Announcement on the Controlled Subsidiary Being Approved to Produce Foot-and-Mouth Disease Vaccine (SAT 1)
Securities code: 603566 Securities abbreviation: Pleco Announcement number: 2026-030
Placo Bioengineering Co., Ltd.
Announcement on the approval of the controlled subsidiary to produce South African type 1 foot-and-mouth disease vaccine
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 assume legal responsibility for the authenticity, accuracy and completeness of its contents.
According to the "Veterinary Drug Administration Regulations", "Veterinary Drug Product Approval Number Management Measures" and other relevant regulations, after review by the Ministry of Agriculture and Rural Affairs, Zhongpu Biopharmaceutical Co., Ltd. (hereinafter referred to as "Zhongpu Bio"), a holding subsidiary of Pleco Bioengineering Co., Ltd. (hereinafter referred to as the "Company"), recently received the "Porcine Foot and Mouth Disease Type O, South Africa Type 1 Bivalent Inactivated Vaccine" and "Cattle and Sheep Foot and Mouth Disease Type O, A, South Africa" issued by the Ministry of Agriculture and Rural Affairs Veterinary drug product approval documents for the two products "Type 1 Trivalent Inactivated Vaccine". Details are as follows:
1. Basic information on temporary approval number of veterinary drug products
(1) Porcine foot-and-mouth disease type O and South African type 1 bivalent inactivated vaccine
Common name: Porcine foot-and-mouth disease type O, South Africa type 1 bivalent inactivated vaccine (O/CATHAY/GX202401 strain + O/MYA98/YN202501 strain + SAT1/GS202601 strain)
Veterinary drug product approval number: Veterinary drug Linzi 250047577
Content specification: 20ml/bottle, 30ml/bottle, 40ml/bottle, 50ml/bottle, 80ml/bottle, 100ml/bottle, 250ml/bottle
Validity period: July 20, 2026 to July 19, 2028
(2) Cattle and sheep foot-and-mouth disease type O, type A, South African type 1 trivalent inactivated vaccine
Common name: Cattle and sheep foot-and-mouth disease type O, type A, South African type 1 trivalent inactivated vaccine (O/Ind2001/XJ202401 strain + A/SC202501 strain + SAT1/GS202601 strain)
Veterinary drug product approval number: Veterinary drug Linzi 250047576
Content specification: 20ml/bottle, 30ml/bottle, 40ml/bottle, 50ml/bottle, 80ml/bottle, 100ml/bottle, 250ml/bottle
Validity period: July 20, 2026 to July 19, 2028
2. R&D background and related market conditions
Foot-and-mouth disease is an acute, febrile, highly contagious animal disease that can spread rapidly over long distances and is caused by Foot and Mouth Disease Virus (FMDV). It mainly infects cattle, pigs, sheep and other cloven-hoofed animals. The disease is a legally reportable disease by the World Health Organization. my country lists foot-and-mouth disease as a Class I disease and FMDV as a Class I animal pathogenic microorganism. The disease is divided into seven serotypes, namely O, A, C, South African type 1, South African type 2, South African type 3 and Asian type 1. There is no cross-protection between different serotypes.
According to the "Technical Guidelines for Compulsory Immunization of Foot-and-Mouth Disease in Autumn 2026" (Epidemic Prevention and Control [2026] No. 90) issued by the China Center for Animal Disease Control and Prevention on May 25, 2026, adhering to the principle of "all exemptions should be avoided, leaving no gaps", the herd immunity density of foot-and-mouth disease should be maintained at more than 90% all year round, the immunity density of immunized livestock should reach 100%, and the immune antibody qualification rate should be maintained at More than 70%; cattle, sheep, etc. are recommended to use type O, type A, and South Africa type 1 foot and mouth disease trivalent vaccines to ensure coverage of type O Ind2001 strain, type A Sea97 strain and SAT1 strain; pigs are recommended to use type O, South Africa type 1 foot and mouth disease bivalent vaccine to ensure coverage of type O CATHAY-3 strain, type O Mya98 strain and SAT1 strain.
Type O and type A foot-and-mouth disease strains have long been prevalent in China. In March 2026, South Africa type 1 foot-and-mouth disease was introduced into my country for the first time. After the epidemic was confirmed, the company relied on its technical advantages in foot-and-mouth disease vaccine research and development and related production technology reserves, and cooperated with the China Animal Disease Prevention and Control Center and other units to carry out related research and development work including South Africa type 1 foot-and-mouth disease vaccine. Both products are multivalent inactivated vaccines developed against current epidemic strains, which can achieve targeted immunity for breeding groups and meet national disease prevention and control requirements. The approved product has undergone multi-stage concentration and purification to effectively remove impurities and reduce immune stress. During the production process, antigen inactivation testing, sterility testing, 146S content testing, total protein content testing and endotoxin testing are strictly carried out in accordance with national standards to ensure that the antigen is safe and effective. After emulsification into seedlings, it has good stability and long-lasting effectiveness.
3. Related procedures before product launch
This time, the company has obtained the provisional approval number for veterinary drug products of two products, "bivalent inactivated vaccine for pig foot-and-mouth disease type O and South Africa type 1" and "trivalent inactivated vaccine for cattle and sheep foot-and-mouth disease type O, type A and South Africa type 1". It has met the production conditions, and will need to complete the batch release and other procedures for veterinary drug products before it can be put on the market. The existing production line capacity of Zhongpu Biological Production Base is sufficient. The company will actively promote production guarantee work and strive to quickly put it on the market to ensure the healthy and stable development of the animal husbandry industry.
4. Impact on the company
The approval of the production of the South African type 1 foot-and-mouth disease vaccine will further enrich the company's foot-and-mouth disease vaccine product matrix, improve the layout of major animal disease prevention and control products, and improve domestic prevention and control methods for current epidemic strains; at the same time, the company will speed up the completion of batch issuance and other pre-marketing work, and rely on the existing production and marketing system to quickly implement it, which is expected to enhance the profitability and market competitiveness of Zhongpu Biotech and bring new performance growth points to the company.
5. Risk warning
The approval of this product is a temporary approval number, and there is some uncertainty as to whether the formal production approval can be successfully obtained in the future. At the same time, product sales are affected by multiple factors such as national epidemic prevention policies, market capacity, animal epidemics, and provincial immunization plans, and there is also uncertainty. Investors are advised to make prudent decisions and pay attention to investment risks. Announcement hereby
Board of Directors of PLC Bioengineering Co., Ltd.
July 21, 2026