| 股代码：688428 A | 股简称：诺诚健华 A | 公告编号：2025-039 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于佐来曲替尼（ICP-723）在中国 上市申请获得批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 NTRK 融合基因存在于各种类型的肿瘤，目前已在超过 26 种实体瘤中发现 了 NTRK 融合基因。中国每年新发的携带 NTRK 融合基因的肿瘤人群预估 6,500 例，这些患者生存期短、疾病进展快、致残率高，而由于目前金标准检测方法— —下一代测序（NGS）的普及率较低，导致诊断延迟，因此仍存在未被满足的临 床需求。广谱抗癌药佐来曲替尼的出现，为患者带来了新的治疗选择。 在针对 NTRK 融合阳性的实体瘤患者的关键注册临床试验中，佐来曲替尼 作为不限瘤种的广谱抗癌药展示了卓越的有效性和安全性。注册临床研究结果显 示总缓解率（ORR）达 89.1%，疾病控制率（DCR）为 96.4%，24 个月无进展生 ...

智通财经APP获悉，中信证券发布研报称，IBD作为自身免疫疾病中的"硬骨头"，拥有巨大的未满足临 床需求和广阔的市场空间。尽管IBD领域的靶点不断丰富，但诱导期的临床缓解率(经安慰剂调整后)依 然非常有限，大多数药物的临床缓解率在10%-20%之间的水平，已获批药物的高剂量组临床缓解率通常 在15%以上。当前IBD的治疗新老产品更新迭代，对新机制新疗法的需求急迫，注射长效化+口服多点 开花。MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角。该行建议关注新靶点新机制， 密切跟踪相关临床试验的开展和进度以及重点数据的读出。 中信证券主要观点如下： MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角 作为自身免疫疾病领域中，患者人数众多且当前一年维持期疗效仍仅有30%-50%临床缓解率的适应症， IBD吸引了众多MNC布局。老玩家通过新产品巩固领先优势;慢病头部企业通过资源倾斜快速布局;肿瘤 领域核心玩家通过BD、收购等模式进入。根据过往交易规模以及MNC对产品峰值的预期，该行预计一 项临床阶段的优质IBD资产的交易对价在20亿美金以上。 中国企业紧跟全球趋势并展现出差异化创新能力：云顶新耀引 ...

12.5亿美元首付款，60亿美元总交易额，三生制药与辉瑞的一纸协议，在今年5月点燃了资本市场的热 情，也映照出中国创新药的"DeepSeek时刻"。在本轮行情中，百济神州、百利天恒、诺诚健华等一批企 业凭借技术实力和出海策略脱颖而出，它们可以作为观察行业趋势的典型样本。它们是当下的典型，未 来却绝不是"全部"。 资本市场敏锐地嗅到了变化。今年以来，二级市场上创新药板块成为明星。港股创新药指数一度飙升逾 100%，A股创新药板块亦亮点频现。水涨船高之下，A股和港股千亿市值创新药企已达8家。 与此同时，港交所迎来药企扎堆申报，仅11月就有近10家创新药企递表，其中不乏多轮融资但仍未盈利 的创新药企。资本的热浪席卷着二级市场，而在这背后，中国创新药企正用实实在在的临床数据和商业 价值实现价值重估。 /二级市场狂欢/ 资本市场总是先知先觉。经历近四年的深度调整后，创新药在2025年迎来强势反弹。 东方财富显示，自4月9日阶段性探底后，港股创新药板块发起猛攻，截至11月19日收盘，港股创新药指 数累计涨幅达到110.75%，期间一度涨超100%。A股创新药板块同样大涨。4月9日至11月19日，A股创 新药板块累计上涨4 ...

