Haili Biotech’s announcement on obtaining the registration certificate for the products of its holding subsidiary in Indonesia
Securities code: 603718 Securities abbreviation: Haili Biotechnology Announcement number: 2026-016
Shanghai Haili Biotechnology Co., Ltd.
Announcement on Obtaining the Registration Certificate for the Products of the Holding Subsidiary in Indonesia
The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records or misleading statements.
statements or major omissions, and shall 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's GORORISE ResorbableCollagen Membrane (GORORISE absorbable collagen membrane) product to the Indonesian Ministry of Health (hereinafter referred to as "MOH") in December 2025. Ruisheng Biotech recently received notification from MOH that Ruisheng Biotech’s GORORISE absorbable collagen membrane product has been approved by MOH. The relevant information is now announced as follows:
1. Contents of registration certificate
GORORISE ResorbableCollagen Membrane (GORORISE absorbable collagen membrane)
Registration certificate number: KEMENKES RIAKL30602620091
Product name: GORORISE ResorbableCollagen Membrane
Certificate validity period: 2026.04.01-2027.09.01
Product classification: Passive sterile/Grade D
2. Basic situation of medical devices
The GORORISE absorbable collagen membrane that obtained the Indonesian 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.
Ruisheng Bioabsorbable Collagen Membrane obtained the Class III medical device product registration certificate issued by the China State Food and Drug Administration in April 2020 under the product name of "Oral Absorbable Biomembrane"; in March 2026, it obtained the Vietnam Class D medical device product registration certificate; in April 2026, it obtained the Indonesian Class D medical device product registration certificate.
3. Impact on the company and risk warning
This time, Ruisheng Biological Products obtained a registration certificate in Indonesia, 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 Indonesia. Sales have not yet been formed, and will be affected by uncertain factors such as overseas regulations and policies, market environment changes, and exchange rate fluctuations. 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.
April 8, 2026