Systemic Mastocytosis

2023年总收入为人民币4.638亿元，其中商业化收入人民币3.681亿元。 稳健的财务状况，截至2023年12月31日现金储备为10.3亿人民币；年内亏损减少57%。 基石药业与多家公司建立战略合作关系，通过充分发挥双方优势，实现商业化效率和产品价值的最大化。同时，普吉华 ® 与泰吉华 ® 地产化进程顺利，预期将大幅降低药品成本。未来，基石药业的发展战略将更专注于研发。 管线2.0重磅产品CS5001 (ROR1 ADC）的国际多中心临床试验进展迅速，已成为首个在实体瘤中显示出临床抗肿瘤活性的ROR1 ADC。另有多款同类首创ADC和多特异性抗体进一步补强早期产品线。 五项新药上市申请获批，包括舒格利单抗的一线胃癌、一线食管癌以及淋巴瘤三项适应症；以及普拉替尼治疗一线肺癌适应症的两项上市申请。 舒格利单抗（抗PD-L1单抗）两项新药上市申请正在英国和欧盟审评中且进展顺利，并已通过欧洲药品管理局（EMA）的药物临床试验质量管理规范（GCP）检查。预期两项申请将在2024年陆续获批。 苏州 2024年3月27日 /美通社/ -- 基石药业（香港联交所代码：2616），一家专注于研究开发及商业化创新肿瘤免疫疗法及精准治疗药物的领先生物制药公司，今日公布其2023年年度业绩及近期业务亮点。 基石药业首席执行官兼研发总裁杨建新博士表示：“2023年对基石药业来说是机遇和挑战并存的一年。我们在商业合作、产品管线、及临床开发也都取得了突破性进展。 2023年，我们积极拓展并建立了与多家公司的战略合作关系，包括与艾力斯签订RET抑制剂普吉华 ® 在中国大陆的独家商业化推广协议，以及与三生制药达成nofazinlimab（抗PD-1单抗）在中国大陆地区战略合作和独家许可协议。同时，普吉华 ® 与泰吉华 ® 地产化进程顺利，预计短期内不仅能够大幅降低生产成本，还能增加产品供应的灵活性，并将进一步拓展普吉华 ® 与泰吉华 ® 在中国市场的影响力和竞争优势。未来，我们将继续发挥自身优势，将战略重心聚焦于差异化创新药的研发，以满足患者和市场的需求，进一步提升公司长期价值。 基石管线2.0重磅产品CS5001（ROR1 ADC）的国际多中心临床试验进展迅速，目前正在美国、澳大利亚以及中国同步开展剂量爬坡和扩展。已有数据显示，CS5001具有良好的耐受性和安全性，并且在多种晚期、多线经治的实体瘤和淋巴瘤中观察到令人鼓舞的抗肿瘤活性；CS5001也因此成为首个在实体瘤中展示出临床抗肿瘤活性的ROR1 ADC。我们将于近期的国际学术会议上公布CS5001的详细临床数据。 此外，我们也在不断强化早期产品管线。多款基石自研、具有新颖靶点的同类首创ADC和多特异性抗体研发推进迅速。其中，靶向PD-1, CTLA-4, VEGFa的三特异性抗体CS2009预期于今年达到IND阶段；另外两款创新靶点的ADC也将于今年进入PCC阶段。 临床开发和注册方面也是捷报频传。近期，舒格利单抗（抗PD-L1单抗）的第五项适应症——联合化疗用于治疗一线胃及胃食管结合部腺癌的上市申请已获中国NMPA批准，舒格利单抗也因此成为了全球首个针对该适应症获批的PD-L1单抗。同时，舒格利单抗在英国和欧盟用于治疗一线IV期非小细胞肺癌的两项上市许可申请正在审评中；基石药业也于年初成功完成了欧洲药品管理局（EMA）的药物临床试验质量管理规范（GCP）检查；预计这两项申请将在2024年下半年陆续获批，以实现基石药业在国际市场的重要布局。 展望未来，基石药业将坚守以临床价值为导向的研发策略，通过多种创新渠道丰富管线建设和加速研发进程，同时不断深化战略合作伙伴关系，以促进公司商业化和产品管线的全面发展。我们期待登陆国际市场，为全球患者带来更多的创新药物，并持续为合作伙伴和投资者创造更大的长期价值。” 业务摘要 截至2023年12月31日止年度及截至本公告日期，我们的产品管线及业务经营均已取得重大进展。我们在此期间取得的成就包括： 总收入达人民币4.638亿元，包括商业收入人民币3.681亿元，其中精准治疗药物销售额为人民币3.367亿元，舒格利单抗特许权使用费收入为人民币3143万元。其他收益及亏损为人民币1.995亿元，主要是由于将艾伏尼布业务的授权转让给Les Laboratoires Servier（施维雅）的收益净额人民币1.795亿元。 普拉替尼及舒格利单抗获授五项新药申请（NDA）批准：针对普拉替尼，在中国大陆获批用于一线治疗转染重排（RET）融合阳性非小细胞肺癌（NSCLC），从而使普拉替尼在一线及二线NSCLC的应用范围扩大；在中国台湾用于治疗RET融合阳性NSCLC、RET突变的甲状腺髓样癌（MTC）及 RET融合阳性甲状腺癌（TC）。针对舒格利单抗，在中国大陆获批单药治疗复发或难治性（R/R）结外自然杀伤细胞/T细胞淋巴瘤（ENKTL）；在中国大陆获批联合化疗用于治疗一线食管鳞癌（ESCC）及在中国大陆获批联合化疗用于一 线治疗胃腺癌/胃食管结合部腺癌（GC/GEJ）。 两项NDA现处于审评中：在英国舒格利单抗联合化疗用于治疗一线IV期NSCLC及在欧盟舒格利单抗联合化疗用于治疗一线IV期 NSCLC。欧洲药品管理局（EMA）已在两个研究中心及医药研发合同外包服务机构（CRO）完成针对一线IV期NSCLC的药物临床试验质量管理规范（GCP）检查。 CS5001国际多中心临床试验进展迅速：CS5001（一种受体酪氨酸激酶样孤儿受体1（ROR1）抗体偶联药物（ADC））首次人体（FIH）全球试验在美国、澳大利亚及中国进行中；CS5001具有良好的耐受性和安全性，并在实体瘤和淋巴瘤中显示出良好的抗肿瘤活性。迄今为止，CS5001 是首个在实体瘤中显示出临床抗肿瘤活性的ROR1 ADC。 其他重要临床项目进展顺利：洛拉替尼针对c-ros oncogene1（ROS1）阳性晚期NSCLC在中国大陆的关键研究达到主要研究终点；nofazinlimab联合 LENVIMA ® (lenvatinib)用于治疗一线不可切除或转移性肝细胞癌（HCC）的全球III期试验正在进行持续随访。 于全球学术会议（如美国临床肿瘤学会（ASCO）年会、欧洲肿瘤内科学会（ESMO）大会、ESMO世界胃肠道肿瘤大会（ESMO GI大会））展示或于顶尖医学期刊（如《临床肿瘤学杂志》、《Nature Medicine》及《Nature Cancer》）发布十项相关数据。 开展超过十个发现阶段项目，包括多特异性抗体、抗体偶联药物及用于治疗难治性细胞内靶点的专有细胞穿透治疗（CPT）平台；一个多特异性抗体项目及一个ADC项目已进入临床前候选药物（PCC）阶段。 已建立三项商业合作，从而借助多家公司的优势，同时使基石药业能够战略性地专注于未来研发：在中国就nofazinlimab与三生制药建立新的合作伙伴关系，以加快nofazinlimab化学成分生产和控制（CMC）的开发及商业化；在中国就普吉华 ® （普拉替尼）与艾力斯医药（艾力斯）建立新的合作伙伴关系，以显著扩大商业化支持及提高该业务的整体盈利能力；我们按最多5千万美元（包括首付款4 千4百万美元）的转让价，将拓舒沃 ® （艾伏尼布）在大中华区及新加坡的权利转让予全球许可证持有人Les Laboratois Servier（施维雅），以收回对该资产的过往投资及变现未来潜在现金流。 阿伐替尼的技术转移申请正处在中国国家药品监督管理局（国家药监局）药品审评中心（CDE）的审核中。普拉替尼技术转移（包括生产及临床生物等效性（生物等效性）研究）已完成，申请资料已提交予CDE。这将有助于降低成本并提高产品的长期盈利能力。 I. 通过合作关系实现商业价值最大化 截至本公告日期，我们的商业活动摘要及详情如下： 与多家公司在中国大陆进行商业合作 为进一步提高商业化效率，年内我们已与多家公司建立商业合作，在充分发挥各自优势的同时，基石药业也将自身更多战略重心聚焦于研发。 - 2023年11月，我们向艾力斯授出RET抑制剂普吉华 ® （普拉替尼）在中国大陆的独家商业化权利。此项交易将普吉华 ® （普拉替尼）纳入艾力斯的高度协同肺癌业务部，并使普吉华 ® （普拉替尼）能够受益于艾力斯更成熟的商业团队及更广泛的市场覆盖范围，同时使基石药业能够降低与普吉华 ® （普拉替尼）商业化相关的运营成本，从而提升整体盈利能力。 - 2023年12月，我们将在大中华区（包括中国大陆、香港、澳门及台湾）及新加坡开发、生产及商业化拓舒沃 ® （艾伏尼布）的独家权利转让予施维雅，并将最多获得5千万美元的转让价款。该交易将有助于扩大拓舒沃 ® （艾伏尼布）的适应症并提高其对大中华区及新加坡患者的可及性，同时变现基石药业的未来潜在现金流及收回对该资产的过往投资。 新适应症实现成功上市 我们扩大上市产品的适应症，旨在为未来贡献稳定的收益。 - 普吉华 ® （普拉替尼）：一线治疗局部晚期或转移性RET融合阳性NSCLC患者的新适应症在中国大陆上市。 - 普吉华 ® （普拉替尼）：治疗局部晚期或转移性RET融合阳性NSCLC、晚期或转移性RET突变MTC及RET融合阳性TC患者的适应症在中国台湾上市。 - 择捷美 ® （舒格利单抗）：联合氟尿嘧啶及含铂化疗用于一线治疗不可切除局部晚期、复发或转移性ESCC患者的新适应症在中国大陆上市。 - 择捷美 ® （舒格利单抗）：单药治疗R/R ENKTL患者的新适应症在中国大陆上市。 - 择捷美 ® （舒格利单抗）：联合化疗用于一线治疗局部晚期或转移性GC/GEJC患者的新适应症在中国大陆上市。 制定一系列方法，提高我们药品的可及性及可负担性 - 我们已更新上市产品的定价策略。具体而言，泰吉华 ® （阿伐替尼）已被纳入中国国家基本医疗保险、工伤保险和生育保险药品目录（2023年）（国家医保目录），用于治疗携带PDGFRA外显子18突变（包括PDGFRA D842V突变）的不可切除或转移性胃肠道间质瘤（GIST）成人患者。 - 更新普吉华 ® （普拉替尼）及拓舒沃 ® （艾伏尼布）患者援助项目（PAP）计划以为一些支付能力低的患者降低门槛并提升价格竞争力。 建立广泛的行业和学术认知度，树立品牌和科学领导力 - 普吉华 ® （普拉替尼）、泰吉华 ® （阿伐替尼）及拓舒沃 ® （艾伏尼布）已纳入21项中国国家指南，用于多个治疗领域的检测及治疗，比如NSCLC、TC、GIST、系统性肥大细胞增生症（SM）及急性髓系白血病（AML）等。