Zhuhai Rundu Pharmaceutical Co., Ltd. Announcement on Obtaining the Drug Registration Certificate for Norepinephrine Hydrochloride Injection

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Stock code: 002923 Stock short name: Runru Co., Ltd. Announcement No.: 2026-023

Zhuhai Runru Pharmaceutical Co., Ltd.

Announcement on Obtaining a Drug Registration Certificate for Norephedrine Hydrochloride Injection

All information disclosure contents of this company and the entire board of directors are true, accurate, and complete. There are no false records, misleading statements, or major omissions.

Zhuhai Runru Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company” or “our Company”) has received the Drug Registration Certificate for Norephedrine Hydrochloride Injection (hereinafter referred to as “this product”) issued by the National Medical Products Administration. Relevant details are hereby announced as follows:

I. Basic Information on the Drug

Drug name: Norephedrine Hydrochloride Injection

Dosage form: Injection

Application items: Drug registration (domestic production)

Specification: 2ml:2.5mg

Registration category: Chemical drug 1

Acceptance number: CXHS2400019

Certificate number: 2026S00977

Drug approval document number: Guo Yao Zhun Zi H20260017

Drug registration standard number: YBH02052026

Approval conclusion: In accordance with the Drug Administration Law of the People’s Republic of China and relevant provisions, after review, this product meets the requirements for drug registration. It is approved for registration and a drug registration certificate is issued. The quality standard, package insert, labels, and production process shall be executed in accordance with the attachments.

II. Indications

This product is a cardiac load testing drug. It is used for radionuclide myocardial perfusion imaging (MPI) to evaluate myocardial ischemia.

III. Research and Development of the Drug

Norephedrine Hydrochloride is a drug developed by chemical total synthesis based on the discovery of the cardiotonic effective ingredient in the medicinal plant “Fuzi” (Aconitum carmichaelii). Research found that the drug is a β-adrenergic receptor agonist class medicine with a novel mechanism of action (Chen YM, Guo BJ, Zhang HD, et al. Higenamine, a Dual Agonist for β 1- and β 2-Adrenergic Receptors Identified by Screening a Traditional Chinese Medicine Library[J]. Planta Med, 2019, 85(9-10):738-744.) cardiac load testing drug, which produces positive inotropic and chronotropic effects on the cardiovascular system (Zhang Zheng, Chen Baoling, Liu Xiujie, et al. Effects of norephedrine on hemodynamics and tolerance and safety[J]. Chinese Medical Journal, 2002, (Issue 5). 352-355.), and the mechanism by which it induces myocardial ischemia is similar to that of the body’s natural exercise load testing (Huang Gang, Shi Hongcheng. Cardiac Nuclear Medicine[M]. Shanghai: Shanghai Scientific & Technical Publishers, 2011…). Activation of β1 receptors can significantly enhance myocardial contractility, increase heart rate, and increase coronary blood flow, and improve atrioventricular conduction; activation of β2 receptors in peripheral blood vessels causes a slight decrease in diastolic blood pressure, and under the clinically specified dosing conditions, it has little effect on blood pressure (Liu Xiujie, Tao Zhonghua, Shi Rongfang, et al. Animal experimental study of the novel cardiac load testing drug norephedrine[J]. Chinese Circulation Journal, 1997, (Issue 4). 304-307.).

Norephedrine Hydrochloride Injection is the company’s first global innovative drug developed. It is the only approved domestically β-adrenergic receptor agonist class radionuclide myocardial perfusion imaging cardiac load testing drug. Its safety and efficacy have been verified through multiple clinical trials, providing a new option for diagnosing myocardial ischemia. Research results show that: when Norephedrine Hydrochloride Injection is used as a cardiac load testing drug for radionuclide myocardial perfusion imaging to evaluate myocardial ischemia, adverse reactions are mild, and after discontinuation of the drug they quickly improve or disappear. It has good safety and can be safely applied to drug-load testing in myocardial perfusion imaging.

