New drug for plaque psoriasis in China! Tremfya of Xi'an Janssen (tenoya, gusecchiumab) was approved by the State Drug Administration (nmpa) to be listed in the mainland!

December 27, 2019 / BIOON / -- recently, the State Drug Administration approved the application for import registration of gusequimab injection (trade name: tenoya) of Xi'an YANGSEN for adult patients with moderate and severe plaque psoriasis who are suitable for systematic treatment Gusecchiumab injection is the first anti-human interleukin-23 (IL-23) monoclonal antibody approved for psoriasis treatment in the world By blocking the binding of IL-23 with IL-23 receptor on the cell surface, it destroys il-23-mediated signal transduction, activation and cytokine cascade reaction, inhibits the biological activity of IL-23, and plays a therapeutic effect on plaque psoriasis The approved injection was declared by Janssen cilag international NV on behalf of Xi'an Janssen Pharmaceutical Co., Ltd., which was listed in the first batch of overseas new drugs in urgent clinical need The State Food and Drug Administration accelerated the approval of the listing of the product in accordance with the priority review and approval procedures Up to now, the State Food and drug administration has approved 25 drugs to be listed on the list of clinically urgent overseas new drugs It is worth mentioning that tenor is the third innovative drug for the treatment of psoriasis launched by Xi'an Janssen in China after sildenafil (ulinuzumab) and rifexemab (infliximab) Professor Zhang Xuejun, chairman of psoriasis professional committee of Chinese Medical Association, pointed out: "psoriasis is a chronic, recurrent and lifelong disease, which can not be cured at present It is very important to provide long-term treatment for patients who want to keep skin lesions clear for a long time and are often worried about drug failure " Tremfya (Chinese trade name: tenoya, general name: guselkumab, gussechiumab) is a human monoclonal antibody developed by Johnson & Johnson against the P19 subunit of IL-23, which is the first approved selective IL-23 inhibitor IL-23 is a cytokine that plays a key role in many autoimmune diseases At present, tremfya is also being developed for the treatment of other autoimmune diseases, including Crohn's disease (stage IIb / III), ulcerative colitis (stage IIb / III), pyogenic sweat adenitis (stage II) Tremfya was injected subcutaneously The treatment plan for plaque psoriasis was: once in the first week and once in the fourth week, and then once every 8 weeks with a dose of 100mg So far, tremfya has been approved in many countries and regions around the world for the treatment of adult patients with moderate to severe plaque psoriasis In China, tremfya was approved to be listed in Hong Kong in November 2018 and declared to be listed in the mainland in late June this year It is worth mentioning that tremfya has also been listed in the list of the first batch of overseas new drugs urgently needed in clinical practice issued by the drug evaluation center (CDE) of China National Drug Administration (nmpa) The treatment indications are: erythrodermic psoriasis, plaque psoriasis, pustular psoriasis, psoriatic arthritis, and psoriasis vulgaris "We are very pleased to see that tenor Asia has achieved accelerated approval in China, which shows the importance of this innovative treatment for patients with psoriasis," said Asgar rangoonwala, President of tremfya new one press single dose self syringe Xi'an Janssen Pharmaceutical Co., Ltd The approval of tenor is another embodiment of Xi'an Janssen's continuous care for Chinese patients for more than 30 years In the future, we will work closely with relevant agencies to improve the accessibility of drugs and benefit Chinese patients " At the end of February this year, tremfya's new one press single dose self syringe was approved by the US FDA, which is the first FDA approved product to provide one press patient control syringe One press is designed for the patient: it can be comfortably placed on the hand, provides controllable injection, and hides the needle throughout the process One press is designed to allow patients to control the speed and pressure of the injection, with a slight tick when the injection is completed, and nearly 99% of patients report successful first injection In addition, one press includes a security system to protect the needle after use Tremfya needs to be used under the guidance and supervision of doctors After the approval of doctors and proper training, patients can use tremfya one press to inject themselves In the clinical study, the patients' average score of "self injection satisfaction" was 9.18 (10 points indicated "very satisfied"), while the average score of "ease of use" was 9.24 (10 points indicated "very easy") Original source: nmpa