特别是，中国临床肿瘤学会（CSCO）非小细胞肺癌诊疗指南（2023年版）、CSCO胃肠道间质瘤诊疗指南（2022年版）、中国成人系统性肥大细胞增多症诊疗指南（2022年版）及中国抗癌协会（CACA）血液肿瘤指南（2022年版）等。 - 我们继续与研究者合作进行上市后临床项目，如研究者发起的试验（IIT）和真实世界的研究（RWS），以于多个癌症适应症中生成更多数据。例如，一项多中心RWS评估了泰吉华 ® （阿伐替尼）在中国GIST患者中的安全性及疗效；另一项IIT旨在研究泰吉华 ® （阿伐替尼）对于治疗携带有KIT D816或N822突变的R/R 核心结合因子（CBF）-AML患者的疗效及安全性。 与辉瑞就舒格利单抗在中国的商业化进行合作 - 我们正与合作伙伴辉瑞展开密切合作，以推进择捷美 ® （舒格利单抗）在中国大陆的商业化。 - 2023年，择捷美 ® （舒格利单抗）作为III期NSCLC的治疗方案在CSCO非小细胞肺癌治疗指南（2023年版）及CSCO免疫治疗指南（2023年版）中已升级至一级推荐。此外，择捷美 ® （舒格利单抗）用于治疗III期NSCLC亦已获纳入中华医学会临床实践指南（2023年版）。 II. 不断发展的管线的临床进展 详情如下： CS5001 (LCB71，ROR1 ADC) - 本潜在同类最优（BIC）ROR1 ADC的FIH全球试验已迅速推进到美国、澳大利亚及中国剂量递增部分的患者招募阶段。 - 2023年12月20日，我们报告了正在进行的FIH试验早期阶段的初步结果，当时已完成第7级剂量水平的安全性评估及正在进行疗效评估。CS5001展现了良好的耐受性和安全性，并在实体瘤和淋巴瘤中显示出良好的抗肿瘤活性。CS5001是迄今为止所报告第一个对实体瘤具有临床抗肿瘤活性的ROR1 ADC。 - 截至本公告日期，我们已将剂量水平递增至第9级。我们未观察到剂量限制性毒性（DLT）；且尚未达到最大耐受剂量（MTD）。在未考虑ROR1状况的情况下入组及接受大量先前治疗的淋巴瘤或实体瘤患者中，随着剂量水平增加，CS5001保持良好的耐受性；未观察到第4至5级治疗相关不良事件。CS5001的药代动力学（PK）特征符合预期，并显示ADC具有优异的稳定性。我们从第5级剂量水平开始观察到令人鼓舞的抗肿瘤活性，包括晚期实体瘤（如肺癌及胰腺癌）及淋巴瘤（如霍奇金淋巴瘤及弥漫性大B 细胞淋巴瘤（DLBCL））的部分及完全缓解。我们预计将于2024年上半年确定CS5001的初步推荐2期剂量（RP2D），并计划于2024年底前启动注册性Ib/II期试验。随着剂量增加过程中所积累的数据越来越丰富，我们计划于2024年在国际学术会议(包括ASCO、ESMO及美国血液学会年会（ASH））上进行多次汇报。 - CS5001有许多差异性特征，包括专有的位点特异性偶联、肿瘤选择性可切割连接子及前药技术。与参比具有单甲基澳瑞他汀E（MMAE）毒素的ROR1 ADC相比较，CS5001已于套细胞淋巴瘤及三阴性乳腺癌异种移植模型显示出BIC潜力。此外，CS5001在体外共培养系统显示出旁观者效应，表明ROR1异质性/低表达的实体瘤亦可能受益。2023年3月，我们于第13届世界ADC伦敦大会（世界ADC伦敦）上以口头汇报形式展示CS5001的转化数据。 - 此外，为确保生物标记物驱动患者的选择乃基于肿瘤ROR1表达，我们已识别有潜力的候选ROR1 抗体克隆用于免疫组化（IHC），以支持未来有关精准治疗药物的工作。 舒格利单抗 （CS1001，PD-L1抗体），新适应症正在审评中并正扩展至欧洲及英国。 - IV期NSCLC： 在大中华区以外的市场，IV期NSCLC适应症的上市许可申请（MAA）正在由多个国家及地区的监管机构审评。2023年2月及2022年12月，舒格利单抗联合化疗一线治疗转移性NSCLC患者的MAA获欧盟EMA及英国药品和医疗保健用品管理局（MHRA）受理。目前，此适应症正由双方审评。2023年7月，我们收到来自欧盟EMA就此适应症进行GCP检查的通知。2023年10月，我们收到MHRA发出的第80天的进一步资料要求（RFI），当中并无任何无法解决的问题。2023年12月，我们收到EMA发出的第180天未决问题清单（LoOI），表明所有问题已于前几轮沟通中得到妥善解决。2024年2月，我们完成了EMA在两个研究中心及CRO的GCP检查。 2023年6月，我们宣布对于IV期NSCLC患者的注册性 GEMSTONE-302 研究的总生存期（OS）期中分析结果已在世界知名的肿瘤学期刊－《Nature Cancer》上发表。 - GC/GEJ C ： 2024年3月，舒格利单抗用于一线治疗局部晚期或转移性GC/GEJC (CPS≥5)患者的NDA获国家药监局批准。 2023年2月，舒格利单抗用于一线治疗局部晚期或转移性GC/GEJC (CPS≥5)患者的NDA获国家药监局受理。 2023年10月，GEMSTONE-303研究中的预设无进展生存期（PFS）和OS最终分析主要研究结果被接收为重磅摘要（LBA），并在ESMO大会（2023年）上以口头汇报形式展示。与安慰剂联合化疗相比，舒格利单抗联合化疗显著改善 PFS和OS，此差异具有统计学显著性与临床意义。 - ESCC： 2023年12月，舒格利单抗用于一线治疗不可切除的局部晚期、复发或转移性ESCC患者的NDA获国家药监局批准。 2023年4月，舒格利单抗用于一线治疗不可切除的局部晚期、复发或转移性ESCC患者的NDA获国家药监局受理。 2023年1月，一线治疗不可切除的局部晚期、复发或转移性ESCC的GEMSTONE-304研究达到主要研究终点。与安慰剂联合化疗相比，舒格利单抗联合化疗明显改善 PFS和OS，此差异具有统计学显著性与临床意义。我们于2023年6月在ESMO GI大会上公布了该研究的详细结果。 2024年2月，注册性GEMSTONE-304研究的PFS最终分析结果及OS期中分析结果刊发于顶尖医学期刊—《Nature Medicine》。 - R/R ENKTL： 2023年10月，舒格利单抗用于单药治疗R/R ENKTL患者的NDA获国家药监局批准。 2023年3月， R/R ENKTL患者的注册性GEMSTONE-201研究的结果发表于顶级肿瘤学期刊－《临床肿瘤学杂志》。 2023年12月，我们在有关R/R ENKTL适应症注册途径的B类咨询方面与美国食品药品监督管理局达成协议。 Nofazinlimab（CS1003，PD-1抗体） - 2024年3月，完成了nofazinlimab联合LENVIMA ® (lenvatinib)一线治疗不可切除或转移性HCC患者的全球III期试验的预设期中分析；我们并无观察到新增或意外安全性信号；独立数据监察委员会（iDMC）建议在不修改方案的情况下进行持续随访，直至OS最终评估。 - 2023年9月， nofazinlimab用于治疗晚期实体瘤患者的FIH试验(CS1003-101)结果已发表于高引用率的期刊《英国癌症杂志》(British Journal of Cancer)。 普拉替尼（CS3009，RET抑制剂） - 2023年1月，普拉替尼用于治疗局部晚期或转移性RET融合阳性NSCLC、晚期或转移性 RET突变MTC及RET融合阳性TC患者的NDA获中国台湾食品药物管理署（TFDA）批准。 - 2023年6月，普拉替尼用于一线治疗先前未接受系统治疗的局部晚期或转移性RET融合阳性NSCLC患者的NDA获国家药监局批准。 - 2023年6月，RET融合阳性NSCLC中国患者的I/II期 ARROW试验的最新结果发表于《Cancer》。 阿伐替尼（CS3007，KIT/PDGFRA 抑制剂 ） - 2023年5月，我们的合作伙伴Blueprint Medicines Corporation（Blueprint Medicines）就该产品在美国获得来自美国食品和药品监督管理局（FDA）的批准，将其用于治疗惰性系统性肥大细胞增多症（ISM）成人患者。 - 2023年12月，我们的合作伙伴Blueprint Medicines获得来自 EMA的批准，授予其可用于治疗在系统治疗中出现中重度症状控制不充分的惰性系统性肥大细胞增多症成人患者。迄今为止，阿伐替尼是欧洲首个亦是唯一获批准用于治疗惰性系统性肥大细胞增多症患者的疗法。 - 2023年6月，阿伐替尼用于治疗晚期GIST患者的新数据在美国临床肿瘤学会年会（2023年）上发表。 - 2023年11月，阿伐替尼治疗晚期GIST的全球1期NAVIGATOR及中国桥接1/2期(CS3007-101)研究的事后数据分析在知名肿瘤学期刊《Clinical Cancer Research》发表。 艾伏尼布（CS3010，IDH1抑制 剂 ） - 2023年12月，艾伏尼布用于治疗R/R AML的常规批准而提交的补充资料获国家药监局受理。 - 2023年5月，艾伏尼布用于治疗R/R AML的常规批准的监管途径与药品审评中心达成一致。 - 2023年1月，完成艾伏尼布在R/R AML患者的中国桥接研究。 洛拉替尼（ ALK/ROS-1抑制 剂 ） - 我们正针对先前经克唑替尼及含铂化疗后的ROS1 阳性晚期NSCLC患者进行关键研究。2023年6月，我们就该项研究完成了患者入组。2024年2月，该关键研究达到主要终点，我们正在与药品审评中心及辉瑞就于2024年在中国大陆提交ROS1阳性晚期NSCLC的pre-NDA/NDA进行讨论。 III. 利用多种创新渠道建立研究管线 精准治疗药物及免疫肿瘤药物联合治疗仍然是我们的战略重点。将细胞毒性药物精确地输送到肿瘤的ADC，以及可创造新生物学及组合的多特异性生物制品代表两种早期开发的短期模式。 2023年，我们已通过若干举措取得重大进展： 同类首创 / 同类最优（ FIC/BIC）ADC： 两个同类首创ADC项目正在向完成临床候选分子的筛选阶段推进。其中一个针对多种高发肿瘤适应症并采用内部机器学习生物信息学算法识别的新型肿瘤相关抗原的ADC项目CS5006预计将于2024年上半年完成临床前候选分子的筛选。另外，另一同类首创GPCR-x ADC CS5005的先导抗体已选定。共轭先导分子在体外及体内均表现出令人鼓舞的疗效；预计该两种同类首创ADC将于二零二五年提交相关注册性新药上市申请（IND）。