Xi'an Janssen Launches STELARA® (Ustekinumab) in China, Introducing a Long-Acting and Convenient Treatment Option for Moderate-to-Severe Plaque Psoriasis
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Xian Janssen
Pharmaceutical R&D and Manufacturer
BEIJING, June 5, 2019 /PRNewswire/ -- Xian Janssen Pharmaceutical Ltd., the pharmaceutical subsidiary of Johnson & Johnson in China, announced today that STELARA® (ustekinumab injection), the world’s first fully human “dual-target” inhibitor of interleukin-12 (IL-12) and interleukin-23 (IL-23), has been launched in China. STELARA® is a biologic agent featuring an innovative dosing regimen—once-every-three-months subcutaneous injection during the maintenance phase—for the treatment of adult patients with moderate-to-severe plaque psoriasis who are non-responsive to, have contraindications for, or are intolerant of other systemic therapies, such as cyclosporine, methotrexate (MTX), or PUVA (psoralen and ultraviolet A).[1]。
Professor Zhang Jianzhong, former Chairman of the Chinese Society of Dermatology and Venereology under the Chinese Medical Association and Director of the Department of Dermatology at Peking University People’s Hospital, pointed out："Psoriasis is a chronic, recurrent, inflammatory disease characterized primarily by erythema and scaling. Epidemiological surveys indicate that there are over 6.5 million psoriasis patients in China."[2]，[3], of whom 80%-90% have plaque psoriasis, and approximately 30% have moderate-to-severe plaque psoriasis, which significantly impacts patients' quality of life and requires active treatment.”
Mr. Shi Xingxiang, founder of the Psoriasis Patient Mutual Aid Network, emphasized："Patients with moderate-to-severe psoriasis urgently need long-acting, safe, and convenient medical solutions to help improve their quality of life and minimize the negative impact of the disease on their physical health, work, and daily living."
Stelara® is a fully human monoclonal antibody that specifically targets IL-12 and IL-23. It binds with high affinity to the p40 protein subunit shared by IL-12 and IL-23, thereby inhibiting these two cytokines that play a key role in the pathogenesis and progression of psoriasis.
Professor Li Chengxin, Director of the Department of Dermatology at the Chinese PLA General Hospital in Beijing, stated：“The application of biologics has brought about a significant transformation in the treatment of psoriasis. Unlike traditional systemic therapies, it specifically targets and blocks the particular immune pathways responsible for the excessive proliferation of skin cells in patients with psoriasis. As a leading biologic therapy, Stelara® boasts over a decade of clinical use data worldwide, with its efficacy, safety, and compliance validated by numerous real-world studies.”
The results of two randomized, double-blind, placebo-controlled Phase III clinical trials, PHOENIX 1 and PHOENIX 2, involving 1,996 patients, demonstrated that Stelara® provides durable long-term efficacy, maintaining skin clearance and improved quality of life for up to 5 years.[4]. Another Phase III clinical trial, LOTUS, conducted in the Chinese population showed that 82.5% (132/160) of patients treated with Stelara® achieved the primary endpoint of PASI 75 at Week 12, compared to 11.1% in the placebo group. All key secondary endpoints also demonstrated significant improvement, including more than 80% of patients treated with Stelara® achieving PASI 90 at Week 28.[5]。
Additionally, PHOENIX Long-Term Extension Study 4[6]Data demonstrate that STELARA® can maintain clinical treatment response in psoriasis over the long term. With prolonged STELARA® treatment, no dose-related or cumulative toxicity was observed. The real-world PSOLAR study included data from more than 12,000 patients treated with STELARA® and other therapeutic regimens over an 8-year period; the study results were consistent with the overall safety profile of STELARA®.[7]Furthermore, multiple real-world registry studies have demonstrated that STELARA® exhibits higher overall drug persistence and a lower risk of discontinuation compared to other biologics included in the studies.[8]，[9]，[10]。
Li Bin, Vice President of Medical Affairs at Xian Janssen, stated, “As the first biologic agent approved in China for maintenance therapy with once-every-three-months dosing, the launch of STELARA® provides patients with moderate-to-severe plaque psoriasis in China with a novel, long-acting, and convenient treatment option.”
“Janssen remains committed to providing innovative biologics and healthcare solutions for patients with autoimmune diseases, including those with psoriasis. We will continue to focus on addressing their urgent unmet treatment needs, helping them achieve tangible improvements in treatment outcomes and return to normal lives.” — President of Xian JanssenAsgar Rangoonwala“Xian Janssen will remain committed to its promise to patients in China, continuing to work closely with relevant institutions to make relentless efforts to improve drug accessibility and benefit patients in China.”
Currently, Stelara® has entered the Chinese market, covering cities such as Beijing, Shanghai, and Guangzhou.
STELARA® has been approved in 89 countries; previously, ustekinumab received the Galien “Innovative Product Award” in Canada.[11], U.S. Galen “Best Biotechnology Product Award”[12]and the International Galen Award[13]。
[1] Ustekinumab Injection Package Insert
[2] Ding X, et al. Eur J Dermatol 2012; 22(5): 663-667
[3] http://data.stats.gov.cn/easyquery.htm?cn=C01&zb=A030605&sj=2018
[4] Kimball et al. JEADV 2013;27:1535-45.
[5] Xuejun Zhu et al. J Drugs Dermatol. 2013; 12 (2): 166-174
[6] Papp, et al. BJD 2013;168:844-54
[7] Papp, et al. JDD 2015;14:706-14.
[8] Menter, et al. JEADV 2016;30:1148-58
[9] Egeberg et al. BJD 2018;178:509-19
[10] Warren et al. JID 2015;135:2632-40