Shanghai Haohai Biological Technology Co., Ltd. Announces Clinical Trial Filing and Initiation for Medical Device Developed by Wholly-Owned Subsidiary

Original Title: Shanghai Haohai Biological Technology Co., Ltd. Announcement on the Filing of Medical Device Clinical Trials by Its Wholly-Owned Subsidiary and the Commencement of Clinical Trials

The Board of Directors and all directors of the Company hereby guarantee that there are no false records, misleading statements, or material omissions in the contents of this announcement, and shall bear legal liability for the truthfulness, accuracy, and completeness of its contents in accordance with the law.

Shanghai Haohai Biological Technology Co., Ltd. (hereinafter referred to as the “Company”) announced that its wholly-owned subsidiary, Shanghai Qisheng Biological Preparation Co., Ltd., has obtained ethical approval from the lead site for the clinical trial of its investigational product, linear cross-linked sodium hyaluronate gel for intraocular filling (the “Product” or “this Product”). The product has also recently completed filing with the Shanghai Municipal Medical Products Administration. The Company has completed all preparatory work for the clinical trial and determined that the conditions for initiating the trial have been met; therefore, it has decided to commence the clinical trial. The main relevant details are hereby announced as follows:

I. Basic Information of the "Medical Device Clinical Trial Filing Form"

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II. Product Overview

The application of this product represents an internationally innovative technological development and research effort, primarily intended for sealing retinal breaks to treat rhegmatogenous retinal detachment. Retinal detachment typically requires treatment via vitrectomy. Traditional therapeutic approaches necessitate that patients maintain specific postoperative positions (most commonly the prone position) for 1–3 months, allowing the vitreous cavity tamponade agent (typically gas or silicone oil) to exert pressure on the retina, thereby facilitating its anatomical and functional reattachment. This product is designed to cover and adhere to retinal breaks postoperatively without requiring additional tamponade agents, thus sparing patients the discomfort associated with prolonged prone positioning after surgery and significantly enhancing convenience for patient recovery and return to normal daily activities. Furthermore, this product holds promise for reducing postoperative complications such as proliferative vitreoretinopathy caused by the leakage of subretinal substances, tamponade-related cataracts, and secondary glaucoma.

The clinical trials for this product are scheduled to be conducted at seven hospitals as planned. Among these, the lead investigational site has already initiated patient enrollment, while the remaining six hospitals will sequentially undergo ethical review and filing before commencing clinical trials. This marks the official entry of this product into the clinical trial phase.

III. Risk Warnings

In accordance with the relevant laws and regulations governing medical device registration in China, medical devices must complete the clinical trials required by such regulations and obtain approval from the National Medical Products Administration (NMPA) before they can be marketed. Based on the product’s clinical trial protocol, the Company estimates that the clinical trial period will last 2–3 years. However, the process from clinical trials to commercial production and market launch is lengthy and involves numerous stages, making it susceptible to various unpredictable factors. There are significant uncertainties regarding the progress and outcomes of the clinical trials, as well as the future competitive landscape for the product. The Company will timely fulfill its information disclosure obligations in accordance with the progress of research and development. Investors are hereby advised to exercise caution and be aware of investment risks.

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

August 4, 2020