Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology, and this strategic collaboration is an exciting step forward in delivering potential antitumor medicines to patients worldwide. We look forward to a productive partnership.”
SystImmune首席执行官朱义博士表示：” 近期BL-B01D1的临床试验表明，该药物在已接受治疗的多种实体瘤患者中展现出广泛的抗肿瘤潜力，同时具有可管理的安全性特征， 我们长期以来一直钦佩百时美施贵宝在肿瘤领域的研发、创新和商业化能力。这次战略合作是向全球患者提供潜在抗肿瘤药物的重要一步。我们期待着积极和富有成果的合作。”
“Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said Samit Hirawat, MD, Ｅxecutive Vice President, Chief Medical Officer, Global Drug Development at Bristol Myers Squibb. “SystImmune’s BL-B01D1 adds yet another ADC to our diverse pipeline and helps strengthen our approach of matching the most appropriate therapeutic modality to areas of unmet medical need across solid tumor oncology. We look forward to working with SystImmune to advance BL-B01D1 in hopes of offering a differentiated treatment option for patients in need.”
百时美施贵宝全球执行副总裁、首席医学官兼药物开发负责人赫思鸣（Samit Hirawat）博士表示:“与SystImmune的合作将加强我们在肿瘤学领域的领导地位，也一以贯之了我们通过不止步于免疫肿瘤的多元化发展来改变患者生命的战略。SystImmune的BL-B01D1使我们多元化的研发管线又多了一款ADC，这与我们为尚未被满足的实体瘤治疗需求提供最合适治疗模式的战略充分契合。我们期待携手SystImmune，让BL-B01D1成为有需求患者的差异化治疗选择。“
Financial Highlights
Bristol Myers Squibb will pay SystImmune $800 million in an upfront payment and up to $500 million in contingent near-term payments. SystImmune is eligible to receive additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones for a total potential consideration of up to $8.4 billion. The companies will share certain global development expenses and profits and losses in the United States. Through its affiliates, SystImmune will retain exclusive development and commercialization rights in Mainland China, where Bristol Myers Squibb will receive a royalty on net sales. Outside the United States and Mainland China, SystImmune will receive a tiered royalty on net sales. The agreement is subject to customary clearance by antitrust regulators.
交易概况
百时美施贵宝将向SystImmune支付8亿美元的首付款，和最高可达5亿美元的近期或有付款；达成开发、注册和销售里程碑后，SystImmune将获得最高可达71亿美元的额外付款；潜在总交易额最高可达84亿美元。双方公司将分担 BL-BO1D1 全球开发费用，以及在美国市场的利润和亏损。SystImmune将通过其关联公司保留 BL-B01D1在中国大陆的独家开发和商业化权利，百时美施贵宝将从中国大陆的净销售额中获得特许权使用费。在美国和中国大陆以外，SystImmune将从净销售额中收取分级特许权使用费。此协议尚需获得反垄断监管机构的必要批准。
About SystImmune’s BL-B01D1
BL-B01D1 is a potentially first-in-class bispecific ADC developed by SystImmune, targeting both EGFR and HER3, which are highly expressed in most epithelial tumors. BL-B01D1 is comprised of SystImmune's proprietary bispecific antibody and linker-payload which contains a stable, cleavable linker and a topoisomerase inhibitor.
关于BL-B01D1
BL-B01D1是由SystImmune开发的首创双特异性抗体ADC药物，可靶向在大多数上皮性肿瘤中高度表达的EGFR和HER3。BL-B01D1由SystImmune 独家拥有的双特异性抗体和 “连接子 - 有效载荷”组成，其中包含稳定的、可切割的连接子和拓扑异构酶抑制剂。
About SystImmune
SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. SystImmune specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bispecific, multi-specific antibodies, and ADCs. For more information visit systimmune.com.
关于SystImmune
SystImmune是一家位于华盛顿州雷德蒙德的临床阶段生物制药公司。SystImmune致力于利用其已建立的成熟药物开发平台开发创新的癌症疗法，专注于双特异性、多特异性抗体和抗体药物偶联物（ADCs）的研发。欲了解更多信息，请访问systimmune.com。
Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
关于Bristol Myers Squibb
Bristol Myers Squibb是一家全球性生物制药公司，其使命是发现、开发并提供创新药物，帮助患者战胜严重疾病。欲了解更多关于Bristol Myers Squibb的信息，请访问BMS.com，或在领英、推特、YouTube、Facebook和Instagram上关注。
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