Shanghai, October 9, 2023 - Luye Pharma Group today announced the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) through the 505(b)(2) pathway for its LY03010 (Paliperidone Palmitate Extended-release Injectable Suspension) for the treatment of schizophrenia and schizoaffective disorder. LY03010 is developed on Luye Pharma’s platform for long-acting and extended-release drug delivery systems. It is expected to become China’s first long-acting paliperidone palmitate injectable suspension to be approved in the U.S.
Yang Rongbing, President of Luye Pharma Group, said: “LY03010 is also under review for its Marketing Authorization Application(MAA) in China, another CNS candidate from our company to have its MAA reviewed in both the U.S. and China. New CNS drugs from China are rarely available globally. We have a strong pipeline in this therapeutic area. With more and more candidates from this pipeline being commercially launched, we will be able to accelerate our global expansion by leveraging our existing commercial system for CNS.”
Addressing the challenge in treating schizophrenia to improve patient compliance
Paliperidone is a first-line treatment for schizophrenia. It can relieve the positive symptoms of psychosis and improve the cognitive-affective symptoms in schizophrenia patients. Paliperidone is available in both oral tablets and long-acting injections. Compared with oral tablets, long-acting injections require less frequent administration and are able to maintain a stable and effective concentration of the active ingredient in the blood for an extended period of time. This allows them to improve patient compliance, to significantly lower the risk of relapse during long-term treatments, and to improve the long-term outcomes for patients.
LY03010 is a long-acting injectable formulation of paliperidone, administered once a month. Its NDA submitted in the U.S. is based on a randomized, multiple-dose, open-label, and parallel-group pivotal study evaluating the relative bioavailability of LY03010 versus INVEGA SUSTENNA®. In this study, LY03010 was demonstrated to be bioequivalent to INVEGA SUSTENNA at steady state after multiple administrations. Furthermore, compared with INVEGA SUSTENNA, the initial dosing was optimized for LY03010 by omitting the injection on Day 8 after the first injection, resulting in comparable total drug exposure. This study suggests that LY03010 may improve patient compliance by optimizing the initial dosing, while ensuring efficacy and safety.
Schizophrenia is a severe mental disorder that affects about 24 million people worldwide1. The main challenge in treating schizophrenia as a chronic disease is that it tends to relapse and become protracted, resulting in poor patient compliance. Long-acting injections have become an important formulation for antipsychotics because they can better address clinical needs such as significantly improving patient compliance and reducing relapses. The market approval of LY03010 will provide a new treatment option for patients. Publicly available information shows that Paliperidone Palmitate Long-acting Injection generated global sales of USD 4.14 billion in 2022 and USD 2.075 billion in the first half of 2023, respectively.
Building an internationally competitive CNS portfolio
The CNS therapeutic area, which includes schizophrenia, has long been a strategic focus for Luye Pharma. With frequent breakthroughs in new drug development and a growing portfolio, the company is cementing its leading position in the Chinese market for CNS products. This also helps to accelerate the company’s global expansion.
The company has built a diversified CNS portfolio. In January 2023, Rykindo® (risperidone) for extended-release injectable suspension was approved for marketing in the U.S., making it the first new CNS drug developed by a Chinese pharmaceutical company to get approved for use in the U.S. In November 2022, Ruoxinlin (Toludesvenlafaxine Hydrochloride Sustained-release Tablets) was approved for marketing in China as the first “Class 1 Chemical Drug” for the treatment of Major Depression Disorder developed by a Chinese company. Other products in the portfolio such as Seroquel® (quetiapine fumarate) and its extended-release tablets, as well as Rivastigmine Transdermal Patches (once daily and multi-day), are sold in China and other major markets.
In the company’s pipeline, LY03003 (Rotigotine Extended-Release Microspheres for Injection), which is being developed in China and abroad, has seen its NDA accepted in China and granted the priority review designation. Several other new products, such as LY03015, a VMAT2 inhibitor, are undergoing clinical trials in China and abroad. The company has built competitive capabilities in conducting R&D, regulatory, clinical, supply chain, and commercial activities internationally, laying a solid foundation for commercializing new products around the world in the future.
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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 comprising 8 manufacturing sites, establishing GMP quality management and international standard control systems. With more than 30 marketed products covering the oncology, central nervous system, cardiovascular, metabolism and other therapeutic areas, the company conducts business 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.
reference：
1. https://www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed in October 2023.
