News>Press Releases
Luye Pharma’s Ruoxinlin and Other Drugs Included on China’s 2024 National Reimbursement Drug List
November 28,2024

Shanghai, November 28, 2024 – Luye Pharma Group today announced that several of its innovative products (including new indications) have been included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2024 Version) (the 2024 NRDL). These include Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets), which has made the list for the first time, Baituowei (goserelin microspheres for injection), which is included with a new indication for breast cancer, and Lipusu (paclitaxel liposome for injection), which is included in the regular catalogue of the list. The 2024 NRDL will officially take effect on January 1, 2025. 

Ruoxinlin: the first Class 1 innovative chemical drug made in China for treating MDD

Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets) is a Class 1 innovative chemical drug for the treatment of Major Depressive Disorder (MDD). The drug has debuted on the NRDL for the first time following successful negotiations. It is China’s first locally developed proprietary antidepressant approved for marketing through the pathway for Class 1 chemical drugs, marking a breakthrough in this therapeutic area as a “Made-in-China” innovative drug. 

Nonclinical studies have showed that Ruoxinlin acts as a serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRI). In addition, a PET/CT study has showed that Ruoxinlin can bind to DA transporters in the brains of both rats and healthy subjects, another piece of strong evidence proving it is an SNDRI. Clinical studies have demonstrated that it is able to treat MDD in a comprehensive and stable manner. Specifically, it significantly reduces anxiety, retardation/fatigue and anhedonia, improves cognitive abilities, and promotes the recovery of social functions, in addition to being safe and well-tolerated, without causing somnolence or negatively affecting sexual functioning, bodyweight, and lipid metabolism. A meta-analysis that reveals Ruoxinlin’s superior efficacy than other 21 antidepressants has been published in the Chinese Medical Journal.

By effectively addressing the unmet needs of MDD patients, Ruoxinlin has become one of the fastest-growing new antidepressants in recent years. More than 25,000 patients have benefited from the drug to date.

Baituowei: the world’s only marketed formulation of long-acting goserelin microspheres

Baituowei (goserelin microspheres for injection) is the world’s only marketed formulation of long-acting goserelin microspheres. It is indicated for treating prostate cancer in patients requiring androgen deprivation therapy (ADT), and treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones. The drug was already included in the 2023 NDRL for its indication to treat prostate cancer. The 2024 NDRL expands its coverage to include the indication for treating breast cancer. 

Baituowei was developed on Luye Pharma’s globally leading microsphere platform. With its upgraded microsphere formulation and improved injection method, the product is able to keep a balance of efficacy, safety, and patient experience, and to provide a more convenient option for patients. Luye Pharma and BeiGene are working together to commercialize this product in China.

Lipusu: the world’s only marketed paclitaxel liposome for injection

Lipusu (paclitaxel liposome for injection) has been include in the regular catalogue of the 2024 NRDL, which covers all of its indications, including non-small-cell lung cancer, ovarian cancer, and breast cancer.

Lipusu is the only marketed paclitaxel liposome for injection in the world. Its unique formulation allows it to target tumors and lymph nodes and have a longer half-life, making the drug more potent in killing tumor cells, and also safer and better-tolerated. Lipusu has been widely recognized by physicians and patients in clinical practice, and has also been recommended by multiple authoritative guidelines and consensuses for its efficacy and safety since it was launched years ago.

Yang Rongbing, President of Luye Pharma Group, said: "The government’s health insurance system has been reformed to ensure access to basic drugs while increasing support for innovative products highly needed in clinical practice, to make them affordable to as many patients as possible. The newly inclusion of Ruoxinlin, the expanded coverage of Baituowei, and the inclusion of Lipusu in the regular catalogue of the latest NRDL will dramatically increase their affordability to patients and reduce the financial burden of patients. I’m excited about that. Next, we’ll work hard to bring them to patients as soon as possible along with the adoption of the new NRDL in various regions.”

###

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 achieved multiple innovations in new chemical entities and antibodies, and is also 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.

