A Phase 1/2, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JIN-A02 in Patients With EGFR Mutant Advanced Non-small Cell Lung Cancer

This study is a Phase I/II open-label, multi-center study to evaluate the safety, tolerability, PK, and an anti-tumor activity of JIN-A02, a 4th generation EGFR-TKI agent for oral administration, in EGFR mutant-positive, advanced NSCLC subjects who showed disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy and/or no more than a single platinum-based anticancer chemotherapy. In Part A of the study, dose escalation is carried out where MTD is evaluated using Bayesian Optimal Interval (BOIN) design in subjects with advanced NSCLC harboring EGFR-mutation of C797S or T790M. In Part B, dose exploration is carried out to further evaluate the safety of JIN-A02 and to determine the RP2D using 2 preliminary effective dose levels and with the help of a safety review committee (SRC) in advanced NSCLC subjects harboring EGFR mutant C797S or T790M. In Part C dose expansion study, subjects with EGFR mutant who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy with activity against T790M such as Osimertinib and/or no more than one platinum-based anticancer chemotherapy, are divided into 5 different cohorts based on the EGFR mutation and the anti-tumor activity of JIN-A02 is evaluated. Before enrollment in the study, the EGFR mutant profile is determined using either tumor tissue and/or plasma ctDNA. The profile is determined locally through a test method approved by the sponsor. The sponsor reviews and approves each potential subject for enrollment. Study eligibility evaluation will utilize local test(s).

开始日期2023-07-30

申办/合作机构

J INTS BIO

100 项与 JIN-A02 相关的临床结果

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100 项与 JIN-A02 相关的转化医学

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100 项与 JIN-A02 相关的专利（医药）

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项与 JIN-A02 相关的文献（医药）

2025-06-01·BIOORGANIC & MEDICINAL CHEMISTRY

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer

Review

作者: Patel, Harun M ; Patil, Chandragouda R ; Gawli, Chandrakant S

"Epidermal growth factor receptor (EGFR)" mutations are pivotal in the pathogenesis of "Non-Small Cell Lung Cancer (NSCLC)," which is associated with high morbidity and mortality rates. The advent of third and fourth-generation EGFR tyrosine kinase inhibitors (TKIs) has significantly advanced the therapeutic landscape for EGFR-mutant NSCLC, particularly in overcoming resistance mutations such as T790M and C797S. This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib. Furthermore, it explores emerging fourth-generation EGFR TKIs designed to address resistance mechanisms beyond those targeted by their predecessors. Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation. The review emphasizes the importance of these advanced inhibitors in enhancing "progression-free survival and overall survival rates". By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors.

