Mobocertinib Succinate

“悟空28”首次通过随机对照III期研究，在全球范围内证实了舒沃替尼作为口服靶向药在EGFR ex20ins NSCLC这一难治领域中的疗效显著优于既往以化疗为基础的标准治疗方案▎Armstrong2026年5月30日，迪哲医药在2026年美国临床肿瘤学会（ASCO）年会上，发布了舒沃替尼（舒沃哲®）国际多中心III期临床研究“悟空28”（WU-KONG28）的最新研究成果。该研究以最新突破摘要（LBA）形式进行了口头报告，这也是今年ASCO大会上，中国Biotech斩获的LBA中唯一一项国际多中心III期研究，并获ASCO官方第一时间专题报道。“悟空28”LBA主要作者、德克萨斯大学MD安德森癌症中心的John V. Heymach教授表示，该研究首次通过随机对照III期研究，在全球范围内证实了舒沃替尼作为口服靶向药在EGFR ex20ins NSCLC这一难治领域中的疗效显著优于既往以化疗为基础的标准治疗方案，有望重塑EGFR ex20ins NSCLC一线治疗格局。同时，研究全文同步发表于国际顶尖医学期刊《新英格兰医学杂志》（NEJM，影响因子：78.5）。“悟空28”研究结果显示，相较含铂双药化疗，舒沃替尼单药一线治疗表皮生长因子受体（EGFR）20号外显子插入突变（ex20ins）非小细胞肺癌（NSCLC），在主要研究终点无进展生存期（PFS）上展现出具有统计学意义和临床意义的显著改善。EGFR exon20ins NSCLC：巨头折戟的研发深水区EGFR突变是NSCLC中最常见的驱动基因。EGFR ex20ins是仅次于两大敏感突变（L858R、19del）的EGFR第三大原发突变，约占EGFR突变NSCLC患者的4%-12%，是NSCLC治疗领域公认的难治靶点。由于其亚型繁多、异质性强，具有特殊的空间构象，传统EGFR TKI难以与该靶点结合，且与野生型EGFR结构非常相似，导致药物研发困难，全球研发屡次折戟。阿斯利康明星药物奥希替尼即便是剂量翻倍也未能叩开该靶点大门；武田制药的莫博赛替尼因一线III期验证性临床失败而遗憾全球退市。埃万妥单抗与含铂双药化疗联用是目前全球唯一获批的一线靶向治疗方案，且改善了患者获益，但依然捆绑含铂双药化疗，还需输注给药。反复输液、化疗相关的毒性以及累积的治疗负担可能会限制患者的长期耐受性和依从性，因此临床仍缺乏安全有效、便利且无需化疗的靶向治疗方案。“悟空28”研究首证：一线口服单药获益更优“悟空28”是一项开放标签、随机对照、国际多中心III期研究，在全球15个国家和地区开展，覆盖中国、美国及欧洲主要国家，旨在评估舒沃替尼对比含铂双药化疗，一线治疗EGFR ex20ins NSCLC患者的有效性与安全性。截至2026年1月16日，全球共324例患者按1:1比例随机纳入舒沃替尼组和化疗组。主要研究终点为经盲态独立影像评审委员会（BIRC）评估的PFS。研究结果显示，在300 mg每日一次剂量下，舒沃替尼单药在多个关键疗效指标上均展现出显著更优的抗肿瘤疗效：主要研究终点PFS具有统计学意义和临床意义的显著改善：经BIRC评估，舒沃替尼组中位PFS达到10.3个月，显著优于化疗组的7.5个月，疾病进展或死亡风险降低35%（HR=0.65；P=0.0008），且在各亚组中均显示出一致的PFS获益；更高且更持久的肿瘤缓解：经BIRC评估，舒沃替尼组最佳客观缓解率（BoR）达到68.1%，高于化疗组的35.4%；舒沃替尼组中位缓解持续时间（DoR）达到11.2个月，而化疗组为7.1个月；长期获益趋势积极：总生存期（OS）数据尚未成熟（成熟度为38.9%），且化疗组有90.2%的患者在进展后交叉接受舒沃替尼治疗，舒沃替尼组中位PFS2达到了21.7个月，高于化疗组的15.5个月，提示一线优先使用靶向治疗可能带来更长期生存获益；整体安全性良好：安全性与既往研究一致，不良反应总体可管理、可逆，未发现新的安全性信号。基于“悟空28”研究取得的积极结果，舒沃替尼用于一线治疗EGFR ex20ins NSCLC的新增适应症新药上市申请（NDA）已获得国家药品监督管理局受理，并被纳入优先审评程序，全球其它主要市场的注册工作也在推进中。目前，该领域尚无口服靶向药物获批，随着后续监管审批推进，患者或将迎来无需化疗、安全便利的全新口服靶向治疗选择。此前，中、美两国药监机构已授予舒沃替尼单药一线治疗EGFR ex20ins NSCLC“突破性疗法认定”（BTD）。对于患者而言，这一突破不仅意味着全新的治疗选择，更意味一线治疗体验的提升。相较以化疗为基础的治疗方案，舒沃替尼“口服、单药、每日一次”的治疗模式，有望帮助患者避免化疗相关的毒性累积和反复注射，在疗效、安全性及治疗便利性之间实现更好的平衡，真正进一步提升患者的治疗体验和生活质量。此前，舒沃替尼已凭借二/后线治疗EGFR ex20ins NSCLC的积极数据，相继在中国和美国获批，成为目前该领域唯一实现中美双获批且医保可及的口服靶向药物，并获得《美国国立综合癌症网络（NCCN）指南》《CSCO非小细胞肺癌诊疗指南》等国内外各大权威指南最高等级推荐。小结“悟空28”研究的重要意义，在于首次通过国际多中心随机对照III期临床研究，验证了EGFR ex20ins NSCLC患者一线使用口服靶向单药疗法的临床价值。这不仅意味着舒沃替尼治疗阶段的前移，更重要的是，有望颠覆全球治疗格局，推动EGFR exon20ins NSCLC一线治疗从“以化疗为基础”逐步迈向“去化疗”时代。从舒沃替尼在中美相继获批二/后线适应症，到“悟空28”国际多中心III期研究取得阳性结果，一线适应症全球首个NDA，再到研究成果登上ASCO LBA和NEJM等全球顶尖学术舞台，这一系列里程碑再次验证了迪哲医药对标国际最高标准、经全球验证的独立研发和注册能力，大幅提升了核心产品的全球商业价值兑现确定性。随着舒沃替尼从“二线标杆”加速向“一线基石”迈进，其目标患者人群将显著扩大。若一线治疗顺利获批，舒沃替尼在全球市场的商业价值将加速释放，进一步夯实其在全球EGFR ex20ins NSCLC治疗格局中的领先地位。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

CHENGDU, China, May 29, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced today that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) in combination with pembrolizumab (KEYTRUDA®[1], MSD's anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), was presented as an oral presentation by Professor Caicun Zhou from Shanghai East Hospital, Tongji University (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell). (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) Sac-TMT is designed with a unique, bifunctional linker and differentiated belotecan-derivative payload. The linker is conjugated via cysteine, which maximizes payload delivery to tumor cells both through its irreversible connection with the high-affinity and