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(he)新(xin)澤西普林(lin)斯頓，2025年1二月11日(ri) - 正處于醫學過程(cheng)的(de)(de)(de)生(sheng)(sheng)物(wu)學藥(yao)業有限(xian)集團的(de)(de)(de)集團的(de)(de)(de)SystImmune和(he)百(bai)時美施(shi)貴寶(bao)（紐(niu)交所編碼：BMY）于2025年1二月11日(ri)官宣了就SystImmune的(de)(de)(de)BL-B01D1獲得強勢來(lai)(lai)襲準(zhun)許(xu)與聯合合同范(fan)本書。BL-B01D1有的(de)(de)(de)是款(kuan)內(nei)在(zai)(zai)的(de)(de)(de)相近華宇EGFR/HER3雙特男人(ren)抵抗能力(li)類藥(yao)物(wu)偶聯物(wu)（ADC）。據合同范(fan)本書，男女雙方(fang)將聯合著力(li)推(tui)進(jin)BL-B01D1在(zai)(zai)意大利的(de)(de)(de)研發和(he)商務化(hua)。SystImmune將運(yun)用(yong)其(qi)綁定qq集團的(de)(de)(de)強勢來(lai)(lai)襲提(ti)供BL-B01D1在(zai)(zai)中人(ren)大內(nei)地(di)的(de)(de)(de)研發、商務化(hua)已經(jing)在(zai)(zai)中人(ren)大內(nei)地(di)的(de)(de)(de)生(sheng)(sheng)育(yu)，并提(ti)供生(sheng)(sheng)育(yu)有些供中人(ren)大內(nei)地(di)多于中南(nan)部(bu)運(yun)用(yong)的(de)(de)(de)放(fang)射性藥(yao)品。百(bai)時美施(shi)貴寶(bao)將強勢來(lai)(lai)襲提(ti)供BL-B01D1在(zai)(zai)世界十(shi)大其(qi)它中南(nan)部(bu)的(de)(de)(de)研發和(he)商務化(hua)。
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不(bu)是種鑒于(yu)(yu)雙(shuang)非(fei)特異朋友拓補異構(gou)酶抑制功(gong)效劑的(de)(de)ADC，可(ke)的(de)(de)同時靶點功(gong)效于(yu)(yu)上皮組(zu)織發育(yu)細胞成(cheng)分(fen)腎上腺(xian)(xian)素腎上腺(xian)(xian)素受體兩個人上皮組(zu)織發育(yu)細胞成(cheng)分(fen)腎上腺(xian)(xian)素腎上腺(xian)(xian)素受體3（EGFR X HER3）。當下尚未開展調研(yan)高(gao)度多中(zhong)心站(zhan)I期臨(lin)床藥理(li)理(li)論研(yan)究(jiu)探(tan)(tan)析(xi)探(tan)(tan)析(xi)（BL-B01D1-LUNG101），以評詁其在(zai)適當轉(zhuan)移或不(bu)可(ke)以切去的(de)(de)非(fei)小細胞非(fei)小內部(bu)非(fei)小細胞肺(fei)癌(ai)（NSCLC）用戶中(zhong)的(de)(de)安(an)全可(ke)靠性(xing)和(he)效果性(xing)。BL-B01D1的(de)(de)最早期臨(lin)床藥理(li)理(li)論研(yan)究(jiu)探(tan)(tan)析(xi)探(tan)(tan)析(xi)動態(tai)(tai)統計資(zi)料已在(zai)202四(si)年(nian)的(de)(de)美利堅(jian)共和(he)國臨(lin)床藥理(li)理(li)論研(yan)究(jiu)探(tan)(tan)析(xi)淋(lin)巴(ba)(ba)癌(ai)腫(zhong)(zhong)研(yan)究(jiu)會(hui)(hui)(hui)公司(si)企(qi)業年(nian)會(hui)(hui)(hui)（ASCO）、歐(ou)洲(zhou)各(ge)國醫學(xue)界淋(lin)巴(ba)(ba)癌(ai)腫(zhong)(zhong)研(yan)究(jiu)會(hui)(hui)(hui)公司(si)企(qi)業年(nian)會(hui)(hui)(hui)（ESMO）與圣安(an)東尼奧乳(ru)腺(xian)(xian)纖維(wei)纖維(wei)癌(ai)專題會(hui)(hui)(hui)會(hui)(hui)(hui)（SABCS）上被公布。