Neratinib maleate

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYZB2402236疏风定痛丸呼伦贝尔松鹿制药有限公司————2025年08月05日2CXSS2300100阿达木单抗注射液武汉生物制品研究所有限责任公司国药准字S202500412025年08月05日3CXSS2400051度拉糖肽注射液山东博安生物技术股份有限公司国药准字S202500422025年08月05日4CXSS2400052度拉糖肽注射液山东博安生物技术股份有限公司国药准字S202500432025年08月05日5CXSS2400053度拉糖肽注射液山东博安生物技术股份有限公司国药准字S202500442025年08月05日6CXSS2400054度拉糖肽注射液山东博安生物技术股份有限公司国药准字S202500452025年08月05日7CYHB2201012国硫辛酸注射液山东新时代药业有限公司国药准字H202581542025年08月06日8CYHB2401665注射用头孢哌酮钠舒巴坦钠湖南科伦制药有限公司国药准字H202581562025年08月07日9CYHB2450325盐酸异丙嗪注射液遂成药业股份有限公司————2025年08月07日10CYHB2450337盐酸利多卡因注射液山东圣鲁制药有限公司————2025年08月07日11CYHB2450385盐酸曲马多注射液多多药业有限公司————2025年08月07日12CYHB2450551普伐他汀钠片第一三共制药（上海）有限公司————2025年08月06日13CYHB2450552普伐他汀钠片第一三共制药（上海）有限公司————2025年08月06日14CYHB2500736枸橼酸爱地那非片悦康药业集团股份有限公司————2025年08月07日15CYHB2501142奥拉帕利片南京方生和医药科技有限公司————2025年08月07日16CYHB2501450硝酸异山梨酯注射液湖北美林药业有限公司————2025年08月07日17CYHB2501458维生素B1片浙江兄弟药业有限公司————2025年08月07日18CYHB2501459复方氨酚烷胺片郑州卓峰制药有限公司————2025年08月07日19CYHB2501471玛巴洛沙韦片桂林南药股份有限公司————2025年08月07日20CYHB2501476马来酸奈拉替尼片江苏亚虹医药科技股份有限公司————2025年08月07日21CYHB2501480生理氯化钠溶液兰西哈三联制药有限公司————2025年08月07日22CYHS2303349、CYHB2500074盐酸特比萘芬喷雾剂浙江百代医药科技有限公司国药准字H202550822025年08月05日23CYHS2401261盐酸氨溴索注射液多多药业有限公司国药准字H202550832025年08月05日24CYHS2401668丙酸氯倍他索搽剂江苏知原药业股份有限公司国药准字H202550842025年08月05日25CYZB2501109普乐安片甘肃河西制药有限责任公司————2025年08月05日26CYZB2501458黄藤素分散片湖南湘雅制药有限公司————2025年08月05日27CYZB2501459金刚藤分散片湖南湘雅制药有限公司————2025年08月05日28JXSS2400004埃万妥单抗注射液西安杨森制药有限公司国药准字SJ202500052025年08月05日29JYHB2400557来特莫韦片默沙东研发（中国）有限公司————2025年08月07日30JYHB2400558来特莫韦片默沙东研发（中国）有限公司————2025年08月07日31JYHB2400561来特莫韦注射液默沙东研发（中国）有限公司————2025年08月07日32JYHB2400562来特莫韦注射液默沙东研发（中国）有限公司————2025年08月07日33JYHB2500272尼莫地平注射液简柏特（佛山）信息技术服务有限公司————2025年08月07日

胸腺癌（TC）突破性治疗潜力：HLX43是全球首个布局胸腺癌的PD-L1 ADC，具备突破性治疗潜力，有望填补该罕见高侵袭癌种 ADC治疗的空白； 潜在同类最优（FIC）的广谱抗肿瘤ADC：HLX43在非小细胞肺癌（NSCLC）、胸腺鳞癌（TSCC）等实体瘤中皆展现出“高效、低毒”的治疗潜力，广谱抗肿瘤药物价值凸显； 领跑PD-L1 ADC全球开发：HLX43是全球首款进入II期临床的PD-L1 ADC，复宏汉霖正高效推进该产品在中、美、日、澳等地的国际多中心临床研究，以缩短HLX43的全球上市周期，加速惠及全球患者。 近日，复宏汉霖（2696.HK）宣布，公司创新型程序性死亡-配体1（PD-L1）抗体偶联药物（ADC）注射用HLX43已获得美国食品药品监督管理局（FDA）批准，开展一项涵盖胸腺癌（TC）患者队列在内的I期临床试验，加速惠及更广泛的实体瘤患者。此前，HLX43已获批于中国、美国、日本、澳大利亚等地开展治疗晚期非小细胞肺癌（NSCLC）的国际多中心II期临床研究。全球尚无同类靶向PD-L1的ADC产品获批上市，HLX43为全球首个进入临床II期的PD-L1 ADC。   胸腺癌（Thymic carcinoma）是一种起源于胸腺上皮的罕见恶性肿瘤，约占所有胸腺上皮肿瘤的14%-22%[1]。该疾病呈现侵袭性特征，如局部浸润、胸内淋巴结和远处转移，且预后较差[2]。其病理亚型以鳞状细胞癌（squamous cell carcinoma）为主，占比约70%，其次为淋巴上皮癌、未分化癌等[3]。流行病学研究显示，该疾病中位发病年龄为50-60岁[1]，全球年发病率稳定在0.15/10万，但近年诊断率呈上升趋势[2]。对于早期局限性胸腺癌，手术切除是首选治疗方法。对于晚期或复发转移患者，一线治疗主要为联合化疗方案，二线治疗包括化疗、靶向治疗、免疫治疗等系统治疗。但现有治疗方案存在各种局限，如缺少驱动基因、耐药机制复杂、不良反应严重等，且整体疗效有限，亟待更加安全且有效的新型治疗方案[4-8]。 HLX43是一款靶向程序性死亡-配体1（PD-L1）的广谱抗肿瘤ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤（ADC）和肿瘤免疫治疗（IO）的复合功能：其毒素不仅能够藉靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡；此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。HLX43的I期临床数据展现出令人鼓舞的初步疗效和安全性，对鳞状/非鳞状NSCLC，有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力。值得关注的是，HLX43在胸腺鳞状细胞癌（TSCC）患者人群中展现了优异的疗效数据，75%的胸腺鳞状细胞癌患者达到部分缓解（3/4名，ORR = 75%）。该I期研究数据在2025 美国临床肿瘤学会（ASCO）年会上首次发布，并将于2025年世界肺癌大会（WCLC）以壁报形式进行更新，由该研究的主要研究者，中国医学科学院肿瘤医院王洁教授在壁报导览环节发布。 目前公司正在全力推进HLX43临床开发进程，积极探索其在多种实体瘤中的治疗潜力，包括非小细胞肺癌、胸腺鳞癌、肝细胞癌、食管鳞癌、头颈鳞癌、宫颈癌、鼻咽癌等。单药之外，HLX43联用复宏汉霖自研斯鲁利单抗（H药 汉斯状®，抗PD-1单抗）治疗实体瘤的 Ib/II 期临床试验也正在进行中，进一步探索“ADC+IO”的协同抗肿瘤疗效。HLX43不仅可能克服PD-1/L1免疫疗法不响应或耐药问题，并对化疗、TKI治疗失败的患者都具有潜在疗效，有望为更多晚期/转移性实体瘤患者带来新的治疗选择。 未来，复宏汉霖将加速推动HLX43在全球范围内的研发进程，不断夯实更多创新分子的差异化布局，为更多肿瘤患者带来高质量、可负担的创新治疗方案。 