Shanghai Haixin Group Co., Ltd. Announcement on Subsidiary's Drug Passing Generic Drug Consistency Evaluation

Securities Code: 600851/900917
Securities Abbreviation: Haixin Shares / Haixin B Shares
Announcement No.: 2026-004

Shanghai Haixin Group Co., Ltd.

Announcement Regarding the Approval of a Subsidiary’s Drug for Consistency Evaluation of Generic Drugs

The Board of Directors and all directors of the company guarantee that this announcement contains no false records, misleading statements, or major omissions, and they bear individual and joint responsibility for its authenticity, accuracy, and completeness.

Shanghai Haixin Group Co., Ltd. (hereinafter referred to as “the Company”)’s controlling subsidiary, Jiangxi Gannan Haixin Pharmaceutical Co., Ltd. (hereinafter referred to as “Gannan Haixin”), recently received the “Drug Supplementary Application Approval Notice” issued by the National Medical Products Administration (NMPA) for the chemical drug “Lincomycin Hydrochloride Injection,” which has passed the consistency evaluation of quality and efficacy for generic drugs. The relevant details are hereby announced as follows:

1. Basic Information of the Drug

Drug Name: Lincomycin Hydrochloride Injection
Dosage Form: Injection
Specifications: 1ml: 0.3g (based on C18H34N2O6S), 2ml: 0.6g (based on C18H34N2O6S)
Registration Category: Chemical Drug
Drug Approval Number: China Drug Approval No. H20269053, China Drug Approval No. H20054434
Notice Number: 2026B01486, 2026B01488
Market Authorization Holder and Manufacturer: Jiangxi Gannan Haixin Pharmaceutical Co., Ltd.

Approval Conclusions:

(1) Notice No. 2026B01486: According to the “Drug Administration Law of the People’s Republic of China,” the “Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices” (Guo Fa [2015] No. 44), the “Announcement on Matters Related to the Quality and Efficacy Consistency Evaluation of Generic Drugs” (2017 No. 100), and the “Announcement on Conducting Quality and Efficacy Consistency Evaluation of Chemical Drug Injection Products” (2020 No. 62), after review, this product meets the requirements for drug registration. Approval is granted for the supplementary application to add the 1ml: 0.3g specification, and a drug approval number is issued. The product has passed the consistency evaluation of quality and efficacy for generic drugs. Production processes, quality standards, and instructions are to be implemented as attached, and label content should be consistent with the instructions. Validity period: 18 months.

(2) Notice No. 2026B01488: According to the same regulations as above, after review, this product has passed the consistency evaluation of quality and efficacy for generic drugs. Simultaneously, the following changes are approved: 1. Change in drug formulation and manufacturing process; 2. Change in drug quality standards; 3. Change in packaging materials and containers in direct contact with the drug; 4. Revision of the drug instructions. Production processes, quality standards, and instructions are to be implemented as attached, and label content should be consistent with the instructions. Validity period: 18 months.

2. Other Relevant Information About the Drug

Lincomycin Hydrochloride Injection is used for severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus, but only for patients allergic to penicillin or deemed unsuitable for penicillin use by a doctor. During antibacterial treatment, surgical intervention may be taken based on clinical conditions. If necessary, this product can be used concurrently with other antibacterial drugs. It is not suitable for treating mild bacterial or viral infections. To reduce the emergence of resistant bacteria and maintain the efficacy of lincomycin and other antibiotics, lincomycin should only be used for treating or preventing bacterial infections that are proven or highly suspected.

Gannan Haixin’s Lincomycin Hydrochloride Injection complies with the national drug registration standard YBH06432026 issued by the NMPA.

3. Market Status of Similar Drugs

Lincomycin Hydrochloride Injection was developed by Pzer Inc. in the United States, approved by the U.S. FDA in December 1964, and approved for listing in Japan by the PMDA on April 28, 1965. Currently, the original product is not imported or marketed domestically.

According to the National Medical Products Administration website, as of the disclosure date of this announcement, besides Gannan Haixin, more than ten companies including Ruiyang Pharmaceutical Co., Ltd., Hainan Puli Pharmaceutical Co., Ltd., China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., Yichang Renfu Pharmaceutical Co., Ltd., and Tianfang Pharmaceutical Co., Ltd. have passed or are deemed to have passed the consistency evaluation of this drug.

Based on the Morheng Pharmaceutical database, sales of Lincomycin Hydrochloride Injection in Chinese secondary and above hospitals in 2024 were approximately RMB 11 million.

4. Impact on the Company

Passing the consistency evaluation of quality and efficacy for Gannan Haixin’s Lincomycin Hydrochloride Injection will help enhance the product’s market competitiveness and accumulate experience for subsequent new drug development. This matter will not have a significant impact on the company’s current operating performance.

5. Risk Warning

The company and its controlling subsidiaries attach great importance to drug R&D, strictly controlling quality and safety in R&D, manufacturing, and sales. Due to factors such as national policies, bidding, procurement, and market environment, there are uncertainties in drug sales. Investors are advised to make cautious decisions and be aware of investment risks.

This announcement is hereby made.

Shanghai Haixin Group Co., Ltd.

Board of Directors

March 17, 2026