Shandong Xinhua Pharmaceutical Company Limited has recently received the Notice of Approval of Supplementary Drug Application from the National Medical Products Administration in relation to the approval of Rabeprazole Sodium Enteric-coated Tablets (20mg), which has approved the addition of 20mg specifications and passed the “Consistencyof Qualityand Efficacy Evaluation for Generic Drugs”. Relevant informationisnowannounced as follows: I. Basic information Drug Name: Rabeprazole Sodium Enteric-coated Tablets Dosage form: Tablets Specifications: 20mg Drug Category: Prescription Drugs Registered classification: Chemicals Applicant: Shandong Xinhua Pharmaceutical Company Limited Application Matter: Add specifications and apply for consistency evaluation of generic drug qualityandefficacy Acceptance Number: CYHB2250512 Original drug approval number: Guoyao Zhunzi H20237076 Notification number: 2023B03494 Approval Conclusion: The addition of 20mg specification and passed the consistency of quality andefficacyevaluation for generic drugs. In August 2022, Xinhua Pharmaceutical submitted registration materials to the Center for Drug Evaluationofthe State Drug Administration to apply for “Consistency of Quality and EfficacyEvaluationfor Generic Drugs” for the Product, the receipt of which was accepted.

In July 2023, the CompanyreceivedaSupplemental Drug Application Approval Notice, which approvedthat theaddition of 20mg specification as well as the evaluation for consistency of quality and efficacy of thegenericdrug. Rabeprazole sodium is a third-generation proton pump inhibitor used for the treatment of gastriculcers,duodenal ulcers, anastomotic ulcers, reflux esophagitis, and Zollinger Ellison syndrome. It is alsousedtoassist in eradicating Helicobacter pylori in patients with gastric or duodenal ulcers.

Rabeprazolesodiumenteric-coated tablets belongs to the category B variety of the “National Drug Catalog for BasicMedicalInsurance, Work-Related Injury Insurance and Maternity Insurance (2021 Edition)” (2021). According to relevant data, the sales of rabeprazole inurbanpublic hospitals in China reached RMB 3.33 billion in 2022, of which the sales in oral dosage forms reachedRMB 2.21 billion. The 10mg version of Xinhua Pharmaceutical’s rabeprazole sodium enteric-coated tablets has passedthe“Consistency of Quality and Efficacy Evaluation for Generic Drugs” in June 2023, and the above referstothe20mg version of the generic drug.

The active pharmaceutica ingredients (API) of the above two specificationsof the rabeprazole sodium enteric-coated tablets that passed the evaluation were self-producedbyXinhuaPharmaceutical. Xinhua Pharmaceutical's rabeprazole sodium enteric-coated tablets (specifications: 20mg) has passedthe“Consistency of Quality and Efficacy Evaluation for Generic Drugs” in July 2023, which will be beneficial toenrich the product series, strengthen its production capability, and enhance the competitiveness of theproductin the market. The pharmaceutical sales business is susceptible to changes in policies which affects the domesticpharmaceutical industry, bidding and procurement processses, changes in the market environment andotherfactors, and is subject to uncertainty.

Investors are advised to invest rationally and pay attention toinvestmentrisks.