SHANDONG XINHUA (00719) has announced that it recently obtained the Drug Registration Certificate for Bumetanide Injection from the National Medical Products Administration. In April 2026, the company received the certificate, with the review conclusion being approval for registration.

Bumetanide Injection is indicated for: (1) Edematous conditions including congestive heart failure, cirrhosis, and renal diseases (nephritis, nephrotic syndrome, and acute or chronic renal failure from various causes), particularly when other diuretics are ineffective. It is also used in combination with other drugs to treat acute pulmonary edema and acute cerebral edema. (2) Hypertension. While not a first-line treatment for primary hypertension, it is suitable when thiazide drugs are ineffective, especially in cases complicated by renal insufficiency or hypertensive crisis. (3) Prevention of acute renal failure: used when renal perfusion is inadequate due to causes such as dehydration, shock, poisoning, anesthesia accidents, or circulatory insufficiency. Timely administration alongside volume restoration can reduce the risk of acute tubular necrosis. (4) Hyperkalemia and hypercalcemia. (5) Dilutional hyponatremia, particularly when serum sodium falls below 120 mmol/L. (6) Syndrome of inappropriate antidiuretic hormone secretion (SIADH). (7) Treatment of acute drug or toxin poisoning, such as barbiturate overdose. (8) It may be effective in some cases resistant to furosemide.

Bumetanide Injection is listed as a Category B drug in the National Reimbursement Drug List (2025). According to relevant statistics, sales of Bumetanide Injection in China's public medical institutions reached approximately RMB 470 million in 2024.