- Reporting 24.8% growth of profit attributable to shareholders
- Setting the bar for Chinese pharma with end-to-end global CNS capabilities
Shanghai, August 30, 2026 -- Luye Pharma Group (2186.HK) today announced its 2026 interim results and latest developments.
During the reporting period, the group delivered solid financial results: with a revenue of RMB 3.02 billion, its profit attributable to shareholders was increased by 24.8% year-on-year to RMB 390.5 million; and the group continued to improve efficiency while increasing investment in innovation: its sales expenses, administrative expenses, and finance expenses combined were reduced by 14.5% year-on-year, while its R&D spending, which stood at RMB 257 million, was up 32.8% year-on-year.
The only Chinese pharmaceutical innovator with end-to-end global CNS capabilities
During the reporting period, the group delivered solid financial results: with a revenue of RMB 3.02 billion, its profit attributable to shareholders was increased by 24.8% year-on-year to RMB 390.5 million; and the group continued to improve efficiency while increasing investment in innovation: its sales expenses, administrative expenses, and finance expenses combined were reduced by 14.5% year-on-year, while its R&D spending, which stood at RMB 257 million, was up 32.8% year-on-year.
The only Chinese pharmaceutical innovator with end-to-end global CNS capabilities
In the central nervous system (CNS) therapeutic area, the group has built a global system spanning the entire value chain from R&D and clinical trials to production and commercialization. It is the only Chinese pharmaceutical company with end-to-end capabilities to deliver innovative CNS drugs worldwide.
Being consistently an industry leader, the group's CNS pipeline includes innovative drug candidates for treating major diseases such as schizophrenia, depression, and Alzheimer's disease. Leveraging its R&D platform for CNS drugs, the group is developing multiple new chemical entities with the potential to become first-in-class or best-in-class drugs in China and the U.S. Among them, the group reported positive clinical data in June from a Phase 2 trial of LY03015 in China. LY03015 is the world's first innovative drug candidate targeting both VMAT2 and Sigma-1R and has become one of the group's key innovative assets with potential for overseas collaboration.
The group's new CNS drugs are showing a strong growth momentum. In China, Ruoxinlin® (toludesvenlafaxine hydrochloride extended-release tablets), launched in 2022, has become one of the fastest-growing new antidepressants in recent years. In the U.S., launched more than one year ago, ERZOFRI® (paliperidone palmitate extended-release injectable suspension) has made solid progress in the market and achieved rapid growth. Anchored in the U.S. market, and by relying on its global commercial network built over the years, the group has become the only Chinese pharmaceutical company developing, manufacturing and selling innovative CNS drugs on its own around the world.
With CNS becoming its biggest business, the group is speeding up the upgrade of its oncology portfolio
During the reporting period, the group continued to drive growth with new products in two core businesses: CNS and oncology.
The revenue from CNS was increased by 22.2%, making this a business with the biggest revenue contribution to the group. The growth was driven by the accelerated uptake of CNS products in China and their ramp-up in the U.S. ERZOFRI, the only once-monthly paliperidone palmitate long-acting injectable in the U.S. that requires just one injection during the initiation phase, achieved strong sales growth in the first half of 2026 from the second half of 2025 after it was launched in the U.S. in April 2025 for the treatment of schizophrenia and schizoaffective disorder.
In China, Ruoxinlin, China's first proprietary Class 1 chemical antidepressant, achieved substantial year-on-year sales growth during the reporting period. Its New Drug Application (NDA) for treating generalized anxiety disorder (GAD) was accepted in China in January this year. Meanwhile, the group's three long-acting injectable antipsychotics-Rykindo® (risperidone microspheres for injection (II)), Ruibailai® (paliperidone palmitate injection (II)), and Meibirui® (paliperidone palmitate injection)-also achieved solid growth. The group is currently working with Nhwa Pharma to drive the value realization of this long-acting injectable portfolio.
