SHANDONG XINHUA (00719.HK): Obtains Drug Registration Certificate for Levocarnitine Oral Solution
- The product has a specification of 10 ml : 1 g, a registration classification of Class 4 chemical drug and a drug approval number of H20266018.
- The product is indicated for primary systemic carnitine deficiency and for short-term and long-term treatment of secondary carnitine deficiency caused by inborn errors of metabolism, and is a Class B product in the 2025 national reimbursement drug list.
- Sales of levocarnitine oral solution at public medical institutions in China amounted to approximately RMB 400 million in 2025.
NewTimeSpace News: On 18 September 2026, Shandong Xinhua Pharmaceutical Company Limited (stock code: 00719) disclosed an overseas regulatory announcement that it recently received the drug registration certificate for levocarnitine oral solution approved and issued by the National Medical Products Administration, with a specification of 10 ml : 1 g, a registration classification of Class 4 chemical drug, drug approval number H20266018 and certificate number 2026S03468, with the review conclusion being approval of registration. The Company submitted the marketing authorisation application for domestic production of the product to the Center for Drug Evaluation of the National Medical Products Administration in December 2024, and obtained the registration certificate in September 2026.
The product is indicated for the treatment of primary systemic carnitine deficiency and for short-term and long-term treatment of secondary carnitine deficiency caused by inborn errors of metabolism, and is a Class B product in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2025). According to relevant statistics, sales of levocarnitine oral solution at public medical institutions in China amounted to approximately RMB 400 million in 2025. The Company said the registration certificate further enriches its oral metabolic regulator product line and helps enhance its market competitiveness.
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