Xinhua Pharmaceutical: Announcement on Obtaining the Drug Registration Certificate for L-Carnitine Oral Solution

Securities code: 000756 Securities abbreviation: Xinhua Pharmaceutical Announcement number: 2026-44

Shandong Xinhua Pharmaceutical Co., Ltd.

Announcement on Obtaining the Drug Registration Certificate for L-carnitine Oral Solution

The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and that there are no false records, misleading statements or major omissions.

Recently, Shandong Xinhua Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinhua Pharmaceutical" or the "Company") received the "Drug Registration Certificate" for L-carnitine Oral Solution (hereinafter referred to as "this product") approved and issued by the State Food and Drug Administration. The relevant information is now announced as follows:

1. Basic situation

Drug name: L-carnitine oral solution

Dosage form: oral solution

Specifications: 10ml: 1g

Drug Classification: Prescription Drugs

Registration classification: Chemicals Class 4

Applicant: Shandong Xinhua Pharmaceutical Co., Ltd.

Application matters: Drug registration (domestic production)

Acceptance number: CYHS2404213

Drug approval number: National Drug Approval Number H20266018

Certificate number: 2026S03468

Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration, the registration is approved, and a drug registration certificate is issued. The quality standards, instructions, labels and production processes are as attached. Pharmaceutical manufacturing enterprises must comply with the requirements of pharmaceutical quality management regulations before they can produce and sell drugs.

2. Other related information

In December 2024, Xinhua Pharmaceutical submitted the registration application materials for the domestically produced drug marketing authorization of levocarnitine oral solution to the Center for Drug Evaluation (CDE) of the State Drug Administration and was accepted. In September 2026, it obtained the "Drug Registration Certificate" and the review conclusion was approval of registration.

This product is used to treat primary systemic carnitine deficiency. In reported cases, clinical manifestations include recurrent Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms include skeletal muscle hypotonia, muscle weakness, and failure to thrive. Diagnosis of primary carnitine deficiency is based on low levels of carnitine in the serum, red blood cells, and/or tissues of patients who do not have a primary fatty acid or organic acid oxidation defect (see Clinical Pharmacology section). In some patients, particularly those presenting with cardiomyopathy, supplementation with carnitine can rapidly relieve signs and symptoms of the disease. In addition to carnitine, supportive care and other therapeutic measures should be given according to the patient's condition. It is also indicated for the short- and long-term treatment of secondary carnitine deficiency caused by inborn errors of metabolism.

This product belongs to Category B of the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2025)". According to relevant statistics, sales of levocarnitine oral solution in China's public medical institutions in 2025 will be approximately RMB 400 million.

3. Impact on listed companies and risk warnings

Xinhua Pharmaceutical's levocarnitine oral solution obtained a drug registration certificate in September 2026, further enriching the company's oral metabolism regulating preparation product series and helping to improve market competitiveness.

Since the pharmaceutical sales business is susceptible to changes in domestic pharmaceutical industry policies, bidding and procurement, market environment changes and other factors, there are uncertainties. Investors are advised to invest rationally and pay attention to investment risks.

Announcement is hereby made.

Board of Directors of Shandong Xinhua Pharmaceutical Co., Ltd.

September 18, 2026