奥布替尼在多项淋巴瘤研究中展现了良好的有效性和安全性，包括边缘区淋巴瘤（MZL）、套细胞淋 巴瘤（MCL）、慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）、原发中枢神经系统淋巴瘤 （PCNSL）和弥漫性大B细胞淋巴瘤（DLBCL）。主要研究数据如下： 口头报告 在预测新诊断的PCNSL对基于奥布替尼诱导方案治疗的缓解和生存方面，治疗中期脑脊液ctDNA和 MYD88清除优于PET-CT：一项前瞻性生物标志物研究（报告编号：59） 研究表明，奥布替尼联合利妥昔单抗和高剂量甲氨蝶呤在新诊断PCNSL治疗中展现了良好的有效和耐 受性。在治疗中期，脑脊液（CSF）中ctDNA和MYD88的早期清除相比PET-CT提供了更优越的预测和 预后价值。这些分子生物标志物能够实现实时风险分层，并能够指导早期治疗调整。将脑脊液ctDNA监 测纳入临床工作流程，有望改善PCNSL的反应预测和长期预后。 完成六个治疗周期后，总缓解率（ORR）为89.5%，完全缓解率（CRR）为78.9%。中位起效时间为2.6 个月，2年持续缓解率（DoR）为72.4%。中位随访时间为18.9个月；预估的2年无进展生存（PFS）率和 总生存 ...

Core Insights - InnoCare Pharma presented over 20 studies on its BTK inhibitor orelabrutinib at the 67th Annual Meeting of the American Society of Hematology (ASH) [1] Efficacy and Safety - Orelabrutinib has shown significant efficacy and safety across multiple lymphoma types, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), and diffuse large B-cell lymphoma (DLBCL) [2] - In a study involving newly diagnosed PCNSL, the combination of orelabrutinib, rituximab, and high-dose methotrexate achieved an objective response rate (ORR) of 89.5% and a complete response (CR) rate of 78.9% [4] - The orelabrutinib and obinutuzumab combination demonstrated an ORR of 96.0% in treatment-naïve MZL patients, with no severe toxicities reported [6][5] - Orelabrutinib combined with rituximab showed an ORR of 81.8% and a CR rate of 72.7% in treatment-naïve MZL patients who were unsuitable for local therapy [7][8] - The orelabrutinib plus bendamustine-rituximab regimen showed promising tumor response and survival outcomes in transplant-ineligible, intermediate- to high-risk MCL patients [9] Real-World Studies - A large-scale real-world study in China indicated that R-CHOP plus orelabrutinib achieved a CR rate of 81.4% in MCD-like DLBCL patients, supporting subtype-directed therapy [11] - Preliminary results from a phase II study suggest that the PRO-Pola regimen is a potential treatment option for elderly, unfit, or frail DLBCL patients, with a CRR of 77.8% and an ORR of 100% among those completing three cycles [12][13] - A retrospective real-world study indicated that orelabrutinib monotherapy achieved an ORR and disease control rate (DCR) of 100% in CLL patients [14] Future Directions - Additional studies on orelabrutinib have been selected for poster presentation and publication at the 2025 ASH Annual Meeting, indicating ongoing research and development efforts [15]

BEIJING, Dec. 09, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chr ...

Mesutoclax在治疗复发/难治性套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 （CLL/SLL）和急性髓系白血病（AML）的研究中，都展现了卓越的有效性和安全性。Mesutoclax治疗 复发/难治性MCL的研究入选口头报告，Mesutoclax治疗CLL/SLL和AML的两项研究入选海报展示。 中证报中证网讯（王珞）12月9日，诺诚健华在其微信公众号宣布，公司自主研发的新型BCL2抑制剂 Mesutoclax（ICP-248）共有三项研究在第67届美国血液学会（ASH）年会上进行了公布。 ...

