Pembrolizumab

— The study shows that EGFR-TKIs induce TROP2 upregulation in DTP cells, providing a mechanistic basis for combining sac-TMT with EGFR-TKI. — The Company is conducting a Phase III registrational study of sac-TMT plus osimertinib as first-line treatment for advanced EGFR-mutant NSCLC (enrollment completed; follow‑up phase) and a Phase II study of the same combination as neoadjuvant treatment for EGFR-mutant resectable NSCLC. — Sac-TMT has been approved in China for advanced EGFR-mutant NSCLC following progression on TKI therapy or TKI therapy and platinum-based chemotherapy, and has demonstrated significant PFS and OS benefits in TKI-resistant settings. June 22, 2026 -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") announced that translational research results on its sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) in combination with osimertinib as first-line treatment for advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) have been published online in Cancer Cell, an international academic journal. The paper, titled "Targeting TROP2 in drug-tolerant persister cells delays EGFR tyrosine kinase inhibitor resistance in non-small-cell lung cancer," was led by Professor Li Zhang and Professor Wenfeng Fang from the Sun Yat-sen University Cancer Center. The study shows that trophoblast cell-surface antigen 2 (TROP2) expression is upregulated in residual drug-tolerant persister (DTP) cells after EGFR tyrosine kinase inhibitor (TKI) treatment; in preclinical models, sac-TMT combined with osimertinib inhibited DTP cell formation and delayed tumor recurrence. These findings provide translational medicine evidence for the combination of TROP2-directed antibody drug conjugate (ADC) and EGFR‑TKI in delaying drug resistance, and further underscore the differentiated value of sac-TMT as a key combination partner for EGFR-TKIs. Building on the above research and clinical development plans, the Company is advancing a Phase III registrational study (NCT06670196) of sac-TMT in combination with osimertinib versus osimertinib monotherapy as first-line treatment for locally advanced or metastatic EGFR-mutant non-squamous NSCLC. The study is designed to evaluate the efficacy and safety of sac-TMT (4 mg/kg, Q2W) plus osimertinib compared with osimertinib monotherapy in this indication. Patient enrollment in China has been completed, and the study is currently in the follow-up and data maturity phase. In addition, the Company is advancing clinical exploration of sac-TMT for earlier-stage EGFR-mutant NSCLC. A Phase II study (NCT07329322) is ongoing to evaluate sac-TMT in combination with osimertinib or as monotherapy in the neoadjuvant setting for EGFR-mutant resectable NSCLC, further exploring the potential value of sac-TMT in perioperative treatment. This publication in Cancer Cell reinforces the