Shanghai, China, December 13, 2023 – Luye Pharma Group today announced that two of its in-house developed innovative formulations have been included on the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2023 Version) (2023 National Reimbursement Drug List). The two formulations are Baituowei (Goserelin Microspheres for Injection) and Rykindo (Risperidone Microspheres for Injection (II)). Baituowei made the list for the first time. Rykindo was put on the list again under a renewed contract, with the payment standard under the health insurance remaining the same. The 2023 National Reimbursement Drug List will become effective on January 1, 2024.
Baituowei: the world’s only long-acting microsphere formulation of goserelin approved for use
Baituowei was approved for marketing in China in June 2023 for the treatment of prostate cancer in patients who need to receive the androgen deprivation therapy. This indication is now covered by the 2023 National Reimbursement Drug List. In addition, Baituowei was also approved in China in September this year for the treatment of breast cancer in premenopausal and perimenopausal women who can be treated with hormones.
Developed on Luye Pharma’s globally leading microsphere platform, Baituowei is currently the only long-acting microsphere formulation of goserelin approved for use. With its upgraded microsphere formulation and improved injection style, Baituowei is able to keep a balance of efficacy, safety, and patient experience, and provide a more convenient option for patients. Luye Pharma and BeiGene are working together to commercialize this product in China.
Rykindo: China’s first new CNS drug launched in both China and the U.S.
Rykindo was approved for launch in China in January 2021 for the treatment of patients with acute and chronic schizophrenia and those with clear positive or negative symptoms of other psychotic conditions. The contract for this product with the health insurance authority has been successfully renewed to put it on the 2023 National Reimbursement Drug List with the payment standard remaining unchanged.
Rykindo combines the benefits of a long-acting injection and an atypical antipsychotic. With its unique pharmacokinetic profile and pharmacodynamic property, Rykindo has been proved to be effective and safe throughout the treatment process of schizophrenia patients.
In addition to China, Rykindo was also approved for marketing by the U.S. Food and Drug Administration (FDA) in January 2023. This product is the first new drug in the central nervous system (CNS) therapeutic area developed by a Chinese pharmaceutical company to be approved for launch in the U.S. It is also the first product with a complex dosage form developed by a pharmaceutical company from Mainland China to be approved by the FDA pursuant to section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.
Yang Rongbing, President of Luye Pharma Group, said: "The reform of the government’s health insurance system in recent years has been a major move to ensure basic healthcare and promote innovation. Having innovative products such as Baituowei and Rykindo covered by the health insurance system’s National Reimbursement Drug List allows them to be available to patients at lower prices under insurance, so as to reduce the financial burdens of patients. This also helps to accelerate the commercialization of those products and further increase the rewards for innovation. At Luye Pharma, we will continue to improve the accessibility of these innovative products by taking various measures in response to the government’s call, and to work hard to alleviate patient burdens and improve their health."
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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, China, December 13, 2023 – Luye Pharma Group today announced that two of its in-house developed innovative formulations have been included on the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2023 Version) (2023 National Reimbursement Drug List). The two formulations are Baituowei (Goserelin Microspheres for Injection) and Rykindo (Risperidone Microspheres for Injection (II)). Baituowei made the list for the first time. Rykindo was put on the list again under a renewed contract, with the payment standard under the health insurance remaining the same. The 2023 National Reimbursement Drug List will become effective on January 1, 2024.
Baituowei: the world’s only long-acting microsphere formulation of goserelin approved for use
Baituowei was approved for marketing in China in June 2023 for the treatment of prostate cancer in patients who need to receive the androgen deprivation therapy. This indication is now covered by the 2023 National Reimbursement Drug List. In addition, Baituowei was also approved in China in September this year for the treatment of breast cancer in premenopausal and perimenopausal women who can be treated with hormones.
Developed on Luye Pharma’s globally leading microsphere platform, Baituowei is currently the only long-acting microsphere formulation of goserelin approved for use. With its upgraded microsphere formulation and improved injection style, Baituowei is able to keep a balance of efficacy, safety, and patient experience, and provide a more convenient option for patients. Luye Pharma and BeiGene are working together to commercialize this product in China.
Rykindo: China’s first new CNS drug launched in both China and the U.S.
Rykindo was approved for launch in China in January 2021 for the treatment of patients with acute and chronic schizophrenia and those with clear positive or negative symptoms of other psychotic conditions. The contract for this product with the health insurance authority has been successfully renewed to put it on the 2023 National Reimbursement Drug List with the payment standard remaining unchanged.
Rykindo combines the benefits of a long-acting injection and an atypical antipsychotic. With its unique pharmacokinetic profile and pharmacodynamic property, Rykindo has been proved to be effective and safe throughout the treatment process of schizophrenia patients.
In addition to China, Rykindo was also approved for marketing by the U.S. Food and Drug Administration (FDA) in January 2023. This product is the first new drug in the central nervous system (CNS) therapeutic area developed by a Chinese pharmaceutical company to be approved for launch in the U.S. It is also the first product with a complex dosage form developed by a pharmaceutical company from Mainland China to be approved by the FDA pursuant to section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.
Yang Rongbing, President of Luye Pharma Group, said: "The reform of the government’s health insurance system in recent years has been a major move to ensure basic healthcare and promote innovation. Having innovative products such as Baituowei and Rykindo covered by the health insurance system’s National Reimbursement Drug List allows them to be available to patients at lower prices under insurance, so as to reduce the financial burdens of patients. This also helps to accelerate the commercialization of those products and further increase the rewards for innovation. At Luye Pharma, we will continue to improve the accessibility of these innovative products by taking various measures in response to the government’s call, and to work hard to alleviate patient burdens and improve their health."
###
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.
