Janssen's Tremfya (Guselkumab) Approved by China's NMPA for Moderate-to-Severe Plaque Psoriasis

December 27, 2019 News /BioValleyBIOON/ -- Recently, the National Medical Products Administration approved the import registration application for guselkumab injection (brand name: Tremfya) from Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (JNJ), for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Guselkumab Injection is the world’s first monoclonal antibody targeting human interleukin-23 (IL-23) approved for the treatment of psoriasis. By blocking the binding of IL-23 to its cell surface receptor, it disrupts IL-23-mediated signaling, activation, and cytokine cascades, thereby inhibiting the biological activity of IL-23 and exerting therapeutic efficacy in plaque psoriasis.

The approved guselkumab injection was submitted by Xian Janssen Pharmaceutical Ltd. on behalf of Janssen-Cilag International NV. This product was included in the first batch of the National List of Overseas New Drugs in Urgent Clinical Need. The National Medical Products Administration (NMPA) accelerated its market approval through the priority review and approval pathway. To date, the NMPA has approved the import and marketing of 25 drugs listed in the National List of Overseas New Drugs in Urgent Clinical Need.

Tremfya (Chinese brand name: Te Nuoya; generic name: guselkumab) is a human monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), developed by Johnson & Johnson. It is the first approved selective IL-23 inhibitor. IL-23 is a cytokine involved in variousAutoimmunityplayed a key role in the treatment of inflammatory diseases. Currently, Tremfya is also being developed for otherAutoimmunityTreatment of inflammatory diseases, including Crohn's disease (Phase IIb/III), ulcerative colitis (Phase IIb/III), and hidradenitis suppurativa (Phase II). Tremfya is administered via subcutaneous injection. The dosing regimen for plaque psoriasis is 100 mg administered at Weeks 0 and 4, followed by 100 mg every 8 weeks thereafter.

To date, Tremfya has been approved in multiple countries and regions worldwide for the treatment of adult patients with moderate-to-severe plaque psoriasis. In China, Tremfya (Tenuoya) was approved for marketing in Hong Kong in November 2018, and its marketing application was submitted in mainland China in late June of this year. Notably, Tremfya was included in the “First Batch of Clinically Urgent Overseas New Drugs” list released by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. The indicated therapeutic uses are: erythrodermic psoriasis, plaque psoriasis, pustular psoriasis, psoriatic arthritis, and psoriasis vulgaris.

Tremfya Novel One-Press Single-Dose Self-Injector

In late February this year, the new Tremfya One-Press single-dose self-injector was approved by the U.S. FDA for market launch, markingFDAThe first approved product featuring the One-Press patient-controlled injector. One-Press is meticulously designed for patients: it fits comfortably in the hand, delivers controlled injections, and keeps the needle concealed throughout the entire process.

The One-Press design allows patients to control the speed and pressure of the injection, with a gentle click sound indicating completion. Nearly 99% of patients reported successful first-time injections. Additionally, One-Press includes a safety system that protects the needle after use.

Tremfya should be used under the guidance and supervision of a physician. After approval by a physician and receiving appropriate training, patients can self-administer Tremfya using the One-Press injector. In clinical studies, patients gave an average rating of 9.18 out of 10 for “satisfaction with self-injection” (with 10 indicating “very satisfied”) and an average rating of 9.24 out of 10 for “ease of use” (with 10 indicating “very easy to use”). (Bioon.com)

Original Source: NMPA