scientific foundation for combining sac-TMT with EGFR-TKIs as first-line treatment for EGFR-mutant NSCLC. The Company will continue to explore the potential of this combination regimen in earlier-line treatment, resistance delay, and long-term benefit, building on the approved indications and clinical development plan of sac-TMT in EGFR-mutant NSCLC. Kelun-Biotech remains committed to driving innovation in treatment paradigms for EGFR-mutant NSCLC and expanding therapeutic options for patients. 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 EGFR-TKI therapy and platinum-based chemotherapy; 3) 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®[1]) as first‑line treatment for locally advanced or metastatic NSCLC who have programmed death ligand 1 (PD-L1) tumor proportion score (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. 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. The content above comes from the network. if any infringement, please contact us to modify.

2026.6.22 CDE受理品种信息如下: 一,上市申请3个: 序号 受理号 药品名称 药品类型 申请类型 注册分类 企业名称 承办日期 1 JXHS2600071 甲苯磺酸他拉唑帕利胶囊 化药 进口 2.4 Pfizer Europe MA EEIG;Excella GmbH   & Co. KG;Pfizer Investment CO., Ltd.; 2026/6/22 2 CYHS2601459 盐酸多西环素片 化药 仿制 3 福建海西新药创制股份有限公司;福建海西新药创制股份有限公司; 2026/6/22 3 CXZS2600032 清金化痰汤颗粒 中药 新药 3.1 湖南九典制药股份有限公司;湖南九典制药股份有限公司; 2026/6/22 二, 一次性进口申请1个: 4 JTH2600114 二丙酸倍他米松 进口 化药 MSD   Singapore;MSD Singapore;杭州默沙东制药有限公司; 2026/6/22 三, 补充申请23个: 5 JYSB2600171 司美格鲁肽注射液 治疗用生物制品 补充申请 Novo Nordisk   A/S;Novo Nordisk A/S; 2026/6/22 6 JYSB2600170 司美格鲁肽注射液 治疗用生物制品 补充申请 Novo Nordisk A/S;Novo Nordisk A/S; 2026/6/22 7 JYSB2600169 司美格鲁肽注射液 治疗用生物制品 补充申请 Novo Nordisk A/S;Novo Nordisk A/S; 2026/6/22 8 JYSB2600168 司美格鲁肽注射液 治疗用生物制品 补充申请 Novo Nordisk A/S;Novo Nordisk A/S; 2026/6/22 9 JYSB2600167 司美格鲁肽注射液 治疗用生物制品 补充申请 Novo Nordisk A/S;Novo Nordisk A/S; 2026/6/22 10 CYZB2602830 生脉饮口服液 中药 补充申请 黑龙江久久药业有限责任公司;黑龙江瑞格制药有限公司; 2026/6/22 11 CYZB2602829 热毒平颗粒 中药 补充申请 贵州颐和药业有限公司;贵州颐和药业有限公司; 2026/6/22 12 CYZB2602828 穿心莲片 中药 补充申请 四川好医生攀西药业有限责任公司;四川好医生攀西药业有限责任公司; 2026/6/22 13 CYZB2602827 穿心莲片 中药 补充申请 四川好医生攀西药业有限责任公司;四川好医生攀西药业有限责任公司; 2026/6/22 14 CYZB2602826 木香槟榔丸 中药 补充申请 湖北龙辅药业有限公司;武汉钧安制药有限公司; 2026/6/22 15 CYZB2602825 风寒咳嗽颗粒 中药 补充申请 原9 云南铭鼎药业有限公司;云南铭鼎药业有限公司; 2026/6/22 16 CYZB2602824 小儿止咳糖浆 中药 补充申请 黑龙江珍宝岛药业股份有限公司;黑龙江珍宝岛药业股份有限公司; 2026/6/22 17 CYZB2602823 乌杞调脂口服液 中药 补充申请 黑龙江珍宝岛药业股份有限公司;黑龙江珍宝岛药业股份有限公司; 2026/6/22 18 CYZB2602822 生芪消渴胶囊 中药 补充申请 贵州益佰制药股份有限公司;贵州益佰制药股份有限公司; 2026/6/22 19 CYZB2602821 舒心颗粒 中药 补充申请 原9 云南铭鼎药业有限公司;云南铭鼎药业有限公司; 2026/6/22 20 CYZB2602820 壮筋续骨丸 中药 补充申请 吉林省中研药业有限公司;吉林省中研药业有限公司; 2026/6/22 21 CYZB2602819 骨折再生丸 中药 补充申请 吉林省中研药业有限公司;吉林省中研药业有限公司; 2026/6/22 22 CYZB2602818 仙黄颗粒 中药 补充申请 扬子江药业集团江苏制药股份有限公司;扬子江药业集团上海海尼药业有限公司; 2026/6/22 23 CYZB2602817 五虎丹胶囊 中药 补充申请 扬子江药业集团江苏龙凤堂中药有限公司;扬子江药业集团有限公司; 2026/6/22 24 CYZB2602816 补中益气丸 中药 补充申请 上海宝龙安庆药业有限公司;上海宝龙安庆药业有限公司; 2026/6/22 25 CYHB2601157 依那普利氢氯噻嗪咀嚼片 化药 补充申请 无 山东宜岛康制药有限公司;德州博诚制药有限公司; 2026/6/22 26 CXSB2600115 TST002注射液 治疗用生物制品 补充申请 1 创胜生物医药（杭州）有限公司;/; 2026/6/22 27 CXSB2600114 注射用FH-006 治疗用生物制品 补充申请 1 江苏恒瑞医药股份有限公司;上海甫弘生物医药有限公司;江苏恒瑞医药股份有限公司; 2026/6/22 数据来源: 国家药品监督管理局药品审评中心（CDE） 经检索, 甲苯磺酸他拉唑帕利胶囊的适应症应为转移性去势抵抗性前列腺癌（mCRPC).  