LIVZON PHARMA Secures Regulatory Approval for Subcutaneous Injection Drug

Stock News
Aug 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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