Lukang Pharmaceutical’s announcement on its holding subsidiary obtaining a drug registration certificate
Securities code: 600789 Securities abbreviation: Lukang Pharmaceutical Announcement number: 2026-008
Shandong Lukang Pharmaceutical Co., Ltd.
Announcement on Obtaining a Drug Registration Certificate for a Holding Subsidiary
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 Company"), a holding subsidiary of Shandong Lukang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the "Drug Registration Certificate" (approval number: 2026S00478, 2026S00479) for minoxidil liniment (hereinafter referred to as the "drug") issued by the State Food and Drug Administration. The drug is classified according to the new registration 3 Approved generic drugs are deemed to have passed the quality and efficacy consistency evaluation of generic drugs. The relevant information is now announced as follows:
1. Basic information on drug certificates
Drug name: Minoxidil liniment
Dosage form: Liniment
Specifications: 5% (60 ml: 3.0 g), 2% (60 ml: 1.2 g)
Original drug approval number: National Drug Approval Number H20263408, National Drug Approval Number H20263407
Drug registration standard number: YBH35432025
Registration classification: Chemical drugs Class 3
Manufacturer: Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
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. This product should undergo pre-market compliance inspection with Good Manufacturing Practices.
2. Drug R&D and market conditions
Minoxidil belongs to the potassium channel opening class of antihypertensive drugs but has the side effect of hirsutism. The American company Upjohn conducted research on this adverse reaction and found that its solution has significant efficacy in the topical treatment of alopecia. In September 1988, the U.S. FDA approved 2% minoxidil topical solution for the treatment of male alopecia areata and post-chemotherapy baldness. In 1991, the FDA approved its use in women. In 1997, the FDA approved the listing of 5% minoxidil topical solution for male patients. At present, there are minoxidil liniment, minoxidil tincture and other related dosage forms used to treat alopecia in China. This product is used to treat male pattern baldness and alopecia areata.
At present, there are 98 minoxidil liniment production approval documents issued by 58 companies in China, all of which are generic drugs approved according to the new registration classification of chemical drugs. According to Minai.com data, the purchase amount of minoxidil topical preparations in the Chinese pharmaceutical market in 2024 will be RMB 2.361 billion.
Since the development of the drug, Saite's cumulative R&D investment has been approximately RMB 3.8535 million (unaudited).
3. Impact on the company and risk warning
The company attaches great importance to drug research and development and strictly controls the quality and safety of drug research and development, manufacturing and sales. Obtaining the "Drug Registration Certificate" for minoxidil liniment will help the company optimize its product structure, continue to maintain stable production capacity, meet market demand, and will 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.
February 25, 2026