targeting anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a moderately toxic novel topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. In the OptiTROP-Lung05 study, a total of 413 patients were randomized (1:1) to receive either sac-TMT in combination with pembrolizumab or pembrolizumab monotherapy. As of the data cutoff date (September 29, 2025), with a median follow‑up of 10.5 months, the study demonstrated that: Progression-free survival (PFS) showed statistically significant and clinically meaningful benefit in sac-TMT plus pembrolizumab compared with pembrolizumab alone. The median PFS assessed by blinded independent central review (BICR) was not reached (NR) vs 5.7 months (HR=0.35; 95% CI: 0.26-0.47; p<0.0001). The 12-month PFS rate was 62.4% vs 29.0%. Consistent benefit across prespecified subgroups: In patients with PD‑L1 TPS ≥50% and TPS 1–49%, the PFS HRs were 0.47 (95% CI: 0.29–0.77) and 0.28 (95% CI: 0.19–0.41), respectively. In patients with non‑squamous and squamous NSCLC, the PFS HRs were 0.28 (95% CI: 0.18–0.43) and 0.44 (95% CI: 0.29–0.66), respectively. Overall survival (OS) was not yet mature but showed a positive trend: median OS was NR vs 14.5 months (HR = 0.55; 95% CI: 0.36–0.85). The 12‑month OS rate was 80.4% vs 68.9%. The combination group showed improvements over pembrolizumab monotherapy group in objective response rate (ORR) (70.2% vs 42.0%), deep response rate (49.0% vs 25.9%), and 12-month duration of response rate (77.7% vs 59.4%). The incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in the combination group, primarily driven by the expected hematologic adverse events of sac-TMT. Incidence of discontinuation of pembrolizumab due to TEAEs was similar in both groups. No sac-TMT-related deaths occurred. Adverse events of special interest (AEOSIs) were consistent with the known safety profiles of each individual agent, and no new safety signals were identified. The interim analysis results show that sac-TMT plus pembrolizumab significantly prolonged PFS and reduced the risk of disease progression or death compared with pembrolizumab alone, with consistent PFS benefits observed across all prespecified subgroups (including PD‑L1 expression levels and histological subtypes). A positive trend in OS was also observed. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone. Notably, the findings of OptiTROP-Lung05 have been simultaneously published in The Lancet（Impact Factor=88.5）, indicating that its clinical and academic value has received dual recognition from a leading international academic conference and an authoritative journal. Professor Caicun Zhou, the national leading principal investigator from Shanghai East Hospital, Tongji University, said: "The positive results of the OptiTROP‑Lung05 study are encouraging. The study not only supports the application of sac‑TMT in an earlier-line setting for lung cancer, but also provides evidence of the 'ADC+IO' synergistic strategy being evaluated in the first-line setting for PD‑L1‑positive advanced NSCLC, potentially bringing a new option to a broad population of patients with lung cancer." About sac-TMT( 佳泰莱 ® ) Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA). Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA®) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . SOURCE Kelun-Biotech 21% more press release views with Request a Demo