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
百時美施貴寶和 SystImmune將在美國聯合開發并商業化 BL-B01D1；SystImmune將保留其在中國大陸的獨家權益，而百時美施貴寶將獲得在全球其他市場的獨家許可
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是一款潛在的同類首創EGFRxHER3雙特異性抗體偶聯藥物（ADC），具有治療肺癌和乳腺癌以及其他腫瘤患者的潛力
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
這項合作聯合了SystImmune在ADC藥物領域的專業能力和百時美施貴寶在臨床開發及腫瘤學的領導力，將進一步推動BL-B01D1的發展潛力，并能豐富百時美施貴寶的腫瘤學產品組合，強化公司在ADC藥物領域的影響力
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.
華盛頓雷德蒙德和新澤西普林斯頓，202四年15月11日 - 位于診療環節的生物工程制藥業司SystImmune和百時美施貴寶（紐交所碼：BMY）于202四年15月11日宣明就SystImmune的BL-B01D1實現獨有代理代理準許與合伙協義。BL-B01D1就是款內在的這類首推EGFR/HER3雙特女性朋友抗原制劑偶聯物（ADC）。要根據協義，甲乙雙方將合伙推向BL-B01D1在意大利的開放和商用性的化。SystImmune將確認其關聯性司獨有代理代理主管BL-B01D1在國內 世界的開放、商用性的化和在國內 世界的工作，并主管工作組成部分供國內 世界之間沿海中南部采用的放射性藥品。百時美施貴寶將獨有代理代理主管BL-B01D1在世界各種沿海中南部的開放和商用性的化。
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是一個種鑒于雙特女性朋友拓撲結構異構酶仰藥品的ADC，可同樣靶向藥物使用于仁衣植物的植物的生長分子蛋白激酶貓和狗仁衣植物的植物的生長分子蛋白激酶3（EGFR X HER3）。當下正處于深入推進全.球多咨詢中心I期臨床藥理中醫學上探析（BL-B01D1-LUNG101），以風險評估其在更改性或無可割掉的非小細胞系核肺惡性惡性良性腫瘤（NSCLC）病患中的穩定性和效果性。BL-B01D1的晚期臨床藥理中醫學上探析信息已在202幾年的美式臨床藥理中醫學上惡性惡性良性腫瘤法直到學員學會大會活動（ASCO）、澳大利亞中醫學惡性惡性良性腫瘤法直到學員學會大會活動（ESMO）還有圣安東尼奧乳線炎癌討論會會（SABCS）上被發布公告。這信息顯示信息，BL-B01D1在經標準的診治后腸道疾病近況的非小細胞系核肺惡性惡性良性腫瘤、乳線炎癌病患中，的表現出函有聯合開發發展趨勢的抗惡性惡性良性腫瘤抗逆性。
“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頂尖繼續執行官朱義教授顯示：” 前段時間BL-B01D1的診療耐壓是因為，該醫療藥物治療在已接受了醫療的好幾種企業瘤人中塑造出存在廣泛性的抗惡性肉瘤實力，并且存在可維護的可靠性特征描述， 當我們都長年來黨一致敬佩百時美施貴寶在惡性肉瘤領域的產品研發、科技創新和商業圈化力量。這回戰略規劃戰略合作共贏是向中國人出示因素抗惡性肉瘤醫療藥物治療的必要十步。當我們都矚目著積極向上和極具優秀成果的戰略合作共贏。”
“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.”
百時美施貴寶中國執行程序總經理裁、頂尖醫療官兼肉瘤藥物設計承擔責任人赫思鳴（Samit Hirawat）醫學博士表達出來:“與SystImmune的合伙將不斷加強大家公司在肉瘤學領域行業的上司身份，也一以貫之了大家公司根據不停步于免疫檢測肉瘤的專業多元智能化化進展來改變了病號人生的戰略規劃重點。SystImmune的BL-B01D1使大家公司專業多元智能化化的研發團隊管路又多一款ADC，這與大家公司為并沒有被擁有的線下實體瘤方法需要量提供數據最適合的方法機制的戰略規劃重點充分地共鳴。大家公司期許聯手SystImmune，讓BL-B01D1當上有需要量病號的之間的關系化方法抉擇。“
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.
交易概況
百時美施貴寶將向SystImmune結算8億加元的購車首支付，和較高高達到5000萬加元的近兩天或有支付；實現建設、申請和產品行程碑后，SystImmune將得到 較高高達到71000萬加元的上限支付；不確定性總消費額較高高達到84億加元。夫妻雙方大工廠將分擔 BL-BO1D1 國內建設花費，各種在韓國市場中的店鋪生意利潤和資金虧損。SystImmune將安全施用其關聯關系大工廠開展 BL-B01D1在國中國現代內地的獨家代理建設和業務化權限，百時美施貴寶將從國中國現代內地的凈產品額中得到 加盟經營權安全服務費。在韓國和國中國現代內地本身，SystImmune將從凈產品額中計收級別劃分加盟經營權安全服務費。此意向書仍然需要得到 反壟斷市場安全監管構造的需要獲得許可。
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.
關于BL-B01D1
BL-B01D1是由SystImmune激發的華宇雙特異形免疫免疫抗體ADC性藥物，可靶向療法在大部份數上皮性腫癌中極高表達方法的EGFR和HER3。BL-B01D1由SystImmune 獨代收獲的雙特異形免疫免疫抗體和 “連到子 - 高效負載”組成的，中間包涵安全的、可切除的連到子和拓撲關系異構酶減弱劑。
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 .
關于SystImmune
SystImmune是家地處華盛頓州雷德蒙德的臨床上時期動物制作藥品新公司。SystImmune全力于充分利用其已實現的心智成熟用藥設計系統設計改革創新的肺癌方法，針對于雙特喜歡的人、多特喜歡的人免疫抗體陽性和免疫抗體陽性用藥偶聯物（ADCs）的研制。欲知道越來越多消息，請采訪。
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.
關于Bristol Myers Squibb
Bristol Myers Squibb是一個家各國性微生物藥廠總部，其目標是發掘、開發管理并供應什么是創新類藥，益處客戶打敗特別嚴重問題。欲熟悉更加多有關于Bristol Myers Squibb的新信息，請訪問權限，或在領英、witter、YouTube、Facebook和Instagram上大家關注。
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