Axitinib Tablets (Keshida®), independently developed by Kairuite Pharmaceutical, has been granted a drug registration certificate.

Release time:

2026-04-23

Guangzhou Kairuite Pharmaceutical Co., Ltd. is a chemical pharmaceutical company based in Guangzhou, China, specializing in the field of anti-tumor drugs, hereinafter referred to as “Kairuite Pharmaceutical.”

2026 year 04 month 14 Day, Coret Pharmaceutical The fifth independently developed product—axitinib tablets—has obtained a drug registration certificate. this The approved indications are: 1 , for advanced renal cell carcinoma in patients who have previously received and failed treatment with a tyrosine kinase inhibitor or cytokine therapy. R Carbon copy ) adult patients. 2 , United Toripalimab Used as first-line treatment for patients with intermediate- to high-risk unresectable or metastatic renal cell carcinoma.

Our company Axitinib Tablets Using self-made active pharmaceutical ingredients, the reaction mechanism of the preparation process is well-defined, the process is highly controllable, and with reference to ICH Guiding Principles Strictly control the quality of starting materials, each intermediate step, and the final product. Reference I CH Guiding principles have been established, along with stringent internal control standards, to ensure the safety of clinical drug use. For the formulation and manufacturing process of axitinib tablets, a comprehensive quality comparison study and bioequivalence study were conducted, using the originally marketed reference product in China as the comparator. The results demonstrated no statistically significant differences in the rate and extent of in vivo absorption between the two formulations, confirming that their quality and therapeutic efficacy are consistent.

About Axitinib

Axitinib ( A xitinib ) was developed by Pfizer Inc. of the United States and was 2012 It was approved for marketing in the United States last year and has since been approved for marketing in multiple countries worldwide. The formulation is 2015 It was first approved in China this year and has now been included in the National Medical Insurance Catalogue.

Currently, it has been approved by the U.S. Food and Drug Administration ( Food and Drug Administration, FDA ) Approved targeted therapies include multi-target tyrosine kinase inhibitors (such as sorafenib and axitinib) and the mammalian target of rapamycin complex. -1 Kinase inhibitors (such as temsirolimus and everolimus), humanized anti-vascular endothelial growth factor ( vascular endothelial growth factor, VEGF ) monoclonal antibodies (such as bevacizumab), among others. Among these, targeted therapy using tyrosine kinase inhibitors is widely used in first- and second-line clinical treatment. A randomized Phase III clinical trial comparing axitinib with sorafenib for the treatment of advanced renal cell carcinoma has established that axitinib prolongs progression-free survival in patients with renal cell carcinoma who have failed systemic therapy. progression-free survival, PFS ) advantages, axitinib median PFS for 6.7 months, median sorafenib PFS for 4.7 months, with objective response rates of 19% and 9% , with statistically significant differences. 2012 year FDA Approval has been granted for the marketing of axitinib oral formulation, primarily indicated for advanced disease following failure of systemic therapy. RCC It has now become the first-line standard regimen for advanced renal cell carcinoma.

Regarding Renal Cell Carcinoma (RCC)

Renal cell carcinoma ( RCC ) is a highly malignant tumor of the urinary system and one of the most common tumors, also known as renal adenocarcinoma, accounting for 80% ~ 90% According to surveys, renal cell carcinoma ranks second among urogenital system tumors in China, surpassed only by bladder cancer, and accounts for a certain proportion of adult malignant tumors. 2% ~ 3% , pediatric malignant tumors 20% Left and right. There is a significant difference in the incidence rates between males and females; according to statistics, the male-to-female ratio is 2:1 The incidence of renal cell carcinoma increases with age; data indicate that the peak incidence occurs at 40 ~ 55 years. In addition, the incidence of renal cell carcinoma exhibits marked international variation, with significantly higher rates in European and North American countries compared with Asian countries; countries such as Japan and India have lower incidence rates. Urban areas also exhibit higher incidence than rural areas. 2020 Global new cases this year RCC Cases exceed 43 Ten thousand cases, with 18 Ten thousand people have died from this disease. In our country, 2020 Approximately new cases of renal cell carcinoma nationwide each year 74000 For example, accounting for approximately global new cases. 17.0% As is well known, renal cell carcinoma is insensitive to conventional radiotherapy and chemotherapy. alpha Interferon and interleukins -2 Even cytokine-based therapies often fail to achieve optimal therapeutic outcomes, whereas advances in targeted therapy have delivered remarkable clinical benefits for this disease.

About CoreTech

Guangzhou Coret Pharmaceutical Co., Ltd. is a subsidiary of the Qixi Group, established in 2013. It is a modern, integrated pharmaceutical enterprise that encompasses research and development, manufacturing, and marketing. The company’s R&D center is located in the Guangzhou High-Tech Industrial Development Zone, while its self-built manufacturing facility is situated in the Yonghe Development Zone of Huangpu District, Guangzhou, covering an area of approximately 13,000 square meters. The facility comprises four major buildings: an oral solid dosage workshop, an active pharmaceutical ingredient (API) workshop, a Class A warehouse, and an environmental protection station.

After years of steady development, the company has assembled a highly qualified R&D team with strong technical expertise and established comprehensive GMP and EHS management systems. To date, it has successfully overcome technical barriers for more than ten anti-cancer drugs, including lenalidomide, erlotinib, imatinib, and sunitinib, and has developed API and formulation products that leverage its proprietary manufacturing advantages.

Keruite Pharmaceutical upholds the mission of “Putting Life First, Quality as Our Foundation” and adopts the quality policy of “Striving for Perfection and Creating Better Health Through Superior Quality,” continuously implementing its quality objectives. In 2022, the company obtained its first Drug Production License, with the current scope of production authorization covering active pharmaceutical ingredients, tablets, and hard capsules; in 2023, it successfully passed the GMP compliance inspection for tablets and hard capsules. As a critical component of the health industry, Keruite Pharmaceutical is committed to reducing medical expenses for cancer patients, providing them with safe, effective, and affordable high-quality medicines, while also helping to alleviate the healthcare burden on the nation.

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Axitinib Tablets (Keshida®), independently developed by Kairuite Pharmaceutical, has been granted a drug registration certificate.