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1 Sanqiang Road, Xinzhen, Fangshan District, Beijing, China
Zip code:102413  
Tel:+86-10-6935 8839
Mail:hta_imd@circ.com.cn

 

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HTA Co., Ltd. Obtained the Drug Registration Approval for the New Product

HTA Co., Ltd. Obtained the Drug Registration Approval for the New Product

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[Abstract]:
HTA Co., Ltd. (hereinafter referred to as HTA) recently received the drug registration approval for "Sodium Iodide [I-131] Capsules for Therapeutic Use" issued by the National Medical Products Adminis

The "Sodium Iodide [131I] Capsules for Therapeutic Use" is the first new radiopharmaceutical (first generic) approved in China since 2005, and the first pharmaceutical product that HTA has successfully declared after the release of China’s new “Provisions for Drug Registration”. Also, it is the first variety that has passed the consistency evaluation as an oral solid preparation.

HTA submitted the production application of the product in December 2006, according to the former classification system for chemical drug category V. On August 29, 2008, the company has obtained the clinical approval issued by the NMPA (formerly known as the China Food and Drug Administration or CFDA). After completing drug clinical trials, at the end of November 2016, the production application of chemical drug categoryIII was submitted in the light of new classification system. Then, HTA has passed on-site inspection and two clinical investigations. After the submission of additional information, HTA obtains approval from NMPA in April 2021

The “Sodium Iodide [131I] Capsules for Therapeutic Use” has a broad market prospect. Its successful launch will meet the clinical demand and provide a new choice for the treatment of clinical thyroid cancer and hyperthyroidism in China. With its continuous promotion in clinical application, it will improve the majority of patients’ life quality.

This approval plays an effective role in the R&D, registration and production of radiopharmaceuticals in HTA, which is expected to become one of the new economic growth points of the company and further enhance its core competencies. Also, it has a special significance to the development of domestic radiopharmaceutical industry and nuclear medicine. With the mission of “strengthening nuclear industry to build a strong country and benefiting the mankind”, HTA will constantly build the core competency of science and technology innovation, and contribute to the development of nuclear technology application industry.