SINO BIOPHARM(01177.HK): Class 1 Innovative Drug Pelecanam Spray (Puyike®) Approved by NMPA for Secondary Wound Infection Caused by Burns and Scalds
NewTimeSpace News: Sino Biopharmaceutical Limited (01177.HK) announced on 23 June that its Class 1 innovative drug Pelecanam Spray (trade name: Puyike®) has obtained marketing approval from the National Medical Products Administration (NMPA), indicated for secondary wound infection resulting from burns and scalds. As a first-in-class ganan-class anti-infective agent globally, it delivers potent bactericidal efficacy against multiple drug-resistant bacteria. Key clinical trials demonstrated its therapeutic effect significantly outperforms the control group. Chia Tai Tianqing holds the exclusive commercialization rights for the product in China.
NewTimeSpace News: On 23 June 2026, Sino Biopharmaceutical Limited (01177.HK) released a voluntary announcement stating that Pelecanam Spray (trade name: Puyike®), a Class 1 innovative drug under exclusive cooperation of the Group’s subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has been approved for marketing by the NMPA. It is indicated for the treatment of secondary wound infection of Grade I or superficial partial-thickness burns and scalds induced byStaphylococcus epidermidis,Staphylococcus haemolyticusandAcinetobacter baumannii.
Pelecanam is the world’s first ganan-class anti-infective agent, a broad-spectrum polypeptide antibacterial drug that exerts bactericidal effects by disrupting the barrier function of bacterial biofilm systems. It presents prominent bactericidal activity against various drug-resistant bacteria, including MRSA (methicillin-resistantStaphylococcus aureus) and multidrug-resistantAcinetobacter baumanniicarrying the NDM-1 gene. Supported by the National Major New Drug Creation Special Projects during the 12th and 13th Five-Year Plans, it is the first ganan-class anti-infective agent in China to receive a WHO generic name.
Key clinical research results are as follows: In Phase IIIa trial, the clinical effective rates of the treatment group and positive control group were 90.4% versus 78.7% (p=0.0006); in Phase IIIb trial, the complete wound healing rates reached 64.3% versus 43.1% (p=0.0002). The therapeutic efficacy of the treatment group was statistically superior to that of the control group in both trials. In January 2023, Chia Tai Tianqing entered into a strategic cooperation with ProteLight Pharma and obtained exclusive commercialization rights of this drug in China.
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