/SHANDONG XINHUA - Overseas Regulatory Announcement-Announcement on the Ibuprofen Granules of Subsidiary Having Obtained the Drug Registration Certificate
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SHANDONG XINHUA - Overseas Regulatory Announcement-Announcement on the Ibuprofen Granules of Subsidiary Having Obtained the Drug Registration Certificate

HKEXnews
2026/03/23[Overseas Regulatory Announcement - Other]

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 the Ibuprofen Granules of subsidiary having obtained the Drug Registration Certificate" on CNINFO

http://www.cninfo.com.cn (巨潮資訊網) on 24 March 2026. The English translation of the relevant

document is hereby included for reference. If there is any inconsistency between the English version and the Chineseversion,theChineseversionshallprevail.

ByOrderoftheBoard

ShandongXinhuaPharmaceuticalCompanyLimited HeTongqing

Chairman

23March2026,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.XuLie

Mr.ZhangChengyong

StockCode:000756 StockShortName:XinhuaPharmaceutical AnnouncementNo.:2026-08

ShandongXinhuaPharmaceuticalCompanyLimited

AnnouncementontheIbuprofenGranulesofsubsidiaryhavingobtained

theDrugRegistrationCertificate

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

Shandong Zibo Xincat Pharmaceutical Company Limited (hereinafter referred to as "Xincat Pharmaceutical"), a wholly-owned subsidiary of Shandong Xinhua Pharmaceutical Company Limited (the "Company"), has recently received the Drug Registration Certificate (药品注册证书) in connection with its Ibuprofen Granules (hereinafterreferredtoas the "Product")approvedandissuedbytheNationalMedicalProducts Administration. Relevantinformationisnowannouncedasfollows:

I. Basicinformation

Drugname: IbuprofenGranules

Dosageform: Granules

Specifications: 0.2g

Drugcategory: Over-the-counterdrug

Registeredclassification: Class3chemicals

Applicant: ShandongZiboXincatPharmaceuticalCompanyLimited

Applicationmatter: Drugregistration(Domesticproduction)

Casenumber: CYHS2303506

Drugapprovalnumber: NationalMedicineZhunzi (国药准字)H20263621

Notificationnumber: 2026S00744

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 Product conforms with the applicable requirements of drug registration, the drug registration is approved and the Drug Registration Certificate has been issued. It is approved that this product shall be administered as (class A) over-the-counter drug. The standard of quality, product instructions, labels as well as production processes concerning the Product shall be consummated in accordance with relevant documentation. Pharmaceutical production enterprises are required to meet requirements of pharmaceutical production quality management standards prior to the production and saleofdrugs.

II. Otherrelevantinformation

In December 2023, Xincat Pharmaceutical submitted application materials to the Center for Drug Evaluation of the State Drug Administration (药品审评中心) (CDE) concerning the marketing of Ibuprofen granules and the application materials were accepted. In March 2026, Xincat Pharmaceutical obtained the Drug Registration Certificate,andthereviewconclusionwasthattheProductshallbeapprovedforregistration.

Ibuprofenisusedtorelievemildtomoderatepainsuchasheadache,arthralgia,migraine,toothache,musclepain, neuralgia,anddysmenorrhea.Itcanalsobeusedtotreatfevercausedbycommoncoldorinfluenza.

Ibuprofen granules is listed in the "National Drug Catalogue for Basic Medical Insurance, Work Related-Injury Insurance,andMaternityInsurance(2025)"asaCategoryBproduct.Accordingtorelevantstatistics,thesalesof IbuprofengranulesinChina'spublicmedicalinstitutionsamountedtoapproximatelyRMB4.4billionin2024.

III. ImpactontheCompanyandriskwarning

The approval of the above-mentioned products has further enriched the Company's Ibuprofen dosage forms, providingpatientswithmoremedicationoptions.

The pharmaceutical sales business is susceptible to changes in domestic pharmaceutical industry policies, bidding and procurement processes, changes in the market environment and other factors, and is subject to uncertainty.Investorsareadvisedtoinvestsensiblyandpayattentiontoinvestmentrisks.

ByOrderoftheBoard

ShandongXinhuaPharmaceutical

CompanyLimited

23March2026