Shanghai, June 11, 2024 - Luye Pharma Group today announced that its second-generation long-acting injectable (LAI) antipsychotic Meibirui (Paliperidone Palmitate Injection) has been approved for marketing by China’s National Medical Products Administration (NMPA), to be used for the acute and maintenance treatment of schizophrenia.
Targeting the difficulties in schizophrenia treatment, Meibirui reduces the risks of recurrence and re-hospitalization
Schizophrenia is a chronic, highly recurrent and highly disabling disease, with about 24 million patients worldwide , of which approximately 1/3 or 8 million are in China . One of the major challenges in treating this disease is that the condition frequently becomes recurrent because of treatment interruption or reduced dosage by patients themselves, which may lead to refractory schizophrenia.
Compared with oral medications, long-acting injectable antipsychotics can significantly improve patient compliance and provide an important treatment strategy for relapse prevention . Meibirui is a long-acting injection of paliperidone palmitate administered once a month. Paliperidone, its active ingredient, is a first-line treatment for this disease, which is effective in improving the positive symptoms, negative symptoms, emotional symptoms and cognitive functions of schizophrenia patients.
Professor Wang Gang, President of the Capital Medical University's Beijing Anding Hospital and Director of the National Medical Center for Mental Disorders, who is the principal investigator for Meibirui’s clinical study in China, said: "Schizophrenia needs lifelong treatment and it's hard to ensure patient compliance. Using long-acting injections early allows the medications to act continuously and stably in patients and helps to maximize patient benefits. Using Meibirui helps patients maintain a standard treatment for schizophrenia from beginning to end and reduce the risks of recurrence and re-hospitalization. I’m looking forward to its use in clinical application, to help improve patient conditions, promote their rehabilitation, and allow them to get back to normal as early as possible."
Building an internationally competitive CNS portfolio
The central nervous system (CNS) is a strategic therapeutic area of Luye Pharma. The company has built a CNS product portfolio, which includes not only Meibirui mentioned above, but Rykindo (risperidone) for extended-release injectable suspension, Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets), Seroquel (quetiapine fumarate tablets), Seroquel XR (quetiapine fumarate extended-release tablets), Rivastigmine once-a-day transdermal patch, and Rivastigmine twice-weekly transdermal Patch. These products are marketed in over 80 countries and regions around the world, including major pharmaceutical markets like China, the U.S., Europe, and Japan, as well as high-potential emerging markets. In addition, the company is developing multiple investigational drugs both in China and abroad, such as Rotigotine Extended-release Microspheres for Injection (LY03003) and a VMAT2 inhibitor (LY03015).
Yang Rongbing, President of Luye Pharma Group, said: "New CNS drugs from China are rare in the world today. At Luye Pharma, we have built a strong portfolio in this therapeutic area. We look forward to the launch of more innovative drugs. Working in synergy with our existing commercial system for CNS, they will help to speed up our global expansion and serve as a ‘new quality productive force’ for China's pharmaceutical industry."
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About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
Shanghai, June 11, 2024 - Luye Pharma Group today announced that its second-generation long-acting injectable (LAI) antipsychotic Meibirui (Paliperidone Palmitate Injection) has been approved for marketing by China’s National Medical Products Administration (NMPA), to be used for the acute and maintenance treatment of schizophrenia.
Targeting the difficulties in schizophrenia treatment, Meibirui reduces the risks of recurrence and re-hospitalization
Schizophrenia is a chronic, highly recurrent and highly disabling disease, with about 24 million patients worldwide , of which approximately 1/3 or 8 million are in China . One of the major challenges in treating this disease is that the condition frequently becomes recurrent because of treatment interruption or reduced dosage by patients themselves, which may lead to refractory schizophrenia.
Compared with oral medications, long-acting injectable antipsychotics can significantly improve patient compliance and provide an important treatment strategy for relapse prevention . Meibirui is a long-acting injection of paliperidone palmitate administered once a month. Paliperidone, its active ingredient, is a first-line treatment for this disease, which is effective in improving the positive symptoms, negative symptoms, emotional symptoms and cognitive functions of schizophrenia patients.
Professor Wang Gang, President of the Capital Medical University's Beijing Anding Hospital and Director of the National Medical Center for Mental Disorders, who is the principal investigator for Meibirui’s clinical study in China, said: "Schizophrenia needs lifelong treatment and it's hard to ensure patient compliance. Using long-acting injections early allows the medications to act continuously and stably in patients and helps to maximize patient benefits. Using Meibirui helps patients maintain a standard treatment for schizophrenia from beginning to end and reduce the risks of recurrence and re-hospitalization. I’m looking forward to its use in clinical application, to help improve patient conditions, promote their rehabilitation, and allow them to get back to normal as early as possible."
Building an internationally competitive CNS portfolio
The central nervous system (CNS) is a strategic therapeutic area of Luye Pharma. The company has built a CNS product portfolio, which includes not only Meibirui mentioned above, but Rykindo (risperidone) for extended-release injectable suspension, Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets), Seroquel (quetiapine fumarate tablets), Seroquel XR (quetiapine fumarate extended-release tablets), Rivastigmine once-a-day transdermal patch, and Rivastigmine twice-weekly transdermal Patch. These products are marketed in over 80 countries and regions around the world, including major pharmaceutical markets like China, the U.S., Europe, and Japan, as well as high-potential emerging markets. In addition, the company is developing multiple investigational drugs both in China and abroad, such as Rotigotine Extended-release Microspheres for Injection (LY03003) and a VMAT2 inhibitor (LY03015).
Yang Rongbing, President of Luye Pharma Group, said: "New CNS drugs from China are rare in the world today. At Luye Pharma, we have built a strong portfolio in this therapeutic area. We look forward to the launch of more innovative drugs. Working in synergy with our existing commercial system for CNS, they will help to speed up our global expansion and serve as a ‘new quality productive force’ for China's pharmaceutical industry."
###
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