News>Press Releases
Luye Pharma’s Ruoxinlin and Other Drugs Included on China’s 2024 National Reimbursement Drug List
November 28,2024

Shanghai, November 28, 2024 – Luye Pharma Group today announced that several of its innovative products (including new indications) have been included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2024 Version) (the 2024 NRDL). These include Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets), which has made the list for the first time, Baituowei (goserelin microspheres for injection), which is included with a new indication for breast cancer, and Lipusu (paclitaxel liposome for injection), which is included in the regular catalogue of the list. The 2024 NRDL will officially take effect on January 1, 2025. 

Ruoxinlin: the first Class 1 innovative chemical drug made in China for treating MDD

Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets) is a Class 1 innovative chemical drug for the treatment of Major Depressive Disorder (MDD). The drug has debuted on the NRDL for the first time following successful negotiations. It is China’s first locally developed proprietary antidepressant approved for marketing through the pathway for Class 1 chemical drugs, marking a breakthrough in this therapeutic area as a “Made-in-China” innovative drug. 

Nonclinical studies have showed that Ruoxinlin acts as a serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRI). In addition, a PET/CT study has showed that Ruoxinlin can bind to DA transporters in the brains of both rats and healthy subjects, another piece of strong evidence proving it is an SNDRI. Clinical studies have demonstrated that it is able to treat MDD in a comprehensive and stable manner. Specifically, it significantly reduces anxiety, retardation/fatigue and anhedonia, improves cognitive abilities, and promotes the recovery of social functions, in addition to being safe and well-tolerated, without causing somnolence or negatively affecting sexual functioning, bodyweight, and lipid metabolism. A meta-analysis that reveals Ruoxinlin’s superior efficacy than other 21 antidepressants has been published in the Chinese Medical Journal.

By effectively addressing the unmet needs of MDD patients, Ruoxinlin has become one of the fastest-growing new antidepressants in recent years. More than 25,000 patients have benefited from the drug to date.

Baituowei: the world’s only marketed formulation of long-acting goserelin microspheres

Baituowei (goserelin microspheres for injection) is the world’s only marketed formulation of long-acting goserelin microspheres. It is indicated for treating prostate cancer in patients requiring androgen deprivation therapy (ADT), and treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones. The drug was already included in the 2023 NDRL for its indication to treat prostate cancer. The 2024 NDRL expands its coverage to include the indication for treating breast cancer. 

Baituowei was developed on Luye Pharma’s globally leading microsphere platform. With its upgraded microsphere formulation and improved injection method, the product is able to keep a balance of efficacy, safety, and patient experience, and to provide a more convenient option for patients. Luye Pharma and BeiGene are working together to commercialize this product in China.

Lipusu: the world’s only marketed paclitaxel liposome for injection

Lipusu (paclitaxel liposome for injection) has been include in the regular catalogue of the 2024 NRDL, which covers all of its indications, including non-small-cell lung cancer, ovarian cancer, and breast cancer.

Lipusu is the only marketed paclitaxel liposome for injection in the world. Its unique formulation allows it to target tumors and lymph nodes and have a longer half-life, making the drug more potent in killing tumor cells, and also safer and better-tolerated. Lipusu has been widely recognized by physicians and patients in clinical practice, and has also been recommended by multiple authoritative guidelines and consensuses for its efficacy and safety since it was launched years ago.

Yang Rongbing, President of Luye Pharma Group, said: "The government’s health insurance system has been reformed to ensure access to basic drugs while increasing support for innovative products highly needed in clinical practice, to make them affordable to as many patients as possible. The newly inclusion of Ruoxinlin, the expanded coverage of Baituowei, and the inclusion of Lipusu in the regular catalogue of the latest NRDL will dramatically increase their affordability to patients and reduce the financial burden of patients. I’m excited about that. Next, we’ll work hard to bring them to patients as soon as possible along with the adoption of the new NRDL in various regions.”

###

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 achieved multiple innovations in new chemical entities and antibodies, and is also 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.