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上海 2023年10月15日 /美通社/ -- 第六届中国国际进口博览会（以下简称"进博会"）倒计时20天之际，作为进博会医疗器械专业委员会副会长单位，美敦力将以"生命因科技不凡"的主题，携60余款创新展品，包括一款全球首展、一款亚太首展和六款中国首秀产品，亮相进博舞台。同时还将首次在进博会上发布以人工智能驱动的骨科及神外手术生态系统，全面展示美敦力科技创新应用于医疗领域的革命性成果。 作为进博"老友"，美敦力深度参与每一届进博会，共累积带来近300款创新产品及疗法，其中包括近50款首展产品和技术。依托进博会平台强大的影响力和溢出效应，美敦力加速从产品进口向本土化制造跃升，再到本土价值链的全面建设，同时助力中国本土医疗科技产业的整体发展。 美敦力全球高级副总裁及大中华区总裁顾宇韶先生 表示："进博会是中国链接世界、共享中国发展机遇的重要舞台。美敦力与进博携手同行六年，我们期待借助进博会强大的影响力和溢出效应，加速引入美敦力全球创新科技进入中国，全面激发中国本土创新能力，携手更多的行业合作伙伴，持续助力中国医疗健康事业发展，为构筑‘健康中国'贡献更多力量。" 年年上新，全球顶尖创新展品接力亮相 今年，美敦力有八款来自不同治疗领域的创新产品和技术将在进博会上迎来首秀。其中，全球首展产品PulseSelect™脉冲场消融系统是电生理领域前沿消融技术的代表之作，也是首个进入国家药品监督管理局创新医疗器械特别审批通道的心脏脉冲场消融产品，获批后美敦力将成为国内首个同时具备"冰火电"三种消融能量类型的心脏电生理整体解决方案提供者。此外，美敦力新一代ClosureFast静脉腔内射频闭合导管将首次在亚太地区展出，相较上一代产品，全面升级后的ClosureFast将有效提升手术效率与治疗体验，为中国近一亿潜在静脉曲张患者提供新的治疗选择。 除此之外，美敦力带来六款中国首秀产品。其中，五款来自于心脏及血管相关领域，包括被誉为"全球最小心脏起搏器" [i] 的升级版本--Micra™ VR 2 & Micra™ AV 2，其电池寿命最长可提升至近17年；全球首个获得FDA批准的短瘤颈肾下腹主动脉瘤解决方案Heli-FX™ EndoAnchor™系统，该系统适用于腔内主动脉覆膜支架和自体动脉之间的固定和密封，大大降低在肾下腹主动脉瘤手术中发生内漏或其他并发症的风险；Concerto可解脱弹簧圈适用于外周血管动脉和静脉栓塞，可在术中提供良好的血管贴合效果及成型性以及快速、可靠的输送和解脱；SimuForm™半硬质成型环适用于心脏外科二尖瓣修复，可使术后收缩期前向运动症发生率降低，同时能大幅提高手术的安全性；Attain Stability™ Quad MRI SureScan™ 4798植入式左心室起搏电极导线，提升心脏起搏器植入的精准度，减少电极脱落的风险。此外，美敦力PillCam Patency探路胶囊也将首次亮相，作为可摄入、可溶解的非视频胶囊，它将为临床医生在进行胶囊内镜检査前，提供良好的依据。 从加速引进到本土价值链建设 ，溢出效应 全面叠加释放 目前，美敦力有10款首秀的创新产品及疗法实现从"展品到商品"的转变，加速服务中国本土患者。例如，在心脏与血管领域，美敦力专为中国用户设计的心脏植入式电子装置数据传输器MyCareLink™自2019年进博首展之后，通过"心脏电子装置植入患者社区远程随访项目"，已惠及3,000多名心脏疾病患者；另一款心脏领域的创新展品Percepta™ CRTP MRI SureScan™植入式心脏再同步治疗起搏器于2022年首次参展进博会后，仅用半年时间即成为首个在药监局获批的具备蓝牙通讯功能的心脏再同步治疗起搏器，让医患实现"零时差"病情管理。 此外，Symplicity Spyral*肾动脉交感神经多极射频消融系统及导管于2020年起连续三年参展进博会，目前已在博鳌先行区开展先行先试，共惠及50多名中国高血压患者。在神外领域，两款首展于第四届进博会的产品均于今年7月取得重要进展：一款是正式在中国上市的Stealth Autoguide™神经外科手术机器人；另一款是已成功完成国内首批植入手术的Percept PC™，该产品是目前全球前沿的智能可感知脑起搏器，它的出现代表着脑起搏器治疗从"盲人摸象"跨入精准治疗的时代。 乘进博劲风，美敦力不断夯实本土价值链布局，为持续服务中国患者提供坚实基础。以美敦力中国骨科业务为例，Mazor X脊柱外科手术导航定位系统首次参展第三届进博会，一年后就获批上市并投入临床应用。为了更好地满足中国本土需求，美敦力加速推动机器人本土化进程，于美敦力康辉常州科技园投入建设机器人产线，2023年4月，中国版Mazor--Mazor™ XC--工程样机下线。与此同时，在上半年美敦力正式发布了"AiBLE数智骨科/神外创新生态"，将引领行业迈入全病程管理的数智化时代。在短短三年时间内，完成从产品进口向本土化制造跃升，再到本土生态的建设启动，助力推动中国本土医疗科技创新产业链的整体提升。 [i] 新闻联播 (2020). 瑞金医院心内科成功完成全世界最小的心脏起搏器手术。 http://www.rjh.com.cn/2018RJPortal/doc/2020/10/19/52410.shtml *该产品尚未在国内注册上市 关于美敦力 美敦力大胆行动，积极应对人类所面临的严峻健康挑战。秉承"减轻病痛、恢复健康、延长寿命"的企业使命，美敦力全球 9 万多名员工凝聚力量，凭借在医疗与科技领域的专长，以及帮助他人的初衷，提供创新医疗科技，以洞察驱动医疗服务，提供以人为本的体验，改善人们的健康与生活，带来更好的普惠成果。 美敦力，生命因科技不凡。 欲了解更多信息，请访问全球官网 http:\/\/www.medtronic.com 和大中华区官网 http:\/\/www.medtronic.com.cn 声明 – 本文涉及的部分产品未在国内上市。本文内容仅作新闻和科普用途，不应被视为对所涉医疗产品的推荐或功效证明。涉及疾病诊断、治疗、康复相关的，请务必前往专业医疗机构就诊，寻求专业意见。本文使用的相关观点已获得相应授权。

Azer-Cel Safety Pro Significantly Improved Compared to Prior Cohorts in Patients Dosed Using Optimized Product at Lower Intensity Lymphodepletion; No Grade 3 or Greater Allogeneic CAR T Related Adverse Events Were Observed Azer-Cel Achieved 83% Overall Response Rate (ORR), 61% Complete Response (CR) Rate with 55% Durable Response Greater Than or Equal to Six Months Among Evaluable CAR T Relapsed Subjects (n=18) Upcoming Azer-Cel Meeting with FDA in June to Align on Potential Phase 2 Study in CAR T Relapsed Diffuse Large B-cell Lymphoma (DLBCL); Focus on Trial Design, Size, and Endpoints PBCAR19B Stealth Cell Proof of Concept Achieved; Designed to Enable Expansion and Persistence by Delaying Host Rejection Through Immune Cloaking PBCAR19B Stealth Cell Achieved 71% ORR with No Grade 3 or Greater Allogeneic CAR T Related Adverse Events; Most Compelling Signal in Third Line DLBCL (n=5) with 80% ORR and 60% CR (MRD-) Company to Host Webcast and Conference Call Today at 8:30 AM ET DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS®-based in vivo