项与 JIN-A02 相关的新闻（医药）

2025-06-07

·研发客

挑战奥希替尼耐药，中国Biotech谁先夺魁？

// 中国公司在奥希替尼耐药后治疗策略的开发上非常活跃，HER3 ADC、Trop-2 ADC展示了积极的数据，三代EGFR+MET双靶的方向和四代EGFR已经表现出治疗潜力。2025年ASCO文章回顾亚盛医药：从纳斯达克IPO到8次亮相ASCO大涨17.64%！连涨五日！谁是赢家？在2025 ASCO会议中，针对奥希替尼耐药后治疗策略的探索各显神通。虽有HER3 ADC的失利，但本土Biotech映恩生物和百利天恒的产品都展现出不错的早期数据。领先于Dato-DXd和Trodelvy，科伦博泰的Trop-2 ADC芦康沙妥珠单抗在二线NSCLC的EGFR耐药治疗中首先撞线。MET和三代EGFR联合方案在EGFR耐药后的MET突变显示出治疗潜力。国产迪哲医药的四代EGFR药物DZD6008初露锋芒。HER3 ADC“后继有人”HER3靶向ADC药物patritumab deruxtecan（HER3-DXd）在今年ASCO会议上遭遇失利，且撤销了之前向FDA递交的上市申请。3期研究Herthena-Lung02研究数据显示，主要终点中位无进展生存期（mPFS）虽具有统计学意义的改善，即P=0.011，但mPFS相比化疗组仅有0.4个月的改善（5.8个月 vs 5.4个月）。安全性方面也暴露出问题，药物相关间质性肺疾病（ILD）14例，其中有2例死亡。来源 | ASCO摘要HER3-DXd的折戟并未影响同靶点的后继者们。中国Biotech在ASCO中公布的两项研究结果，又给HER3靶点注入了新希望。映恩生物披露了HER3 ADC药物DB-1310在标准治疗失败的晚期实体瘤患者的1/2a期研究结果。其中在EGFR突变NSCLC亚组中，未经确认的客观缓解率（uORR）达44%，疾病控制率（DCR）高达91%，mPFS为7.0个月，中位总生存期（mOS）为18.9个月。尤其是在5.5mg/kg剂量组中，uORR高达66.7%。公司还自主研发了一款EGFR×HER3双抗ADC管线DB-1418，该产品以5000万美元首付款授权给DualityBio，并于近期获得FDA批准开展临床。另一项研究来自百利天恒的EGFR×HER3双抗ADC iza-bren（BL-B01D1）。这项1期临床研究纳入了经典EGFR突变外的不同突变类型的NSCLC患者，且包含了接受1线、2线、3线及以上治疗的各类患者。来源 | ASCO摘要研究显示，患者整体的ORR为46.2%，cORR为39.7%，DCR为85.9%，mPFS为7.0个月。细分人群中，在EGFR 20外显子插入突变和非经典突变患者中cORR达69.2%，DCR为92.3%，mPFS为10.5个月。Trop-2崭露头角与HER3 ADC失利不同，Trop-2 ADC则在2025 ASCO中展现出优势。科伦博泰披露了核心产品Trop-2 ADC芦康沙妥珠单抗（sac-TMT）的3期Opti-TROP Lung-03研究结果。该研究的所有患者均携带EGFR突变，且接受三代EGFR药物治疗。结果显示，sac-TMT在主要研究终点ORR中达到45.1%，对照组多西他赛仅有15.6%，两组相差接近30%。次要终点mPFS也显示出阳性结果，sac-TMT达到6.9个月，而多西他赛组仅为2.8个月。来源 | ASCO摘要凭借此数据，sac-TMT在2025年3月获得NMPA批准拓展新适应症，治疗经EGFR-TKI和含铂化疗（序贯或联合）治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌。回顾2024 ASCO，同属Trop-2 ADC赛道的Dato-DXd和Trodelvy都在单药二线NSCLC治疗中失利，彼时sac-TMT就将目光聚焦在EGFR突变的细分领域中。如今该研究的积极结果也使其超越Dato-DXd和Trodelvy，成为全球首个在肺癌适应症获批上市的Trop-2 ADC药物。联用的智慧MET过表达是EGFR-TKI治疗进展的主要耐药机制，针对该方向的治疗方案多采用联合用药方式。今年ASCO公布了阿斯利康/和黄医药联合开展的奥希替尼联合赛沃替尼3期临床研究SACHI的结果。试验共纳入211位一线EGFR-TKI治疗失败、局部晚期或转移性EGFR突变且MET扩张的NSCLC患者。结果显示，研究者评估的治疗组mPFS达到8.2个月，化疗组为4.5个月；独立审查委员会（IRC）评估的mPFS分别为7.2个月和4.2个月；ORR分别为58%、34%；DCR分别为89%、67%；中位缓解持续时间（DoR）分别为8.4个月、3.2个月。再看同类研究，鞍石生物公布了伯瑞替尼联合安达替尼（PLB1004）的1b/2期KYLIN-1研究结果，在入组的85例患者中观察到ORR为48.3%，DCR为85.1%，mPFS达到11个月。上述两项研究均是三代EGFR+MET小分子的组合。事实上，三代EGFR与c-Met ADC联合对EGFR耐药后的MET扩增或过表达同样展示出治疗潜力。在2025 ASCO上，荣昌生物披露了c-Met靶向ADC RC108联合伏美替尼的临床1b/2期疗效数据。在MET免疫组化（IHC）细分的两组患者中，ORR分别达到40.5%和61.1%，mPFS分别为7.1个月和8.2个月。荣昌生物公开表示，正在筹备该联合疗法的3期临床研究。四代EGFR初露锋芒四代EGFR开始展现初步疗效。2025 ASCO展示的有迪哲医药的DZD6008、威尚生物的WSD0922-FU、韩国J INTS BIO公司的JIN-A02、CCM Biosciences开发的CCM-205和CCM-308。大多的四代EGFR开发只针对奥希替尼耐药的C797S突变激酶抑制，迪哲医药的DZD6008则对多种EGFR突变具有广谱活性，包括EGFR致敏突变（L858R/del19）、耐药双突变（T790M和L858R/del19）和三重突变（C797X、T790M和L858R/del19）。ASCO中公布的是针对晚期EGFR突变阳性NSCLC的1/2期研究（TIAN-SHAN2），共入组12例患者，10例（83.3%）显示靶病灶肿瘤缩小。在起始剂量20mg及更高剂量组，携带多种不同EGFR突变类型的患者中均观察到肿瘤部分缓解（PR）。未报告剂量限制性毒性，且未达到最大耐受剂量。DZD6008另外一项值得关注之处是，在基线脑转移患者中具有血脑屏障穿透性，临床表现为，脑脊液中药物浓度与游离血浆药物浓度比值超过1。威尚生物的WSD0922-FU在ASCO中展示了研究海报，未披露试验数据。目前全球的四代EGFR大多都在临床1期和2期，既往的研发并不顺利，有多款药物如BLU-945、BBT-176、EAI045等停止开发。本土四代EGFR研究，除了ASCO中披露的两个之外，还有翰森制药的HS-10504、浦合医药的PH009-1、正大天晴的TQB3002等。其他的创新疗法如三抗、EGFR PROTACs也在积极开发中，为EGFR耐药突变治疗提供更多可能性。编辑 | 姚嘉yao.jia@PharmaDJ.com总第2460期访问研发客网站，深度报道和每日新闻抢鲜看www.PharmaDJ.com

