Haili Biotech’s announcement on obtaining registration certificates for its subsidiary’s products in Vietnam
Securities code: 603718 Securities abbreviation: Haili Biotechnology Announcement number: 2026-012
Shanghai Haili Biotechnology Co., Ltd.
Announcement on Obtaining Registration Certificates for the Products of the Holding Subsidiary in Vietnam
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 bear individual and joint liability for the authenticity, accuracy and completeness of its contents.
Shaanxi Ruisheng Biotechnology Co., Ltd. (hereinafter referred to as "Ruisheng Bio"), a holding subsidiary of Shanghai Haili Biotechnology Co., Ltd. (hereinafter referred to as the "Company"), submitted the registration application materials for Ruisheng Bio-absorbable collagen membrane products to the Ministry of Health of Vietnam in December 2025. Ruisheng Biotech recently received notification from the Ministry of Health of Vietnam that Ruisheng Biotech’s absorbable collagen membrane product has been approved. The relevant information is now announced as follows:
1. Contents of registration certificate
Product name: Absorbable collagen membrane
Registration certificate number: 2600683ĐKLH/HTTB-ĐKKD
Certificate validity period: 2026.03.19 - permanently valid
Product classification: Category D (high-risk medical devices)
2. Basic situation of medical devices
The absorbable collagen film that obtained the Vietnam registration certificate this time is a decellularized matrix material (Decellularized extracellular matrix, dECM) developed and produced by Ruisheng Biotechnology. After clinical patients lose teeth, the alveolar bone in the missing tooth area often undergoes progressive resorption due to lack of functional stimulation, which in turn leads to the problem of insufficient bone mass for dental implants. To address this problem, absorbable collagen membranes are used in combination with oral bone filling materials to reconstruct the alveolar bone tissue in the oral implant area of patients with missing teeth during oral implant surgery. This prevents fibroblasts and epithelial cells in the soft tissue from growing in when there is insufficient horizontal or vertical bone in the oral implant area of patients with missing teeth. This provides time and space for osteoblasts with a slow proliferation rate to preferentially enter the bone defect area and guide the regeneration of bone tissue/periodontal tissue.
The absorbable collagen membrane obtained the Class III medical device product registration certificate issued by the China State Food and Drug Administration under the product name of "Oral Absorbable Biomembrane" in April 2020, and obtained the Vietnam Class D medical device product registration certificate in March 2026.
3. Impact on the company and risk warning
This time, Ruisheng Biological Products obtained a registration certificate in Vietnam, which is conducive to its expansion in the Southeast Asian market. However, obtaining the registration certificate only means that Ruisheng Biological Products has the access conditions for sales in Vietnam. Sales have not yet been formed, and will be affected by overseas regulations and policies, market environment changes, and exchange rate fluctuations and other uncertain factors. Product sales and profit contributions are uncertain, and its specific impact on the company's future performance cannot be predicted. Investors are kindly requested to invest with caution and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Shanghai Haili Biotechnology Co., Ltd.
March 21, 2026