Announcement of Ningbo Menohua Pharmaceutical Co., Ltd. on its wholly-owned subsidiary obtaining the drug registration certificate for Irbesartan Hydrochlorothiazide Tablets
Securities code: 603538 Securities abbreviation: Minova Announcement number: 2025-105 Convertible bond code: 113618 Convertible bond abbreviation: Minova convertible bonds
Ningbo Menohua Pharmaceutical Co., Ltd.
Regarding the acquisition of irbesartan hydrochlorothiazide tablets by a wholly-owned subsidiary
Announcement of 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.
Ningbo Minohua Tiankang Pharmaceutical Co., Ltd. (hereinafter referred to as "Minohua Tiankang"), a wholly-owned subsidiary of Ningbo Minohua Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), recently received the "Drug Registration Certificate" for Irbesartan Hydrochlorothiazide Tablets approved and issued by the State Food and Drug Administration (hereinafter referred to as the "State Food and Drug Administration"). The relevant information is now announced as follows:
1. Drug related information
Drug name: Irbesartan Hydrochlorothiazide Tablets
Dosage form: tablets
Specifications: Each tablet contains 150mg of irbesartan and 12.5mg of hydrochlorothiazide.
Application matters: Drug registration (domestic production)
Registration classification: Class 4 chemicals
Acceptance number: CYHS2402184
Drug approval number: National Drug Approval Number H20255680
Drug approval number is valid until October 13, 2030
Marketing authorization holder: Ningbo Meinuohua Tiankang Pharmaceutical Co., Ltd.
Manufacturer: Ningbo Meinuohua Tiankang Pharmaceutical 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. Pharmaceutical manufacturing enterprises must comply with the requirements of pharmaceutical quality management regulations before they can produce and sell drugs.
2. Other related information about drugs
Drug indications: used to treat essential hypertension.
Irbesartan and Hydrochlorothiazide are a combination of the angiotensin-II receptor antagonist irbesartan and the thiazide diuretic hydrochlorothiazide. The combination of hydrochlorothiazide and irbesartan can produce synergistic hypotensive effects within the recommended therapeutic dose range.
On July 16, 2024, Minova Tiankang submitted its first domestic drug registration application to the State Food and Drug Administration for irbesartan hydrochlorothiazide tablets and was accepted. As of the date of this announcement, the company has invested RMB 5.8747 million in research and development expenses (unaudited).
As of the date of this announcement, major domestic companies that have approved Irbesartan Hydrochlorothiazide Tablets include Sinopharm Guorui Pharmaceutical Co., Ltd., Beijing Sihuan Kebao Pharmaceutical Co., Ltd., Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd. (data from Yaozhi.com). Global sales of irbesartan hydrochlorothiazide tablets in 2024 will be US$817 million, of which sales in China will be US$184 million (according to IMS data).
3. Impact on the company and risk warning
This time, Irbesartan Hydrochlorothiazide Tablets obtained the "Drug Registration Certificate" from the State Food and Drug Administration, which marks that the company has obtained the qualification to produce and sell the drug in the domestic market, which enhances the market competitiveness of the company's products and further enriches the company's cardiovascular product pipeline. It has a certain positive effect on the company's business development.
Due to the industry characteristics of pharmaceutical products, the future sales of this drug may be affected by various uncertain factors such as policy changes, market demand, and market competition for similar drugs. It is highly uncertain. Investors are advised to pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Ningbo Menohua Pharmaceutical Co., Ltd.
October 21, 2025