| 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 ...

Core Viewpoint - The biopharmaceutical company, Nuo Cheng Jian Hua, announced the presentation of over 20 research data on its novel BTK inhibitor, Oubatinib, at the 67th American Society of Hematology (ASH) annual meeting, showcasing its efficacy and safety across various lymphoma studies. Group 1: Efficacy and Safety Data - Oubatinib demonstrated a total response rate (ORR) of 89.5% and a complete response rate (CRR) of 78.9% after six treatment cycles, with a median time to response of 2.6 months and a 2-year duration of response (DoR) of 72.4% [2] - In a study involving newly diagnosed primary central nervous system lymphoma (PCNSL), Oubatinib combined with rituximab and high-dose methotrexate showed superior predictive and prognostic value compared to PET-CT, with early clearance of ctDNA and MYD88 [1] - The combination of Oubatinib and Obinutuzumab for initial treatment of marginal zone lymphoma (MZL) showed an ORR of 96.0% and a CRR of 72.0% in 27 evaluable patients, with 100% ORR in 10 patients completing six cycles [3] - Oubatinib combined with rituximab in treatment-naïve MZL patients showed an ORR of 81.8% and a CRR of 72.7%, indicating promising efficacy despite small sample size [4] - Oubatinib combined with bendamustine-rituximab demonstrated favorable tumor response and survival outcomes compared to bendamustine-rituximab alone in high-risk mantle cell lymphoma (MCL) patients [5] Group 2: Real-World Studies and Future Research - A large-scale real-world study provided insights into treatment patterns and outcomes for different genetic subtypes of diffuse large B-cell lymphoma (DLBCL) in China, showing enhanced efficacy of R-CHOP plus BTK inhibitors in MCD-like subtype patients [6] - In the MCD-like treatment group, the CRR for R-CHOP combined with Oubatinib was 81.4% [7] - A prospective study indicated that the combination of pomalidomide, rituximab, and Oubatinib is a potential treatment option for elderly or frail DLBCL patients, achieving a 100% ORR in patients completing three cycles [7] - Oubatinib monotherapy for chronic lymphocytic leukemia (CLL) patients showed a 100% ORR and disease control rate (DCR) in both first-line and subsequent treatments [8] - Additional studies on Oubatinib are set to be presented at the 2025 ASH annual meeting, covering various combinations and treatment strategies for different lymphoma types [8]

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]

Core Viewpoint - InnoCare Pharma has presented over 20 studies on its BTK inhibitor orelabrutinib at the 67th Annual Meeting of the American Society of Hematology, highlighting its efficacy and safety in treating various lymphomas and chronic lymphocytic leukemia [1][2]. Group 1: Efficacy and Safety of Orelabrutinib - Orelabrutinib has shown significant efficacy in multiple lymphoma types, including marginal zone lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, primary central nervous system lymphoma, and diffuse large B-cell lymphoma [2]. - In a study involving newly diagnosed primary central nervous system lymphoma, 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 marginal zone lymphoma patients, with no severe toxicities reported [5][6]. Group 2: Treatment Outcomes and Comparisons - The orelabrutinib plus bendamustine-rituximab regimen showed promising tumor response and survival outcomes compared to the standard bendamustine-rituximab regimen in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma [9]. - In a large-scale real-world study of diffuse large B-cell lymphoma in China, the R-CHOP regimen combined with orelabrutinib achieved a CR rate of 81.4% in MCD-like patients, supporting subtype-directed therapy [11]. - A prospective phase II study indicated that the combination of pomalidomide, rituximab, and orelabrutinib is a potential treatment option for elderly, unfit, or frail patients with diffuse large B-cell lymphoma, achieving a CR rate of 77.8% among those who completed three cycles [12][13][14]. Group 3: Future Research and Development - 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]. - InnoCare is committed to discovering and commercializing innovative drugs for cancer and autoimmune diseases, with a focus on addressing unmet medical needs [17].

Core Insights - The company announced the presentation of three studies on its novel BCL2 inhibitor Mesutoclax (ICP-248) at the 67th American Society of Hematology (ASH) annual meeting [1] - Mesutoclax demonstrated excellent efficacy and safety in treating relapsed/refractory mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML) [1] - The study on Mesutoclax for relapsed/refractory MCL was selected for oral presentation, while the studies for CLL/SLL and AML were selected for poster display [1]

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]

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。 （编辑 郭之宸） 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。 本报记者 许林艳 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） ...

Core Insights - The 2025 National Medical Insurance Drug List was officially announced on December 7, 2023, in Guangzhou, including the addition of the BTK inhibitor, Ibrutinib (brand name: Acalbrutinib), developed by Nocera Pharmaceuticals, for the first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) patients [1][2] - Acalbrutinib 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 Highlights - Nocera Pharmaceuticals showcased its core pipeline and innovative highlights at the conference, representing innovative drug companies [1] - Acalbrutinib, as a result of the national "Major New Drug Creation" initiative, demonstrates nearly 100% target selectivity for BTK, with minimal inter-individual variability and no significant inhibition of other kinases, ensuring efficacy while avoiding adverse effects due to off-target effects [2] - The drug offers the convenience of once-daily oral administration, facilitating continuous treatment for patients [2]

Core Points - The 2025 National Medical Insurance Drug List was officially announced in Guangzhou on December 7, 2023, including the addition of the BTK inhibitor Ibrutinib (brand name: Aobutini) for the first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) patients [2] - Aobutini also successfully renewed its indications for previously treated CLL/SLL, Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL) [2] - The new drug list will be implemented starting January 1, 2026, and was released during the 2025 Innovative Drug High-Quality Development Conference [2] Company Highlights - Aobutini was approved for the first-line treatment of CLL/SLL patients in April 2023, marking its fourth indication in China [3] - As a result of the "Major New Drug Creation" initiative, Aobutini has nearly 100% target selectivity for the BTK target, with minimal inter-individual variability and no significant inhibitory effects on other kinases, ensuring efficacy while avoiding adverse reactions due to off-target effects [3] - Aobutini offers the convenience of once-daily oral administration, facilitating continuous treatment for patients [3]

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]