Janssen's Long-Acting Injectable Paliperidone Palmitate (6M) – Invega Hafyera® – Approved in China for Adults with Schizophrenia
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Johnson & Johnson announced today that its long-acting injectable medication, administered once every six months, Shan Jiuda®(Paliperidone Palmitate Injection (6M), INVEGA HAFYERA)®The English generic name: Paliperidone Palmitate Injection (6M) has recently been granted marketing approval by the National Medical Products Administration for adult schizophrenia patients who have received adequate treatment with Paliperidone Palmitate Injection (3M) for at least 3 months.[1]。
As a new member of the Johnson & Johnson long-acting injectable family, Sanjiuda®Is currently the first and only long-acting injectable antipsychotic drug approved in China that requires only two injections per year.[2], achieving continuous treatment and symptom control for up to six months through slow release into the bloodstream at the injection site.[3]. In existing products (Invega Sustenna, administered once a month)®And Sandoz's once-a-month injection®) On this basis, Johnson & Johnson, driven by the actual medication needs of schizophrenia patients, continues to optimize its products, providing durable, stable, and upgradeable treatment solutions for the entire course of treatment and management of schizophrenia.
Schizophrenia is a serious mental illness caused by the interaction of genetic, biological, and environmental factors, often accompanied by disorders in perception, thinking, emotion, and behavior.[4]Due to its long course, severe condition, and tendency to recur, schizophrenia imposes a significant disease burden on patients, their families, and society.[3]Relevant studies show that the relapse rate of Chinese schizophrenia patients within one year after discharge is as high as 33.4%.[5], and discontinuing medication or reducing the dosage on one's own is an important reason for the recurrence of the disease.[5]。
Compared with oral medications, long-acting injections have many advantages in the treatment of schizophrenia, including improved patient compliance, avoiding repeated reminders for medication, more convenience, and reduced risk of accidental or overdose.[6]Long-acting injections with longer dosing intervals can better support disease management and help patients achieve the ultimate goal of returning to family and society.[7][8]。
"This time, Johnson & Johnson®"The approval once again demonstrates Johnson & Johnson's continuous care for Chinese patients over the past thirty-nine years. As an innovative leader in the field of mental health, we deeply understand the importance of innovative drugs such as long-acting injections to patients, and we will continue to optimize our product line to provide more options for patients." Cherry Huang, President of Johnson & Johnson Innovative Pharmaceuticals China, stated, "In the future, we will closely collaborate with the government and relevant institutions to introduce this revolutionary treatment, Symproic®, as soon as possible, ensuring that our breakthrough achievements can help more patients return to a normal life."
Support this Johnson & Johnson®Data from a randomized, double-blind, non-inferiority global Phase 3 clinical trial [2], which received marketing authorization approval, showed that at the end of 12 months, Shanjiuda®In terms of preventing disease recurrence, it is non-inferior compared to Xiantuoda® (i.e., Xiantuoda®(With considerable therapeutic effects). At the same time, the open-label extension study conducted on the basis of this research[9]Results suggest that 96.1% of schizophrenia patients are treated with Johnson & Johnson products.®No recurrence after 2 years of treatment.
References:
[1] Paliperidone Palmitate Injection (6M) Instructions, June 2024.
[2] Center for Drug Evaluation, National Medical Products Administration. Directory of Chemical Drugs, May 14, 2024. https://www.cde.org.cn
[3]NajarianD,etal.Arandomized,double-blind,multicenter,noninferioritystudycomparingPaliperidonePalmitate6-monthversusthe3-monthlong-actinginjectableinpatientswithschizophrenia.IntJNeuropsychopharmacol.2022Mar17;25(3):238-251.
Editor: Baiji
Disclaimer: This article is a reprint from Pharma Intelligence Network. The images and text are the original property of the author, and the purpose of the reprint is to convey more information. It does not represent the views of this platform. If there are any issues regarding the content, copyright, or other aspects, please leave a message on this platform, and we will address it promptly.
