Unprecedented! Three Domestic Ustekinumab Biosimilars Approved Within Two Days, Ending Original Drug's Monopoly Era

May 23, 2026 10:33 CST Updated 10:33

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Bio-Thera

Innovative Drug Developer

CSPC

Innovative Drug Research and Development, Manufacturer

Johnson & Johnson

Medical Device R&D and Manufacturer

On May 21-22, 2026, the National Medical Products Administration (NMPA) issued several significant drug approvals consecutively.Ustekinumab Biosimilars from Three Major Chinese Pharmaceutical Companies — Huadong Medicine, Bio-Thera, and CSPC — Approved for密集上市, creating a rare surge of approvals in China's autoimmune biologics field. Among them,Huadong Medicine, Bio-TheraOn May 21, the Crohn's disease indication was simultaneously approved, with both intravenous infusion and subcutaneous injection formulations available.CSPCEnyike® was officially approved for the indication of plaque psoriasis on May 22.

This recent batch of approvals has completely ended the six-year exclusive monopoly of Johnson & Johnson's Stelara®, significantly expanding the treatment options for autoimmune diseases in China and providing millions of Chinese patients suffering from psoriasis and inflammatory bowel disease with more accessible and higher-quality domestically produced treatment alternatives.

Millions of Patients' Urgent Need: Huge Gap in Autoimmune Disease Treatment

Crohn's disease is a chronic, disabling inflammatory bowel disease with complex etiology and prolonged difficult recovery, and the lesions can affect the entire digestive tract of the human body. The disease easily induces severe complications such as spasmodic abdominal pain, recurrent diarrhea, perianal fistulas, intra-abdominal abscesses, and intestinal obstruction. Long-term persistence also poses a risk of cancer, and it is clinically referred to as "green cancer," seriously damaging the physical and mental health and quality of life of patients.

In recent years, the incidence of Crohn's disease in China has been continuously increasing, with a significant trend towards younger patients. Public clinical data shows,The annual incidence rate of Crohn's disease in urban areas of China is approximately 0.71 per 100,000, with the high-risk population concentrated among young adults aged 25-34.Patients in the prime of their work and life are plagued by chronic pain and face multiple pressures such as social interaction, daily living, and employment. The unmet clinical needs are extremely urgent.

Traditional clinical treatments often rely on glucocorticoids and conventional immunosuppressants, which generally have significant toxic side effects, low symptom remission rates, and a tendency for the condition to relapse easily. With advancements in biologic technology, the treatment landscape for Crohn's disease is undergoing a revolutionary transformation. The "Chinese Guidelines for the Diagnosis and Treatment of Crohn’s Disease (2023 Edition)" explicitly include ustekinumab as a core treatment option for patients with moderate to severe active disease, suitable for both induction of remission and long-term maintenance therapy, particularly appropriate for those with perianal fistulas or at high risk of postoperative recurrence. Clinical studies have confirmed,Early intervention with ustekinumab within 2 years of diagnosis can significantly improve mucosal healing rates and reduce the risk of long-term recurrence.。

Psoriasis: A Highly Prevalent Chronic Autoimmune Disease Troubling Millions of Patients

Plaque psoriasis is the most common chronic inflammatory autoimmune skin disease clinically, with a large patient base in China, and the total number of patients is about 6.5 million, of which nearly 30% are moderate to severe patients. The disease not only causes skin lesions, itching, scaling, and other appearance damage but also easily leads to systemic complications such as psoriatic arthritis and metabolic syndrome, seriously affecting the physical and mental health and daily life of patients.

With the core advantages of long-acting, safety, and excellent tolerability, ustekinumab has become a first-line preferred biologic for moderate to severe plaque psoriasis. Its long-acting dosing regimen of once every 12 weeks significantly simplifies the treatment process and greatly improves patient adherence to long-term treatment. Previously, the market in China was monopolized by Johnson & Johnson's Stelara®. Although the drug has been continuously included in the National Reimbursement Drug List, many patients still cannot receive standardized biologic treatment due to issues such as drug accessibility and financial burdens.

Three-Way Battle: Chinese-produced Ustekinumab Shows Unique Strengths

Ustekinumab is a fully human monoclonal antibody targeting the shared p40 subunit of IL-12 and IL-23. It can precisely block the signaling of these two core inflammatory factors, inhibiting the body's inflammatory cascade from the source to achieve highly effective anti-inflammatory and stable disease control effects. The three domestically produced products recently approved in this batch were all developed strictly in accordance with biosimilar research and development standards. They are highly consistent with the original product Stelara® in terms of quality attributes, pharmacokinetics, clinical efficacy, and safety. At the same time, each product has formed distinct differentiated advantages, ushering in a new competitive landscape for domestically produced autoimmune drugs in China.

Huadong Medicine's Saluxin ®/Sajiening ®: China-produced First Ustekinumab Achieves Another Milestone

Jointly developed by Huadong Medicine and Quanxin Biotech, with exclusive commercialization rights held by Huadong MedicineCelestone® (Subcutaneous Injection) / Celestene® (Intravenous Infusion), is the first domestically produced ustekinumab biosimilar to be successfully approved in China. The product pipeline has been strategically laid out, with approval for the treatment of adult patients with moderate to severe plaque psoriasis granted in October 2024, followed by an expansion to include pediatric plaque psoriasis in March 2025. The recent successful approval for Crohn's disease further solidifies its position asCurrently the most comprehensive indication coverage of Ustekinumab domestically produced in China。

The two parties reached a cooperation development and commercialization agreement for the China mainland region in August 2020. Relying on Huadong Medicine's academic promotion capabilities in the autoimmune field, developed over many years, as well as its comprehensive nationwide sales network and mature patient lifecycle management system, the product has core advantages of rapid clinical penetration and grassroots implementation, with substantial market growth potential.

