/Announcement from Lukang Pharmaceutical on Obtaining Drug Registration Certificate
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Announcement from Lukang Pharmaceutical on Obtaining Drug Registration Certificate

Shanghai Stock Exchange
2026/04/03

Securities code: 600789 Securities abbreviation: Lukang Pharmaceutical Announcement number: 2026-011

Shandong Lukang Pharmaceutical Co., Ltd.

Announcement on Obtaining Drug Registration Certificate

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 Co., Ltd. (hereinafter referred to as the "Company") received the "Drug Registration Certificate" (certificate number: 2026S00837, 2026S00838) for oxacillin sodium for injection (hereinafter referred to as the "drug") issued by the State Food and Drug Administration, and the drug was approved for registration. The relevant information is now announced as follows:

1. Basic information on drug certificates

Drug name: Oxacillin sodium for injection

Dosage form: injection

Specifications: 1.0g based on C₁₉H₁₉N₃O₅S, 2.0g based on C₁₉H₁₉N₃O₅S

Approval number: National Drug Approval Number H20263702, National Drug Approval Number H20263703

Drug standard: YBH34312025

Registration classification: Chemicals Class 3

Manufacturer: Shandong Lukang Pharmaceutical Co., Ltd.

Approval conclusion: This product meets the relevant requirements for drug registration. The registration is approved and a drug registration certificate is issued.

2. Drug R&D and market conditions

Oxacillin sodium is a penicillinase-resistant penicillin that exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls when penicillin-sensitive microorganisms are actively proliferating. Resistance to penicillins may result from disruption of the beta-lactam ring by beta-lactamases, altered penicillin affinity for the target, or reduced antibiotic concentration that penetrates the target area. Resistance to oxacillin suggests resistance to all other beta-lactam antibiotics, except for newly developed drugs that are effective against methicillin-resistant Staphylococcus aureus.

After inquiry, there are currently 19 domestic companies of this drug that have been approved as generic drugs through consistency evaluation or new registration classification. According to PDB data, domestic sample hospital sales of oxacillin sodium for injection in 2025 will be 1.127 billion yuan.

As of the date of this announcement, the company's investment in R&D of oxacillin sodium for injection is approximately RMB 5.23 million (unaudited).

3. Impact on the company and risk warning

Oxacillin sodium for injection was approved for registration, providing effective assistance to the company to improve its market competitiveness. Since drug sales are affected by national policies, market environment and other factors, there are uncertainties. Investors are advised to make prudent decisions and pay attention to investment risks.

Announcement is hereby made.

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

April 3, 2026