此外，CS5007（预计将成为同类最优特异性ADC）及其相应的特异性抗体CS2011，正在向临床前候选药物阶段推进。CS5007（CS2011）靶向经过验证的靶点，具有经证实的同源有效性。预计将于2024年上半年完成关键的双特异性抗体候选分子的筛选，且预计将于2024年底宣布该双特异性ADC完成临床前候选药物的筛选。 免疫肿瘤多特异性抗体： CS2009为针对PD-1、VEGFa及CTLA-4靶点的三特异性分子，正处于细胞株开发阶段，且相关IND预计于2024年提交。这是一种潜在的同类首创下一代肿瘤免疫骨架产品，其靶向肿瘤微环境中的三个关键免疫抑制途径，并可加深基于PD-(L)1疗法治疗高发肿瘤类型（包括NSCLC及HCC）的疗效。 细胞穿透治疗平台： 许多众所周知的肿瘤学靶点是现有治疗方法认为不可成药的细胞内蛋白。我们正在针对该等难治性靶点开发一种专有的细胞穿透治疗平台。该平台的开发已取得重大进展，具有针对肿瘤及其他疾病的广泛治疗潜力。 IV. 战略关系促进商业化活动及管线开发 我们不断发展与深化与全球主要战略合作伙伴（包括中国的合作伙伴）的关系，扩展已上市及晚期药物的商业化，巩固我们潜在同类首创/同类最优分子的早期产品管线，获取更多能够加强我们研发实力的技术。 2023年11月，我们与三生制药就nofazinlimab达成在中国大陆的战略合作，并授予三生制药在中国大陆开发、注册、生产和商业化nofazinlimab的独家权利。该合作伙伴关系将加快nofazinlimab的CMC开发及商业化。 2023年11月，我们与艾力斯在中国就普拉替尼的推广及上市达成商业合作伙伴关系。该交易将普拉替尼纳入艾力斯的高度协同肺癌业务部，并使普拉替尼受益于艾力斯更成熟的商业团队及更大的市场覆盖范围，同时使基石药业能够减少与普拉替尼商业化相关的经营费用及运营成本，从而提高整体盈利能力。 2023年12月，我们将艾伏尼布在大中华区及新加坡的权利转让予全球许可证持有人施维雅，转让价最多为5千万美元（包括首付款4400万美元（转让艾伏尼布业务））。此项高增值交易使基石药业能够收回其对该资产的初始投资，并变现该业务的未来潜在现金流。 根据我们与江苏恒瑞医药股份有限公司（恒瑞）就抗CTLA-4 单克隆抗体 (CS1002)建立的合作关系，恒瑞正在进行关于CS1002联合疗法用于治疗晚期实体瘤（包括HCC及NSCLC）的Ib/II期试验。目前，该试验正在顺利招募患者。2024年1月，恒瑞就评估CS1002(SHR-8068)联合adebrelimab及化疗用于一线治疗晚期或转移性非鳞状NSCLC患者的疗效取得国家药监局的 IND批准。 随着基石药业与EQRx就舒格利单抗及nofazinlimab订立的授权协议于2023年5月9日终止，我们重新获得舒格利单抗及nofazinlimab于大中华区以外地区的开发及商业化权利。有关权利过渡已于2023年8月完成。我们目前正主导配合EMA及英国MHRA对舒格利单抗进行MAA审查的监管流程。终止该授权协议将不会影响先前自EQRx收取的首付款及里程碑付款。我们目前正在寻求舒格利单抗及nofazinlimab于大中华区以外地区的潜在合作机会。 V. 其他业务进展 生产： 我们也正在进行多款进口产品的技术转移，这将有助于降低成本，提高我们产品的长期盈利能力。具体而言，有关阿伐替尼的技术转移申请正在药品审评中心审核中。同时，普拉替尼的技术转移（包括生产及临床生物等效性研究）已成功完成，申请资料已提交予CDE。 未来及愿景 展望未来，我们将继续推进创新管线药物，并最大限度地发挥成熟药物的商业价值。 预期的近期催化剂细节载列如下： 舒格利单抗：2024年上半年人用医药产品委员会（CHMP）就在欧盟用于一线治疗IV期NSCLC向MAA提供意见，并于2024年下半年获得MAA批准；2024年下半年在英国获得用于一线治疗IV期NSCLC的 MAA批准；中国以外地区合作关系的探索。 洛拉替尼：2024年在中国大陆用于治疗ROS 1阳性晚期NSCLC的pre-NDA/NDA 阿伐替尼：预期2024年下半年本地化生产的原研转地产申报（ANDA）获批准 普拉替尼：预期2024年上半年本地化生产的ANDA获受理 Nofazinlimab：2025年OS的最终分析结果及中国以外地区合作关系的探索 CS5001：在国际学术会议（如2024年上半年的ASCO及2024年下半年的ESMO/ASH）上披露最新的临床安全性及疗效数据；于2024年启动注册性研究；预计将于2024年或2025年达成全球BD合作关系 CS2009：2024年底前向澳大利亚人类研究伦理委员会（HREC）提交申请临床试验通知（CTN），并于2025年第一季度提交中国IND申请 CS5006：2024年上半年完成临床前候选分子的筛选，并预计于2025年提交IND申请 CS5005：2024年完成临床前候选分子的筛选，并预期于2025年提交IND申请 财务摘要 国际财务报告准则计量： 收入截至2023年12月31日止年度为人民币4.638亿元，其中包括药品销售收入人民币3.367亿（包括阿伐替尼、普拉替尼及艾伏尼布）、人民币0.957亿元的授权费收入以及人民币0.314亿元的舒格利单抗特许权使用费收入，授权费收入及特许权使用费收入同比增加人民币0.101亿元或8.6%，其在很大程度上抵销了药品销售收入的减少，因而总收入同比减少人民币0.175亿元或下降了3.6%。 研发开支截至2023年12月31日止年度为人民币5.278亿元，较截至2022年12月31日的6.142亿元减少了人民币0.864亿元，主要由于里程碑费用及第三方合约成本以及雇员成本降低。 行政开支截至2023年12月31日止年度为人民币1.827亿元，较截至2022年12月31日的2.491亿元减少了人民币0.664亿元，主要由于雇员成本降低。 销售及市场推广开支截至2023年12月31日止年度为人民币1.993亿元，较截至2022年12月31日的3.273亿元减少了人民币1.28亿元，主要是由于雇员成本和专业费用的降低。 期内亏损截至2023年12月31日止年度为人民币3.672亿元，较截至2022年12月31日的9.027亿元减少了人民币5.355亿元，降幅达到59.3%，主要是由于雇员成本的大幅减少和转让艾伏尼布业务的净收益。 非国际财务报告准则计量： 研发开支截至2023年12月31日止年度，扣除以股份为基础的付款开支后为人民币5.347亿元，较截至2022年12月31日止年度的5.591亿元减少了人民币2,444万元，主要由于里程碑费用及第三方合约成本以及雇员成本降低。 行政以及销售及市场推广开支截至2023年12月31日止年度，扣除以股份为基础的付款开支后为人民币3.382亿元，较截至2022年12月31日止年度的4.893亿元减少了人民币1.511亿元，主要由于雇员成本及专业费用减少所致。 期内亏损截至2023年12月31日止年度，扣除以股份为基础的付款开支后为人民币3.302亿元，较截至2022年12月31日止年度的7.606亿元减少了人民币4.304亿元，或56.6%，主要是由于雇员成本的大幅减少和转让艾伏尼布业务的净收益。 关于基石药业 基石药业（香港联交所代码: 2616）是一家生物制药公司，专注于研究开发及商业化创新肿瘤免疫治疗及精准治疗药物，以满足中国和全球癌症患者的殷切医疗需求。成立于2015年底，基石药业已集结了一支在新药研发、临床研究以及商业运营方面拥有丰富经验的管理团队。公司以肿瘤免疫治疗联合疗法为核心，建立了一条12种肿瘤候选药物组成的丰富产品管线。自成立以来，基石药业已经获得了多款药物（包括艾伏尼布）的14项新药上市申请的批准。多款后期候选药物正处于关键性临床试验或注册阶段。基石药业的愿景是成为享誉全球的生物制药公司，引领攻克癌症之路。 如需了解有关基石药业的更多信息，请访问：www.cstonepharma.com。 前瞻性声明 本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内所有陈述乃本文章刊发日期作出，可能因未来发展而出现变动。

Expanded savings programs build on company’s longstanding commitment to addressing barriers to access and affordability for patients WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.* Expanding the savings programs will help make its inhalers more affordable to the most vulnerable patients living with asthma and chronic obstructive pulmonary disease (COPD), including those who are uninsured and underinsured. Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “AstraZeneca’s expanded savings programs build on our longstanding commitment to addressing barriers to access and affordability for patients living with respiratory diseases to ultimately help patients lead healthier lives. We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone. It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future.” Starting June 1, 2024, eligible patients will pay no more than $35 per month for all AstraZeneca US inhaled respiratory medicines, including: AIRSUPRA® (albuterol and budesonide) BEVESPI AEROSPHERE® (glycopyrrolate and formoterol fumarate) Inhalation Aerosol BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol SYMBICORT® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol In addition, AstraZeneca substantially reduced the list price of SYMBICORT on January 1, 2024. The Company will continue to provide discounts and rebates off the list price to help patients afford its inhaled respiratory medicines. For more than 50 years, AstraZeneca has served respiratory patients by investing in the research and development of new drug-device combinations, as well as next-generation biologics and novel mechanisms to address the vast unmet needs of these chronic, often debilitating diseases. AstraZeneca remains dedicated to transforming patient outcomes, while ensuring access and affordability of our innovative medicines. *Terms and conditions apply. Government restrictions exclude people enrolled in federal government insurance programs from co-pay support. IMPORTANT SAFETY INFORMATION AIRSUPRA® (albuterol and budesonide) Contraindications: Hypersensitivity to albuterol, budesonide, or to any of the excipients Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient continues to experience symptoms after using AIRSUPRA or requires more doses of AIRSUPRA than usual, it may be a marker of destabilization of asthma and requires evaluation of the patient and their treatment regimen Paradoxical Bronchospasm: AIRSUPRA can produce paradoxical bronchospasm, which may be life threatening. Discontinue AIRSUPRA immediately and institute alternative therapy if paradoxical bronchospasm occurs. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister Cardiovascular Effects: AIRSUPRA, like other drugs containing beta2-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by pulse rate, blood pressure, and/or other symptoms. If such effects occur, AIRSUPRA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression. Therefore, AIRSUPRA, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Do Not Exceed Recommended Dose: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs Hypersensitivity Reactions, Including Anaphylaxis: Can occur after administration of albuterol sulfate and budesonide, components of AIRSUPRA, as demonstrated by cases of anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash, and urticaria. Discontinue AIRSUPRA if such reactions occur Risk of Sympathomimetic Amines with Certain Coexisting Conditions: AIRSUPRA, like all therapies containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines Hypokalemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. The decrease in serum potassium is usually transient, not requiring supplementation Immunosuppression and Risk of Infections: Due to possible immunosuppression from the use of inhaled corticosteroids (ICS), potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients Oropharyngeal Candidiasis: Has occurred in patients treated with ICS agents. Monitor patients periodically. Advise patients to rinse his/her mouth with water, if available, without swallowing after inhalation Hypercorticism and Adrenal Suppression: May occur with very high doses in susceptible individuals. If such changes occur, consider appropriate therapy Reduction in Bone Mineral Density: Decreases in bone mineral density have been observed with long-term administration of ICS. For patients at high risk for decreased bone mineral density, assess initially and periodically thereafter Glaucoma and Cataracts: Have been reported following the long-term administration of ICS, including budesonide, a component of AIRSUPRA Effects on Growth: Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of AIRSUPRA have not been established in pediatric patients, and AIRSUPRA is not indicated for use in this population Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, and dysphonia Drug Interactions: AIRSUPRA should be administered with caution to patients being treated with: Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects) Short-acting bronchodilators (concomitant use of additional beta-agonists with AIRSUPRA should be used judiciously to prevent beta-agonist overdose) Beta-blockers (may block pulmonary effects of beta-agonists and produce severe bronchospasm) Diuretics