News>Press Releases
Luye Pharma Announces 2023 Financial Results：Showing solid sales growth and improved financial structure
March 27,2024
Shanghai, March 27, 2024 – Luye Pharma Group (2186.HK) today announced its 2023 financial results and latest developments.

During the reporting period, the group's revenue was approximately RMB 6.14 billion, up 2.7 percent year-over-year, EBITDA was approximately RMB 2.08 billion, up 14.6 percent year-over-year, and profit before tax was approximately RMB 700 million, up 4.5 percent year-over-year. The group’s liabilities-to-assets ratio was 46.9 percent, going down 7.6 percentage points year-over-year. 

In its revenue, the income from product sales was approximately RMB 5.63 billion, up 11.2 percent year-over-year. Specifically, the sales income was approximately RMB 1.92 billion for oncology products, up 26.3 percent year-over-year, approximately RMB 1.39 billion for Central Nervous System (CNS) products, up 14.8 percent year-over-year, and approximately RMB 1.69 billion for cardiovascular products, up 10.8 percent year-over-year. 

Growing momentum driven by a wave of new product approvals

The group began to reap the benefits of pipelines years in the making with a focus on oncology and CNS. A wave of new product approvals in recent years fueled its growth. 

Oncology

During the reporting period, the group had two new drugs approved, to address the unmet needs in clinical practice.

Baituowei (goserelin microspheres for injection) was approved for the treatment of prostate cancer and breast cancer in China, to become the only formulation of long-acting goserelin microspheres approved for launch in the world. It was put on China’s National Reimbursement Drug List (NRDL) in the same year, to significantly increase patient coverage.

Zepzelca® (lurbinectedin injection) was approved in Hong Kong and Macao as a second-line treatment for small cell lung cancer(SCLC), and was also expected to become available to patients in the Chinese mainland soon at designated healthcare facilities in Guangdong via a Greater Bay Area initiative for medical services. It was the only new chemical entity approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed SCLC over the past 27 years.

CNS

The group reached major pharmaceutical markets in the world with its CNS pipeline and portfolio covering multiple diseases, to demonstrate its value as a potential leader in this therapeutic area. In 2023, the group had three new CNS products approved, which further cemented its competitive edge in CNS.

It’s worth mentioning that Rykindo® (risperidone) for extended-release injectable suspension was approved by the FDA during the reporting period for the treatment of schizophrenia and bipolar I disorder, making it the first innovative CNS drug developed by a Chinese company to be approved in the U.S. The group is working on the commercialization for this product. In China, the product continued to see robust sales growth and had its NRDL contract renewed in 2023 maintaining the same reimbursement standards. 

Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets), China’s first locally developed Class 1 innovative chemical drug for the treatment of Major Depressive Disorder (MDD), delivered an exceptional sales performance in 2023, the first full calendar year after its approval for marketing in November 2022 and was quickly recognized by physicians and patients alike for its clinical value.

Fundamentals cemented by solid sales of established products

The group saw solid sales of key established products in three therapeutic areas: oncology, CNS, and cardiovascular. Several exclusive products demonstrated their competitive edge in terms of therapeutic effects and sales, helping to cement the group’s fundamentals.

During the reporting period, the market share of Lipusu® (paclitaxel liposome for injection) increased significantly, and Seroquel® (quetiapine fumarate, immediate and extended release formulations) and Xuezhikang® delivered solid sales growth. In addition, Oukai® (sodium aescinate tablets) maintained a strong growth momentum.

LY03010 is likely to be approved in the U.S. ahead of schedule

Apart from the approval of Rykindo®, the FDA also started to review the New Drug Application (NDA) of LY03010 (paliperidone palmitate extended-release injectable suspension) for the treatment of schizophrenia last year. The drug is likely to be approved in the U.S. this year, earlier than expected, as the patent barriers to its approval have been removed in the review process.

Five new products are likely to be approved this year

In the group’s pipeline, several investigational drugs are now being reviewed for marketing or are undergoing Phase 3/pivotal clinical trials, to provide a strong momentum for commercialization. The following five new products are likely to be approved this year:

Oncology:
CNS:
In addition, a Phase 3 clinical trial has been completed for BA5101 (dulaglutide injection, a biosimilar to Trulicity®) in China, and a Biologics License Application (BLA) is to be submitted for it. BA5101 is the world’s first biosimilar to Trulicity® to complete a Phase 3 clinical trial. Meanwhile, the group is also conducting clinical trials of multiple innovative antibodies and other biosimilars in China and abroad.

A new round of high-speed growth ahead

2024 marks the 30th anniversary of Luye Pharma Group. It has ushered in the first wave of new product approvals thanks to many years of hard work on new drug development. The group looks to be better positioned to address the unmet needs with these new products and fuel a new round of fast growth both in China and abroad. Looking forward, it will spare no effort to drive the lab-to-market process of key candidates in China and abroad, and will also take various measures to improve operation and management, to increase profitability, and to maximize the value for patients, shareholders and the general public.

###
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.
News>Press Releases
Luye Pharma Announces 2023 Financial Results：Showing solid sales growth and improved financial structure
March 27,2024
Shanghai, March 27, 2024 – Luye Pharma Group (2186.HK) today announced its 2023 financial results and latest developments.

During the reporting period, the group's revenue was approximately RMB 6.14 billion, up 2.7 percent year-over-year, EBITDA was approximately RMB 2.08 billion, up 14.6 percent year-over-year, and profit before tax was approximately RMB 700 million, up 4.5 percent year-over-year. The group’s liabilities-to-assets ratio was 46.9 percent, going down 7.6 percentage points year-over-year. 

