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Shanghai Haohai Biotechnology Co., Ltd. Announcement on Voluntary Disclosure of Medical Device Registration Certificate Obtained by Wholly-owned Subsidiary for Intraocular Cross-linked Sodium Hyaluronate Gel Product
Stock Code: 688366 Stock Name: Haohai Biological Science Announcement No.: 2026-004
Shanghai Haohai Biological Technology Co., Ltd.
Announcement on Voluntary Disclosure of Fully Owned Subsidiary’s Approval for Medical Device Registration of Intraocular Cross-linked Sodium Hyaluronate Gel Product
The Board of Directors and all directors of the company guarantee that the content of this announcement is free from any false records, misleading statements, or major omissions, and assume legal responsibility for its authenticity, accuracy, and completeness.
Shanghai Haohai Biological Technology Co., Ltd. (hereinafter referred to as “the Company”)’s wholly owned subsidiary, Shanghai Qisheng Biological Preparations Co., Ltd. (hereinafter referred to as “Qisheng Biological”), recently received the “Medical Device Registration Certificate of the People’s Republic of China” issued by the National Medical Products Administration for the intraocular cross-linked sodium hyaluronate gel product (hereinafter referred to as “this product”). The relevant details are hereby announced as follows:
Product Name: Intraocular Cross-linked Sodium Hyaluronate Gel
Registrant: Shanghai Qisheng Biological Preparations Co., Ltd.
Model: 16mg/mL
Specifications: 0.25 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.75 mL, 0.8 mL, 0.9 mL, 1 mL
Scope of Application: This product is suitable for rhegmatogenous retinal detachment with PVR grading not exceeding B, tear size within one quadrant, tear size ≤3PD, tear number ≤3, without concurrent choroidal detachment or macular hole. It is used intraoperatively during vitrectomy to assist in temporarily sealing the tear with sterile air.
Validity Period of Registration Certificate: March 11, 2026, to March 10, 2031
Qisheng Biological initiated clinical trials for this product in August 2020. For details, please refer to the company’s announcement on the Shanghai Stock Exchange website (www.sse.com.cn): “Shanghai Haohai Biological Technology Co., Ltd. Announces the Filing and Initiation of Clinical Trials for Medical Devices of Its Wholly Owned Subsidiary” (Announcement No.: 2020-030). After prospective multicenter clinical validation and over two years of rigorous review, Qisheng Biological recently obtained the Class III medical device registration certificate issued by the National Medical Products Administration.
This product uses an innovative molecular linear rearrangement cross-linking patent technology, designed for treating rhegmatogenous retinal detachment, specifically for sealing retinal tears caused by holes. Traditional treatments typically involve vitrectomy followed by filling the vitreous cavity with gas or silicone oil to tamponade the retina, requiring patients to maintain specific postures for 1-3 months to facilitate physiological and functional reattachment of the retina. These methods have limitations such as posture restrictions, visual disturbances, and potential damage to the lens, along with long-term risks.
This product directly establishes a localized cohesive barrier at the tear site, allowing retinal stabilization and reattachment without the need for prolonged prone positioning, reducing caregiving needs, and significantly improving patients’ quality of life during recovery. Additionally, it is expected to maintain retinal stability and reattachment while potentially shortening the early postoperative visual recovery period for some patients.
This is the company’s first product in the field of retinal treatment. Its approval not only enriches the company’s ophthalmology product portfolio but also broadens application scenarios, marking the formation of a comprehensive product matrix and business system covering cataracts, optometry, refractive surgery, ocular surface, and retina throughout the entire eye health lifecycle. While meeting diverse clinical needs, it continuously enhances the technological barrier of the company’s ophthalmic products, injecting new momentum into high-quality development.
This product has not yet been commercialized and therefore will not have a significant impact on the company’s recent performance. The actual sales after approval will be influenced by policy changes, market environment, sales channels, and other factors, and future sales are highly uncertain. Investors are advised to make cautious decisions and be aware of investment risks.
This announcement is hereby made.
Shanghai Haohai Biological Technology Co., Ltd. Board of Directors
March 17, 2026