Changchun High-Tech Gains After US FDA Approves Its Children's Hypertension Drug
Liao Shumin
DATE:  Jul 30 2025
/ SOURCE:  Yicai
Changchun High-Tech Gains After US FDA Approves Its Children's Hypertension Drug Changchun High-Tech Gains After US FDA Approves Its Children's Hypertension Drug

(Yicai) July 30 -- Shares of Changchun High-Tech Industry Group rose after the US Food and Drug Administration approved a child-friendly hypertension formulation developed by the Chinese biopharmaceutical company's subsidiary Brillian Pharma.

Changchun High-Tech [SHA: 000661] closed 2.8 percent up at CNY108.81 (USD15.16) in Shanghai today. The Shanghai Composite Index rose 0.2 percent.

The FDA has approved Brillian Pharma's amlodipine freeze-dried powder as an oral solution for the treatment of hypertension and angina in patients older than six years old, the Changchun-based parent company announced yesterday.

Amlodipine freeze-dried powder for oral solution is an innovative 505(b)(2) reformulation capable of lowering blood pressure in both children over six and adults, thereby reducing the risk of fatal and non-fatal cardiovascular events.

The US hypertension guidelines for treating hypertension in children and adolescents indicate that the overall goal of pharmacological therapy is to reduce the risk of organ damage, hypertension, and cardiovascular diseases in adulthood. Amlodipine, as a long-acting dihydropyridine calcium channel blocker, is the preferred medication for the initial treatment of hypertension in children.

The prevalence of hypertension among children aged six to 17 in the US was 3.8 percent between August 2021 and August 2023, according to data released by the US Centers for Disease Control and Prevention last October 2024. The prevalence significantly increased to 47.7 percent in adults aged 18 and older.

The FDA's approval of this product will help Changchun High-Tech diversify its product portfolio in the United States and enhance its competitiveness in the pharmaceutical industry, the firm noted.

Last year, Changchun High-Tech's GenSci098 injection for the treatment of thyroid eye disease, Class-1 new chemical drug GenSci122 tablets for advanced solid tumors, and Class-1 new chemical drug GS1-144 tablets for menopausal vasomotor symptoms received clinical trial approvals in China and implicit permission for clinical trials from the FDA, the company told investors.

Editor: Futura Costaglione

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Keywords:   Changchun High-Tech Industries Group