Genuine Biotech Recognized as "Drug, Device, and Cosmetic Enterprise with Outstanding Performance in Drug, Device, and Cosmetic Adverse Reaction Monitoring and Evaluation in 2025"

Recently, the National Center for ADR Monitoring issued the "Announcement on Commending the Entities with Outstanding Performance in National Drug, Device, and Cosmetic Adverse Reaction Monitoring and Evaluation in 2025", and Genuine Biotech was rated as a "Drug, Device, and Cosmetic Enterprise with Outstanding Performance in Drug, Device, and Cosmetic Adverse Reaction Monitoring and Evaluation in 2025".

This honor is not only a high recognition of the achievements made in the construction of the pharmacovigilance system of Genuine Biotech, but also an authoritative affirmation of the company's long-term commitment to drug safety and the effective fulfillment of corporate responsibilities.

Adverse drug reactions‌ refer to the harmful reactions that occur under normal usage and dosage of qualified drugs and are not related to the purpose of medication. Drug, device, and cosmetic adverse reaction monitoring refers to the whole-process management mechanism for systematic collection, reporting, analysis, evaluation, and risk control of adverse reactions or adverse events that may occur during the normal use of drugs, medical devices, and cosmetics, aiming to timely discover potential safety risks and ensure public health. The registrant/filing entity should assume the main responsibilities, and establish a monitoring system to actively collect and report adverse reactions, and conduct analysis and evaluation. The manufacturer is responsible for the safety management of the whole life cycle of the product, and should take measures such as recall and revision of the package insert after risks are found.

As a biopharmaceutical enterprise that has obtained conditional marketing approval for its drugs and is innovation-driven, Genuine Biotech consistently bears in mind its social responsibilities while deeply engaging in R&D. The company always regards pharmacovigilance as the core work of drug safety, builds a pharmacovigilance system covering the whole life cycle of drugs with high standards, establishes a risk monitoring mechanism from the R&D stage to the post-marketing stage of drugs, and realizes the rapid collection and scientific evaluation of drug safety information. The company has set up a professional pharmacovigilance team, which strictly follows the national regulatory requirements, improves the whole-process specifications for risk monitoring, assessment, understanding, and control, efficiently carries out drug safety risk prevention and control, and protects and promotes public health.

Azvudine is a Class 1.1 innovative drug of Genuine Biotech with fully independent intellectual property rights. It was conditionally approved by the NMPA for the treatment of HIV-1 infection in Jul. 2021 and for the treatment of COVID-19 in Jul. 2022, becoming the first domestic oral anti-COVID-19 drug approved in China. Since being included in China's national medical insurance in 2023, Azvudine has covered more than 50,000 medical terminals in 31 provinces and cities across China, with cumulative sales of more than 10 million bottles.

In the future, Genuine Biotech will continue to improve its pharmacovigilance system, building a solid foundation for safety in innovation and safeguarding public health.