/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]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