ASCO会议抗体药物偶联物临床3期引进/卖出临床结果

2025-06-04

·E药经理人

AZ“腹背受敌”！30+管线“围剿”奥希替尼，谁能成功？

EGFR不是“过去完成式”，而是“现在进行时”与“未来进行时”，尤其是在面对异质性极强的耐药机制时，新一代靶向技术正变得至关重要。撰文| Kathy2025年ASCO年会如火如荼，EGFR，一个“老”靶点依旧屹立潮头。作为非小细胞肺癌（NSCLC）精准治疗的起点，EGFR靶向治疗已经走过近二十年的进化与迭代。从第一代吉非替尼、厄洛替尼，到第二代阿法替尼，再到第三代奥希替尼，这条路径见证了分子靶向治疗从尝试到成熟的蜕变。然而，“耐药”这个问题是连头顶“重磅炸弹”与“诊疗金标准”光环的奥希替尼都无法逾越的鸿沟。也正因如此，谁能成为下个奥希替尼，这一悬而未决的挑战，倒逼着行业前赴后继投身于此，寻找突破口。本次ASCO上与EGFR相关的口头报告、壁报及摘要展示依然有数十项，涵盖小分子、ADC、双抗、蛋白降解剂（PROTAC）等多个技术路径，EGFR这个“老靶点”正经历一场从传统小分子药物向新兴技术融合的转型升级。而这场新竞赛，中国药企的活跃度要是称第二，几乎再无药企称第一。奥希替尼之后，EGFR-TKI尚无王者EGFR-TKI的发展史堪称是一部不断“破而后立”的演进史。第一代EGFR-TKI如吉非替尼、厄洛替尼，首次实现对EGFR敏感突变患者的精准打击，却在T790M突变面前折戟；第二代药物如阿法替尼强化了不可逆结合，却因毒性和选择性问题未能实现大规模替代；直到第三代EGFR-TKI奥希替尼的横空出世，通过特异性靶向T790M突变，才真正延长了生存时间与无进展生存期（mPFS）。奥希替尼凭借对T790M耐药突变的精准抑制，成为三代EGFR-TKI家族的“标杆”，在FLAURA研究中，其mPFS达到18.9个月，mOS更是刷新纪录至38.6个月，堪称EGFR治疗史上的高光时刻。据阿斯利康公布2024年业绩，奥希替尼已上市近10年时间，但作为治疗非小细胞肺癌的重要药物，其全球年销售额实现了16%的同比增长，达65.80亿美元，稳居“肺癌药王”宝座。然而，C797S突变、EGFR变构改变、旁路激活等复杂耐药机制，依旧在治疗中期悄然酝酿。强如奥希替尼，也未能终结这场“追逐战”，在经奥希替尼二线治疗后出现耐药的NSCLC患者中，大约10%-26%的患者存在EGFR C797S耐药性突变。在国内市场，已经有7款三代EGFR-TKI被批准用于治疗伴有EGFR 19外显子缺失、21外显子L858R以及20外显子T790M突变的非小细胞肺癌，分别是奥希替尼、阿美替尼、伏美替尼、贝福替尼、瑞齐替尼、瑞厄替尼和利厄替尼。在研并且进入III期临床的三代EGFR-TKI，也已经超过了10款。迭代升级之路，在浩浩荡荡的研发大军里延伸出来。能够看到，第四代EGFR-TKI已经呼之欲出。贝达的BPI-43487、正大天晴的TQB3804、齐鲁的QLH11811……一众中国药企均已布局四代EGFR-TKI，直指奥希替尼耐药的C797S突变。在这一背景下，如何绕开C797S等耐药突变、同时延长疾病控制时间，成为全球创新药企正面临的技术挑战。值得一提的是，Blueprint的BLU-945，曾是近两年最受关注的四代EGFR-TKI药物。2020年ESMO，BLU945迎来首秀高光时刻。BLU945在体外实验中对T790M/C797S共突变展现出抑制作用，前期研究的成功推动了I/II期SYMPHONY研究启动。2022 AACR年会上报道的I/II期SYMPHONY 研究的成果初步证实了其临床获益，因此彼时BLU-945被寄予厚望。然而到了2024年1月初，在第42届JPM年会上，Blueprint表示停止对BLU-945和BLU-451进一步投资。明星管线被放弃的原因也很简单：安全性问题。研究显示，高剂量BLU-945组（400-600mg/天）患者中出现12例剂量限制性毒性，主要是肝功能异常，联合治疗组起效剂量高过限制性毒性剂量，限制它的临床使用。从2020年ESMO的高光到2024年JPM的折戟，短短4年，新星便陨落。不过，“九死一生”的残酷现实并未让后来者却步。Black Diamond Therapeutics研发的BDTX-1535“接力”而来。BDTX-1535是第四代不可逆脑渗透性EGFR-TKI，可靶向NSCLC一系列经典/非经典EGFR驱动基因突变和耐药突变（包括C797S、G719X和S768I等）。重要的是，I期临床前研究显示，BDTX-1535穿过血脑屏障能力优秀，或可填补中枢神经系统（CNS）转移患者治疗的空白。临床前研究数据显示，BDTX-1535对C797S和多种罕见EGFR突变具有较低的半数抑制浓度（IC50），而对野生型EGFR的IC50极高。这意味着BDTX-1535在抑制耐药突变的同时，对正常细胞的损伤较小，从而降低了相关不良反应的发生。如火如荼召开的2025 ASCO年会上，也不乏四代EGFR-TKI的身影。