那些動態(tai)(tai)統計資(zi)料彰顯，BL-B01D1在(zai)經(jing)標淮診治后疾病癥狀(zhuang)重大(da)突破的(de)(de)非(fei)小細胞非(fei)小內部(bu)非(fei)小細胞肺(fei)癌(ai)、乳(ru)腺(xian)(xian)纖維(wei)纖維(wei)癌(ai)用戶中(zhong)，的(de)(de)表現出函(han)有開發未來趨勢(shi)的(de)(de)抗淋(lin)巴(ba)(ba)癌(ai)腫(zhong)(zhong)活(huo)性(xing)酶。
“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頂尖審理官朱義搏士說明(ming)：” 最進BL-B01D1的臨(lin)床藥(yao)學經過多次實驗發(fa)現證明(ming)，該中藥(yao)在已(yi)認可(ke)手(shou)術(shu)治療的各(ge)種(zhong)實體(ti)的瘤糖尿(niao)病求美(mei)者(zhe)中展示出出廣(guang)泛應用的抗(kang)癌腫優(you)勢，同時(shi)含有可(ke)管控的平(ping)安性特色， 你(ni)們都經常(chang)性起來一(yi)種(zhong)佩服百(bai)時(shi)美(mei)施貴寶(bao)在癌腫區域的產品研發(fa)、研發(fa)和服務(wu)業(ye)化(hua)效果。這一(yi)次戰略(lve)布(bu)局達成達成合作是向中國糖尿(niao)病求美(mei)者(zhe)可(ke)以(yi)提供潛在的抗(kang)癌腫中藥(yao)的首要(yao)1步。你(ni)們都感(gan)觸著(zhu)及(ji)時(shi)和極富成就的達成達成合作。”
“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.”
百時美施貴(gui)寶環球連接總監裁、首席總裁醫美官兼藥建(jian)設(she)有擔當(dang)人赫思鳴（Samit Hirawat）搏士(shi)帶表:“與(yu)(yu)SystImmune的(de)(de)相互合作將增加咱(zan)們(men)(men)公(gong)司(si)大(da)(da)家(jia)在淋巴良(liang)性腫瘤(liu)學領(ling)域的(de)(de)干部認知度，也一以貫之(zhi)了咱(zan)們(men)(men)公(gong)司(si)大(da)(da)家(jia)確認不是只有步于免疫性淋巴良(liang)性腫瘤(liu)的(de)(de)多(duo)樣化不斷發展來變動的(de)(de)人生活(huo)的(de)(de)戰(zhan)略定位(wei)重點。SystImmune的(de)(de)BL-B01D1使(shi)咱(zan)們(men)(men)公(gong)司(si)大(da)(da)家(jia)多(duo)樣化的(de)(de)新產品研發輸水管線又(you)多(duo)沒(mei)事款(kuan)ADC，這與(yu)(yu)咱(zan)們(men)(men)公(gong)司(si)大(da)(da)家(jia)為還被充分的(de)(de)滿足的(de)(de)實體(ti)線瘤(liu)診(zhen)(zhen)療(liao)使(shi)用需求(qiu)(qiu)量供應最(zui)適宜診(zhen)(zhen)療(liao)經濟模式的(de)(de)戰(zhan)略定位(wei)重點充分的(de)(de)切合。咱(zan)們(men)(men)公(gong)司(si)大(da)(da)家(jia)期許共同SystImmune，讓(rang)BL-B01D1成了有使(shi)用需求(qiu)(qiu)量的(de)(de)人的(de)(de)差異(yi)性化診(zhen)(zhen)療(liao)會選擇。“
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
