Shanghai, China, November 24th, 2025 — Luye Pharma Group announced today that its next-generation serotonin 2A receptor (5-HT2AR) inverse agonist and serotonin 2C receptor (5-HT2CR) antagonist has received clearance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate clinical trials in the United States. Code-named LY03017, this innovative drug is intended to treat Alzheimer’s disease psychosis (ADP), Parkinson’s disease psychosis (PDP), and the negative symptoms of schizophrenia (NSS). FDA has exempted the single ascending dose (SAD) trial in the Phase I clinical trial of LY03017, and the drug can directly proceed to the multiple ascending dose (MAD) trial and subsequent clinical trials. Developed simultaneously in China and the U.S. on the company’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03017 is another innovative drug of Luye Pharma for treating central nervous system (CNS) diseases. The drug is undergoing a Phase I clinical trial in China. Globally there are large numbers of patients with ADP, PDP, and NSS. Specifically, there are about 45 million people with Alzheimer’s disease worldwide, of which 25–50% will develop psychotic symptoms at some point during the course of their illness; Parkinson’s disease affects more than 8.5 million individuals globally, and the lifetime prevalence of psychosis in them is approximately 60%; , and schizophrenia affects approximately 23 million people, with an estimated 60% of them having NSS. , Currently, there is only one drug approved by the FDA for the treatment of PDP, which is not yet approved in China; globally there are no drugs approved for treating ADP; and only a few drugs are effective in treating NSS, with efficacy unsatisfactory. There is an urgent need for developing new therapies against the three indications above. LY03017 is a next-generation, dual-targeted investigational drug that acts as a 5-HT2AR inverse agonist and a 5-HT2CR antagonist. By inhibiting dopamine release in the ventral striatum and enhancing dopamine release in the prefrontal cortex, LY03017 has the potential to address hallucinations and delusions in patients with PDP and ADP while improving NSS as well. In preclinical studies, LY03017 demonstrated a higher pharmacological activity, a better tissue distribution, and a higher level of cardiac safety both in vitro and in vivo than existing commercially available or investigational therapies for the same indications. Dr. Tian Jingwei, Executive Vice President of R&D at Luye Pharma Group, said: “There is a huge need for treatments in patients with ADP, PDP, and NSS, but the existing treatment options are very limited. We are developing new drugs to address this need. LY03017 is intended to be such a drug for treating ADP. Hopefully it can also become a better option for patients with PDP and NSS.” CNS is a key strategic focus for Luye Pharma. The company has built a differentiated portfolio of innovative therapies for multiple CNS diseases such as major depressive disorder, schizophrenia, bipolar disorder, and Alzheimer's disease, including Erzofri® (paliperidone palmitate) extended-release injectable suspension and Rykindo® (risperidone) for extended-release injectable suspension, both approved for marketing in the U.S.; Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in multiple European countries, Japan, and China; and Ruoxinlin® (toludesvenlafaxine hydrochloride sustained-release tablets) and Jinyouping® (rotigotine microspheres for injection), both approved for marketing in China. In addition, Luye Pharma is also conducting clinical studies for several other next-generation investigational drugs, including LY03015, which targets VMAT2/Sigma-1R; LY03020, which targets TAAR1/5-HT2CR; and LY03021, which targets NET/DAT/GABAAR. 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 in two categories: new chemical entities and antibodies. From 2021 to 2025, the company has had a total of 14 new drugs approved for marketing 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 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, and also including fast-growing emerging markets.

November 24,2025