SHANDONG XINHUA - Overseas Regulatory Announcement-Announcement on Obtaining the Notice of Approval for Drug Clinical Trials

山東新華製藥股份有限公司

ShandongXinhuaPharmaceuticalCompanyLimited

(ajointstockcompanyestablishedinthePeople'sRepublicofChinawithlimitedliability)

(StockCode:00719)

OVERSEASREGULATORYANNOUNCEMENT

Thisoverseas regulatoryannouncement is made pursuanttoRule13.10Bof theRules Governingthe Listing ofSecuritiesonTheStockExchangeofHongKongLimited.

Shandong Xinhua Pharmaceutical Company Limited (the "Company") will publish the "Announcement on obtainingtheNotice of Approval forDrugClinicalTrials" onCNINFO http://www.cninfo.com.cn (巨潮資訊網) on 23 June 2026. The English translation of the relevant document is hereby included for reference. If there is any inconsistency between the English version and the Chinese version, the Chinese version shall prevail.

ByOrderoftheBoard

ShandongXinhuaPharmaceuticalCompanyLimited HeTongqing

Chairman

22June2026,Zibo,thePeople'sRepublicofChina

Asatthedateofthisannouncement,theboardofdirectorsoftheCompanycomprises:

ExecutiveDirectors: IndependentNon-executiveDirectors:

Mr.HeTongqing(Chairman) Mr.PanGuangcheng

Mr.XuWenhui Mr.ZhuJianwei

Mr.HouNing Mr.LingPeixue

Ms.CheungChingChing,Daisy

Non-executiveDirectors:

Mr.ZhangChengyong

StockCode:000756 StockShortName:XinhuaPharmaceutical AnnouncementNo.:2026-32

ShandongXinhuaPharmaceuticalCompanyLimited

AnnouncementonobtainingtheNoticeofApprovalforDrugClinicalTrials

The Company and its board of directors confirm that the contents of this announcement are true, accurate and completewithoutanyfalseinformation,misleadingstatementsormaterialomissions.

Shandong Xinhua Pharmaceutical Company Limited (hereinafter referred to as "Xinhua Pharmaceutical" or the "Company") has recently received the Notice of Approval for Drug Clinical Trials in connection with its LXH-2103 injection (hereinafter referred to as, the "Product") approved and issued by the National Medical ProductsAdministration.Relevantinformationisnowannouncedasfollows:

I. Basicinformation

Drugname: LXH-2103injection

Dosageform: Injection

Specifications: 1ml:50mg

Drugcategory: Prescriptiondrugs

Registeredclassification: Class1chemicaldrug

Applicant: ShandongXinhuaPharmaceuticalCompanyLimited

Applicationmatter: Drugregistration(Clinicaltrials)

Casenumber: CXHL2600424

Notificationnumber: 2026LP01818

Reviewconclusion: In accordance with the Pharmaceutical Administration Law of the People'sRepublicofChina(中华人民共和国药品管理法)andrelevant regulations, upon review, the application for clinical trial of the LXH- 2103 injection accepted on 9 April 2026 meets the relevant requirements for drug registration and it is agreed that clinical trials for

thetreatmentofmoderatetoseverepostoperativepainmayproceed.

II. Otherrelevantinformation

InNovember2025,XinhuaPharmaceuticalsubmittedanapplicationtotheCenterforDrugEvaluation(CDE)of the National Medical Products Administration for a consultation meeting concerning clinical trials for the Product.In March2026, CDE provided feedback onthe issues submitted for discussion, andin the same month, the Company submitted an application for clinical trials in connection with the Product, which application was accepted in April. In June 2026, the Notice of Approval for Drug Clinical Trials was obtained, with the review concludingthatapprovalwasgrantedfortheclinicaltrialstoproceed.

LXH-2103 injection is a Class 1 innovative drug developed by Xinhua Pharmaceutical for the treatment of moderate to severe postoperative pain. As a novel analgesic, it is designed to resolve interindividual differences in the efficacy and safety of conventional opioids (such as hydrocodone, codeine and tramadol) arising from CYP2D6 genetic polymorphism. Studies have shown that LXH-2103 functions as a biased mu-opioid receptor (MOR) agonist. This property allows the Product to bypass the influence of CYP2D6 genetic polymorphism whileofferingsignificantanalgesicpotentialandasuperiorsafetyprofile.

Ⅲ. Riskwarning

The Company will conduct clinical trials in strict accordance with the requirements as specified in the approval document. Upon the completion of clinical trials, the Company will submit a clinical trial report and relevant documentstotheNationalMedicalProductsAdministrationtoapplyforproductionregistrationapproval.

The research anddevelopment of pharmaceutical products (including clinical trials), andthe whole process from registrationapplicationtoindustrial production(involvinga lengthycycle withmultiple stages),may be affected by various uncertainties including, without limitation, technical issues and review procedures, and the competitivelandscapeoffutureproductsmayalsoevolve.TheCompanywillcloselymonitortheactualprogress of the drug registration application in connection with the Product and fulfil its information disclosure obligationsina timelymanner.Investors areremindedtomake rationalinvestment decisionsandpayattentionto investmentrisks.

ByOrderoftheBoard

ShandongXinhuaPharmaceuticalCompany Limited

22June2026