Lecankitug Injection Receives NMPA Approval: China’s First IL-17A/F Dual-Targeted Innovative Biologic Enters Clinical Practice

Lecankitug Injection receives NMPA approval. On August 27, 2026, Livzon Pharmaceutical Group Inc. announced that its holding subsidiary, Livzon Biologics Inc., had received the Drug Registration Certificate issued by the National Medical Products Administration (NMPA). Lecankitug Injection (Subcutaneous Injection), marketed under the brand name LiBeiTan® (丽倍坦®), has officially been approved for marketing for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

✨ The approval adds a domestically developed innovative biologic therapy to the treatment landscape for moderate-to-severe plaque psoriasis in China. LiBeiTan® features an IL-17A/F dual-target mechanism, simultaneously targeting IL-17A and IL-17F, two cytokines involved in the inflammatory pathways associated with psoriasis. This mechanism provides a new therapeutic option among biologic therapies targeting the IL-17 pathway.

As more domestically developed innovative biologics enter the field of autoimmune diseases, the Chinese psoriasis biologics market continues to expand, with greater diversity in mechanisms of action and product offerings.

LiBeiTan® Officially Approved, Targeting Moderate-to-Severe Plaque Psoriasis

The generic name of LiBeiTan® is Lecankitug Injection (Subcutaneous Injection). The product was jointly developed by Livzon Biologics Inc. and Beijing Xinkanghe Biotechnology Co., Ltd. According to publicly available information, Lecankitug is a recombinant humanized monoclonal antibody targeting human IL-17A/F. Its product design focuses on simultaneously targeting IL-17A and IL-17F, thereby blocking two cytokines closely associated with the inflammatory response involved in psoriasis.

The newly approved indication is for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. For patients with more severe disease, extensive skin lesions, or insufficient response to conventional treatments, biologic therapies have become an important component of modern systemic treatment for psoriasis. The launch of LiBeiTan® further expands the range of domestically developed biologic treatment options available in this therapeutic area.

Key Product Information for LiBeiTan®

Item	Details
Generic Name	Lecankitug Injection (Subcutaneous Injection)
Brand Name	LiBeiTan® (丽倍坦®)
Active Ingredient	Lecankitug
Drug Type	Recombinant humanized monoclonal antibody targeting IL-17A/F
Key Targets	IL-17A / IL-17F
Route of Administration	Subcutaneous injection
NMPA Approval Date in China	August 27, 2026
Approved Indication	Adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Developers	Livzon Biologics Inc.; Beijing Xinkanghe Biotechnology Co., Ltd.

Psoriasis Treatment Is Moving Toward Precision Targeting, with the IL-17 Pathway as a Key Therapeutic Focus

Psoriasis is a chronic, recurrent, immune-mediated inflammatory disease, with plaque psoriasis being one of the most common clinical forms. The disease can cause significant skin lesions and itching and may have a long-term impact on patients’ quality of life. For patients with moderate-to-severe disease, when topical treatments do not provide adequate disease control or more intensive systemic treatment is required, conventional systemic therapies, phototherapy, and biologic therapies may all be considered as part of the treatment strategy.

As immunological research continues to advance, the treatment of psoriasis has gradually shifted from broad immunosuppression toward precision interventions targeting key inflammatory pathways. The IL-23/IL-17 inflammatory axis plays an important role in the pathogenesis of psoriasis. As a result, biologic therapies targeting this pathway have become an important area of innovative drug development for psoriasis in recent years.

Within this therapeutic landscape, IL-17A was among the key inflammatory cytokines to receive early attention, while IL-17F also contributes to inflammatory responses and psoriasis-related pathological processes. Drugs targeting different components of the IL-17 pathway have gradually entered clinical practice, contributing to the diversification of biological treatment strategies for psoriasis beyond single-target mechanisms.

Lecankitug was developed in this context as an IL-17A/F dual-targeted biologic therapy, designed to simultaneously target IL-17A and IL-17F.

IL-17A/F Dual-Target Mechanism and Subcutaneous Administration: Exploring a New Treatment Option for Psoriasis

The significance of Lecankitug’s approval extends beyond its entry as a domestically developed innovative biologic into the treatment landscape for moderate-to-severe plaque psoriasis. Another key feature is its dual-target mechanism against IL-17A and IL-17F, with its efficacy evaluated in a Phase III clinical study. In addition, its subcutaneous route of administration offers characteristics that may be suitable for long-term treatment management.

Considering its mechanism of action, clinical efficacy, and route of administration, Lecankitug demonstrates several distinct product characteristics and provides a new biologic treatment option for adults with moderate-to-severe plaque psoriasis.