In oncology, the group is building its second growth curve with new products. The market share of Baituowei® (goserelin microspheres for injection), the world's only long-acting microsphere formulation of goserelin for the treatment of prostate cancer and breast cancer, is quickly increasing, and Zepzelca® (lurbinectedin for injection), a new second-line treatment for small cell lung cancer (SCLC) in more than 20 years, was included in China's first Commercial Health Insurance Innovative Drug List and achieved fast sales growth in the reporting period compared with the second half of 2025.
Innovating to drive growth with AI both internally and externally
Leveraging its strength in CNS and oncology, the group will continue to drive strategic investments in the two core therapeutic areas. It is actively seeking strategic opportunities in cutting-edge technologies and quality assets for innovation such as AI-enabled drug discovery and therapeutic mRNA vaccines for cancer. By applying AI across its value chain, the group is re-vamping value creation to build competitive CNS and oncology portfolios while exploring external growth opportunities driven by AI.
Advancing its pipelines of next-generation drugs
The group will focus on developing new molecules with the potential to become first-in-class or best-in-class new drugs in CNS and oncology. With core drug candidates entering key clinical trial phases one after another, the group is accelerating the transition of its pipelines from early-stage drug development to clinical trials. It hopes to unleash the value of those assets through global development activities and partnerships.
In CNS, the group is developing multiple new molecules in China and the U.S. For example, LY03015 (VMAT2/Sigma-1R) is intended for the treatment of tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). In June 2026, the group reported positive data from a Phase 2 clinical trial of the drug in China. In the trial, LY03015 demonstrated robust efficacy across all three dose groups, showing a rapid and significant improvement of TD symptoms and a clear dose-response relationship. Notably, the Abnormal Involuntary Movement Scale (AIMS) response rate, defined as the proportion of patients achieving a ≥50% improvement in AIMS Items 1-7, reached 76.5% in the 20 mg dose group. This result was nearly twice the response rates reported in publicly available historical data from double-blind, placebo-controlled registrational trials of existing first-line therapies. A bridging study of LY03015 has been successfully completed in the U.S., and the plan for Phase 3 clinical trials of the drug to be conducted in China and the U.S. will be confirmed in Q4 2026.
In addition to LY03015, the group also has several other investigational CNS drugs undergoing clinical trials. Among them, LY03017, a next-generation 5-HT2AR inverse agonist/5-HT2CR antagonist, is undergoing a Phase 2 clinical trial in China for the treatment of Alzheimer's disease psychosis (ADP); and LY03020, the world's first dual-target agonist against TAAR1/5-HT2CR, is also undergoing a Phase 2 clinical trial in China for the treatment of schizophrenia.
In oncology, the group, through its subsidiary Boan Biotech, is building pipelines of the next-generation bispecific/multispecific immuno-oncology (IO) drugs and antibody-drug conjugates (ADCs). One key asset in the pipelines is BA1302, the world's only anti-CD228 ADC currently under clinical development. In China, the Phase 1a, dose-escalation clinical trial of BA1302 as a monotherapy has been completed, and the Phase 1b, dose-expansion clinical trial of it will begin soon. It has also received clearance from the FDA for clinical trials in the U.S. BA1203, another asset in the pipelines, is an anti-PD-1/IL-2 antibody-cytokine fusion protein and the world's only anti-PD-1/IL-2 molecule featuring high-activity IL-2α receptor engagement, a masked design, and PD-1 blocking functionality. Its Investigational New Drug (IND) application has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). In addition, BA1106, China's first innovative non-IL-2-blocking anti-CD25 antibody to undergo clinical development for the treatment of solid tumors, has been approved by the CDE for a Phase 2 clinical trial, which is designed to evaluate the drug candidate in combination with Boan Biotech's proprietary PD-1 inhibitor BA1104 as a first-line or a second-line treatment for non-small cell lung cancer.
The group is also working on therapeutic mRNA vaccines. LY01620, an mRNA vaccine candidate under development for the treatment of cervical precancerous lesions and HPV-associated tumors, has achieved positive results from a Phase 1 clinical trial in China and is expected to undergo a Phase 2 clinical trial in China soon.
