Announcement on voluntary disclosure of ophthalmic preparation GB10 injection obtaining drug clinical trial approval notice
Securities code: 688136 Securities abbreviation: Sinovac Pharmaceutical Announcement number: 2025-099
Sinovac Biopharmaceutical Co., Ltd.
Announcement on Voluntary Disclosure of Obtaining Drug Clinical Trial Approval Notice for Ophthalmic Preparation GB10 Injection
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 in accordance with the law.
Recently, Shenzhen Sinovac Pharmaceutical Co., Ltd. (hereinafter referred to as "Shenzhen Sinovac"), a wholly-owned subsidiary of Sinovac Biopharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the "Drug Clinical Trial Approval Notice" issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA"). The State Food and Drug Administration approved Shenzhen Sinovac to conduct clinical trials of "GB10 Injection".
The relevant information is now announced as follows:
1. Basic information on the “Drug Clinical Trial Approval Notice”
Product name: GB10 injection
Acceptance number: CXSL2500841
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the clinical trial application for GB10 injection meets the relevant requirements for drug registration, and it is approved to carry out clinical trials of this product for the treatment of neovascular age-related macular degeneration (nAMD).
2. Introduction to drugs
GB10 injection is an anti-VEGF/Ang-2 dual-target antibody high-concentration ophthalmic protein pharmaceutical preparation independently developed by Shenzhen Sinovac and possessing global intellectual property rights. The concentration of GB10 injection reaches 140mg/mL, which can reduce the injection volume or increase the dosage, and extend the dosage cycle. It is expected to be administered once every 4 months, which greatly improves patient compliance.
Preclinical data show that its biological activity and animal efficacy have reached the level of international competitive products, and it can effectively inhibit fundus angiogenesis in the laser-induced monkey CNV (choroidal neovascularization) efficacy model.
3. Impact on the company
The approval of the State Food and Drug Administration for this clinical trial of GB10 injection will not have a significant impact on the company's recent financial status and operating results.
The clinical trial of the company's GB10 injection was approved by the State Food and Drug Administration, which is an important step in the company's innovative drug research and development process. It marks the key progress of Sinovac's dual-antibody research and development strategy based on its independent technology platform. If the drug research and development is successfully launched in the future, it will be able to provide more diversified products to meet market demand, which will help enrich the company's product layout and further enhance the company's market competitiveness.
4. Risk warning
The approval of the State Food and Drug Administration for the clinical trial of GB10 injection this time is a phased achievement of new drug research and development. The drug development, clinical trial approval, and production have a long cycle and many links. There are still many uncertainties in the subsequent research process, research results, approval results, and marketing.
The company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations and fulfill its information disclosure obligations on the subsequent progress of the projects in a timely manner.
Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Sinovac Biopharmaceutical Co., Ltd.
December 9, 2025