or non-potassium-sparing diuretics (may potentiate hypokalemia or ECG changes). Consider monitoring potassium levels Digoxin (may decrease serum digoxin levels). Consider monitoring digoxin levels Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants (Use AIRSUPRA with extreme caution; may potentiate effect of albuterol on the cardiovascular system) Use AIRSUPRA with caution in patients with hepatic impairment, as budesonide systemic exposure may increase. Monitor patients with hepatic disease Please see full Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products. BEVESPI AEROSPHERE® (glycopyrrolate and formoterol fumarate) Inhalation Aerosol CONTRAINDICATIONS All long-acting beta2-adrenergic agonists (LABAs), including formoterol fumarate, are contraindicated in patients with asthma without use of an inhaled corticosteroid. BEVESPI is not indicated for the treatment of asthma. BEVESPI is contraindicated in patients with hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product. WARNINGS AND PRECAUTIONS The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma Use of LABAs as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When LABAs are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone. Available data do not suggest an increased risk of death with use of LABAs in patients with chronic obstructive pulmonary disease (COPD) BEVESPI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition BEVESPI should not be used for the relief of acute symptoms (ie, as rescue therapy for the treatment of acute episodes of bronchospasm). Acute symptoms should be treated with an inhaled short-acting beta2-agonist (SABA) BEVESPI should not be used more often or at higher doses than recommended, or with other LABAs, as an overdose may result If paradoxical bronchospasm occurs, discontinue BEVESPI immediately and institute alternative therapy If immediate hypersensitivity reactions occur, in particular, angioedema, urticaria, or skin rash, discontinue BEVESPI at once and consider alternative treatment BEVESPI can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, BEVESPI may need to be discontinued Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines Be alert to hypokalemia and hyperglycemia Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction, and instruct patients to contact a physician immediately if symptoms occur ADVERSE REACTIONS The most common adverse reactions with BEVESPI (≥2% and more common than placebo) were cough, 4.0% (2.7%) and urinary tract infection, 2.6% (2.3%). DRUG INTERACTIONS Use caution if administering additional adrenergic drugs because the sympathetic effects of formoterol may be potentiated Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of formoterol Use with caution in patients taking non-potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta2-agonists The action of adrenergic agonists on the cardiovascular system may be potentiated by monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. Therefore, BEVESPI should be used with extreme caution in patients being treated with these agents Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD Avoid co-administration of BEVESPI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects INDICATION BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. LIMITATION OF USE Not indicated for the relief of acute bronchospasm or for the treatment of asthma. Please read full Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products. BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines Be alert to hypokalemia or hyperglycemia Most common adverse reactions in a 52-week trial (incidence ≥ 2%) were upper respiratory tract infection (5.7%), pneumonia (4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza (2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough (2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial, adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle spasms (3.3%) BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system BREZTRI should be administered with caution to patients being treated with: Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects) Adrenergic drugs (may potentiate effects of formoterol fumarate) Xanthine derivatives, steroids, or non-potassium sparing diuretics (may potentiate hypokalemia and/or ECG changes) Beta-blockers (may block