Shanghai Haohai Biological Technology Announces Its Wholly-Owned Subsidiary Receives Medical Device Registration Certificate for Intraocular Cross-Linked Sodium Hyaluronate Gel

Stock Code: 688366 Stock Abbreviation:Haohai Biological TechnologyAnnouncement No.: 2026-004

Shanghai Haohai Biological Technology Co., Ltd.

Regarding the Voluntary Disclosure of the Wholly-Owned Subsidiary's Intraocular Cross-Linked Sodium Hyaluronate Gel Product

Announcement on Obtaining Medical Device Registration Certificate

The board of directors and all directors of the company guarantee that there are no false records, misleading statements, or significant omissions in the content of this announcement, and they assume legal responsibility for the authenticity, accuracy, and completeness of its content.

Shanghai Haohai Biological Technology Co., Ltd. (hereinafter referred to as "the Company") wholly-owned subsidiary, Shanghai Qisheng Biological Preparation Co., Ltd. (hereinafter referred to as "Qisheng Biological"), has 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 information is hereby announced as follows:

1. Basic Information of Medical Device Registration Certificate

Product Name: Cross-linked Sodium Hyaluronate Gel for Intraocular Use

Registrant Name: Shanghai Qisheng Biological Preparation Co., Ltd.

Model: 16mg/mL

Specification: 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, retinal breaks within 1 quadrant, break size ≤3PD, number of breaks ≤3, without concurrent choroidal detachment or macular hole. It is used to temporarily assist in sealing the breaks during vitrectomy and retinal reattachment surgery in combination with sterile air.

Registration Certificate Validity Period: March 11, 2026 to March 10, 2031

2. Impact on the Company

Qisheng Biological initiated the clinical trial of this product in August 2020. For more details, please refer to the announcement disclosed on the Shanghai Stock Exchange website (www.sse.com.cn), titled "Announcement of Shanghai Haohai Biological Technology Co., Ltd. on the Clinical Trial Filing and Initiation by its Wholly-Owned Subsidiary for Medical Devices" (Announcement No.: 2020-030). After validation through a prospective multi-center clinical trial 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 adopts an innovative patented technology of molecular linear rearrangement cross-linking, used for the treatment of rhegmatogenous retinal detachment, and is suitable for the closure of retinal rhegmatogenous breaks. Traditional treatment methods typically involve the use of vitreous fillers (usually gas or silicone oil) to press against the retina after vitrectomy, requiring patients to maintain a specific posture for 1-3 months post-surgery to help the retina achieve physiological and functional repositioning. This approach carries burdens and long-term risks such as restricted posture, impaired vision, and lens damage. By directly establishing a localized cohesive blocking barrier at the site of the break, this product enables stable retinal repositioning without the need for prolonged prone positioning, reducing the need for supervision and significantly enhancing convenience and quality of life during patient recovery. Additionally, while ensuring retinal stability and repositioning, this product has the potential to further shorten the early postoperative visual recovery process for some patients.

This product is the company's first offering in the field of retinal treatment. The approval of this product not only further enriches the company's ophthalmology product portfolio but also broadens its application scenarios, marking that the company has formed a comprehensive product matrix and business system covering the entire life cycle of eye health, including cataracts, optometry, refractive surgery, ocular surface, and retina. While meeting diverse clinical needs, this product continuously enhances the technological barriers of the company’s ophthalmic products, injecting new momentum into the company’s high-quality development.

3. Risk Warning

This product has not yet formed sales, so it will not have a significant impact on the company's recent performance. The actual sales situation after the product is approved for marketing will be affected by policy changes, market environment, sales channels and other factors, and the future sales situation has greater uncertainty. Investors are advised to make prudent decisions and pay attention to prevent investment risks.

Hereby announced.

Board of Directors of Shanghai Haohai Biological Technology Co., Ltd.

March 17, 2026