gene editing and ex vivo allogeneic CAR T therapies, today announced program updates across its allogeneic CAR T pipeline. The Company highlighted new interim clinical data for its lead candidate, azercabtagene zapreleucel (azer-cel), as a potential first-in-class allogeneic CD19 CAR T for the growing CAR T relapsed patient population with DLBCL. The Company also provided the first clinical update on PBCAR19B stealth cell, which is in development as a potential best-in-class allogeneic CAR T therapy for patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL), with primary focus on DLBCL. “Over the last two years, we have pursued a deliberate, multi-faceted approach in the development of our CAR T programs with the aim of bringing off-the-shelf therapies to patients. In the process, we have built one of the most extensive data packages for an allogeneic product, with the goal of tailoring azer-cel for patients who have relapsed following autologous CAR T treatment,” said Michael Amoroso, Chief Executive Officer at Precision BioSciences. “With the updated clinical data presented today, including safety, efficacy, and durability, we believe we have identified the recommended azer-cel dosing regimen to discuss in a clinical meeting with the U.S. Food and Drug Administration (FDA) to align on next steps.” Mr. Amoroso continued, “In addition to azer-cel, we are also advancing our CD19-targeted program, PBCAR19B stealth cell, which incorporates an immune cloaking approach designed to allow greater CAR T expansion and persistence. Last year, we applied platform-wide manufacturing optimizations using ARCUS for CAR T insertion for both of our clinical candidates. We believe the optimized stealth cell product resulted in preliminary efficacy and safety on par with autologous CAR T in the r/r DLBCL setting. The interim data highlighted today supports further investigation of the stealth cell product candidate in DLBCL patients. Looking ahead, we will continue to evaluate the durability of response in the stealth cell patients and seek potential partnerships in this larger, earlier line setting.” Azer-cel as a Potential First-in Class Allogeneic CAR T Product Candidate for CD19+ CAR T Relapsed Patients As of May 30, 2023, we observed continued high response rates with an acceptable safety pro r/r NHL patients. Among all evaluable subjects (n=61), ORR was 58% with 41% achieving a CR, across all doses and lymphodepletion regimen. Activity was most compelling among the azer-cel treated subjects who had relapsed following autologous CAR T therapy (n=18); ORR was achieved in 83% of subjects and 61% achieved CR. In CAR T relapsed evaluable subjects (n=11), 55% had ongoing durable responses for ≥ 6-months. In the most recent CAR T relapsed cohort receiving optimized Dose Level 4b with FluCy7501 (n=5), 60% ORR was achieved, and 66% of evaluable patients achieved a full molecular remission (MRD-) which may be predictive of durability. No Grade 3 or greater cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection or graft versus host disease was observed in the most recent cohort. “Azer-cel continues to demonstrate promising results in DLBCL patients who relapsed following CAR T, and we are encouraged by the high overall response rates with molecular remissions in this patient setting,” said Alan List, M.D., Chief Medical Officer at Precision BioSciences. “Based on this dataset, azer-cel has the potential to improve outcomes in this large and growing population with high unmet need. Also based on these results, a clinical meeting with the FDA has been scheduled in June to discuss next steps for azer-cel in the CAR T relapsed setting. We