- New Product Sales Up 32%, International Strategy Upgraded -

Shanghai, August 28, 2025 -- Luye Pharma Group (2186.HK) today announced its 2025 half-year results and latest developments. During the reporting period, its revenue was about RMB 3181 million, up 3.5% YoY, its EBITDA was about RMB 1204 million, up 4.2% YoY, and its net profit attributable to the parent company was RMB 313 million.

Upgrading international strategy driven by “in-house + BD” operations

As a global pharmaceutical company developing, producing and selling innovative medications, Luye Pharma now operates across more than 80 countries and regions, with a portfolio spanning multiple therapeutic areas including oncology, the Central Nervous System (CNS), and cardiovascular diseases. The group has successfully upgraded its international strategy for innovation from Version 1.0 (driven by overseas M&A) to Version 2.0 (driven by self-expansion). It is now accelerating the transition towards Version 3.0 of the strategy driven by “in-house + BD” operations. 

With the approval of the ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for marketing in the U.S., Luye Pharma set a precedent for a Chinese company to launch an in-house developed new CNS drug abroad all on its own. And with its acquisition of the transdermal patch business as well as the assets and rights of Seroquel® and Seroquel XR® (quetiapine fumarate, immediate and extended-release formulations) in 51 countries and regions, the group has built a global commercial system, marking the iteration from Strategy 1.0 to Strategy 2.0. In particular, the successful launch of ERZOFRI in the U.S. marked the continuous improvement of this global commercial system and the enhancement of the group’s competitive edge in CNS.

Looking ahead, as Strategy 2.0 is gaining momentum, the group will accelerate the commercialization of high-quality candidates in its pipeline by building high-value partnerships. This will allow the group to move towards Strategy 3.0 and build a unique competitive edge globally. 

Growing contribution of new products to sales

CNS and oncology are two high-potential areas for Luye Pharma where it has unleashed the first wave of new product launches. During the reporting period, several new products got off to a good start with a growing contribution to sales. Their sales recorded a 32% growth, helping to drive growth in the two core therapeutic areas. 

5.4% growth in CNS driven by new flagship products:

• Since its launch in the U.S. this April, the commercialization of ERZOFRI has been progressing smoothly. The product was also featured at the 2025 American Psychiatric Association (APA) Annual Meeting, catching a lot of attention from the international academic community.
• During its first half-year reporting period after being included in the new edition of China’s National Reimbursement Drug List (NRDL), Ruoxinlin® (toludesvenlafaxine hydrochloride extended-release tablets), an antidepressant designated as a Class 1 new drug in China, recorded a more than fourfold YoY growth in sales volume, significantly boosting its market share. Its New Drug Application (NDA) for the treatment of generalized anxiety disorder in China is expected to be submitted by the end of this year.
• The group’s transdermal patch products are being made available in many more global markets. During the reporting period, the group’s Rivastigmine Twice Weekly Transdermal Patch and Rotigotine Transdermal Patch were launched in Japan and the U.K. respectively.

 

13.5% growth in oncology driven by new product launches:

• Baituowei® (goserelin microspheres for injection), the only microsphere formulation of goserelin approved for marketing in the world, recorded a YoY sales growth of over 3 times in the reporting period. The drug has been covered by the new NRDL for all of its approved indications. The drug’s increased accessibility to patients is driving the accelerated unleashing of the demand for it. 
• In April 2025, Zepzelca® (lurbinectedin), the only new chemical entity approved by the U.S. FDA for the treatment of relapsed Small Cell Lung Cancer (SCLC) in almost 28 years, was launched in the Chinese mainland. The drug saw a significant sales growth driven by huge unmet needs.

The first wave of product launches followed by accelerated R&D

Since 2021, Luye Pharma has had 10-plus 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. In this year alone, the group has had two products approved for marketing: its Rivastigmine Twice Weekly Transdermal Patch was approved for launch in Japan, which was the first extended-release transdermal formulation of Rivastigmine approved for launch in Japan; and its Boyouping® (Dulaglutide Injection) was approved for marketing in China, which was the first locally developed dulaglutide injection approved for marketing in China. In addition, the group also has several other investigational drugs under review for their NDA or undergoing late-stage clinical development, which will further drive the group’s growth once launched. 

