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/LIVZON PHARMA - VOLUNTARY ANNOUNCEMENT THE NOTICE OF DRUG CLINICAL TRIAL APPROVAL OF BREXPIPRAZOLE MICROSPHERES
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LIVZON PHARMA - VOLUNTARY ANNOUNCEMENT THE NOTICE OF DRUG CLINICAL TRIAL APPROVAL OF BREXPIPRAZOLE MICROSPHERES

HKEXnews
2026/03/26[Other - Business Update]
schizophreniainadults.Detailsareasfollows: BASICINFORMATIONABOUTTHEDRUG Drugname:BrexpiprazoleMicrospheresforInjection Dosageform:Injection Registrationclassification:Class2.2modifiednewchemicaldrug Appliedindication:Forthetreatmentofschizophreniainadults Approval conclusion: In accordance with the Drug Administration Law of the People's Republic ofChina(《中華人民共和國藥品管理法》)andrelatedregulations,uponreview,theapplication for Brexpiprazole Microspheres for Injection accepted on 7 January 2026 complies with relevant requirements for drug registration. Approval is granted to conduct clinical trials for the treatment ofschizophreniainadults. DRUGDEVELOPMENTANDRELATEDCONDITIONS Brexpiprazole Microspheres for Injection is a sustained-release microsphere formulation independently developed by the Company, and is a new generation treatment for schizophrenia. This product exerts its therapeutic effects through partial agonism of dopamine D2 and 5-HT1A receptors and antagonism of norepinephrine receptors, demonstrating superior performance on multiplesafetyindicatorscomparedtootherdrugsofthesamegeneration. This product employs a long-acting sustained-release design, with a proposed dosing regimen of once-monthly intramuscular injection, which may improve patient medication adherence, reduce relapse risk, address the clinical challenges of low treatment adherence and high relapse rates in schizophreniapatients,andmeettheneedsforlong-termmaintenancetherapy. Currently, oral brexpiprazole formulations have been approved globally for multiple psychiatric indications, while no brexpiprazole long-acting formulation has been approved for marketing. Thisproductisamodifiednewdrugdevelopedtofillthisclinicalgap. As at the date of this announcement, the cumulative direct research and development expenses incurred for Brexpiprazole Microspheres for Injection amount to approximately RMB 7.5264 million. MARKETSITUATIONOFDRUG AccordingtothewebsiteoftheCenterforDrugEvaluation(CDE)ofNMPA,asatthedateofthis announcement, no brexpiprazole long-acting formulation has been approved for marketing in China. RISKWARNING In accordance with the relevant laws and regulations governing drug registration in China, following the receipt of the Notice of Drug Clinical Trial Approval, the drug is still required to undergo clinical trials and must be subject to review and approval by the NMPA before it can be manufactured and marketed. Due to the inherent nature of drug research and development, the progression from clinical trials to commercial production and market launch is a lengthy process involving multiple stages, and may be subject to various uncertainties. There are inherent uncertainties regarding the progress and outcomes of the clinical trials, as well as the future competitive landscape for the product. The Company will fulfill its information disclosure obligations in a timely manner based on the progress of research and development, and investors areadvisedtopayattentiontoinvestmentrisks. ByorderoftheBoard LivzonPharmaceuticalGroupInc.* 麗珠醫藥集團股份有限公司 LiuNing CompanySecretary Zhuhai,China 26March2026 Asatthedateofthisannouncement,theExecutiveDirectorsoftheCompanyareMr.Tang Yanggang(ViceChairman);theNon-ExecutiveDirectorsoftheCompanyareMr.ZhuBaoguo (Chairman),Mr.LinNanqiandMr.QiuQingfeng;theEmployeeRepresentativeDirectorisMs. RanYongmei;andtheIndependentNon-ExecutiveDirectorsoftheCompanyareMr.BaiHua,Mr. LuoHuiyuan,Ms.CuiLijieandMs.WangZhiyao. * Foridentificationpurposeonly