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]

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]

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]