Following the first wave of product launches, the group is looking to develop the next-generation blockbusters in its core therapeutic areas. At the same time, it is actively talking with several potential partners, including multinational pharmaceutical companies, to unleash the value of innovation to the maximum extent possible.

On the one hand, the group is developing small-molecule investigational drugs building on its competitive edge in CNS: 

 

LY03015

• This is a next-generation VMAT2 inhibitor/Sigma-1 receptor agonist filed under China’s Class 1 pathway for new drugs.
• It's intended to treat tardive dyskinesia and Huntington's disease.
• The drug is currently undergoing a Phase 2 clinical trial in China, which is expected to be completed by the end of 2025 and deliver the data on efficacy in the first half of 2026.
• It's been cleared by the U.S. FDA for clinical trials.

LY03017

• This is a 5-HT2AR inverse agonist/5-HT2CR antagonist filed under China’s Class 1 pathway for new drugs.
• It's intended to treat Parkinson’s psychosis, Alzheimer’s psychosis, and negative symptoms of schizophrenia.
• It's currently undergoing a Phase 1 clinical trial in China expected to be completed by the end of 2025.
• Its IND is expected to be approved by the U.S. FDA in Q3 2025.

LY03020

• This is the world's first TAAR1/5-HT2CR agonist filed under China’s Class 1 pathway for new drugs.
• It's intended to treat schizophrenia and Alzheimer’s psychosis.
• It's currently undergoing a Phase 1 clinical trial in China expected to be completed in Q1 2026.
• It's been cleared by the U.S. FDA for clinical trials.

LY03021

• This is a GABAAR PAM/NET/DAT inhibitor filed under China's Class 1 pathway for new drugs.
• It's intended for treating Major Depressive Disorder with a novel triple-target mechanism of action.
• It's currently undergoing a Phase 1 clinical trial in China.
• On the other hand, the group is developing innovative biologics via its subsidiary Boan Biotech. 

BA1106

• This is a non-IL-2 blocking anti-CD25 antibody.
• It’s the first innovative anti-CD25 antibody to undergo clinical trials in China for the treatment of solid tumors.
• It’s currently undergoing a Phase 1 clinical trial in China, with the dose-escalation part of the trial used in combination with a PD-1 inhibitor expected to be completed this year. 
• The early results of the Phase 1 clinical trial were presented at this year’s annual meeting of the American Association for Cancer Research.

BA1302

• This is the first innovative anti-CD228 antibody-drug conjugate (ADC) undergoing a clinical trial in China.
• The dose-escalation part of the Phase 1 clinical trial in China with the drug as a monotherapy is expected to be completed this year.
• It’s been granted an Orphan Drug Designation (ODD) by the U.S. FDA for treating squamous non-small cell lung cancer and pancreatic cancer. 

BA1301

• This is an anti-Claudin18.2 ADC.
• It's currently undergoing a Phase 1 clinical trial in China, with the dose-expansion part of the trial using the drug as a monotherapy expected to be completed this year. 
• It's been granted an ODD by the U.S. FDA for the treatment of gastric cancer and pancreatic cancer.
• Interim results of the trial will be presented at this year’s annual meeting of the European Society for Medical Oncology.

The group also has other innovative antibodies expected to enter the clinical development stage soon, including BA1304 (a bispecific ADC targeting EGFR and B7-H3), PR201 (an antibody-cytokine fusion protein targeting PD-1 and IL-2), and PR203 (a bispecific antibody targeting TL1A and IL23).

The management of Luye Pharma Group, said: “We had several new products gaining momentum in the reporting period. Although still early, they have become our new growth drivers. This, plus our commercial efforts in the U.S., allows us to believe that we are on track for fast growth with growing contribution from our new products to sales. Meanwhile, we are also building a high-value pipeline and new global partnerships. While unleashing the value of innovation for us, this will also enable us to deepen our international strategy for innovation, better serve patients around the world, and deliver sustainable long-term returns for our investors.”