look forward to providing updates on the path forward in the near future.” PBCAR19B Stealth Cell as a Potential Best-in Class Allogeneic CAR T Product Candidate for Earlier Line CAR T Naïve CD19+ DLBCL PBCAR19B is Precision’s anti-CD19 targeting allogeneic CAR T candidate designed to evade immune rejection by host T cell and NK cells with a single ARCUS gene edit to insert a CD19 CAR transgene, knock-down beta-2 microglobulin, and insert an HLA-E transgene. The treatment goal of this program is to potentially displace autologous CAR T in the 2nd line DLBCL setting. As of May 30, 2023, in Phase 1 results we observed an acceptable safety pro high overall response rates among all evaluable subjects with evidence of molecular remission (MRD-) and preliminary durability at Dose Level 2 (540 million cells)2. Out of seven evaluable subjects at Dose Level 2, five with DLBCL and two with mantle cell lymphoma, PBCAR19B achieved 71% ORR and 43% CR rate. In DLBCL patients, ORR was achieved in 80% of subjects and 60% achieved a CR (MRD-). No Grade 3 or greater cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection or graft versus host disease was observed. PBCAR19B stealth cell achieved proof of concept and appeared to be effective in delaying recovery of host T- and NK-cells. PBCAR19B stealth cell dosed at 540M cells + FluCy750 has been established as the dosing regimen for further investigation in DLBCL patients. “We are impressed with our PBCAR19B stealth cell construct which appeared to delay host rejection through immune cloaking. Stealth cell achieved a high response rate, especially in DLBCL subjects with a high frequency of MRD- complete responses, and acceptable safety with our improved manufacturing process at Dose Level 2 in the Phase 1 study,” said Dr. List. “The next steps for stealth cell will be to await further durability data and seek thoughtful partnership for ongoing development in the earlier line DLBCL setting.” Company-Hosted Webcast and Conference Call Information Precision will host a conference call and webcast today, May 31, 2023, at 8:30 AM ET. The dial-in conference call number is (800) 715-9871 and the conference ID number for the call is 4729500. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: . About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of several in vivo gene editing candidates designed to cure genetic and infectious diseases where no adequate treatments exist and multiple ex vivo clinical candidates. For more information about Precision BioSciences, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected efficacy and benefit of our product candidates, the expected timing of updates regarding our allogenic CAR T and in vivo programs, the expected timing of regulatory processes, expectations about our operational initiatives and business strategy, expectations around partnership opportunities, and expectations about achievement of key milestones. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” or the negative thereof and similar words and expressions. Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, but involve number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of the COVID-19 pandemic and variants thereof, or any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price, and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com. All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 Dose Level 4b = 500 × 106 (flat dose). FluCy750 lymphodepletion = fludarabine 30 mg/m2 × 3 days + cyclophosphamide 750 mg/m2 × 3 days. 2 Dose Level 2 = 540 × 106 (flat dose) with FluCy750 lymphodepletion (fludarabine 30 mg/m2 × 3 days + cyclophosphamide 750 mg/m2 × 3 days).