Gelonghui, September 3 | Shandong Xinhua Pharmaceutical Co., Ltd. (00719.HK) announced that recently, the company received the “Drug Supplement Application Approval Notice” for pentoxifylline injection (hereinafter referred to as “this product”) from the State Drug Administration to approve the supplementary transfer application from the marketing license holder of this product. The relevant information is now announced as follows:

I. Basic situation

Drug name: Pentoxifylline Injection

Dosage form: injections

Specification: 5ml: 0.1g

Drug Classification: Prescription Drugs

Registration category: Chemical drug category 3

Applicant: Shandong Xinhua Pharmaceutical Co., Ltd

Application matters: Change of listing license holder

Acceptance number: CYHB2401223

Drug Approval Number: Sinopharm Standard H20243881

Notification No.: 2024B03985

Approval conclusion: According to the “Drug Administration Law of the People's Republic of China” and related regulations, after review, the application for this product met the relevant requirements for drug registration, and it was agreed to approve the change of marketing license holder for this product in accordance with the relevant provisions of the “Administrative Measures on Changes After Drug Marketing (Trial)”.