Koruite Pharmaceutical's sunitinib malate capsules (Koleishu®) have obtained a drug registration certificate


Release time:

2025-07-07

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

On June 30, 2025, Coretech Pharmaceutical obtained the drug registration certificate for its fourth generic drug product—Sunitinib Malate Capsules.

Indications:

1. Advanced renal cell carcinoma (RCC) that cannot be surgically removed;

2. Imatinib Mesylate Gastrointestinal stromal tumor (GIST) that has failed treatment or cannot tolerate it;

3. Unresectable, metastatic, high-grade advanced Pancreatic neuroendocrine tumor (pNET) in adult patients.

Our company's sunitinib malate uses self-made raw materials. The reaction mechanism of the preparation process is clear, the process controllability is strong, and the quality of the starting materials, each intermediate, and the finished product are strictly controlled in accordance with ICH guidelines. Referring to ICH guidelines, strict internal control standards have been established to ensure the safety of clinical medication. The prescription and process of sunitinib malate capsules use the domestically listed original research drug as the reference preparation. Comprehensive quality comparison studies and bioequivalence studies have been conducted, confirming that there is no statistically significant difference in the absorption rate and extent in vivo between the two, and the product quality and efficacy are consistent.

 

About Sunitinib Malate

 

            Sunitinib Malate was developed by Pfizer, Inc. of the United States and was approved for marketing in the United States in 2006. It has now been approved for marketing in many countries around the world. The capsule formulation was approved for import into China in 2007 and is currently included in the national medical insurance catalog.

Sunitinib is the first drug approved for adjuvant therapy in high-risk RCC patients. In July 2006, it was approved for use as a first-line drug for advanced and/or metastatic renal cell carcinoma (mRCC), and was the first multi-target first-line drug for mRCC approved by the EU tyrosine kinase receptor inhibitor . In 2007, sunitinib was approved for marketing without clinical trials. Phase IV clinical evidence in China shows that sunitinib is a suitable first-line treatment drug for Chinese patients with advanced RCC. Sunitinib malate capsules were listed as a Category B drug under the National Medical Insurance in 2020.

 

About Renal Cell Carcinoma (RCC)

           Renal cell carcinoma ( RCC ) is a highly malignant tumor in the urinary system and one of the most common tumors. It is also known as renal adenoma and accounts for 80%90% of renal malignant tumors. According to surveys, renal cell carcinoma ranks second among urological and reproductive system tumors in China, second only to bladder tumors, accounting for 2%3% of adult malignant tumors and 20% of pediatric malignant tumors. There is a significant difference in incidence rates between men and women. According to statistics, the male-to-female ratio is 2:1 . The incidence of renal cell carcinoma increases with age. Data show that the high-incidence age of renal cell carcinoma is 4055 years old. In addition, the incidence of renal cell carcinoma varies significantly internationally, with significantly higher rates in European and American countries than in Asian countries. The incidence rates in countries such as Japan and India are relatively low. The incidence rate in urban areas is higher than that in rural areas. 2020 New global cases in RCC exceeded 43 ten thousand cases, with 18 ten thousand people dying from the disease. In China, 2020 new cases of renal cancer in the country were approximately 74000 cases, accounting for approximately 17.0%

of global new cases.

   Gastrointestinal stromal tumors (GISTs) are tumors with varying malignant potential, originating from the smooth muscle layer of the digestive tract wall, mainly growing into the lumen. They are found in various parts of the digestive tract, including the stomach (approximately 60%–65%, mostly in the upper part of the stomach), small intestine (20%–25%, mainly in the duodenum and proximal jejunum), colon, and rectum (including low GISTs, mainly in the distal rectum), and esophagus (1%). The clinical incidence is 8/1000,000, with the highest incidence in the 70–79 age group. Micro-GISTs with a diameter of <1 cm occur in 20%–30% of elderly people. In addition, GISTs have the highest incidence in the stomach and small intestine, accounting for 50%–60% and 30%–35%, respectively. The incidence in the colorectum and esophagus is 5% and <1%, respectively. GISTs have a potential for malignant transformation and recurrence and metastasis. 10%–30% are malignant tumors, with a 5-year survival rate of approximately 79%. Advanced age, Black race, male sex, and high-risk grading are independent risk factors for low survival rates.

The clinical manifestations of patients are related to the tumor location, size, and growth direction. Because they are located submucosally and are not invasive, most patients do not show corresponding symptoms until the late stage. They usually manifest as abdominal pain, abdominal distension, etc. Patients located at the gastroesophageal junction may experience dysphagia, and patients with submucosal growth may develop ulcers, manifesting as gastrointestinal bleeding and anemia. Although more than half of micro-stromal tumors exhibit benign tumor characteristics, as gastrointestinal stromal tumors increase in size, some may become malignant and metastasize. In more than 50% of patients with gastrointestinal stromal tumors who seek medical attention for the first time, liver metastasis and peritoneal metastasis have already occurred, with 65% of patients metastasizing to the liver, thus proving fatal.

About Pancreatic Neuroendocrine Tumors (pNETs)

   Pancreatic neuroendocrine tumors (pNETs) are a group of rare and highly heterogeneous tumors originating from neuroendocrine islet cells in the pancreas. They account for only 5% of pancreatic tumors, making them a rare malignancy. The annual incidence rate is 2-3 per 100,000. pNETs are classified as functional or non-functional. Functional pNETs exhibit clinical symptoms based on the hormone secreted; non-functional pNETs lack typical symptoms and signs, making early diagnosis difficult. pNETs tend to develop relatively slowly. Early diagnosis and timely surgery can lead to a favorable prognosis. CT and MRI have become the primary imaging methods for evaluating pancreatic tumors, offering significant value in tumor characterization and prognosis assessment.

 

About Corete

Guangzhou Corete Pharmaceutical Co., Ltd., a subsidiary of Qi Xi Group, was established in 2013. It is a modern, comprehensive pharmaceutical company integrating R&D, production, and marketing. Its R&D center is located in Guangzhou High-tech Industrial Development Zone, and its self-built factory is located in Yonghe Development Zone, Huangpu District, Guangzhou, covering an area of approximately 13,000 square meters. The factory includes four main buildings: an oral solid preparation workshop, a raw material workshop, a Class A warehouse, and an environmental protection station.

After years of development, the company has assembled a research and development team with high educational backgrounds and strong technical capabilities, and established a complete GMP and EHS management system . It has successfully overcome the technical barriers of more than ten anti-tumor drugs, including lenalidomide, erlotinib, imatinib, and sunitinib, developing raw materials and formulations with its own production advantages.

Corete Pharmaceutical adheres to the mission of "Life First, Quality-Based" and the quality policy of "Striving for Excellence, Creating Better Health with Superior Quality," continuously implementing quality objectives. The company obtained its first "Drug Production License" in 2022. The current production license scope includes raw materials, tablets, and hard capsules. In 2023, it passed the GMP compliance inspection for tablets and hard capsules. As a key link in the health industry, Corete Pharmaceutical aims to reduce medical expenses for cancer patients, providing safe, effective, and affordable high-quality medicines while alleviating the medical burden on the country.