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Jiangsu Lianhuan Pharmaceutical Co., Ltd. Announcement on the Subsidiary’s Receipt of the "Notice of Approval for the Supplementary Drug Application"
Stock Code: 600513 Stock Short Name: Lianhuan Pharmaceutical Announcement No.: 2026-015
Jiangsu Lianhuan Pharmaceutical Co., Ltd.
Announcement on the Controlled Subsidiary Obtaining the “Notice of Approval for Drug Supplementary Application”
The Board of Directors and all directors of the Company hereby guarantee that this announcement contains no false statements, misleading representations, or material omissions, and assume legal responsibility for the truthfulness, accuracy, and completeness of the contents.
Jiangsu Lianhuan Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”)’s controlled subsidiary Xinxiang Changle Pharmaceutical Co., Ltd. (hereinafter referred to as “Changle Pharmaceutical”) has recently received the “Notice of Approval for Drug Supplementary Application” for Bumetanide Injection (hereinafter referred to as the “Product” or “the Drug”), which was duly issued upon approval by the National Medical Products Administration (hereinafter referred to as the “National Medical Products Administration”). The relevant details are hereby announced as follows:
I. Basic Information of the Drug
■
II. Other Information about the Drug
Bumetanide Injection is mainly indicated for: (1) edematous conditions, including congestive heart failure, liver cirrhosis, kidney diseases, and used in combination with other drugs to treat acute pulmonary edema and acute cerebral edema, etc.; (2) hypertension; (3) prevention of acute renal failure; (4) hyperkalemia and hypercalcemia; (5) dilutional hyponatremia; (6) excessive secretion of antidiuretic hormone; (7) acute drug poisoning and toxin poisoning, etc. As of the disclosure date of this announcement, the sales revenue of this Drug in domestic sample hospitals for 2024 was approximately RMB 290 million, and the sales revenue of this Drug in domestic sample hospitals for the first three quarters of 2025 was approximately RMB 103 million (data source: Mofang · Medical Database).
As of the disclosure date of this announcement, Changle Pharmaceutical’s R&D investment for this Drug is approximately RMB 5.4160 million (unaudited).
As of the disclosure date of this announcement, Changle Pharmaceutical has already obtained 3 production licenses in 2026.
III. Impact on the Company and Risk Notice
This time, Changle Pharmaceutical obtained the “Notice of Approval for Drug Supplementary Application” for Bumetanide Injection, further enriching the product categories of the Company and its subsidiaries, which is beneficial for enhancing the market competitiveness of the Company and its subsidiaries. It is expected that obtaining the above-mentioned “Notice of Approval for Drug Supplementary Application” will not have a material impact on the Company and its subsidiaries’ near-term operating performance. Since drug sales are affected by factors such as national policies, market environment, market acceptance, market competitiveness, etc., there are uncertainties. All investors are kindly requested to make prudent decisions, and to be mindful of investment risks.
This announcement is hereby issued.
Board of Directors of Jiangsu Lianhuan Pharmaceutical Co., Ltd.
April 1, 2026
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