- New product sales up 56.8% -
- Net profit attributable to parent company up 31.1% -
Shanghai, March 31, 2026 -- Luye Pharma Group (2186.HK) today announced its annual results for fiscal year 2025 and the latest developments.
In the reporting period, the group’s revenue was RMB 6,308.4 million, up 4.1%, its EBITDA was RMB 2,470.7 million, up 12.7%, and its net profit attributable to parent company was RMB 618.7 million, up 31.1%.
New product sales up 56.8%
With a focus on Oncology, Central Nervous System (CNS), and Biologics, the group launched 15 new drugs in multiple countries and regions during the past 5 years. The first blockbusters of them are now commercially available, leading to optimized revenue streams for the group. In the reporting period, new product sales were up 56.8%, to become a new growth driver.
Oncology sales increased 10.2% to RMB 2,297.2 million, mainly driven by key products:
- Baituowei® (goserelin microspheres for injection), the world’s only commercially available microsphere formulation of goserelin for the treatment of prostate cancer and breast cancer, achieved several-fold sales growth in the reporting period. At the end of 2025, the drug continued to get covered by the National Reimbursement Drug List (NRDL) of China.
- Zepzelca® (lurbinectedin for injection) was approved in April 2025 for marketing in the Chinese mainland, indicated to treat Small Cell Lung Cancer (SCLC), making it a new second-line treatment for SCLC that had not been available in the market for a long time. In the reporting period, its sales grew several-fold. At the end of 2025, it was included in China’s first Commercial Insurance Innovative Drug List.
CNS sales increased 25.7% to RMB 2028.0 million, mainly driven by new products in China and abroad:
- Ruoxinlin® (toludesvenlafaxine hydrochloride extended-release tablets), China’s first Class 1 new antidepressant, saw strong sales growth in the first year after its NRDL coverage. It has also received a Class 1A recommendation in the Chinese Guidelines for the Diagnosis and Treatment of Depressive Disorders (2025 Edition). In addition, its marketing authorization application for the treatment of Generalized Anxiety Disorder (GAD) was accepted in China in January 2026.
- ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension—since its launch in the U.S. in April 2025—has caught the attention of many American psychiatrists thanks to its unique dosing regimen as a long-acting injectable (LAI) for the treatment of schizophrenia.
Milestones achieved for several new drugs:
In the reporting period, Rivastigmine Twice Weekly Transdermal Patch was launched in Japan; Rotigotine Transdermal Patch was launched in the UK; Boyoujing® (aflibercept intravitreous injection) and Boyouping® (dulaglutide injection) were launched in China; and Mimeixin® (oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets) was covered by the NRDL.
Launched in the U.S., ERZOFRI is expected to boost international sales
ERZOFRI is the only LAI paliperidone palmitate in the U.S. requiring just one injection in the first month. In 2025, the first year after the drug was launched in the U.S., the group did a lot of work to scale up its commercial presence including team building, insurance coverage, market access, and academic exchange. The successful launch of ERZOFRI in the U.S. laid the foundation for growing its sales and unlocking its value. The drug is expected to boost the group’s performance in international markets.
Beyond the U.S., the group is also working with local partners in Europe, Japan, Southeast Asia, and other regions to commercialize multiple products and enhance its global presence.
A robust commercial network powered by “in-house + BD” operations
When it comes to sales & marketing, the group takes a two-pronged approach: while having an in-house team, it also works with partners to target specific therapeutic areas across channels.
During the reporting period, the group granted Nhwa Pharmaceutical commercialization rights for three long-acting injectable antipsychotics in the Chinese mainland, to drive market penetration across all levels of healthcare facilities and retail pharmacies. Furthermore, the group formed strategic partnerships with Sinopharm Group and Sinopharm CNCM to expand the market reach of Mimeixin and other products. In addition, the group’s subsidiary, Boan Biotech, joined hands with partners such as Shaphar, King-friend, and Kexing Biopharm to accelerate the commercialization of its biologics portfolio around the globe.
Accelerating next-gen R&D and leveraging partnerships to unlock value
With its first wave of new drugs all commercialized, Luye Pharma is shifting its strategic focus toward a next-generation pipeline of candidates with first-in-class or best-in-class potential. To maximize the value of these innovations, the group is actively pursuing collaborations with diverse partners, including multinational pharmaceutical companies (MNCs).
In the area of chemical drugs for CNS diseases, the group is developing Class 1 innovative drugs simultaneously both in China and in the U.S. with a focus on addressing the unmet needs. Such drugs include LY03015, the world’s first investigational drug targeting both VMAT2 and Sigma-1R, which is expected to obtain the data of a Phase 2 clinical trial conducted in China by mid-2026, and a pharmacokinetic (PK) bridging study of which has been initiated in the U.S.; LY03017 (next-generation 5-HT2AR inverse agonist/5-HT2CR antagonist), a Phase 2 clinical trial of which has been initiated in China, and clinical trials of which as an investigational new drug (IND) have been approved in the U.S.; and LY03020, the world’s first TAAR1/5-HT2CR agonist, a Phase 2 clinical trial of which has been initiated in China, and clinical trials of which as an investigational new drug (IND) have also been approved in the U.S.
In the area of biologics, the group’s subsidiary Boan Biotech is fast-tracking the clinical development of multiple innovative biologics, including BA1106, China’s first innovative anti-CD25 antibody to undergo a clinical trial for the treatment of solid tumors, and BA1302, China’s first innovative anti-CD228 ADC under clinical development. The company also has several antibodies that will enter the stage of clinical development soon, including BA1304 (a bispecific ADC targeting EGFR and B7-H3), BA1203 (an antibody-cytokine fusion protein targeting PD-1 and IL-2), and BA2201 (a bispecific antibody targeting TL1A and IL23).
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to developing, manufacturing, and selling innovative medications. With R&D centers in China, the U.S., and Europe, the company is an international leader in novel drug delivery systems such as microspheres, liposomes, and transdermal patches. It also has multiple innovative products under development in two categories: new chemical entities and antibodies. From 2021 to 2025, the company had 15 new drugs approved for marketing with each in one or several markets such as the U.S., Japan, China, and several European countries.
Luye Pharma has 8 manufacturing facilities worldwide, which follow internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched over 30 products in the central nervous system, oncology, cardiovascular, and other therapeutic areas. It conducts business in over 80 countries and regions, including major pharmaceutical markets such as China, the U.S., Europe, and Japan, as well as fast-growing emerging markets.
