LIVZON PHARMA (01513.HK): Lecankitug injection approved for marketing; first domestic IL-17A/F dual-target biologic in China
NewTimeSpace News: On 27 August 2026, Livzon Pharmaceutical Group Inc. (stock code: 01513) announced that its controlling subsidiary, Zhuhai Livzon Monoclonal Antibody Biotechnology Co., Ltd., has received the Drug Registration Certificate (Certificate No. 2026S03179) issued by the National Medical Products Administration (NMPA), approving the registration of lecankitug injection (subcutaneous injection), with the approval number "Guoyao Zhunzi S20260065" valid until 24 August 2031.
According to the announcement, the drug is available in a specification of 160mg (1.6mL) per vial, with a registration classification of Class 1 therapeutic biologics and a shelf life of 24 months. Lecankitug injection was jointly developed by Livzon Monoclonal Antibody and Beijing Xinkanghe Biomedical Technology Co., Ltd., and is a recombinant humanized anti-human IL-17A/F monoclonal antibody injection, being China's first independently developed IL-17A/F dual-target innovative biologic, which acts by simultaneously blocking the pro-inflammatory factors IL-17A and IL-17F. The indication of this registration application is adult patients with moderate-to-severe plaque psoriasis suitable for systemic therapy or phototherapy.
Psoriasis is an inflammatory skin disease induced by both genetic and environmental factors and prone to relapse, affecting approximately 125 million patients globally and over 7 million patients in China, with plaque psoriasis accounting for about 80%. The drug has completed a Phase III clinical trial for moderate-to-severe plaque psoriasis using secukinumab as the active control, with data showing superior onset of action, skin lesion clearance rate and long-term efficacy versus the control group, with comparable safety; the drug requires no initial intensive induction period and has a reduced dosing frequency versus the control, potentially improving patient experience and compliance. As of the date of the announcement, the cumulative direct R&D investment in the drug amounted to approximately RMB 223.31 million.
In terms of the market, as of the date of the announcement, one imported IL-17A/F dual-target product has been approved for marketing in China, and this drug is the first domestic IL-17A/F dual-target product approved for marketing; for single-target IL-17A and IL-17RA, three imported and four domestic products have been approved in China. According to IQVIA sampling estimates, domestic terminal sales of IL-17A and IL-17RA single-target drugs in 2025 amounted to approximately RMB 2.976 billion. The Company cautioned that it can produce and sell the drug after obtaining the registration certificate, but the operating performance of the product is subject to uncertainties arising from factors such as changes in the market environment.
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