The imatinib mesylate tablets (Ruidaxin) independently developed by Kereit Pharmaceutical have obtained the drug registration certificate.

Release time:

2025-03-11

Guangzhou Kereite Pharmaceutical Co., Ltd. is a chemical pharmaceutical company located in Guangzhou, China, focusing on the field of anti-tumor drugs, hereinafter referred to as "Kereite Pharmaceutical."

On March 10, 2025, Kereite Pharmaceutical's third generic product - Imatinib Mesylate Tablets obtained the drug registration certificate.The indications for this product are: 1. For the treatment of Philadelphia chromosome positive (Ph+ CML) chronic phase, accelerated phase, or blast phase; 2. For the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) and other indications.Chronic Myeloid Leukemia(Ph+ CML) chronic phase, accelerated phase, or blast phase; 2. For the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) and other indications.

Our Imatinib Mesylate is a self-manufactured active pharmaceutical ingredient, with a clear reaction mechanism in the preparation process, strong process controllability, and strict control of the quality of starting materials, intermediates at each step, and finished products according to ICH guidelines. Based on ICH guidelines, strict internal control standards have been established to ensure the safety of clinical medications. The formulation process of Imatinib Mesylate Tablets uses the domestic marketed original drug as a reference formulation, conducting comprehensive quality comparison studies and bioequivalence studies, confirming that there is no statistical difference in the absorption rate and extent in vivo, and the product quality and efficacy are consistent.Original DrugA reference formulation, conducting comprehensive quality comparison studies and bioequivalence studies, confirming that there is no statistical difference in the absorption rate and extent in vivo, and the product quality and efficacy are consistent.

About Imatinib Mesylate

Imatinib Mesylate (Imatinib mesylate) was developed by Swiss Novartis and was approved for marketing in the United States in the year.2001It was the first TKI inhibitor approved for marketing.TKIinhibitors, and has been approved for marketing in many countries around the world. The tablet was approved for import in China in the year.2005month1and is now included in the National Essential Medicines List and the National Medical Insurance Catalog.

Imatinib Mesylate is the first inhibitor used for the treatment ofCML.TKIIt can specifically inhibit the activity of kinases such asBCR-ABL,PDGFR,c-Kit.TKIshave pioneered the era of targeted therapy, significantly improving prognosis and overall survival, with approximatelyCMLof patients achieving remission after treatment. Imatinib (CML) is considered the best option for initial treatment of chronic phase patients.60%About400mg/dChronic Myeloid LeukemiaCML Chronic Myeloid Leukemia (chronic myelocytic leukemia, CML), referred to as CML, is a hematological disease originating from bone marrow hematopoietic stem cells, primarily characterized by the proliferation of myeloid cells, accounting for about 15% to 20% of adult leukemia, with a recent upward trend. CML often has a slow onset, and according to the disease progression, it can be divided into chronic phase, accelerated phase, and blast phase. CML patients have a large number of immature granulocytes filling their bone marrow, blood, and spleen, leading to pathological changes such as bone marrow sclerosis, bleeding, and splenomegaly.

Research has found that 95% of CML patients have thePh chromosome, in the process of forming this chromosome, the abl (Abelson leukemia virus) gene on chromosome 9 translocates with the bcr (breakpoint cluster region) gene on chromosome 22, forming a new gene bcr-abl. The fusion protein BCR-ABL expressed by this fusion gene has sustained tyrosine kinase activity, which continuously phosphorylates and activates downstream substrates, opening a series of signaling pathways, promoting cell proliferation, inhibiting apoptosis, leading to the uncontrollable development of CML. In recent years, researchers have continuously developed new drugs to treat CML through experiments and clinical practice.

About Kereite Guangzhou Kereite Pharmaceutical Co., Ltd. is a subsidiary of the Seven-Up Group, established in 2013. It is a modern comprehensive pharmaceutical enterprise integrating research and development, production, and marketing. The R&D center is located in the Guangzhou High-tech Industrial Development Zone, and the self-built factory is located in the Yonghe Development Zone of Huangpu District, Guangzhou, covering an area of approximately 13,000 square meters, with four main buildings including an oral solid preparation workshop, an active pharmaceutical ingredient workshop, and supporting Class A warehouses and environmental protection stations. After years of accumulation, the company has built a high-education level and strong Technology research and development team, established a complete GMP andEHS management system.

Currently, it has successfully overcome the technical barriers of more than ten anti-tumor drugs such as Lenalidomide, Erlotinib, Imatinib, and Sunitinib, and developed active pharmaceutical ingredients and formulation products with its own production advantages. Kereite Pharmaceutical takes "Life First, Quality as the Foundation" as its mission, and takes "Striving for Excellence, Creating Better Health with Better Quality" as its quality policy, continuously implementing quality objectives. The company obtained the "Drug Production License" for the first time in 2022, and the current production license scope includes active pharmaceutical ingredients, tablets, and hard capsules, and passed the GMP compliance inspection for tablets and hard capsules in 2023. As a key part of the health industry, Kereite Pharmaceutical's purpose is to reduce the medical costs of cancer patients, provide safe, effective, and affordable high-quality drugs for patients, and alleviate the medical burden on the country.，在这个染色体形成的过程中，患者9号染色体上的abl( Abelson leukemiavirus) 基因与 22 号染色体上的bcr( breakpointcluster region) 基因发生易位，相互融合形成一个新的基因bcr-abl，由这个融合基因表达的融合蛋白 BCR -ABL具有持续的酪氨酸激酶活性，它通过不断磷酸化及活化下游底物，打开一系列信号通路，促进细胞增殖，抑制凋亡，导致CML不可控的发展。近年来，研究人员通过实验与临床实践不断开发出新的药物以治疗 CML。

关于科锐特

广州科锐特药业有限公司是七喜集团旗下子公司，成立于2013年，是一家集研发、生产、营销为一体的现代化综合性制药企业，研发中心位于广州高新技术产业开发区，自建工厂位于广州市黄埔区永和开发区，占地面积约1.3万㎡，建设了口服固体制剂车间、原料药车间及其配套的甲类仓库和环保站4大主体建筑。

经过多年的沉淀，公司搭建了一支学历层次高、技术力量雄厚的研发队伍，建立了完善的GMP和EHS管理体系。目前已成功地攻克了来那度胺、厄洛替尼、伊马替尼、舒尼替尼等十多种抗肿瘤药物的技术壁垒，开发出了有自己生产优势的原料药和制剂产品。

科锐特药业以“生命至上，质量立本”为使命，将“精益求精，以更优的质量创造更好的健康”作为质量方针，不断贯彻落实质量目标。公司于2022年首次获得《药品生产许可证》，目前生产许可范围包括原料药、片剂、硬胶囊剂，并于2023年通过了片剂、硬胶囊剂的GMP符合性检查。作为健康产业的关键一环，科锐特药业的宗旨是降低肿瘤患者的医疗费用，为患者提供安全、有效、可负担的优质药品，同时为国家减轻医疗负担。

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The imatinib mesylate tablets (Ruidaxin) independently developed by Kereit Pharmaceutical have obtained the drug registration certificate.