该治疗领域的竞争格局概览如下:  转移性去势抵抗性前列腺癌（mCRPC）是前列腺癌的终末阶段，患者中位生存期不足三年，但治疗格局正经历深刻变革。从传统化疗到精准靶向，再到新兴的核药与创新机制药物，市场正从“单一序贯”走向“ biomarker分层与联合治疗”的精细化竞争时代。一、当前标准治疗与指南推荐的竞争版图 根据2025年ASCO指南更新，mCRPC的治疗选择高度依赖于患者在去势敏感阶段的既往治疗史，已形成清晰的阶梯式路径。 1. 雄激素受体通路抑制剂（ARPIs）——基石地位与联合搭档 以恩杂鲁胺、阿比特龙为代表的ARPIs仍是mCRPC治疗的基石。一项网络荟萃分析显示，第二代ARIs在总生存期（OS）、影像学无进展生存期（rPFS）等多个终点上均表现出最佳的单药治疗效果，在多西他赛失败后的二线治疗中同样表现最优。但其竞争焦点已从单药转向联合治疗——与PARP抑制剂或核药的联合方案正成为提升疗效的关键策略。 2. PARP抑制剂——精准医疗的代表 (今日受理的甲苯磺酸他拉唑帕利胶囊属于此类) PARP抑制剂（奥拉帕利、他拉唑帕利等）开辟了基于生物标志物的精准治疗赛道。对于携带BRCA1/2或HRR基因突变的患者，PARPi单药或与ARPI联合使用显示出显著的OS获益。MAGNITUDE、TALAPRO-2、PROpel等III期试验奠定了PARPi+ARPI联合方案在一线（未经ARPI治疗）mCRPC中的地位。然而，这一赛道的竞争仅限于约20-30%的HRR突变人群，市场体量受限于基因检测普及率和患者筛选。 3. 化疗——后线不可替代的选择 多西他赛仍是ARPI经治患者的标准化疗方案。在其之后，卡巴他赛与177Lu-PSMA-617互为后线竞争选择，两者均为ARPI和多西他赛经治患者的推荐方案。值得注意的是，一项正在进行的III期CATCH-177研究正头对头比较卡巴他赛+卡铂方案与177Lu-PSMA-617在侵袭性mCRPC中的疗效，其结果可能重塑后线治疗排序。 4. 免疫治疗的挫败 免疫检查点抑制剂在mCRPC领域遭遇挫折。KEYNOTE-641 III期研究显示，帕博利珠单抗联合恩扎卢胺相比单用恩扎卢胺，并未改善化疗初治mCRPC患者的OS和rPFS，反而增加毒性，研究被提前终止。目前免疫治疗仅局限于MSI-H/dMMR这类极少数分子亚型患者。二、核药（RLT）赛道：最激烈的增长战场 放射性配体疗法是当前mCRPC竞争格局中最受关注的领域，诺华的Pluvicto（177Lu-PSMA-617）已率先获批并占据主导地位。但后来者正通过差异化策略发起挑战。 核药赛道的竞争不仅是疗效比拼，更是供应链、产能和全球化临床开发能力的竞争。Curium通过自建177Lu生产基地掌控核心原料，Lantheus则因试验设计缺陷和商业考量退出，凸显了核药赛道的高门槛与高风险。三、新兴力量：新型机制药物向标准治疗发起挑战 新一代药物正试图通过全新机制突破现有疗效天花板。 1. PRC2抑制剂：rinzimetostat（ORIC-944） 该药物联合达洛鲁胺，在阿比特龙经治的mCRPC患者中展现出 “best-in-disease”潜力。截至2026年1月的数据：中位随访4.9个月，5个月里程碑rPFS率达84%，显著优于现有标准治疗（约60%-75%）；安全性突出，绝大多数AE为1-2级，无剂量减免需求。基于此，ORIC计划于2026年上半年启动全球III期Himalayas-1研究，直接挑战化疗和ARPI的后线地位。该药物瞄准的是阿比特龙经治后缺乏口服、耐受性良好且疗效确切药物的巨大未满足市场（美国年发病人群约1.7万，全球市场潜力70亿美元）。 2. 多特异性抗体：STEAP1×CD3×CD28三抗（HLX3902） 复星医药子公司复宏汉霖自主研发的HLX3902，靶向STEAP1（前列腺癌高度表达抗原）并同时结合CD3和CD28，旨在更高效地激活T细胞。该药物已获NMPA批准开展I期临床，全球尚无同类产品上市，代表了中国企业在新型实体瘤免疫治疗上的前沿探索。四、竞争格局总结与趋势研判 当前mCRPC的竞争呈现以下特征： 治疗线序精细化：竞争不再局限于“谁更优”，而是 “在哪个治疗节点、针对哪类患者更优” 。既往治疗史（是否用过ARPI、多西他赛）和基因突变状态（HRR、BRCA）是决定竞争位次的核心变量。 联合治疗成为主流：单药疗效已接近瓶颈，竞争转向 “ARPI+X”联合方案的开发（X=PARPi、RLT、新型药物）。联合方案的疗效增益与毒性平衡是胜出关键。 核药赛道“一超多强” ：诺华Pluvicto先发优势明显，但后来者（Curium）正通过剂量优化、全球化布局和供应链掌控试图差异化竞争。中国市场成为核药全球竞争的新战场。 创新机制瞄准未满足需求：PRC2抑制剂、多特异性抗体等新机制药物，试图在后线治疗中提供疗效可观、耐受性更优的口服或注射方案，填补传统化疗和ARPI耐药后的空白。 精准与泛人群并行：PARPi锁定生物标志物人群实现精准突破，而RLT和新型药物则面向更广泛的PSMA阳性或非选择人群，两类策略共同驱动市场增长。 免责声明 信息来源与准确性：本公众号发布的信息，来源于国家药品监督管理局药品审评中心（CDE）, “药物临床试验登记与信息公示平台”等公开渠道，仅供行业参考。我们尽力确保信息的准确性，但无法保证其绝对完整、实时或无误，信息应以官方发布的最新版本为准。 非诊疗建议：本公众号所有内容不构成任何形式的诊疗建议或用药指导。患者关于任何治疗方案的决策，务必咨询专业医疗卫生人员。 非官方账号：本公众号为非官方运营账号，与任何政府机构、监管单位无隶属或代理关系。所有内容仅代表个人观点，不代表任何官方立场。 版权与转载：本公众号原创内容版权归作者所有。转载文章或使用图片，我们尽力遵循“合理使用”原则并标注来源，如涉及侵权，请及时联系我们处理。 链接风险：本公众号可能包含外部网站链接，我们对第三方链接的内容、安全性及准确性不负任何责任，访问风险由用户自行承担。 使用风险自担：用户基于本公众号信息所做的一切行为，风险自担，与本公众号及运营者无关。