Announcement on the Company's Sunitinib Malate Capsules Obtaining the Drug Registration Certificate in China
Stock Code: 002422 Stock Abbreviation: Kelun Pharmaceutical Announcement No. 2021-049
Sichuan Kelun Pharmaceutical Co., Ltd.
Announcement on the Company's Sunitinib Malate Capsules
Obtaining the Drug Registration Certificate in China
The company and all members of its Board of Directors hereby confirm that all information disclosed herein is true, accurate and complete with no false or misleading statement or material omission.
Hunan Kelun Pharmaceutical Co., Ltd., a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as “the company” or “Kelun Pharmaceutical”), recently obtained the drug registration certificate of the chemical drug “Sunitinib Malate capsules" from National Medical Products Administration, China. Relevant information is announced as follows:
I. Basic Information of the Drug
Drug name: Sunitinib Malate Capsules
Dosage form: capsules
Strength: 12.5 mg (calculated on sunitinib basis)
Application item: drug registration (domestic production)
Registration category: Category IV of chemical drugs
Reception number: CYHS1900514
NMPA approval number: H20213192
Applicant: Hunan Kelun Pharmaceutical Co., Ltd.
Assessment conclusion: According to the Drugs Administration Law of the People's Republic of China and relevant regulations, this product meets the relevant requirements of drug registration after examination. It is approved for registration and issued with drug registration certificate.
II. Other Relevant Information of Drugs
Sunitinib Malate Capsules was originally developed by Pfizer. It was first approved in the United States in 2006, and then successively approved in Japan, the European Union and other countries and regions. In 2007, the import of this product in China was approved for the treatment of inoperable advanced renal cell carcinoma, gastrointestinal stromal tumors with failure or intolerance of imatinib mesylate treatment and unresectable well-differentiated advanced metastatic pancreatic neuroendocrine tumors.
Sunitinib is a small molecule multi-targeted tyrosine kinase inhibitor with dual anti-tumor effects of anti-angiogenesis and inhibition of tumor cell proliferation. It is the first small molecule targeted drug in the world that can improve the overall survival of patients with kidney cancer to more than 2 years. It has been recommended by NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer (2021.V1), CSCO 2020 Guidelines for the Diagnosis and Treatment of Kidney Cancer, Chinese Expert Consensus on Full-Process Management of Gastrointestinal Stromal Tumors (2020 Edition) as well as other domestic and overseas authoritative guidelines and expert consensus as first-line drug for kidney cancer and second-line drug for gastrointestinal stromal tumors. Sunitinib Malate Capsules is category B drug in 2020 China national medical insurance reimbursement list. In 2019, its sales reached RMB 470 million in China.
At present, three anti-tumor drugs of the company have been approved and marketed in China, i.e., Gefitinib Tablets, Zoledronic Acid Injection (4 mg/100ml) and Paclitaxel for Injection (Albumin-Bound), which have formed a preliminary product cluster in the field of oncology. The approval of Sunitinib Malate Capsules this time and the expected approval of subsequent series products will further enrich the company`s product pipeline in the field of oncology.
In 2015, the reformed policy of China National Medical Products Administration required that the generic drugs application newly submitted must be equivalent to reference listed drug in terms of quality and efficacy. Our company's Sunitinib Malate Capsules was developed according to the requirement and was the third Sunitinib Malate Capsules approved in China. The information of reference listed drug published by China National Medical Products Administration is as follows: trade name: Sutent, MA holder: Pfizer Ltd.
III. Risk Analysis
The period from the approval of a drug to its production and marketing may be affected by some uncertainty factors. The company shall timely fulfil the information disclosure obligation based on the subsequent progress. Please make careful decisions and pay attention to the prevention of investment risks.
It is hereby announced.
Board of Directors
Sichuan Kelun Pharmaceutical Co., Ltd.
March 24, 2021
This document is a translated version of the Chinese version announcement, and the published Chinese version announcement shall prevail. The complete published Chinese version announcement may be obtained at www.kelun.com.