像DZD6008、CM-205、CCM-308、WSD0922-FU片和JIN-A02等多款第四代EGFR抑制剂亮相。DZD6008是迪哲医药在研的一款第四代EGFR-TKI，可靶向EGFR敏感突变(L858R/del19)、耐药双突变（T790M+L858R/del19）及三突变（C797X+T790M+L858R/del19），可完全穿透血脑屏障（BBB），能有效抑制多种EGFR突变细胞及肿瘤动物模型的生长，对多种EGFR 突变具有广谱活性。CM-205和CCM-308是CCM Biosciences 的新型第四代EGFR抑制剂，能够靶向EGFR敏感突变（如L858R/19外显子缺失）、T790M耐药突变以及C797S三重突变，且对野生型EGFR的选择性较高，减少脱靶毒性。临床前研究表明，它们通过不可逆结合突变型EGFR的ATP结合位点，抑制肿瘤细胞增殖。另外两款在研第四代靶向口服抑制剂正在进行的临床研究也在海报会议上进行了报告。WSD0922-FU片是威尚生物医药研发的一款口服、可穿透中枢神经系统(CNS)、保留野生型、ATP 非竞争性、可逆的 EGFR/EGFRvIII 第四代口服小分子靶向抑制剂，可有效抑制非小细胞肺癌(NSCLC)和高级别星形细胞瘤(HGA)特异性的 EGFR 突变，以及其他肿瘤的神经中枢转移。JIN-A02是J INTS BIO在研的一种新型口服的第四代EGFR-TKI 靶向药物，可以选择性和可逆性地与EGFR突变结合，尤其是导致对奥希替尼治疗产生耐药性的C797S突变。全球超30+管线竞逐于此，谁能率先跨越耐药这道天堑？迭代为下一个奥希替尼？甚至攻下EGFR这座“碉堡”？推荐阅读 * EGFR打不动了？中国药企抄出底牌* 1000亿魔幻“赌局”：中国双抗“完”了？换个战场，新机制卷翻天了随着对耐药机制研究的深入，开发能够覆盖C797S等新突变的第四代EGFR-TKI之外的另一个策略是——换战场。面对耐药的困境，研发者将目光投向了新兴技术，期望能从中找到攻克 EGFR 靶点的新途径，双抗、ADC、PROTAC技术，都成了这场战疫里的新兵。如通过PROTAC降解EGFR蛋白、利用ADC靶向EGFR表达细胞、或者构建EGFR/MET双靶向药物，绕过传统机制路径。这些新技术平台试图重塑EGFR这一“老靶点”的治疗新范式。强生的埃万妥单抗成功破茧。埃万妥单抗是一种靶向EGFR-MET的双特异性抗体。2021年，FDA批准其用于治疗铂类化疗治疗中或之后疾病进展的携带EGFR外显子20插入突变的局部晚期或转移性NSCLC成人患者。今年2月，埃万妥单抗在国内获批用于联合化疗治疗接受奥希替尼治疗期间或之后疾病进展的EGFR突变NSCLC患者。EGFR ADC则算得上是靶向EGFR的新机制中，开发起步较早的。早在2008年，雅培与Life Science Pharma达成一项合作协议，获得了后者4款靶向EGFR产品的全球开发和商业化许可权益，其中包括了两款EGFR ADC：ABBV-321和ABBV-414，不过这两款药物落入艾伯维的管线后研发并不顺利，相继折戟。有意思的是，从目前布局来看，EGFR ADC赛道的几乎都是来自中国的药企。靶向EGFR的ADC药物，如乐普生物的维贝柯妥塔单抗（MRG003），目前已在国内申报上市。另外，MRG003与PD-1抑制剂普特利单抗的联合治疗也取得了积极进展。百利天恒和BMS合作的靶向EGFR/HER3的双抗ADC产品BL-B01D1，目前已在六大瘤种中开展了III期研究，包括EGFR突变型和野生型非小细胞肺癌、鼻咽癌、食管鳞癌、三阴性乳腺癌以及HER2-/HR+乳腺癌。石药的SYS6010、基石药业的CS5007、百力司康的BB-1705等等一众ADC竞逐其中……值得注意的是，石药集团/新诺威的SYS6010，于2025年3月在CDE登记了一项既往EGFR-TKI治疗失败的EGFR突变局部晚期或转移性NSCLC，成为了首个国产冲击肺癌适应症三期注册临床的EGFR ADC。随着研究的深入，对于EGFR-TKI耐药难题，PROTAC或许也是一个有效的解决方案。PROTAC可以降解整个蛋白，而不仅仅是抑制酶活性，因此EGFR是一个理想的PROTAC靶标。目前海思科的EGFR PROTAC药物HSK40118和贝达药业/C4 Therapeutics的EGFR PROTAC药物CFT8919，分别已获批开展临床试验，用于治疗不可手术的、携带EGFR突变的晚期NSCLC患者。如今再提起EGFR，无论是数十条管线盘踞的三代、四代EGFR-TKI，抑或是PROTAC、ADC、双抗的前沿路径，所有竞逐者都在向同一个目标迈进——试图重构奥希替尼耐药后的EGFR治疗新秩序，并且打破研发追着耐药跑的被动“耐药-研发-再耐药”的循环。而由此带来的下一代EGFR下一代竞赛，或许是未来三到五年最值得关注的赛道。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