关于复宏汉霖 复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。 复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药 汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Henlius to Initiate a Phase 1 Multicenter Study in US of Its PD-L1 ADC HLX43 for the Treatment of Thymic Carcinoma Breakthrough Potential in Thymic Carcinoma (TC): HLX43, the first PD-L1 ADC demonstrating promising efficacy in thymic carcinoma (TC), is positioned to address the critical gap as ADC therapies for this rare, highly aggressive malignancy Potential Best-in-Class Pan-Tumor ADC: HLX43 exhibits "high efficacy and low toxicity" across solid tumors including NSCLC and thymic squamous cell carcinoma (TSCC), highlighting its broad-spectrum therapeutic potential Leading Global Development of PD-L1 ADC: HLX43 is the first PD-L1 ADC advancing to Phase 2 trials globally. The company is accelerating multicenter studies of HLX43 in China, the U.S., Japan, and Australia to expedite global launch to benefit broader patient populations Recently, Shanghai Henlius Biotech, Inc. (2696.HK) announced that HLX43 for Injection, the company‘s innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC) has been approved by the United States Food and Drug Administration (FDA) to initiate a phase 1 clinical trial incorporating thymic carcinoma (TC) cohort to benefit a broader range of tumor patients globally. Previously, HLX43 has already been approved to conduct phase 2 MRCT in patients with advanced non-small cell lung cancer (NSCLC) in China, U.S., Japan and Australia. To date, no PD-L1 targeting ADC has been approved for marketing globally. HLX43 is the first PD-L1 ADC progressed to phase 2 clinical trial development globally. Thymic Carcinoma (TC) is a rare malignant neoplasm originating from thymic epithelial cells, accounting for approximately 14%-22% of all thymic epithelial tumors (TETs) [1]. TC demonstrates aggressive behavior characterized by local invasion, intrathoracic lymph node metastasis, and distant dissemination, correlating with poor prognosis[2]. Histopathologically, thymic squamous cell carcinoma (TSCC) constitutes the predominant subtype (∼70%), followed by lymphoepithelial carcinoma and undifferentiated carcinoma[3]. Epidemiological studies indicate a median age at diagnosis of 50-60 years[1], with a stable global annual incidence of 0.15 per 100,000 person-years; however, increasing diagnostic rates have been observed in recent years[2]. For localized early-stage patients, surgical resection remains the primary therapeutic approach, while advanced or recurrent/metastatic cases require first-line platinum-based combination chemotherapy followed by second-line systemic therapies (including chemotherapy, targeted therapies, and immunotherapy). Critical therapeutic limitations persist, including lack of actionable driver mutations, complex drug resistance mechanisms, significant treatment-related toxicities, and suboptimal efficacy, underscoring the urgent unmet medical need for safer and more effective novel treatment strategies[4-8].  HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1, composed of a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker and topoisomerase inhibitor payload. The drug-to-antibody ratio (DAR) is around 8. Its mechanisms of action integrate targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon binding to tumor cells with PD-L1 expression, the cytotoxic payload of HLX43 will be delivered into tumor cells via dual mechanisms. HLX43 will undergo receptor-mediated endocytosis, releasing the cytotoxic payload intracellularly via linker cleavage, and the payload further diffuses into neighboring tumor cells via bystander effect, thereby blocking DNA replication and triggering tumor cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic anti-tumor efficacy. The results from the phase 1 clinical trial of HLX43 has been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC, including squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative patients. Notably, encouraging preliminary efficacy was observed in thymic squamous cell carcinoma (TSCC) patients, 75% patients with TSCC achieved partial response (ORR=75%, 3/4). Updated phase 1 clinical data will be presented in the poster tour session by Jie wang from Cancer Hospital Chinese Academy of Medical Sciences, the leading PI（principal investigator) of this study at the upcoming 2025 World Conference on Lung Cancer (WCLC) . The company is currently accelerating the clinical development of HLX43 and actively exploring its therapeutic potential in various solid tumors, including NSCLC, TSCC, hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), cervical cancer (CC) and nasopharyngeal cancer (NPC). Both monotherapy studies and a phase 1b/2 trial combining HLX43 with serplulimab (Henlius' proprietary anti-PD-1 monoclonal antibody) are ongoing simultaneously to further exploit the synergistic effects of ADC-mediated cytotoxicity and immunotherapy-induced immune activation. HLX43 may benefit more patients with advanced or metastatic solid tumors by providing a novel treatment option for those who are unresponsive or have developed resistance to PD-1/PD-L1-targeted therapies, as well as the patients who have failed prior chemotherapy or TKI therapies. Looking forward, Henlius will accelerate the global development of HLX43, continuously strengthening the differentiated layout of more innovative molecules to bring high-quality, affordable innovative treatment options to tumor patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 【参考文献】 [1] Cabezón-Gutiérrez L, Pacheco-Barcia V, Carrasco-Valero F, Palka-Kotlowska M, Custodio-Cabello S, Khosravi-Shahi P. Update on thymic epithelial tumors: a narrative review. Mediastinum 2024;8:33. [2] Hsu, C. H. et al. Trends in the incidence of thymoma, thymic carcinoma, and thymic neuroendocrine tumor in the United States. PLoS One 14, e0227197, [3] World Health Organization. WHO Classification of Tumors Online, Thoracic Tumors, Tumors of the Thymus, 5th ed.; World Heath Organization: Geneva, Switzerland 2021. Available online: https://tumorclassification.iarc. who.int/chapters/35. [4] 中国医师协会肿瘤多学科诊疗专业委员会. 中国胸腺上皮肿瘤临床诊疗指南(2021版) %J 中华肿瘤杂志. 395-404 (2021). [5] He, Y., Ramesh, A., Gusev, Y., Bhuvaneshwar, K. & Giaccone, G. Molecular predictors of response to pembrolizumab in thymic carcinoma. Cell Rep Med 2, 100392, [6] Zhang, Y. et al. Thymoma and Thymic Carcinoma: Surgical Resection and Multidisciplinary Treatment. Cancers 15 [7] Zhang, C. et al. The Prognostic Value of Postoperative Radiotherapy for Thymoma and Thymic Carcinoma: A Propensity-Matched Study Based on SEER Database. Cancers 14 [8] Kaira, K., Imai, H. & Kagamu, H. Perspective of Immune Checkpoint Inhibitors in Thymic Carcinoma. Cancers 13 联系方式 媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容 点击下方按钮·分享 ·收藏 ·点赞 ·在看