IL-17A/F Dual-Target Mechanism: Expanding the IL-17 Pathway Blockade Strategy

✅ One of the key features of Lecankitug is its ability to simultaneously target IL-17A and IL-17F. Both IL-17A and IL-17F belong to the IL-17 family of cytokines and are closely associated with immune-mediated inflammation and the development of skin lesions in psoriasis. Compared with therapeutic strategies primarily targeting a single cytokine, the IL-17A/F dual-target mechanism incorporates IL-17F into its target profile, providing a treatment approach that differs mechanistically from single-target therapies.

Psoriasis is a disease involving complex immune and inflammatory mechanisms, in which different inflammatory cytokines and signaling pathways interact with one another. Therefore, deeper investigation of targets within the IL-17 pathway has become an important direction in the development of biologic therapies in recent years. However, whether a dual-target mechanism can translate into additional advantages in terms of long-term efficacy, safety, or patient benefit still requires continued evaluation through clinical research and real-world data following market approval.

From a drug development perspective, the launch of LiBeiTan® also reflects the continued expansion of domestically developed innovative biologics toward differentiated mechanisms of action. The introduction of an IL-17A/F dual-targeted product into clinical practice provides a new therapeutic and research option for targeted psoriasis treatment.

Phase III Clinical Study: Focusing on Early Response and High Levels of Skin Clearance

One of the important clinical bases for the approval of Lecankitug was its Phase III clinical study in patients with moderate-to-severe plaque psoriasis. According to publicly disclosed information from Livzon Pharmaceutical Group, the study adopted a multicenter, randomized, double-blind, active-controlled design, with Secukinumab used as the active comparator. A total of 926 patients with moderate-to-severe plaque psoriasis were enrolled across 53 clinical centers in China.

The primary efficacy endpoint was the PASI 100 response rate at Week 12. PASI, or the Psoriasis Area and Severity Index, is a commonly used efficacy assessment tool in clinical studies of psoriasis. A PASI 100 response indicates 100% improvement in PASI, representing a high level of skin clearance. As treatment goals for psoriasis have evolved, clinical management has increasingly moved beyond simply controlling disease activity toward achieving a higher degree of skin clearance and maintaining long-term disease control.

According to data publicly disclosed by the company, Lecankitug demonstrated a relatively rapid onset of efficacy and a high level of skin clearance in the clinical study. Publicly reported data showed that:

• At Week 4, the PASI 75 response rate reached 65.7%.
• At Week 12, the PASI 100 response rate reached 49.5%.
• At Week 52, PASI 100 response rates reached 75.9% and 62.6%, respectively, under different maintenance dosing regimens.

These findings suggest that Lecankitug achieved substantial improvement in skin lesions during the early treatment period, with efficacy maintained during continued treatment. However, the above figures are primarily based on company announcements and publicly available information. Detailed statistical analyses, confidence intervals, subgroup results, and comprehensive safety data should be interpreted based on the clinical study report, approved prescribing information, or peer-reviewed publications when available.

Subcutaneous Administration: A Consideration for Long-Term Treatment Convenience

In addition to its mechanism of action and clinical efficacy, the route of administration is another factor worth considering in the long-term use of biologic therapies. Lecankitug is administered by subcutaneous injection, which may offer a relatively convenient administration approach compared with certain biologics that require intravenous infusion in a healthcare setting. According to publicly available clinical study information, Lecankitug includes corresponding maintenance dosing regimens, and different maintenance treatment strategies were evaluated during the study.

For psoriasis, a chronic inflammatory disease that typically requires long-term management, treatment decisions need to consider not only short-term improvement in skin lesions but also the practical aspects of maintaining treatment over time. Therefore, the mechanism of action, durability of efficacy, and dosing regimen are all factors that may need to be considered when selecting a treatment strategy.

Overall, Lecankitug combines an IL-17A/F dual-target mechanism, a high level of skin-clearance efficacy, and subcutaneous administration, providing a new biologic treatment option for adults with moderate-to-severe plaque psoriasis.

👉 For patients requiring long-term systemic treatment, the mechanism of action, clinical efficacy, safety profile, and dosing regimen should be considered comprehensively. Treatment decisions should be based on the approved prescribing information and made by qualified healthcare professionals according to the individual patient’s clinical circumstances. Patients should not independently adjust the dosage or dosing interval.