The group has obtained end-to-end capabilities for delivering innovative CNS drugs after many years in this therapeutic area, which can be proved by the ongoing ramp-up of core products both in China and abroad. Going forward, the group will continue to focus on CNS and oncology in parallel, to cement its existing competitive edge while expanding its portfolios of innovative products, creating new growth curves, and building a better and more sustainable future.
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 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 in two categories: new chemical entities and antibodies. From 2021 to 2025, the company has had a total of 15 new drugs approved for marketing, with each of them in one or multiple countries such as the U.S., several European countries, Japan, and China.
Being consistently an industry leader, the group's CNS pipeline includes innovative drug candidates for treating major diseases such as schizophrenia, depression, and Alzheimer's disease. Leveraging its R&D platform for CNS drugs, the group is developing multiple new chemical entities with the potential to become first-in-class or best-in-class drugs in China and the U.S. Among them, the group reported positive clinical data in June from a Phase 2 trial of LY03015 in China. LY03015 is the world's first innovative drug candidate targeting both VMAT2 and Sigma-1R and has become one of the group's key innovative assets with potential for overseas collaboration.
The group's new CNS drugs are showing a strong growth momentum. In China, Ruoxinlin® (toludesvenlafaxine hydrochloride extended-release tablets), launched in 2022, has become one of the fastest-growing new antidepressants in recent years. In the U.S., launched more than one year ago, ERZOFRI® (paliperidone palmitate extended-release injectable suspension) has made solid progress in the market and achieved rapid growth. Anchored in the U.S. market, and by relying on its global commercial network built over the years, the group has become the only Chinese pharmaceutical company developing, manufacturing and selling innovative CNS drugs on its own around the world.
With CNS becoming its biggest business, the group is speeding up the upgrade of its oncology portfolio
During the reporting period, the group continued to drive growth with new products in two core businesses: CNS and oncology.
The revenue from CNS was increased by 22.2%, making this a business with the biggest revenue contribution to the group. The growth was driven by the accelerated uptake of CNS products in China and their ramp-up in the U.S. ERZOFRI, the only once-monthly paliperidone palmitate long-acting injectable in the U.S. that requires just one injection during the initiation phase, achieved strong sales growth in the first half of 2026 from the second half of 2025 after it was launched in the U.S. in April 2025 for the treatment of schizophrenia and schizoaffective disorder.
In China, Ruoxinlin, China's first proprietary Class 1 chemical antidepressant, achieved substantial year-on-year sales growth during the reporting period. Its New Drug Application (NDA) for treating generalized anxiety disorder (GAD) was accepted in China in January this year. Meanwhile, the group's three long-acting injectable antipsychotics-Rykindo® (risperidone microspheres for injection (II)), Ruibailai® (paliperidone palmitate injection (II)), and Meibirui® (paliperidone palmitate injection)-also achieved solid growth. The group is currently working with Nhwa Pharma to drive the value realization of this long-acting injectable portfolio.
In oncology, the group is building its second growth curve with new products. The market share of Baituowei® (goserelin microspheres for injection), the world's only long-acting microsphere formulation of goserelin for the treatment of prostate cancer and breast cancer, is quickly increasing, and Zepzelca® (lurbinectedin for injection), a new second-line treatment for small cell lung cancer (SCLC) in more than 20 years, was included in China's first Commercial Health Insurance Innovative Drug List and achieved fast sales growth in the reporting period compared with the second half of 2025.
Innovating to drive growth with AI both internally and externally
Leveraging its strength in CNS and oncology, the group will continue to drive strategic investments in the two core therapeutic areas. It is actively seeking strategic opportunities in cutting-edge technologies and quality assets for innovation such as AI-enabled drug discovery and therapeutic mRNA vaccines for cancer. By applying AI across its value chain, the group is re-vamping value creation to build competitive CNS and oncology portfolios while exploring external growth opportunities driven by AI.