Core Insights - InnoCare Pharma presented three studies on its BCL2 inhibitor, Mesutoclax (ICP-248), at the 67th Annual Meeting of the American Society of Hematology, showcasing its efficacy and safety in treating various hematologic malignancies [1][2]. Group 1: Efficacy in Relapsed/Refractory Mantle Cell Lymphoma (MCL) - Mesutoclax monotherapy demonstrated an overall response rate (ORR) of 87.5% and a complete response rate (CRR) of 46.9% in MCL patients, with an ORR of 84.0% and CRR of 36.0% in BTK inhibitor-refractory patients [3][4]. - The drug was well tolerated across all dose levels (50-150 mg), with no dose-limiting toxicities (DLTs) observed, indicating a promising safety profile [4]. Group 2: Efficacy in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - In CLL/SLL patients, both treatment-naive and relapsed/refractory, the ORR was 100% for those receiving 125 mg of mesutoclax, with a 65% undetectable minimal residual disease (uMRD) rate at week 36 when combined with orelabrutinib [5][6]. - Mesutoclax exhibited a tolerable safety profile, with no DLTs reported up to 150 mg QD [6]. Group 3: Efficacy in Acute Myeloid Leukemia (AML) - The combination of mesutoclax and azacitidine (AZA) achieved a composite complete response (CR+CRi) rate of 92% in treatment-naive AML patients, with 82.6% achieving undetectable minimal residual disease (uMR) [7][8]. - The combination therapy was well tolerated, with no DLTs or tumor lysis syndrome (TLS) events reported, and a 90-day mortality rate of 0% [8]. Group 4: Ongoing Clinical Trials - InnoCare is conducting two registrational clinical trials: one for the combination of mesutoclax and orelabrutinib for treatment-naive CLL/SLL, and another for MCL patients refractory to BTK inhibitors [9]. - The clinical study of mesutoclax as a first-line treatment for AML has entered the dose expansion phase globally, and a study for myelodysplastic syndrome (MDS) is being launched [9].

商保创新药目录的积极探索，能为高价药物开辟新空间，并通过"进入商保—收集真实世界数据—过渡 到医保"的路径，实现制度衔接。 阿尔茨海默疾病负担沉重 阿尔茨海默病是全球主要致死病因之一，疾病负担沉重。我国阿尔茨海默病早诊率低，95%的患者确诊 即中晚期，错失早期诊疗良机。 12月7日，中国国家医疗保障局公布的首版商保创新药目录，纳入卫材及礼来公司的两款阿尔茨海默病 治疗药物引发关注。阿尔茨海默病药物的研发门槛极高，目前在全球范围内的治疗选择都较为有限。 全程治疗费最高近50万元 去年，卫材公司的仑卡奈单抗（商品名：乐意保）以及礼来公司的多奈单抗（商品名：记能达）先后在 国内获批，但治疗费用高昂。复旦大学附属华山医院神经内科郁金泰教授对第一财经记者表示，仑卡奈 单抗和多奈单抗一年的治疗费用分别超过20万元和30万元，一般治疗周期为一年半。这也意味着，患者 全程用药需要支付至少30万元，最高近50万元的治疗费。 第一财经记者了解到，到2025年，礼来的多奈单抗已纳入包括北京、广州、深圳在内的10个省市的城市 商业医疗险。尽管如此，要惠及更多患者，仅靠大城市的商业医疗险仍然不够。 此次两款阿尔茨海默病治疗药物纳入商保 ...

Core Viewpoint - The 2025 National Medical Insurance Drug List has been officially announced, including the addition of the BTK inhibitor, Oubatinib, for the treatment of CLL/SLL patients, marking a significant development for the company and the industry [1] Group 1: Drug Approval and Inclusion - Oubatinib has been included in the 2025 National Medical Insurance Drug List for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients [1] - The drug has also successfully renewed its indications for previously treated CLL/SLL, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) [1] - The new drug list will be implemented starting January 1, 2026 [1] Group 2: Company Representation and Innovation - The announcement of the drug list took place during the 2025 Innovative Drug High-Quality Development Conference, where the company showcased its core pipeline and innovative highlights [1] - Oubatinib received approval for its fourth indication in China in April of this year [1]