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(shí)美施貴寶和 SystImmune將在美國聯(lián)合開發(fā)并商業(yè)化 BL-B01D1；SystImmune將保留其在中國大陸的獨(dú)家權(quán)益，而百時(shí)美施貴寶將獲得在全球其他市場的獨(dú)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(chuàng)EGFRxHER3雙特異性抗體偶聯(lián)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(xiàng)合作聯(lián)合了SystImmune在ADC藥物領(lǐng)域的專業(yè)能力和百時(shí)美施貴寶在臨床開發(fā)及腫瘤學(xué)的領(lǐng)導(dǎo)力，將進(jìn)一步推動BL-B01D1的發(fā)展?jié)摿Γ⒛茇S富百時(shí)美施貴寶的腫瘤學(xué)產(chǎn)品組合，強(qiáng)化公司在ADC藥物領(lǐng)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，2023年12月11日 - 處于臨床階段的生物制藥公司SystImmune和百時(shí)美施貴寶（紐交所代碼：BMY）于2023年12月11日宣布就SystImmune的BL-B01D1達(dá)成獨(dú)家許可與合作協(xié)議。BL-B01D1是一款潛在的同類首創(chuàng)EGFR/HER3雙特異性抗體藥物偶聯(lián)物（ADC）。根據(jù)協(xié)議，雙方將合作推動BL-B01D1在美國的開發(fā)和商業(yè)化。SystImmune將通過其關(guān)聯(lián)公司獨(dú)家負(fù)責(zé)BL-B01D1在中國大陸的開發(fā)、商業(yè)化以及在中國大陸的生產(chǎn)，并負(fù)責(zé)生產(chǎn)部分供中國大陸以外地區(qū)使用的藥品。百時(shí)美施貴寶將獨(dú)家負(fù)責(zé)BL-B01D1在全球其他地區(qū)的開發(fā)和商業(yè)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是一種基于雙特異性拓?fù)洚悩?gòu)酶抑制劑的ADC，可同時(shí)靶向作用于表皮生長因子受體和人表皮生長因子受體3（EGFR X HER3）。目前正在開展全球多中心I期臨床研究（BL-B01D1-LUNG101），以評估其在轉(zhuǎn)移性或不可切除的非小細(xì)胞肺癌（NSCLC）患者中的安全性和有效性。BL-B01D1的早期臨床研究數(shù)據(jù)已在2023年的美國臨床腫瘤學(xué)會年會（ASCO）、歐洲醫(yī)學(xué)腫瘤學(xué)會年會（ESMO）以及圣安東尼奧乳腺癌研討會（SABCS）上被公布。這些數(shù)據(jù)顯示，BL-B01D1在經(jīng)標(biāo)準(zhǔn)治療后疾病進(jìn)展的非小細(xì)胞肺癌、乳腺癌患者中，表現(xiàn)出具有開發(fā)前景的抗腫瘤活性。
“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首席執(zhí)行官朱義博士表示：” 近期BL-B01D1的臨床試驗(yàn)表明，該藥物在已接受治療的多種實(shí)體瘤患者中展現(xiàn)出廣泛的抗腫瘤潛力，同時(shí)具有可管理的安全性特征， 我們長期以來一直欽佩百時(shí)美施貴寶在腫瘤領(lǐng)域的研發(fā)、創(chuàng)新和商業(yè)化能力。這次戰(zhàn)略合作是向全球患者提供潛在抗腫瘤藥物的重要一步。我們期待著積極和富有成果的合作。”
“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.”
百時(shí)美施貴寶全球執(zhí)行副總裁、首席醫(yī)學(xué)官兼藥物開發(fā)負(fù)責(zé)人赫思鳴（Samit Hirawat）博士表示:“與SystImmune的合作將加強(qiáng)我們在腫瘤學(xué)領(lǐng)域的領(lǐng)導(dǎo)地位，也一以貫之了我們通過不止步于免疫腫瘤的多元化發(fā)展來改變患者生命的戰(zhàn)略。SystImmune的BL-B01D1使我們多元化的研發(fā)管線又多了一款A(yù)DC，這與我們?yōu)樯形幢粷M足的實(shí)體瘤治療需求提供最合適治療模式的戰(zhàn)略充分契合。我們期待攜手SystImmune，讓BL-B01D1成為有需求患者的差異化治療選擇。“
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(shí)美施貴寶將向SystImmune支付8億美元的首付款，和最高可達(dá)5億美元的近期或有付款；達(dá)成開發(fā)、注冊和銷售里程碑后，SystImmune將獲得最高可達(dá)71億美元的額外付款；潛在總交易額最高可達(dá)84億美元。雙方公司將分擔(dān) BL-BO1D1 全球開發(fā)費(fèi)用，以及在美國市場的利潤和虧損。SystImmune將通過其關(guān)聯(lián)公司保留 BL-B01D1在中國大陸的獨(dú)家開發(fā)和商業(yè)化權(quán)利，百時(shí)美施貴寶將從中國大陸的凈銷售額中獲得特許權(quán)使用費(fèi)。在美國和中國大陸以外，SystImmune將從凈銷售額中收取分級特許權(quán)使用費(fèi)。此協(xié)議尚需獲得反壟斷監(jiān)管機(jī)構(gòu)的必要批準(zhǔn)。
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(guān)于BL-B01D1
BL-B01D1是由SystImmune開發(fā)的首創(chuàng)雙特異性抗體ADC藥物，可靶向在大多數(shù)上皮性腫瘤中高度表達(dá)的EGFR和HER3。BL-B01D1由SystImmune 獨(dú)家擁有的雙特異性抗體和 “連接子 - 有效載荷”組成，其中包含穩(wěn)定的、可切割的連接子和拓?fù)洚悩?gòu)酶抑制劑。
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 systimmune.com.
關(guān)于SystImmune
SystImmune是一家位于華盛頓州雷德蒙德的臨床階段生物制藥公司。SystImmune致力于利用其已建立的成熟藥物開發(fā)平臺開發(fā)創(chuàng)新的癌癥療法，專注于雙特異性、多特異性抗體和抗體藥物偶聯(lián)物（ADCs）的研發(fā)。欲了解更多信息，請?jiān)L問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.
關(guān)于Bristol Myers Squibb
Bristol Myers Squibb是一家全球性生物制藥公司，其使命是發(fā)現(xiàn)、開發(fā)并提供創(chuàng)新藥物，幫助患者戰(zhàn)勝嚴(yán)重疾病。欲了解更多關(guān)于Bristol Myers Squibb的信息，請?jiān)L問BMS.com，或在領(lǐng)英、推特、YouTube、Facebook和Instagram上關(guān)注。
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