SHANDONG XINHUA (00719): Obtained the Drug Registration Certificate for Levocarnitine Oral Solution

SHANDONG XINHUA (00719) announced that recently, the company received the "Drug Registration Certificate" for Levocarnitine Oral Solution approved and issued by the National Medical Products Administration. In December 2024, Shandong Xinhua Pharmaceutical submitted the domestic production drug marketing authorization registration application materials for Levocarnitine Oral Solution to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which were accepted. In September 2026, the "Drug Registration Certificate" was obtained, with the review conclusion being approval of registration. This product is used for the treatment of primary systemic carnitine deficiency. In reported cases, clinical manifestations include recurrent Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Related symptoms include skeletal muscle hypotonia, muscle weakness, and developmental arrest. The diagnostic criteria for primary carnitine deficiency are low carnitine levels in the patient's serum, red blood cells, and/or tissues, without primary fatty acid or organic acid oxidation defects (see Clinical Pharmacology section). In some patients, especially those presenting with cardiomyopathy, carnitine supplementation can rapidly alleviate the symptoms and signs of the disease. In addition to carnitine, supportive treatment and other therapeutic measures should be provided according to the patient's condition. This product is also used for short-term and long-term treatment of secondary carnitine deficiency caused by congenital metabolic abnormalities. This product belongs to Category B varieties in the "National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog (2025)." According to relevant statistics, the sales of Levocarnitine Oral Solution in Chinese public medical institutions in 2025 were approximately RMB 400 million.