Shandong Xinhua Pharmaceutical Company Limited has received the Drug Registration Certificate of alogliptin benzoate tablets approved and issued by the National Medical Products Administration. Relevant information is now announced as follows: Drug Name: Alogliptin Benzoate Tablets Dosage form: Tablet Specifications: 25mg12.5mg Drug Category: Prescription Drugs Registered classification: Class 4 chemicals Applicant: Shandong Xinhua Pharmaceutical Company Limited Application Matter: Drug registration (Domestic production) Reception Number: CYHS2200419GuoCYHS2200420Guo Original drug approval number: Guoyao Zhunzi () H20234021H20234022 Notification number:2023S012522023S01253. Approval Conclusion: According to the Pharmaceutical Administration Law of the People's Republic of China and relevant regulations, the Product conforms to the relevant requirements of drug registration upon examination.

As such, the drug registration certificate will be issued. In March 2022, Xinhua Pharmaceutical submitted the registration application materials for the marketing of alogliptin benzoate tablets for domestic production to the Center for Drug Evaluation of the State Drug Administration (the "CDE") () and was accepted. In August 2023, the Company obtained the Drug Registration Certificate (), which concluded that the registration was approved.

The Product is suitable for the treatment of type 2 diabetes. Single drug treatment: As an auxiliary treatment for diet control and exercise, the Product is used to improve blood sugar control in patients with type 2 diabetes. Use in combination with Metformin hydrochloride: When Metformin hydrochloride alone cannot effectively control blood sugar, the Product can be used in combination with Metformin hydrochloride to improve blood sugar control in patients with type 2 diabetes on the basis of diet and exercise.

The Product is used to treat type 2 diabetes, and it belongs to the category B variety of the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2022 Edition)"((2022)). According to relevant statistics, the sales of alogliptin related preparations in the global was about $696 million in 2021, the sales of alogliptin related preparations of public medical institutions in China was about RMB 270 million in 2022. Xinhua Pharmaceutical's alogliptin benzoate tablet has obtained the Drug Registration Certificate in August 2023, which is conducive to enriching the Company's product series and providing more drug choices for diabetes patients.

The pharmaceutical sales business is susceptible to changes in domestic pharmaceutical industry policies, bidding and procurement, changes in the market environment and other factors, and is subject to uncertainty. Investors are advised to invest rationally and pay attention to investment risks.