百時美(mei)(mei)施貴寶將(jiang)向SystImmune付 8億(yi)澳元(yuan)的(de)首支(zhi)付帳項(xiang)的(de)款，和(he)是(shi)(shi)最(zui)好(hao)的(de)能(neng)達(da)10億(yi)澳元(yuan)的(de)近幾年或有(you)支(zhi)付帳項(xiang)；確立(li)搭(da)建、注冊成功和(he)銷(xiao)(xiao)量公里數碑(bei)后(hou)，SystImmune將(jiang)兌(dui)(dui)換是(shi)(shi)最(zui)好(hao)的(de)能(neng)達(da)75000萬澳元(yuan)的(de)另外支(zhi)付帳項(xiang)；因素總消費(fei)額(e)是(shi)(shi)最(zui)好(hao)的(de)能(neng)達(da)84億(yi)澳元(yuan)。夫妻之間(jian)企(qi)業(ye)將(jiang)分擔 BL-BO1D1 世界(jie)各國搭(da)建價格，并且(qie) 在(zai)(zai)歐(ou)美(mei)(mei)領域的(de)盈利空(kong)間(jian)和(he)盈利。SystImmune將(jiang)按照其關連(lian)企(qi)業(ye)補齊 BL-B01D1在(zai)(zai)中(zhong)(zhong)地區(qu)的(de)獨門搭(da)建和(he)商(shang)業(ye)區(qu)化支(zhi)配權(quan)，百時美(mei)(mei)施貴寶將(jiang)從里面地區(qu)的(de)凈銷(xiao)(xiao)量額(e)中(zhong)(zhong)兌(dui)(dui)換許(xu)可權(quan)安全(quan)服(fu)務費(fei)。在(zai)(zai)歐(ou)美(mei)(mei)和(he)中(zhong)(zhong)地區(qu)其它，SystImmune將(jiang)從凈銷(xiao)(xiao)量額(e)中(zhong)(zhong)返還分級管(guan)理許(xu)可權(quan)安全(quan)服(fu)務費(fei)。此合同樣本(ben)有(you)待兌(dui)(dui)換反惡性(xing)競爭(zheng)管(guan)理企(qi)業(ye)的(de)必(bi)要(yao)的(de)獲得許(xu)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開(kai)放的(de)首(shou)推(tui)雙(shuang)(shuang)活性(xing)(xing)(xing)朋友抗體陽性(xing)(xing)(xing)陽性(xing)(xing)(xing)ADC藥物劑量，可(ke)靶點在大多(duo)都數上皮性(xing)(xing)(xing)腫癌中角度體現的(de)EGFR和HER3。BL-B01D1由SystImmune 獨特擁有著的(de)雙(shuang)(shuang)活性(xing)(xing)(xing)朋友抗體陽性(xing)(xing)(xing)陽性(xing)(xing)(xing)和 “無線鏈接子 - 更有效載(zai)荷系數”組合(he)，這(zhe)當中構成(cheng)穩定(ding)性(xing)(xing)(xing)高的(de)、可(ke)打磨的(de)無線鏈接子和拓撲關系異構酶促(cu)使(shi)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也是家靠近華(hua)盛頓州雷德蒙德的臨床護理第一階段生物制品醫藥(yao)集團(tuan)我司。SystImmune著(zhu)力(li)推進于合理利用其已創立(li)的成熟完善(shan)腫瘤(liu)口服(fu)藥(yao)物設計APP設計轉(zhuan)型升級的癌病治療法，針對(dui)于雙活性(xing)(xing)聊天、多活性(xing)(xing)聊天抵抗能力(li)和抵抗能力(li)腫瘤(liu)口服(fu)藥(yao)物偶聯物（ADCs）的新產品研(yan)發(fa)。欲了解到多問(wen)題，請訪(fang)問(wen)瀏(liu)覽。
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都是家高度性生物技術生物制藥單位，其擔當是表明、開發管理并給予革新類藥，幫住求美者打敗可怕癥狀。欲了解一下較多關羽Bristol Myers Squibb的圖片信息，請采訪，或在(zai)領英、推遲(chi)、YouTube、Facebook和Instagram上大家關注(zhu)。
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