Johnson & Johnson's pharmaceutical subsidiary in China Xi'an Janssen Pharmaceutical Co., Ltd. today announced the world's first fully human "dual-targeted" interleukin 12 (IL-12) and interleukin 23 (IL-23). The inhibitor STELARA ® (ustekinumab injection) has been launched in China. Xidanuo® is a biological agent with an innovative dosing mode - is subcutaneously injected with once every three months during the maintenance period. It is used to treat reactions to cyclosporine, methotrexate (MTX) or PUVA (psoralen). Adult patients with moderate to severe plaque psoriasis who are unresponsive, contraindicated, or intolerant to other systemic treatments such as prolactin and ultraviolet A).
Professor Zhang Jianzhong, former chairman of the Dermatology and Venereology Branch of 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 with erythema and scale as its main manifestations. Epidemiology Surveys show that there are more than 6.5 million psoriasis patients in my country, 80%-90% of whom have plaque psoriasis, and about 30% of patients have moderate to severe plaque psoriasis, which has a great impact on the patients' quality of life. The impact is serious and requires active treatment.” Mr. Shi Xingxiang, founder of
Psoriasis Patient Mutual Aid Network, emphasized, “Patients with moderate to severe psoriasis urgently need long-term, safe, and convenient medical solutions to help them improve their living conditions and reduce the risk of disease as much as possible. The negative impact of disease on the body, work, and life. "
Xidanuo® is a fully humanized monoclonal antibody targeting IL-12 and IL-23 through p40 shared by IL-12 and IL-23. The protein subunit specifically binds with high affinity, thereby inhibiting these two cytokines that play a key role in the development and progression of psoriasis.
Professor Li Chengxin, director of the Department of Dermatology at the General Hospital of the People's Liberation Army of China, said, "The application of biological agents has brought major changes to the treatment of psoriasis. Unlike traditional systemic therapies, it specifically blocks the skin cells that cause psoriasis in patients. Specific immune link of hyperplasia. As a leader in biological therapy, Xidanuo® has more than ten years of clinical use data around the world, and its effectiveness, safety and compliance have been verified by a large number of real-world studies.”
. The results of two randomized, double-blind, placebo-controlled Phase III clinical trials PHOENIX 1 and PHOENIX 2 involving 1996 patients showed that Xidanuo® has long-term and durable efficacy, maintaining skin lesion clearance and improving quality of life for up to 5 years. Another phase III clinical trial LOTUS for the Chinese population showed that 82.5% (132/60) of patients using Xidanuo® achieved the trial's primary endpoint PASI75 at 12 weeks, while the data for the placebo group was 11.1%. There were also significant improvements in all key secondary endpoints, including more than 80% of patients on Xidanu® achieving PASI90 at 28 weeks.
In addition, the PHOENIX extension study 4 showed that Xidanuo® can maintain the clinical treatment response of psoriasis for a long time. As the treatment time of Xidanuo® was extended, no dose-related or cumulative toxicity was observed. The results of the real-world PSOLAR study, which included data from more than 12,000 patients using SIDANOL® and other treatment regimens over an eight-year period, are consistent with the overall safety profile of SIDANAL®. In addition, multiple real-world registration studies have shown that compared with other biologics included in the studies, Xidanuo® has a higher overall drug retention rate and a lower risk of discontinuation. ,
Li Bin, Vice President of Medical Affairs Department of Xi'an Janssen , said: "As the first biological agent approved in China that can be used every three months during the maintenance period, Xidanuo® is launched for the treatment of moderate to severe plaque psoriasis in China. "
" Janssen is committed to providing innovative biologics and medical solutions to patients with autoimmune diseases, including psoriasis, and we will continue to focus on patients' urgent needs. "Xi'an Janssen will stick to its commitment to Chinese patients and continue to work with relevant institutions to improve drug accessibility and benefit China." patients and make unremitting efforts.”
Currently, Xidanuo® has entered China, covering cities such as Beijing, Shanghai and Guangzhou.
Xidanol® has been approved in 89 countries. Previously, ustekinumab has won the Canadian Galen "Innovative Product Award", the American Galen "Best Biotechnology Product Award" and the International Galen Award.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding STELARA® (ustekinumab injection). Readers are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or are subject to known or unknown risks or uncertainties, actual results may differ materially from the expectations and projections of Xi'an Janssen Pharmaceutical Co., Ltd., any other Janssen Pharmaceutical Company and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty about clinical success and obtaining regulatory approval; uncertainty about commercial success; manufacturing difficulties and delays; competition, including technological advancements, New products and patents obtained by competitors; challenges to patents; product efficacy or safety issues resulting in product recalls or regulatory actions; changes in buyer behavior and spending patterns for healthcare products and services; changes in applicable laws and regulations, including global healthcare health care reform; and trends in health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018 (including under the headings "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors" section), found in the Company's most recently filed Quarterly Statement on Form 10-Q, and in the Company's subsequent filings with the Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com, or upon request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