In its revenue, the income from product sales was approximately RMB 5.63 billion, up 11.2 percent year-over-year. Specifically, the sales income was approximately RMB 1.92 billion for oncology products, up 26.3 percent year-over-year, approximately RMB 1.39 billion for Central Nervous System (CNS) products, up 14.8 percent year-over-year, and approximately RMB 1.69 billion for cardiovascular products, up 10.8 percent year-over-year. 

Growing momentum driven by a wave of new product approvals

The group began to reap the benefits of pipelines years in the making with a focus on oncology and CNS. A wave of new product approvals in recent years fueled its growth. 

Oncology

During the reporting period, the group had two new drugs approved, to address the unmet needs in clinical practice.

Baituowei (goserelin microspheres for injection) was approved for the treatment of prostate cancer and breast cancer in China, to become the only formulation of long-acting goserelin microspheres approved for launch in the world. It was put on China’s National Reimbursement Drug List (NRDL) in the same year, to significantly increase patient coverage.

Zepzelca® (lurbinectedin injection) was approved in Hong Kong and Macao as a second-line treatment for small cell lung cancer(SCLC), and was also expected to become available to patients in the Chinese mainland soon at designated healthcare facilities in Guangdong via a Greater Bay Area initiative for medical services. It was the only new chemical entity approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed SCLC over the past 27 years.

CNS

The group reached major pharmaceutical markets in the world with its CNS pipeline and portfolio covering multiple diseases, to demonstrate its value as a potential leader in this therapeutic area. In 2023, the group had three new CNS products approved, which further cemented its competitive edge in CNS.

It’s worth mentioning that Rykindo® (risperidone) for extended-release injectable suspension was approved by the FDA during the reporting period for the treatment of schizophrenia and bipolar I disorder, making it the first innovative CNS drug developed by a Chinese company to be approved in the U.S. The group is working on the commercialization for this product. In China, the product continued to see robust sales growth and had its NRDL contract renewed in 2023 maintaining the same reimbursement standards. 

Ruoxinlin (toludesvenlafaxine hydrochloride extended-release tablets), China’s first locally developed Class 1 innovative chemical drug for the treatment of Major Depressive Disorder (MDD), delivered an exceptional sales performance in 2023, the first full calendar year after its approval for marketing in November 2022 and was quickly recognized by physicians and patients alike for its clinical value.

Fundamentals cemented by solid sales of established products

The group saw solid sales of key established products in three therapeutic areas: oncology, CNS, and cardiovascular. Several exclusive products demonstrated their competitive edge in terms of therapeutic effects and sales, helping to cement the group’s fundamentals.

During the reporting period, the market share of Lipusu® (paclitaxel liposome for injection) increased significantly, and Seroquel® (quetiapine fumarate, immediate and extended release formulations) and Xuezhikang® delivered solid sales growth. In addition, Oukai® (sodium aescinate tablets) maintained a strong growth momentum.

LY03010 is likely to be approved in the U.S. ahead of schedule

Apart from the approval of Rykindo®, the FDA also started to review the New Drug Application (NDA) of LY03010 (paliperidone palmitate extended-release injectable suspension) for the treatment of schizophrenia last year. The drug is likely to be approved in the U.S. this year, earlier than expected, as the patent barriers to its approval have been removed in the review process.

Five new products are likely to be approved this year

In the group’s pipeline, several investigational drugs are now being reviewed for marketing or are undergoing Phase 3/pivotal clinical trials, to provide a strong momentum for commercialization. The following five new products are likely to be approved this year:

Oncology:
  • The lurbinectedin injection is likely to be approved in the Chinese mainland.
  • BA1102 (denosumab injection, a biosimilar to Xgeva®) is likely to be approved in China.
CNS:
  • LY03010 (paliperidone palmitate extended-release injectable suspension) is likely to be approved in China and the U.S. It is expected to become the first proprietary paliperidone palmitate long-acting injectable developed by a Chinese company to be approved in the U.S.
  • LY03003 (rotigotine extended-release microspheres for injection) is likely to be approved in China. It is the world’s first long-acting extended-release microsphere formulation for the treatment of Parkinson’s disease.
  • LY021702 (oxycodone and naloxone extended-release tablets) is likely to be approved in China for the treatment of moderate to severe chronic pains. It is the first technically challenging product of oxycodone and naloxone extended-release tablets developed by a Chinese company.
In addition, a Phase 3 clinical trial has been completed for BA5101 (dulaglutide injection, a biosimilar to Trulicity®) in China, and a Biologics License Application (BLA) is to be submitted for it. BA5101 is the world’s first biosimilar to Trulicity® to complete a Phase 3 clinical trial. Meanwhile, the group is also conducting clinical trials of multiple innovative antibodies and other biosimilars in China and abroad.

A new round of high-speed growth ahead

2024 marks the 30th anniversary of Luye Pharma Group. It has ushered in the first wave of new product approvals thanks to many years of hard work on new drug development. The group looks to be better positioned to address the unmet needs with these new products and fuel a new round of fast growth both in China and abroad. Looking forward, it will spare no effort to drive the lab-to-market process of key candidates in China and abroad, and will also take various measures to improve operation and management, to increase profitability, and to maximize the value for patients, shareholders and the general public.

###
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.