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Beijing Sunshine Nuohua Pharmaceutical Research Co., Ltd. voluntarily discloses the announcement regarding the approval notice for the clinical trial of ABA001 injection.
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Stock code: 688621 Stock short name: Sunōg Novo Announcement No.: 2026-021
Beijing Sunōg Novo Pharmaceutical Research Co., Ltd.
Voluntary disclosure regarding the announcement of the company’s receipt of a notice of approval for a clinical trial for the ABA001 injection
The board of directors of the Company and all directors hereby guarantee that this announcement contains no false records, misleading statements, or material omissions, and assume legal responsibility in accordance with the law for the truthfulness, accuracy, and completeness of the contents of this announcement.
Recently, Beijing Sunōg Novo Pharmaceutical Research Co., Ltd. (hereinafter referred to as the “Company”) and its wholly owned subsidiary, Beijing Arnaud Technology Co., Ltd., received a notice of approval for a clinical trial for a drug issued and approved by the National Medical Products Administration. The clinical trial application for the Company’s in-development project, the ABA001 injection, has been approved.
● The ABA001 injection’s proposed indication is hypertension.
● Due to the long drug R&D cycle and the many approval steps, it is prone to being affected by certain uncertain factors. Investors are kindly requested to make prudent decisions and take care to prevent investment risks. The relevant details are hereby announced as follows:
I. Basic information about the drug
Applicant: Beijing Sunōg Novo Pharmaceutical Research Co., Ltd.; Beijing Arnaud Technology Co., Ltd.; Beijing Anlong Bio-Pharmaceutical Co., Ltd.
Drug name: ABA001 injection
Specification: 1 ml: 200 mg
Matters applied for: Clinical trial registration for domestically produced drugs
Acceptance number: CXHL2600091
Approval conclusion: In accordance with the Drug Administration Law of the People’s Republic of China and relevant provisions, after review, the ABA001 injection clinical trial application meets the requirements for drug registration, and it is agreed that this product may conduct clinical trials.
II. Other relevant information about the drug
The ABA001 injection submitted this time is a Category 1 innovative drug, with a planned indication of hypertension.
The ABA001 injection is a small interfering nucleotide drug of the messenger RNA (mRNA) gene for targeted angiotensinogen (AGT), coupled with an N-Acetylgalactosamine (N-Acetylgalactosamine, GalNAc) delivery system, enabling the precise delivery of the drug to liver cells. Through the siRNA interference silencing mechanism, it targets and silences the messenger RNA of AGT at the source, blocks the synthesis of the AGT protein, and fundamentally suppresses the effect of the renin-angiotensin-aldosterone system (Renin-Angiotensin-Aldosterone System, RAAS) on increasing blood pressure, thereby lowering blood pressure. Clinical studies of the comparable siRNA drug Zilebesiran have confirmed the efficacy and safety of this mechanism. The therapeutic effect of single dosing can be maintained for 24 weeks, providing sufficient scientific basis for the development of the ABA001 injection. Preclinical studies indicate that 1 mg/kg of this product can significantly reduce blood pressure, with good animal tolerability and relatively high safety. It is expected to achieve a long-acting blood-pressure-lowering effect with dosing once every 3 months or every half-year. Its long-acting dosing characteristics are expected to break through current treatment bottlenecks and provide hypertension patients with a better treatment option.
III. Risk warning
According to the laws and regulations applicable to drug registration in China, after a drug obtains approval for clinical trials, it still needs to conduct clinical trials and apply for a drug marketing authorization. Only after the National Medical Products Administration’s review and approval is completed may the drug be put into production and marketed. Drug R&D features high technology, high risk, and high added value. The period from initial R&D and product development, to clinical trials, to marketing approval, and then to industrialized production is long and involves many steps, making the drug susceptible to various uncertain factors.
The Company will strictly comply with the requirements of relevant laws and regulations and regulatory documents to promptly fulfill its information disclosure obligations. Investors are kindly requested to make prudent decisions and take care to prevent investment risks.
This announcement is hereby issued.
Board of Directors of Beijing Sunōg Novo Pharmaceutical Research Co., Ltd.
April 3, 2026
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