The hydrochloride erlotinib tablets (Rui Bikan®) independently developed by Kereit Pharmaceutical have obtained the drug registration certificate.
Release time:
2025-01-02
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'.
About hydrochloride erlotinib
Hydrochloride erlotinib (Erlotinib hydrochloride) is jointly developed byOSI PHARMACEUTICALS LLCandPfizercompany, with sales authorized by Roche. Hydrochloride erlotinib tablets first obtained2004FDAapproval for marketing inyear, and subsequently marketed in multiple countries including the European Union and Japan. It was approved for entry into China in2006year, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitive mutations in the epidermal growth factor receptor (EGFR).2017It was included in the national medical insurance catalog in
Erlotinib is the first oralTKI, which can significantly increase the survival period of patients with advanced non-small cell lung cancer (EGFR) and relieve symptoms. This drug is an oral formulation, which helps improve patient compliance and has lower toxic side effects compared to other chemotherapy drugs.
About non-small cell lung cancer
Lung cancer is one of the most prevalent cancers in the world, accounting for12.9%, with the number of deaths accounting for about1/5of all cancer deaths worldwide.In China, the incidence and mortality rates of lung cancer are the highest, with approximately85%of lung cancer being non-small cell lung cancer (non-small cell lung cancer, NSCLCEGFR). With the application of new methods such as anti-angiogenic therapy, targeted therapy, and immunotherapy in lung cancer treatment, the survival rate of unresectable5has greatly improved, but lung cancer remains the most deadly cancer in China.
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-educated and technically strong R&D team, established a complete GMP andEHS management system. Currently, it has successfully overcome technical barriers for 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 'striving for excellence, creating better health with better quality' as its quality policy, continuously implementing quality objectives. The company obtained its first 'Drug Production License' 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 for cancer patients, provide safe, effective, and affordable high-quality drugs for patients, and alleviate the medical burden on the country.
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Address: Room 803, Building B3, Science and Technology Enterprise Accelerator, No.11 Kaiyuan Avenue, Huangpu District, Guangzhou
Telephone:020-8985 8964
Address: No.80, Spring Equinox Road, Huangpu District, Guangzhou
Telephone:020-8328 9091
Adverse Drug Reaction/Event Feedback E-mail:pvreport@bio-current.com
