-- Announcement on the Holding Subsidiary Obtaining the Supplementary Application Approval Notice for Methocarbamol Injection and Becoming the Marketing Authorization Holder of the Drug
Securities code: 600789 Securities abbreviation: Lukang Pharmaceutical Announcement number: 2025-043
Shandong Lukang Pharmaceutical Co., Ltd.
Announcement on the controlled subsidiary receiving the approval notice for the supplementary application for Methocarcarmol Injection and becoming the holder of the drug marketing authorization
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
Recently, Shandong Lukang Pharmaceutical Group Saite Co., Ltd. (hereinafter referred to as "Saite"), a holding subsidiary of Shandong Lukang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the "Drug Supplementary Application Approval Notice" (notice number: 2025B03938) for methocarbamol injection (hereinafter referred to as the "drug") approved and issued by the State Food and Drug Administration, agreeing that Saite will be the marketing authorization holder of the above-mentioned drug. The relevant information is now announced as follows:
1. Basic information on drugs
Generic name of the drug: Methocarcarmol Injection
Dosage form: injection
Specifications: 10ml: 1g
Original drug approval number: National Drug Approval Number H20254371
Registration Category: Chemicals
Acceptance number: CYHB2501524
Application content: The drug marketing authorization holder is changed from Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. to Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
Approval conclusion: In accordance with the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this application for this product meets the relevant requirements for drug registration. It is agreed that in accordance with the relevant provisions of the "Administrative Measures for Post-market Changes in Drugs (Trial)", the marketing authorization holder of this product is approved to be "Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. (Address: 3rd Floor, Building 4, No. 2, Zhenxing Road, Science and Technology Park, Changping District, Beijing) 4301)" was changed to "Shandong Lukang Pharmaceutical Group Saite Co., Ltd. (Address: No. 518, Lianhuashan Road, Xintai City, Shandong Province)", and the drug approval number remains unchanged. The production site, prescription, production process, quality standards, etc. of the transferred drugs are consistent with the original drugs and will not be changed. The transferred drugs can be marketed and sold if they meet the product release requirements after passing the Good Manufacturing Practice compliance inspection.
Marketing authorization holder:
Name: Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
Address: No. 518, Lianhuashan Road, Xintai City, Shandong Province
Manufacturing company:
Name: Shanxi Pude Pharmaceutical Co., Ltd.
Address: No. 1 Medical Park, Datong Economic and Technological Development Zone, Shanxi Province
2. Other information about drugs
Methocarcarmol is a central muscle relaxant, a carbamate derivative of guaiacol glyceryl ether, which is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxation effects. This product is clinically used to treat joint muscle sprains, lumbar muscle strains, sciatica and other symptoms. It can also be used to treat proliferative spondylitis, rheumatoid arthritis and rheumatoid arthritis. Methocarbamol also has an anticonvulsant effect and has a protective effect against convulsions caused by strychnine, pentylenetetrazol and electrical stimulation. It can also be used to control pain after cosmetic surgery, patients with severe neurological disorders and skeletal muscle spasm.
At present, there are 30 production approval documents for methocarcarmol injection from 26 domestic companies, all of which are deemed to have passed the consistency evaluation of generic drug quality and efficacy. According to data from Yaozhi, the total sales of methocarbamol injection in hospitals nationwide from 2022 to 2024 will be approximately 213 million yuan, 280 million yuan, and 305 million yuan respectively.
Up to now, Saite has invested approximately RMB 4.5 million (unaudited) in this drug technology transfer project.
3. Impact on the company and risk warning
The company's controlled subsidiary Seth Company has become the marketing license holder for methocarbamol injection, which will help the company optimize its product structure, continue to maintain stable production capacity, meet market demand, and have a positive impact on the company's future operations.
The production and sales of pharmaceuticals are easily affected by many factors such as national policies and market environment, and there are uncertainties. Investors are advised to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Shandong Lukang Pharmaceutical Co., Ltd.
August 30, 2025