Advancing its pipelines of next-generation drugs
The group will focus on developing new molecules with the potential to become first-in-class or best-in-class new drugs in CNS and oncology. With core drug candidates entering key clinical trial phases one after another, the group is accelerating the transition of its pipelines from early-stage drug development to clinical trials. It hopes to unleash the value of those assets through global development activities and partnerships.
In CNS, the group is developing multiple new molecules in China and the U.S. For example, LY03015 (VMAT2/Sigma-1R) is intended for the treatment of tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). In June 2026, the group reported positive data from a Phase 2 clinical trial of the drug in China. In the trial, LY03015 demonstrated robust efficacy across all three dose groups, showing a rapid and significant improvement of TD symptoms and a clear dose-response relationship. Notably, the Abnormal Involuntary Movement Scale (AIMS) response rate, defined as the proportion of patients achieving a ≥50% improvement in AIMS Items 1-7, reached 76.5% in the 20 mg dose group. This result was nearly twice the response rates reported in publicly available historical data from double-blind, placebo-controlled registrational trials of existing first-line therapies. A bridging study of LY03015 has been successfully completed in the U.S., and the plan for Phase 3 clinical trials of the drug to be conducted in China and the U.S. will be confirmed in Q4 2026.
In addition to LY03015, the group also has several other investigational CNS drugs undergoing clinical trials. Among them, LY03017, a next-generation 5-HT2AR inverse agonist/5-HT2CR antagonist, is undergoing a Phase 2 clinical trial in China for the treatment of Alzheimer's disease psychosis (ADP); and LY03020, the world's first dual-target agonist against TAAR1/5-HT2CR, is also undergoing a Phase 2 clinical trial in China for the treatment of schizophrenia.
In oncology, the group, through its subsidiary Boan Biotech, is building pipelines of the next-generation bispecific/multispecific immuno-oncology (IO) drugs and antibody-drug conjugates (ADCs). One key asset in the pipelines is BA1302, the world's only anti-CD228 ADC currently under clinical development. In China, the Phase 1a, dose-escalation clinical trial of BA1302 as a monotherapy has been completed, and the Phase 1b, dose-expansion clinical trial of it will begin soon. It has also received clearance from the FDA for clinical trials in the U.S. BA1203, another asset in the pipelines, is an anti-PD-1/IL-2 antibody-cytokine fusion protein and the world's only anti-PD-1/IL-2 molecule featuring high-activity IL-2α receptor engagement, a masked design, and PD-1 blocking functionality. Its Investigational New Drug (IND) application has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). In addition, BA1106, China's first innovative non-IL-2-blocking anti-CD25 antibody to undergo clinical development for the treatment of solid tumors, has been approved by the CDE for a Phase 2 clinical trial, which is designed to evaluate the drug candidate in combination with Boan Biotech's proprietary PD-1 inhibitor BA1104 as a first-line or a second-line treatment for non-small cell lung cancer.
The group is also working on therapeutic mRNA vaccines. LY01620, an mRNA vaccine candidate under development for the treatment of cervical precancerous lesions and HPV-associated tumors, has achieved positive results from a Phase 1 clinical trial in China and is expected to undergo a Phase 2 clinical trial in China soon.
The group has obtained end-to-end capabilities for delivering innovative CNS drugs after many years in this therapeutic area, which can be proved by the ongoing ramp-up of core products both in China and abroad. Going forward, the group will continue to focus on CNS and oncology in parallel, to cement its existing competitive edge while expanding its portfolios of innovative products, creating new growth curves, and building a better and more sustainable future.
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 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 in two categories: new chemical entities and antibodies. From 2021 to 2025, the company has had a total of 15 new drugs approved for marketing, with each of them in one or multiple countries such as the U.S., several European countries, Japan, and China.
Luye Pharma has 8 manufacturing facilities worldwide, which follow the internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched nearly 50 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, and also including fast-growing emerging markets.