2025年国家医保药品目录在2025创新药高质量发展大会期间发布。作为创新药企业代表，诺诚健华在大 会期间展示了核心管线和创新亮点。 中证报中证网讯（王珞）12月7日，2025年《国家基本医疗保险、生育保险和工伤保险药品目录》（以 下简称"国家医保药品目录"）在广州正式公布。诺诚健华自主研发的布鲁顿酪氨酸激酶（BTK）抑制剂 宜诺凯®（奥布替尼）新增适应症被纳入2025年国家医保药品目录，用于一线治疗慢性淋巴细胞白血 病/小淋巴细胞淋巴瘤（CLL/SLL）患者。与此同时，奥布替尼用于既往至少接受过一种治疗的 CLL/SLL、既往至少接受过一种治疗的套细胞淋巴瘤（MCL）以及既往至少接受过一种治疗的边缘区 淋巴瘤（MZL）三项适应症成功续约。 据悉，新版国家医保目录将于2026年1月1日起开始实施。 转自：中国证券报·中证网 今年4月，奥布替尼获批用于一线治疗CLL/SLL患者，这是奥布替尼在中国获批的第四个适应症。 ...

今年4月，奥布替尼获批用于一线治疗CLL/SLL患者，这是奥布替尼在中国获批的第四个适应症。 作为国家"重大新药创制"专项成果，奥布替尼拥有更精准的靶点选择性，对BTK靶点的占有率近 100%；个体间差异小，对其他激酶无明显抑制作用，在确保疗效的同时又有效避免了由于脱靶效应造 成的不良反应。此外，奥布替尼实现了一天一次口服给药，为患者持续治疗带来了方便。 12月7日，2025年《国家基本医疗保险、生育保险和工伤保险药品目录》(国家医保药品目录)在广州正 式公布。诺诚健华医药有限公司(以下简称"诺诚健华")自主研发的布鲁顿酪氨酸激酶(BTK)抑制剂宜诺 凯(奥布替尼)新增适应症被纳入2025年国家医保药品目录，用于一线治疗慢性淋巴细胞白血病/小淋巴细 胞淋巴瘤(CLL/SLL)患者。与此同时，奥布替尼用于既往至少接受过一种治疗的CLL/SLL、既往至少接 受过一种治疗的套细胞淋巴瘤(MCL)以及既往至少接受过一种治疗的边缘区淋巴瘤(MZL)三项适应症成 功续约。新版国家医保目录将于2026年1月1日起开始实施。 2025年国家医保药品目录在2025创新药高质量发展大会期间发布。作为创新药企业代表，诺诚健华在大 ...

12月7日，2025年《国家基本医疗保险、生育保险和工伤保险药品目录》（国家医保药品目录）在广州 正式公布。诺诚健华医药有限公司（以下简称"诺诚健华"）自主研发的布鲁顿酪氨酸激酶（BTK）抑制 剂宜诺凯®（奥布替尼）新增适应症被纳入2025年国家医保药品目录，用于一线治疗慢性淋巴细胞白血 病/小淋巴细胞淋巴瘤（CLL/SLL）患者。与此同时，奥布替尼用于既往至少接受过一种治疗的 CLL/SLL、既往至少接受过一种治疗的套细胞淋巴瘤（MCL）以及既往至少接受过一种治疗的边缘区 淋巴瘤（MZL）三项适应症成功续约。新版国家医保目录将于2026年1月1日起开始实施。 2025年国家医保药品目录在2025创新药高质量发展大会期间发布。作为创新药企业代表，诺诚健华在大 会期间展示了核心管线和创新亮点。 今年4月，奥布替尼获批用于一线治疗CLL/SLL患者，这是奥布替尼在中国获批的第四个适应症。 作为国家"重大新药创制"专项成果，奥布替尼拥有更精准的靶点选择性，对BTK靶点的占有率近 100%；个体间差异小，对其他激酶无明显抑制作用，在确保疗效的同时又有效避免了由于脱靶效应造 成的不良反应。此外，奥布替尼实现了一天一次口 ...

Core Insights - The National Medical Insurance Drug List for 2025 was officially announced, including the addition of the BTK inhibitor, Ibrutinib (Obinutuzumab), for the first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) patients [1] - Ibrutinib 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, and was released during the 2025 Innovative Drug High-Quality Development Conference [1] Company Overview - Nocere Biopharma is a commercial-stage biopharmaceutical company focused on developing first-in-class drugs for malignant tumors and autoimmune diseases [3] - The company has multiple new drug products at various stages of commercialization, clinical trials, and preclinical development [3] - Nocere Biopharma has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3] Product Details - Ibrutinib, as a result of the national "Major New Drug Creation" initiative, has nearly 100% selectivity for the BTK target, with minimal inter-individual variability and no significant inhibition of other kinases [2] - The drug is administered orally once a day, providing convenience for continuous treatment for patients [2]

Core Viewpoint - The approval of Ibrutinib (Yinokai) for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) in Singapore marks a significant step in the international expansion of the company [1] Group 1: Product Approval and Development - Ibrutinib has received approval from the Health Sciences Authority (HSA) in Singapore for treating adult patients with R/R MZL, representing the second indication approved for the drug in Singapore [1] - The company is advancing Ibrutinib's global development in the field of autoimmune diseases, in addition to its application in lymphoma treatment [1] Group 2: Market Context and Patient Needs - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with an increasing incidence rate globally [1] - There is a lack of effective treatment options for MZL patients who experience disease progression or relapse after first-line therapy [1] Group 3: Previous Approvals - Earlier in April, Ibrutinib was approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - The drug has also been approved in China for treating R/R CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R MZL, with all three indications included in the national medical insurance [2]

Group 1 - The core point of the article is that Innovent Biologics has received approval from the Health Sciences Authority of Singapore for its drug Ibrutinib (宜诺凯®) to treat relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking a significant step in the company's international expansion [2] - Ibrutinib is a highly selective BTK inhibitor developed by Innovent, which aims to improve safety and efficacy by avoiding off-target adverse events, and is being advanced for the treatment of hematological malignancies and autoimmune diseases [2] - The approval in Singapore is the second indication for Ibrutinib, following its earlier approval for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China [3] Group 2 - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with a rising incidence globally, and patients with disease progression/relapse after first-line treatment currently lack effective treatment options [2]

Core Insights - The company Innovent Biologics has received approval from the Health Sciences Authority of Singapore for its drug Ibrutinib (Yinokai) to treat relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking a significant step in its international expansion [1] - Ibrutinib is a highly selective BTK inhibitor that has demonstrated good efficacy and safety in treating R/R MZL, providing new treatment options for lymphoma patients in Singapore [1] - The company is also advancing the global development of Ibrutinib for autoimmune diseases, in addition to its applications in hematologic malignancies [1] Company Developments - In April of this year, Ibrutinib was approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - Prior approvals in China include treatments for previously treated CLL/SLL, relapsed/refractory mantle cell lymphoma (R/R MCL), and R/R MZL, all of which are covered by the national health insurance [2] Industry Context - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with a rising incidence rate globally [1] - Patients with MZL who progress or relapse after first-line treatment currently lack effective therapeutic options [1]