bronchodilatory effects of beta-agonists and produce severe bronchospasm) Anticholinergic-containing drugs (may interact additively). Avoid use with BREZTRI Use BREZTRI with caution in patients with hepatic impairment, as budesonide and formoterol fumarate systemic exposure may increase. Patients with severe hepatic disease should be closely monitored INDICATION BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). LIMITATIONS OF USE Not indicated for the relief of acute bronchospasm or for the treatment of asthma. Please see full BREZTRI Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products. SYMBICORT® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms SYMBICORT should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason Localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with SYMBICORT. Patients should rinse the mouth after inhalation of SYMBICORT Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS Caution should be exercised when considering administration of SYMBICORT in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Long-term use of ICS may result in a decrease in bone mineral density (BMD). Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating SYMBICORT and periodically thereafter ICS may result in a reduction in growth velocity when administered to pediatric patients Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of ICS, including budesonide, a component of SYMBICORT. Close monitoring is warranted in patients with a change in vision or history of increased intraocular pressure, glaucoma, or cataracts In rare cases, patients on ICS may present with systemic eosinophilic conditions SYMBICORT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, pharyngitis, rhinitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents Beta-blockers may not only block the pulmonary effect of beta-agonists, such as formoterol, but may produce severe bronchospasm in patients with asthma ECG changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. Use caution with the coadministration of SYMBICORT INDICATIONS SYMBICORT is indicated for the treatment of asthma in patients 6 years and older not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA (also see DOSAGE AND ADMINISTRATION). SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations. SYMBICORT is NOT indicated for the relief of acute bronchospasm. Please see full Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products. Notes About Asthma Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,1 including approximately 25 million in the US.2 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.3 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.4-5 There are an estimated 136 million asthma exacerbations globally per year,6 including approximately 10 million in the US2; these are physically threatening and emotionally significant for many patients7 and can be fatal.3,8 Inflammation is central to both asthma symptoms4 and exacerbations.9 Many patients experiencing asthma symptoms use a SABA (e.g., albuterol) as a rescue medicine10-12; however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,13 which can result in impaired quality of life,14 hospitalization15 and frequent oral corticosteroid (OCS) use.15 Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.16 International recommendations from the GINA no longer recommend SABA alone as the preferred rescue therapy.3 About COPD COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.17 Affecting an estimated 16 million Americans, COPD is the third leading cause of death due to chronic disease and the sixth overall leading cause of death in the US.18-19 About AIRSUPRA® AIRSUPRA (albuterol and budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery technology. The FDA approval of AIRSUPRA was based on MANDALA and DENALI Phase III trials (Approval press release). In MANDALA, AIRSUPRA significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate-to-severe asthma when used as an as-needed rescue medication in response to symptoms. For patients treated with AIRSUPRA 180 mcg/160 mcg the annualized total systemic corticosteroids dose when compared with albuterol 180 mcg was statistically significantly different, with a reduction in mean annualized dose of 40 mg per patient. In DENALI, AIRSUPRA significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma. About