TREMFYA® (Guselkumab), the First Targeted IL-23 Inhibitor, Launches in China for Moderate-to-Severe Plaque Psoriasis
Xian Janssen
Pharmaceutical R&D and Manufacturer
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
BEIJING, April 21, 2020 /PRNewswire/ -- Johnson & Johnson’s pharmaceutical subsidiary in China, Xian Janssen Pharmaceutical Ltd., recently announced that its Stelara®(Guselkumab Injection, English Brand Name: TREMFYA®, Guselkumab) has been marketed in China for adult patients with moderate-to-severe plaque psoriasis who are suitable for systemic therapy. Tenoaya®YesThe World's FirstApproved interleukin-23 (IL-23) inhibitors can target and inhibit IL-23, a cytokine that plays a key role in psoriasis.[1],[2]。
In December 2019, after receiving accelerated approval from the China National Medical Products Administration (NMPA), Tenoa®Subsequently introduced to China. Its sustained and long-lasting efficacy in clearing skin lesions has been confirmed in global Phase III studies (VOYAGE 1, VOYAGE 2). The studies demonstrated that, at Week 16, 73.3%(VOYAGE 1) and 70.0% (VOYAGE 2) received Tremfya®Patients treated with >90% clearance of skin lesions%(PASI 90), whereas the TNFi control group had only 49.7% (VOYAGE 1) and 46.8% (VOYAGE 2). At week 48, 76%Receiving Tenoja®Treated patients can still maintain a PASI 90 response.[3],[4]Meanwhile, long-term follow-up studies have shown that the use of Tremfya®Patients maintained a high PASI 90 response for up to 4 years of treatment.
At Stelara®In clinical studies, there was no clear signal indicating an increased risk of malignancies, major adverse cardiovascular events, or serious infections; the most common adverse reaction was upper respiratory tract infection.
Tremfya®Represents a significant advancement in the treatment of moderate-to-severe plaque psoriasis, asProfessor Jin Hongzhong, Director of the Department of Dermatology, Peking Union Medical College HospitalAs stated, IL-23 is a core regulatory factor in the pathogenic pathway of psoriasis. By targeting and inhibiting IL-23, it achieves holistic regulation of psoriasis pathogenesis, thereby realizing long-lasting and sustained clearance of skin lesions.
“Patients with psoriasis often endure physical pain caused by erythema, scaling, and skin inflammation,”Professor Zhang Jianzhong, Director of the Department of Dermatology at Peking University People’s Hospital and former Chairman of the Chinese Society of Dermatology and Venereology under the Chinese Medical Association, pointed out"Plaque psoriasis has a significant impact on patients' quality of life and often leads to other serious health problems, such as diabetes, heart disease, and depression."
“Due to the chronic and lifelong nature of psoriasis, patients require long-term treatment but often worry about disease recurrence caused by drug failure.”Mr. Shi Xingxiang, Founder of the Psoriasis Patient Mutual Aid Network“It is therefore emphasized that patients with moderate-to-severe psoriasis also require treatment regimens capable of providing sustained efficacy to maintain long-term clearance of skin lesions.”
“Glad to see Tenoya®“Bringing new treatment options for Chinese patients with psoriasis,” said Dr. Lloyd Miller, Vice President of Global Research and Development in Immunology at Janssen. “There are over one million patients with moderate-to-severe plaque psoriasis in China who are suffering from the pain and even disabling effects of the disease. We must make every effort to continuously improve their quality of life. We believe that Tremfya®, I am very proud that this innovative treatment regimen can meet the urgent therapeutic needs of patients.”
Xian Janssen remains committed to providing innovative biologics and healthcare solutions for patients with autoimmune diseases, including those with psoriasis. Asgar Rangoonwala, President of Xian Janssen Pharmaceutical Ltd., stated, “Xian Janssen will uphold its commitment and continue to collaborate closely with relevant stakeholders to make relentless efforts toward improving medication accessibility and benefiting patients in China.”
Currently, Taltz®Has entered China, covering 26 cities including Beijing, Shanghai, Guangzhou, and ShenzhenCityMeanwhile, the Chinese Red Cross Foundation launched the "Special Start for New Life" assistance program for patients with moderate-to-severe plaque psoriasis, providing Taltz to low-income and subsistence allowance recipients suffering from moderate-to-severe plaque psoriasis.®(Guselkumab Injection) Patient Assistance Program.
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[1] Tang C. et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases, Immunology. 2012 Feb; 135(2): 112–124.
[2] Nawas Z. et al. A Review of Guselkumab, an IL-23 Inhibitor, for Moderate-to-Severe Plaque Psoriasis. Skin Therapy Lett. 2017 Mar;22(2):8-10.
[3] Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76:405-17.
[4] Reich K and Armstrong A.W et al. J Am Acad Dermatol 2017;76(3):418–31.