LiBeiTan® Launch Expands the Landscape of IL-17 Biologics in China

The approval and launch of LiBeiTan® not only adds another biologic treatment option for moderate-to-severe plaque psoriasis but also further expands the product landscape of IL-17-related biologics in China. As the first domestically developed IL-17A/F dual-targeted product approved for marketing in China, its launch has attracted attention from both the clinical and pharmaceutical sectors.

Expanding IL-17-Related Treatment Options

Several biologic therapies targeting different components of the IL-17 pathway have already been approved in China. With the introduction of LiBeiTan® into clinical practice, treatment options targeting the IL-17 pathway have been further expanded. Different products may vary in their mechanisms of action, efficacy profiles, routes of administration, and treatment management requirements. In the future, clinical treatment selection is expected to place greater emphasis on individual patient characteristics and long-term treatment needs.

Reflecting the Trend Toward Innovative Biologic Development

From the perspective of domestic innovative drug development, Lecankitug’s IL-17A/F dual-target mechanism reflects the broader trend toward differentiated mechanisms of action in the development of biologic therapies in China. For patients with psoriasis, the introduction of new therapies means that treatment options continue to expand, but it does not mean that a particular drug is suitable for every patient.

Actual treatment decisions should take into account factors such as disease severity, previous treatments, treatment response, and individual patient needs, with an appropriate treatment plan developed under the guidance of qualified healthcare professionals.

Overall, the launch of LiBeiTan® further enriches the landscape of domestically developed IL-17-related biologics and provides a new treatment option for patients with moderate-to-severe plaque psoriasis. Following the Lecankitug Injection receives NMPA approval milestone, the continued introduction of innovative biologic therapies is expected to further drive psoriasis treatment toward greater diversity and individualized care.

Continued Development in Ankylosing Spondylitis: Future Applications Remain Worth Watching

In addition to its already approved indication for psoriasis, Lecankitug is also being investigated for other immune-mediated inflammatory diseases. According to previously disclosed information from Livzon Pharmaceutical Group, the marketing authorization application for Lecankitug for the treatment of ankylosing spondylitis has been accepted by the National Medical Products Administration (NMPA).

The IL-17 pathway is associated with various immune-mediated inflammatory diseases, providing a scientific rationale for exploring additional indications based on this mechanism. However, the currently approved indication for LiBeiTan® remains adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The application for ankylosing spondylitis is still undergoing regulatory review and should therefore not be presented or used as an indication that has already been approved.

As additional clinical research data become available, the potential application of Lecankitug in other immune-mediated inflammatory diseases will remain an area worth monitoring.

Professional Pharmaceutical Supply and Procurement Consultation

Following the official approval and launch of LiBeiTan®, healthcare institutions, pharmaceutical distributors, and other qualified professional procurement customers are expected to continue monitoring the product’s availability, product information, and requirements related to cross-border procurement.

DengYue Online Pharmacy focuses on supply-chain services for innovative medicines, specialty medicines, and prescription medicines. For qualified healthcare institutions, pharmaceutical distributors, and professional procurement customers, DengYue can provide services including medicine information inquiries, supply coordination, procurement process support, and cross-border logistics coordination. Customers interested in learning more about Lecankitug Injection (LiBeiTan®) or the professional procurement process can consult based on the product’s country of origin, destination market, and applicable local regulatory requirements.

‼️ The procurement, export, and cross-border supply of pharmaceutical products must comply with the applicable laws and regulations of both the country or region of origin and the destination market. Prescription medicines should be obtained through legally authorized channels and used under the guidance of qualified healthcare professionals.

Conclusion

Lecankitug Injection (Subcutaneous Injection), marketed under the brand name LiBeiTan®, was officially approved for marketing on August 27, 2026, providing a new domestically developed innovative biologic treatment option for adults with moderate-to-severe plaque psoriasis in China.

At the same time, the continued development of Lecankitug in other disease areas, including ankylosing spondylitis, remains worth monitoring. As more domestically developed innovative biologics enter clinical practice, the treatment landscape for psoriasis in China continues to expand, with increasingly diverse mechanisms of action and product options. This may provide physicians and patients with more opportunities to consider individualized treatment strategies based on disease characteristics.

From the perspective of pharmaceutical supply and international procurement, LiBeiTan®, as a domestically developed innovative biologic approved in 2026, is also a product worth monitoring within the innovative pharmaceutical supply chain. For qualified professional procurement customers, DengYueRX can provide supply-chain support related to product information, supply coordination, and cross-border procurement processes, while assisting customers in assessing procurement and logistics arrangements according to the regulatory requirements of different markets.

FAQ About Lecankitug Injection Receives NMPA Approval