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，2024年13月11日 - 处在临床试验分阶段的生物制品制药博鱼体育app 司SystImmune和百时美施贵宝（纽交所码：BMY）于2024年13月11日即日起就SystImmune的BL-B01D1达到目标全权首发允许与加盟合同协商。BL-B01D1是一个款潜在性的的同行开创EGFR/HER3双炎症因子朋友表面抗原药偶联物（ADC）。随着合同协商，彼此将加盟促进推动BL-B01D1在英国的建设和工业化。SystImmune将依据其锁定司全权首发主要责任人BL-B01D1在在我国现代世界的建设、工业化或者在在我国现代世界的产出，并主要责任人产出区域供在我国现代世界之间的地方用的医疗药品。百时美施贵宝将全权首发主要责任人BL-B01D1在世界各国的的地方的建设和工业化。
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 pꦰromising 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都是种针对双非特异聊天拓扑关系异构酶限剂型的ADC，可的同时靶点用处于皮下组织生张要素蛋白激酶人与人皮下组织生张要素蛋白激酶3（EGFR X HER3）。现在正实施全球各地多重心I期药学探究（BL-B01D1-LUNG101），以分析其在转到性或不宜淋巴恶性淋巴肿瘤切除的非小細胞非小细胞膜肺癌病患（NSCLC）客户中的平安性和有郊性。BL-B01D1的早期药学探究统计资料已在202三年的美药学淋巴恶性淋巴肿瘤协会公司公司年会（ASCO）ꦍ、荷兰医学专业淋巴恶性淋巴肿瘤协会公司公司年会（ESMO）各种圣安东尼奥乳腺癌炎癌研究讨论会（SABCS）上被展示。以上统计资料表示，BL-B01D1在经标准单位诊治后慢性病发展的非小細胞非小细胞膜肺癌病患、乳腺癌炎癌客户中，特征出函有开发设计发展的抗淋巴恶性淋巴肿瘤生物。
“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总裁来执行官朱义博土写出：” 近几日BL-B01D1的临床实践现场实验揭示，该口服药在已接纳控制的好几种直营瘤朋友中能够 出广泛的的抗良性癌症空间，同一拥有可经营的安会性特点， 博鱼体育app 长时间来说一致崇拜百时美施贵宝在良性癌症科技领域的生产研发、转型升级和房地产业化水平。这次在博鱼体育app 战略合伙是向亚洲朋友可以提供暗藏抗良性癌症口服药的为重要三步。博鱼体育app 瞩目着多方面和精神抖擞效果的合伙。”
“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, Ｅxecutiv༺e 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 op🐟tion for patients in need.”
百时美施贵宝全球各地审理总经理裁、首席总裁临床医学官兼药物剂量制作出示人赫思鸣（Samit Hirawat）医生指出:“与SystImmune的协作将强化博鱼体育app 在肺部肿癌学域的领导干部认知度，也一以贯之了博鱼体育app 采用不尽步于免疫抗体肺部肿癌的多块大洋化发展进步来改动客户生命的意义的方式。SystImmune的BL-B01D1使博鱼体育app 多块大洋化的生产制造的管道又多了一大款ADC，这与博鱼体育app 为无法被出示的小平面瘤的医治诉求出示最适合的的医治机制的方式充分的切合。博鱼体育app 盼望着共谱SystImmune，让BL-B01D1加入有诉求客户的一定的差异化经营的医治进行。“
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缴付8亿人民币的购车首结账，和最快led光通量3亿人民币的近些年或有结账；已达成开放、注册申请和推销公里数碑后，SystImmune将才能得到最快led光通量72亿人民币的加倍结账；潜在的总的收入额总额最快led光通量84亿人民币。夫妻双方工厂将分担 BL-BO1D1 世界十大开放的费用，或是在美利坚行业的利润率和坏账。SystImmune将确认其微信关联工厂𒉰保存 BL-B01D1在国内有內♋地的独特开放和商业区化知情权，百时美施贵宝将从当国内有內地的净推销额中才能得到许可权动用费。在美利坚和国内有內地之内，SystImmune将从净推销额中会收取等级许可权动用费。此协商还需才能得到反行业垄断安全监管贷款机构的必需审批。
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联合开发的第一次双特女性朋友抵抗能力ADC中成药，可靶向疗法在基本上都数上皮性淋ꦰ巴肿瘤中极高呈现的EGFR和HER3。BL-B01D1由SystImmune 独代得到的双特女性朋友抵抗能力和 “联系子 - 合理力矩”结构，当中👍带有保持稳定的、可激光切的联系子和拓扑关系异构酶克溶液剂。
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 .
关于SystImmune
SystImmune就是一家隶属于华盛顿州雷德蒙德的临床药学价段生物制品医药集团有限公司。SystImmune强院ꦗ于合理利用其ꦿ已搭建的稳定口服药发掘管理系统发掘管理创新技术的癌病中医疗法，用心打造于双特女性朋友、多特女性朋友免疫表面抗原和免疫表面抗原口服药偶联物（ADCs）的产品研发。欲要了解更好地信息查询，请访问浏览。
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 L♐inkedIn, Twitter, YouTube, Facebook and Instagram.
关于Bristol Myers Squibb
Bristol Myers Squibb不是家全国性微生物药厂工司，其任务是发现、定制开发并打造博鱼体育app 创新中成药，帮住自身取胜比较严重病毒。欲了解一下一些就Bristol Myers Squibb的消息，请采访，或在领英、推迟、YouTube、Facebook和Instagram上关注博鱼体育app 。
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