BEVESPI AEROSPHERE® BEVESPI AEROSPHERE (glycopyrronium and formoterol fumarate) is a fixed-dose dual bronchodilator in a pMDI, combining glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA). PMDIs are an important choice for COPD patients where limited lung function, advanced age and reduced dexterity or cognition are significant considerations for patients to achieve therapeutic benefits from their medicines. BEVESPI AEROSPHERE is the only LABA/LAMA with Aerosphere delivery technology. Results from an imaging trial have shown that BEVESPI AEROSPHERE effectively delivers medicine to both the large and small airways. About BREZTRI AEROSPHERE® BREZTRI AEROSPHERE (budesonide, glycopyrrolate, and formoterol fumarate) is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurized metered-dose inhaler. BREZTRI AEROSPHERE is approved to treat COPD in more than 50 countries worldwide including the US, EU, China and Japan, and is currently being studied in Phase III trials for asthma. About SYMBICORT® Symbicort (budesonide and formoterol fumarate dihydrate) is the number one ICS/LABA combination therapy in asthma and chronic obstructive pulmonary disease (COPD) in China. It is a combination formulation containing budesonide, an ICS that treats underlying inflammation, and formoterol, a LABA with a fast onset of action, in a single inhaler. Symbicort was launched in 2000 and is approved in approximately 120 countries to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI (pressurised metered-dose inhaler). About AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction. With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit and follow us on social media @AstraZeneca. About AZ&Me™ AstraZeneca’s patient assistance program, AZ&Me Prescription Savings Program (AZ&Me), is part of the Company’s commitment to addressing barriers to access and affordability to improve medication adherence, enhance patient care, and help patients lead healthier lives. AZ&Me is just one of the ways that AstraZeneca makes its life-changing medicines widely available, accessible, and affordable. For over 40 years, AstraZeneca has offered a patient assistance program through AZ&Me and prior legacy free drug programs, making it one of the longest standing patient assistance programs in the country. Since 2007, over five million people have benefited from this program. In addition to its patient assistance programs, AstraZeneca offers other affordability programs and resources to help increase patients’ access to medicines and reduce their out-of-pocket costs including a co-pay savings program for commercially-insured patients and additional affordability resources. Each of these programs offer financial support to particular patient populations, consistent with applicable legal requirements. The goal of AZ&Me is to help patients who have been prescribed an AstraZeneca medication and are having difficulty affording it. Patients enrolled in AZ&Me receive their AstraZeneca medicine for free. To learn more, visit AZ&Me.com. References The Global Asthma Report 2022. Accessed: March 2024. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. Accessed: March 2024. Global Initiative for Asthma. Updated May 2023. Accessed: March 2024. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014;24:14009. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018;6(6): 1989-1998.e3. Data on File. REF-173201. AstraZeneca Pharmaceuticals LP. Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016;9:13. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014;40(4):364-372. Wark PA, et al. Asthma exacerbations. 3: Pathogenesis. Thorax. 2006;61(10):909-915. Johnson DB, et al. Albuterol. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2024 Jan 10. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care. November 2021, 66 (Suppl 10) 3603775. ClinCalc.com. Albuterol Drug Usage Statistics, United States, 2013-2020. Accessed: March 2024. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020;55(4):1901872. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007;16(1):22-27. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019;54(3):1900900. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018;11:193-204. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024. [Online]. Accessed: March 2024. National Heart, Lung, and Blood Institute. What is COPD? Accessed: March 2024. Centers for Disease Control and Prevention. Leading Causes of Death. Accessed: March 2024. # US-87197 Last Updated 3/24 View source version on businesswire.com: Contacts Brendan McEvoy +1 302 885 2677 Jillian Gonzales +1 302 885 2677 US Media Mailbox: usmediateam@astrazeneca.com Source: AstraZeneca View this news release online at:

SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities. The appointment is effective March 11, 2024. “Deyaa’s leadership and expertise in oncology research and clinical development, particularly in bringing oncology therapeutics to market, will be key to accelerating our oncology pipeline and bringing novel cancer therapies to patients in need,” said Thane Wettig, Chief Executive Officer of FibroGen. “We are excited to welcome him to FibroGen during this critical time as we prepare for two pivotal read-outs for pamrevlumab in pancreatic cancer, advance Phase 2 planning for FG-3246 in metastatic castration-resistant prostate cancer, IND for our anti-Galectin-9 antibody and continue IND-enabling work for our anti-CCR8 antibody,” he added. “We will benefit immensely from Deyaa’s broad and deep experience in oncology drug development, including his experiences in both pancreatic and prostate cancers.” “I am excited to join FibroGen and lead the clinical development organization at this important time for our company,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen. “I look forward to working with such a highly talented and deeply experienced group of colleagues as we progress our oncology pipeline with the goal to bring valuable medicines to cancer patients with significant unmet medical need." Dr. Adib, a seasoned industry leader, has over 27 years of medical oncology experience in the biotechnology and pharmaceutical industries, including seven successful registrations across solid tumor and hematologic malignancy indications. Prior to joining FibroGen, he was the Chief Medical Officer of Triumvira Immunologics Inc. where he led the transition of two novel cell therapy programs into clinical development. He previously served as Acting Chief Medical Officer at Rain Therapeutics, and as Vice President of late-stage development at Blueprint Medicines, where he led the development of avapritinib which is currently approved for gastrointestinal stromal tumors and advanced systemic mastocytosis. Dr. Adib also served as Global Therapeutics Head for solid tumors at Baxalta, in-licensing and advancing the development of nanoliposomal irinotecan that was subsequently approved globally for pancreatic cancer, establishing a new standard of care in the second line metastatic setting. He also served as Head of Hematologic Malignancies at ARIAD Pharmaceuticals, leading the global clinical program for ponatinib in chronic myeloid leukemia. Earlier in his career, Dr. Adib held multiple oncology clinical development leadership positions at Aventis, Sanofi and Astellas Pharma, advancing the development of Taxotere in prostate cancer, breast cancer and gastric cancer, oxaliplatin in colorectal cancer and notably enzalutamide, which led to a treatment paradigm shift in prostate cancer. He has served as a scientific advisory board member for multiple biotech companies and provided strategic consulting support to several cell therapy startups. Dr. Adib obtained an M.B., B.Ch. degree from Cairo University School of Medicine in Cairo, Egypt. He completed his postgraduate medical oncology training at the Anglo-American Cancer Institute in Cairo and additionally at Tufts University School of Medicine, Boston, MA, in clinical pharmacology, drug development and regulation. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immunoncology product candidates for the treatment of solid tumors. For more information, please visit . Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs and those of its partner, PanCAN. These forward-looking statements include, but are not limited to, statements regarding the potential and probability of success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. Contacts: FibroGen, Inc. Investors: David DeLucia, CFA Vice President of Corporate FP&A / Investor Relations ddelucia@fibrogen.com Media: Meichiel Keenan Director, Investor Relations and Corporate Communications mkeenan@fibrogen.com