Bio-Thera's Aisali®/Xishali®: An International Product Approved Globally Simultaneously

Bio-TheraIsaforce® (Subcutaneous Injection) / Xisarly® (Intravenous Infusion), is a benchmark product with strong international competitiveness among domestically produced ustekinumab. The product has successively obtained approvals from major global pharmaceutical markets: approved by the U.S. FDA in May 2025, by the EU EMA in August 2025, and by the UK MHRA in February 2026.Following this approval in China, it has officially become the world's first ustekinumab biosimilar to achieve synchronized launches in the US, Europe, the UK, and China.`, demonstrating the global R&D and production strength of China's biopharmaceuticals.`

The product has been approved overseas for a broader range of indications, covering four major areas: moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn's disease, and moderate to severe active ulcerative colitis. This recent approval in China marks the fifth drug launched by Bio-Thera in the country, further solidifying the company’s leading position in the field of autoimmune diseases among Chinese-produced drugs.

CSPC's Enyike®: Strong Academic Endorsement, Quality Aligned with International Standards

CSPCEnyike®Officially approved for marketing on May 22, 2026, the approved indications cover plaque psoriasis in adults, children, and adolescents, precisely meeting unmet clinical needs: for adult patients with moderate to severe plaque psoriasis who have had an inadequate response to systemic treatments such as cyclosporine or methotrexate, or PUVA phototherapy, or who have contraindications or are intolerant to these treatments, as well as pediatric and adolescent patients aged 6 years and above, weighing between 60-100 kilograms, with moderate to severe plaque psoriasis.

This product strictly follows the domestic and international biosimilar development guidelines, completing comprehensive pharmaceutical, non-clinical comparative, and head-to-head clinical studies, fully verifying its high consistency with the originator drug. The core clinical efficacy and safety research findings were successfully published in the top dermatology journal, the "Journal of the American Academy of Dermatology," gaining recognition from authoritative international academic platforms, and endorsing the product's quality and clinical value.

Dual-Agent Synergistic Layout for Precision Treatment Across the Entire Disease Course

The ustekinumab approved for Huadong Medicine and Bio-Thera this time adopts a dual formulation layout of "intravenous infusion + subcutaneous injection," precisely matching the clinical diagnosis and treatment needs of the entire course of Crohn's disease, and addressing the shortcomings of domestically produced drug formulations.

Intravenous Infusion Formulation: Rapid onset, capable of quickly suppressing the inflammatory storm in patients with moderate to severe active disease, suitable for inducing remission during the acute phase of the disease and rapidly controlling severe symptoms;Subcutaneous Injection Formulation: Convenient administration, simple operation, patients can self-administer at home, greatly improving adherence to long-term maintenance therapy, meeting the needs of patients for long-term chronic disease management.

The dual-dosage form combination achieves full-cycle treatment coverage from rapid inflammation control in the acute phase to long-term maintenance in the stable phase, providing personalized treatment options for patients at different stages and with varying conditions. This completely fills the gap in the field of dual-dosage form treatment for Crohn's disease with Chinese-produced ustekinumab.

Industry Value: Accelerating Domestic Substitution, Comprehensively Enhancing Drug Accessibility

Industry experts analyzed and stated that the centralized approval of ustekinumab by three leading Chinese pharmaceutical companies marks a milestone in the development of China's autoimmune biologics industry, with profound significance for the sector.

First, completely break the pattern of exclusive monopoly by original research.After the original Ustekinumab developed by Johnson & Johnson was launched in China in 2017, it long monopolized the domestic market. The entry of three domestically produced drugs will stimulate healthy market competition, effectively reduce overall treatment costs, and enable more patients with moderate to severe autoimmune diseases to afford and access high-quality biologics.

Second, enrich clinical individualized treatment options.The products of the three companies have differentiated advantages in dosage form layout, indication coverage, academic positioning, and market channels, which can meet the diverse treatment needs of patients of different age groups, different stages of disease, and different conditions, helping to implement precise clinical diagnosis and treatment.

Third, it confirms the hardcore strength of China-produced biopharmaceuticals.Ustekinumab has a complex production process and strict quality control standards, making it a high-barrier biosimilar. The simultaneous successful approval of three domestically produced drugs fully demonstrates that China's biopharmaceutical research, production, and quality control systems have reached international advanced levels, significantly accelerating the domestic substitution process in the autoimmune field.

Industry Thoughts and Discussion

In recent years, the domestic substitution of heavyweight biologics in China's autoimmune field has been continuously accelerating, from Adalimumab and Tocilizumab to the recently approved Ustekinumab. Chinese pharmaceutical companies have been breaking through technical barriers, consistently launching high-quality and highly accessible biosimilars, significantly reducing the treatment burden for autoimmune patients in China, and continuously optimizing the diagnosis and treatment landscape for autoimmune diseases in the country.

At the same time, there are still a large number of unmet clinical needs in China's autoimmune sector. Currently, domestically produced drugs are still mainly biosimilars, with relatively few source-innovative drugs that have independent intellectual property rights. The transition from "generic drug substitution" to "source innovation breakthrough" remains the long-term core development direction for domestic autoimmune pharmaceutical companies.

Regarding the significant industry event of the recent approval of three domestically produced ustekinumab drugs, medical professionals, industry researchers, and clinical practitioners are welcome to leave comments and engage in discussions:

Huadong Medicine, Bio-Thera, and CSPC compete head-to-head. Who do you think will ultimately prevail in the Ustekinumab market competition?

What profound impacts will the simultaneous launch of two dosage forms have on clinical treatment practices?

What do you think will be the next major autoimmune drug to achieve full domestic substitution in China?

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