Shanghai, October 9, 2023 - Luye Pharma Group today announced the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) through the 505(b)(2) pathway for its LY03010 (Paliperidone Palmitate Extended-release Injectable Suspension) for the treatment of schizophrenia and schizoaffective disorder. LY03010 is developed on Luye Pharma’s platform for long-acting and extended-release drug delivery systems. It is expected to become China’s first long-acting paliperidone palmitate injectable suspension to be approved in the U.S.
Yang Rongbing, President of Luye Pharma Group, said: “LY03010 is also under review for its Marketing Authorization Application(MAA) in China, another CNS candidate from our company to have its MAA reviewed in both the U.S. and China. New CNS drugs from China are rarely available globally. We have a strong pipeline in this therapeutic area. With more and more candidates from this pipeline being commercially launched, we will be able to accelerate our global expansion by leveraging our existing commercial system for CNS.”
Addressing the challenge in treating schizophrenia to improve patient compliance
Paliperidone is a first-line treatment for schizophrenia. It can relieve the positive symptoms of psychosis and improve the cognitive-affective symptoms in schizophrenia patients. Paliperidone is available in both oral tablets and long-acting injections. Compared with oral tablets, long-acting injections require less frequent administration and are able to maintain a stable and effective concentration of the active ingredient in the blood for an extended period of time. This allows them to improve patient compliance, to significantly lower the risk of relapse during long-term treatments, and to improve the long-term outcomes for patients.
LY03010 is a long-acting injectable formulation of paliperidone, administered once a month. Its NDA submitted in the U.S. is based on a randomized, multiple-dose, open-label, and parallel-group pivotal study evaluating the relative bioavailability of LY03010 versus INVEGA SUSTENNA®. In this study, LY03010 was demonstrated to be bioequivalent to INVEGA SUSTENNA at steady state after multiple administrations. Furthermore, compared with INVEGA SUSTENNA, the initial dosing was optimized for LY03010 by omitting the injection on Day 8 after the first injection, resulting in comparable total drug exposure. This study suggests that LY03010 may improve patient compliance by optimizing the initial dosing, while ensuring efficacy and safety.
Schizophrenia is a severe mental disorder that affects about 24 million people worldwide1. The main challenge in treating schizophrenia as a chronic disease is that it tends to relapse and become protracted, resulting in poor patient compliance. Long-acting injections have become an important formulation for antipsychotics because they can better address clinical needs such as significantly improving patient compliance and reducing relapses. The market approval of LY03010 will provide a new treatment option for patients. Publicly available information shows that Paliperidone Palmitate Long-acting Injection generated global sales of USD 4.14 billion in 2022 and USD 2.075 billion in the first half of 2023, respectively.
Building an internationally competitive CNS portfolio
The CNS therapeutic area, which includes schizophrenia, has long been a strategic focus for Luye Pharma. With frequent breakthroughs in new drug development and a growing portfolio, the company is cementing its leading position in the Chinese market for CNS products. This also helps to accelerate the company’s global expansion.
The company has built a diversified CNS portfolio. In January 2023, Rykindo® (risperidone) for extended-release injectable suspension was approved for marketing in the U.S., making it the first new CNS drug developed by a Chinese pharmaceutical company to get approved for use in the U.S. In November 2022, Ruoxinlin (Toludesvenlafaxine Hydrochloride Sustained-release Tablets) was approved for marketing in China as the first “Class 1 Chemical Drug” for the treatment of Major Depression Disorder developed by a Chinese company. Other products in the portfolio such as Seroquel® (quetiapine fumarate) and its extended-release tablets, as well as Rivastigmine Transdermal Patches (once daily and multi-day), are sold in China and other major markets.
In the company’s pipeline, LY03003 (Rotigotine Extended-Release Microspheres for Injection), which is being developed in China and abroad, has seen its NDA accepted in China and granted the priority review designation. Several other new products, such as LY03015, a VMAT2 inhibitor, are undergoing clinical trials in China and abroad. The company has built competitive capabilities in conducting R&D, regulatory, clinical, supply chain, and commercial activities internationally, laying a solid foundation for commercializing new products around the world in the future.
###
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 comprising 8 manufacturing sites, establishing GMP quality management and international standard control systems. With more than 30 marketed products covering the oncology, central nervous system, cardiovascular, metabolism and other therapeutic areas, the company conducts business 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.
reference：
1. https://www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed in October 2023.
