Shandong Xinhua Pharmaceutical Co Ltd (00719) has announced that it recently received the Drug Registration Certificate for Levocarnitine Oral Solution, officially approved by China's National Medical Products Administration.

In December 2024, the company submitted its application for domestic production and marketing authorization of the drug to the Center for Drug Evaluation (CDE) under the National Medical Products Administration, with the application being accepted for review. Approval for registration was granted in September 2026, with the final review conclusion confirming the drug's authorization.

This medication is indicated for the treatment of primary systemic carnitine deficiency. In documented cases, clinical manifestations have included recurrent Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms include skeletal muscle hypotonia, muscle weakness, and failure to thrive. A key diagnostic marker for primary carnitine deficiency is low carnitine levels in the patient's serum, red blood cells, and/or tissues, in the absence of primary fatty acid or organic acid oxidation defects as detailed in the clinical pharmacology section. For certain patients, particularly those with cardiomyopathy, carnitine supplementation can rapidly alleviate the symptoms and signs of the disease. Beyond carnitine replacement, supportive and other therapeutic measures should be administered according to the patient's condition.

The product is also intended for the short-term and long-term management of secondary carnitine deficiency resulting from congenital metabolic disorders. Additionally, it falls under Category B of the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List (2025). According to relevant statistical data, sales of Levocarnitine Oral Solution in Chinese public medical institutions in 2025 amounted to approximately RMB 400 million.