IV. Market Situation of the Drug

The American Heart Association (AHA) defines ischemic heart disease as heart injury caused by narrowing of the coronary arteries, also known as coronary artery disease and coronary heart disease. When arteries narrow, the blood and oxygen reaching the myocardium decrease, which may trigger a heart attack. The 2021 Global Burden of Disease report (GBD 2021) shows that China’s prevalence of ischemic heart disease is 4,451.34 per 100k, with 63.3313 million patients, 1.9569 million deaths per year among patients, and ischemic heart disease has become an important disease threatening the health of our country’s residents. Therefore, early diagnosis and precise assessment of myocardial ischemia are key to protecting health.

As a cardiac load testing drug, Norephedrine Hydrochloride Injection is indicated for radionuclide myocardial perfusion imaging (MPI) to evaluate myocardial ischemia. Radionuclide myocardial perfusion imaging (MPI) is an accurate, evidence-based, non-invasive method with the most comprehensive medical evidence for diagnosing myocardial ischemia in coronary heart disease. MPI can accurately diagnose myocardial ischemia and the location, severity, and extent of myocardial ischemia. It has important clinical value for the diagnosis of coronary heart disease, risk stratification, treatment decision-making, and prognosis assessment (Wang Yuetao, Yang Minfu, Fang Wei, et al. Nuclear medicine myocardial perfusion imaging clinical application guideline (2018)[J]. Chinese Journal of Cardiology, 2019, (Issue 7). 519-527.), which helps reduce unnecessary coronary angiography examinations and coronary vascular reconstruction and treatment surgical procedures, and improves the level of clinical diagnosis and management of myocardial ischemia. In particular, for patients who cannot exercise adequately and cannot exercise due to non-cardiac causes or restrictions from physiological factors, drug-load testing is an effective approach (Huang Gang, Shi Hongcheng. Cardiac Nuclear Medicine[M]. Shanghai: Shanghai Scientific & Technical Publishers, 2011.). IMV Company’s “2024 US Nuclear Medicine Market Outlook Report” shows that in 2023, there were 4.57 million cases performing MPI in the United States, accounting for 22.3% of the 20.50 million population of coronary heart disease patients that year. Of these, about 2.83 million used drug-load testing; in the domestic market, the penetration rate of MPI medical technology is relatively lower than abroad due to factors such as the scale of MPI medical equipment configuration and clinical diagnosis and treatment habits. The “Brief Report on the National Census of the Current Status of Nuclear Medicine in 2024” shows that in 2023, the number of MPI examinations in China was 120k cases. In December 2021, the “14th Five-Year Plan for Bioeconomy Development” issued by the National Development and Reform Commission proposed to make precision medicine a key development area and shift from “treating disease as the center” to “health as the center,” developing bio-pharmaceutical products facing people’s life and health and meeting the new expectations of the public for more secure life and health protections. From a long-term perspective, ischemic heart disease in our country shows a trend toward younger onset, and population aging is continuously deepening. With a large patient base, in the future as testing equipment continues to become more widely available and diagnostic and treatment concepts such as “precision medicine,” as well as diagnostic guidelines, are promoted, Norephedrine Hydrochloride Injection is expected to benefit more patients.

V. Impact on the Company and Risk Warning

As Norephedrine Hydrochloride Injection, a Category 1 innovative drug, has been approved and launched on the market, it marks a key step in the company’s strategic transformation from a traditional generic drug enterprise to an innovation-driven pharmaceutical company. It has milestone significance for building the company’s R&D system and establishing core technology barriers. The company will rapidly advance the production and commercialization of Norephedrine Hydrochloride Injection, providing patients with a new diagnostic drug option. This approval will not have a major impact on the company’s short-term performance. In the long run, it is beneficial for enhancing the company’s core competitiveness in the fields of cardiovascular and cerebrovascular health.

The company attaches great importance to pharmaceutical R&D and strictly controls the quality and safety of pharmaceutical manufacturing and sales. After the drug obtains the Drug Registration Certificate, production and sales may be affected by some uncertain factors. Investors are kindly requested to make prudent decisions, and be attentive to preventing investment risks.

Announcement is hereby given.

Zhuhai Runru Pharmaceutical Co., Ltd.

Board of Directors

April 04, 2026

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