SBP GROUP - VOLUNTARY ANNOUNCEMENT - PECELEGANAN SPRAY APPROVED FOR MARKETING

(Incorporated in the Cayman Islands with limited liability)

Website: www.sbpgroup.com

(Stock code: 1177)

VOLUNTARY ANNOUNCEMENT

PECELEGANAN SPRAY APPROVED FOR MARKETING

The board of directors (the "Board") of Sino Biopharmaceutical Limited (the "Company", together with its subsidiaries, the "Group") announces that Peceleganan Spray (trade name: 普亦克®), a national Category 1 innovative drug developed under an exclusive partnership by the Group's subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ("CTTQ"), has received approval for marketing by China's National Medical Products Administration (NMPA) for the treatment of wound infections secondary to first-degree or superficial second-degree burns and scalds caused by Staphylococcus epidermidis, Staphylococcus haemolyticus and Acinetobacter baumannii.

Peceleganan is the world's first Ganan-class anti-infective agent. As a broad-spectrum antimicrobial peptide, it exerts bactericidal activity by disrupting the barrier function of bacterial biofilm systems. Grounded in the "Membrane Discrimination Mechanism" theory, it features a novel antimicrobial mechanism of action and demonstrates potent bactericidal efficacy against a broad spectrum of drug-resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Acinetobacter baumannii strains harbouring the NDM-1 gene. It has been consecutively designated as a National Major Scientific and Technological Special Project for "Significant New Drugs Development" during the 12th and the 13th Five-Year Plan Periods, and is the first Ganan-class anti-infective drug in China to be named by the World Health Organisation (WHO).

The NMPA approval of Peceleganan for marketing was primarily supported by findings from several pivotal clinical studies. In a Phase IIIa trial involving patients with secondary wound infections, including those resulting from burns, scalds, physical injuries and diabetic foot infections (DFI), the clinical response rates at Day 1 after the last dose were 90.4% in the study group (2‰ Peceleganan Spray), compared with 78.7% in the active control group (1% silver sulfadiazine cream) (p = 0.0006). In a Phase IIIb trial involving patients with secondary wound infections resulting from burns and scalds, the complete healing rates at Day 1 after the last dose were 64.3% vs 43.1% (p = 0.0002) for the study group and the control group. The efficacy of the study group was significantly better than that of the control group [1,2].

Furthermore, Peceleganan maintains high and sustained local concentrations with prolonged antibacterial activity, independent of microcirculatory impairment or vascular thrombosis at the wound site, thereby enabling profound eradication of drug-resistant bacteria from the wound bed. Multiple strain-based studies have confirmed that Peceleganan possesses broad-spectrum antibacterial activity, with minimum inhibitory concentration (MIC) levels against drug-resistant strains comparable to those observed for susceptible strains. As a non-antibiotic agent, it presents an extremely low risk of inducing antibiotic resistance and exhibits no cytotoxicity towards newly formed granulation tissue, underscoring a favourable safety profile. Furthermore, the spray formulation enables uniform coverage across a diverse range of irregular and complex wound surfaces, offering the advantages of painless administration and precise dosing, whilst effectively mitigating the risks of mechanical trauma and cross-contamination commonly associated with repeated topical application.

In January 2023, CTTQ entered into a strategic partnership with ProteLight Pharmaceuticals, thereby obtaining exclusive commercialisation rights for Peceleganan in China. Leveraging CTTQ's well-established national distribution network and proven expertise in academic promotion within the anti-infective therapeutic area, the two parties are committed to collaborating in accelerating patient access to Peceleganan, thereby improving clinical accessibility for patients with secondary wound infections.

Sources:

[1] Wei Y, Wu J, Chen Y, et al. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. Annals of Surgery 2023, 277, 43-49.

[2] Wei Y, Li Y, et al. Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial. JAMA Network Open. 2024,7(6),e2415310.

By order of the Board

Sino Biopharmaceutical Limited Tse, Theresa Y Y

Chairwoman

Hong Kong, 23 June 2026