LIVZON PHARMA Secures Regulatory Approval for Subcutaneous Injection Drug

Stock News
08/27

LIVZON PHARMA (01513) announced that its controlled subsidiary, Zhuhai Livzon Monoclonal Antibody Biotechnology Co., Ltd., has received the Drug Registration Certificate (Certificate No.: 2026S03179) issued by China's National Medical Products Administration.

The newly approved drug, Levonkitamab injection (subcutaneous), was co-developed by the subsidiary and Beijing Xin Kang He Bio-Pharmaceutical Technology Co., Ltd. This recombinant humanized monoclonal antibody injection targeting IL-17A/F represents China's first domestically developed innovative biologic with dual-target IL-17A/F inhibition. The mechanism works by simultaneously blocking the pro-inflammatory factors IL-17A and IL-17F.

The approved indication for this registration application covers adult patients with moderate-to-severe plaque psoriasis who are suitable for systemic therapy or phototherapy. The product completed a Phase III clinical trial for moderate-to-severe plaque psoriasis, using secukinumab as the active comparator. Trial data demonstrated that this drug showed superior outcomes in onset speed, skin lesion clearance rate, and long-term efficacy compared with the control group, while maintaining a comparable safety profile.

Notably, the drug does not require an initial intensive induction period and offers a reduced dosing frequency relative to the comparator, which may enhance patient experience and improve treatment adherence.

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