抗体药物偶联物ASCO会议临床3期蛋白降解靶向嵌合体

2025-06-02

·PRNewswire

J INTS BIO to Present Global Clinical Results from JIN-A02, a Fourth-Generation EGFR-TKI, at ASCO 2025

Significant anti-tumor responses and reduction of brain metastases observed SEOUL, South Korea , June 1, 2025 /PRNewswire/ -- J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, officially announced interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology 2025 (ASCO 2025), the world's largest oncology conference, held in Chicago, USA. Continue Reading Professor Byoung Chul Cho from Yonsei Cancer Center, posing with the JIN-A02 poster at the ASCO 2025 (Photo=J INTS BIO) JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented. 'Confirmed' clinical response observed in patients with disease progression after 3rd Generation EGFR TKI and chemotherapy One of the key findings of the ASCO presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity. In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases. Safety confirmed up to 300 mg, with therapeutic signals in brain metastases No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug's excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months. In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue. JIN-A02 gains national spotlight as government grants accelerate development In addition to the ASCO announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The 'Baby Unicorn Fostering Project' is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as 'potential unicorns'. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential. With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments. Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA. "The ASCO presentation of JIN-A02's ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance," said Dr. Anna Jo, CEO. "The government's continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization" SOURCE J INTS BIO WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASCO会议临床2期临床1期

100 项与 JIN-A02 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	临床2期	美国	J INTS BIO	2023-07-30
EGFR突变的非小细胞肺癌	临床2期	泰国	J INTS BIO	2023-07-30
非小细胞肺癌	临床前	韩国	J INTS BIO	2022-01-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05394831 (PRNewswire) 人工标引	临床1期	EGFR C797S 突变非小细胞肺癌 EGFR C797S positive	-	JIN-A02	獵製獵遞鏇壓範齋壓餘(鏇製鹹鹹範鑰艱窪顧遞) = 憲觸積膚糧觸蓋範鹹壓獵觸繭觸製餘艱繭築鬱 (艱鹽鹽壓鏇鑰鏇網鏇糧 ) 更多	积极	2024-06-10
NCT05394831 (PRNewswire) 人工标引	临床1/2期	EGFR阳性非小细胞肺癌 EGFR Positive	-	JIN-A02	願獵網網製觸遞積窪鹹(餘廠餘糧鬱膚壓積範範) = 鹹簾選築醖積夢築獵選遞憲顧蓋構願簾糧膚鏇 (積窪繭繭鏇鏇鏇鏇淵鹹 )	积极	2023-12-05
JIN-A02 (ESMO2022)	N/A	非小细胞肺癌	-	JIN-A02	夢鏇糧獵構淵鹹範鏇鹽(淵鹹鹽積醖築廠廠壓壓) = 艱廠糧齋壓夢構鬱積醖築顧顧衊艱夢築糧夢願 (醖艱襯廠顧壓觸壓淵襯 ) 更多	-	2022-09-10