About Us

Genuine Biotech

Genuine Biotech is an innovation- and R&D-driven biotech company dedicated to the development, manufacturing and commercialization of novel drugs for the treatment of viral infections, oncological and cardio-cerebrovascular diseases. The company’s mission is to improve human health through genuine innovation, with a particular focus on the antiviral and anti-tumor fields, and to explore and address drug resistance in existing treatment options. The company aims to find new and better treatment options to address unmet medical needs.

Leveraging the advanced technology platform and strong R&D capabilities, the company has built a broad and competitive product pipeline, especially in the field of antiviral and anti-tumor drugs. The Core Product, azvudine, a Class 1.1 innovative drug, was conditionally approved by the NMPA for the treatment of HIV infection and COVID-19 in July 2021 and July 2022, respectively. Azvudine was the first NMPA-approved oral antiviral treatment for COVID-19 developed by a Chinese company, demonstrating outstanding efficacy in treating viral infections. With its unique dual target mechanism of action, azvudine has become the world's first HIV infection treatment option for the dual-targeted inhibition of nucleoside reverse transcriptase and the Vif inhibitor. The company is also continuously expanding its applications into new indications and combination treatment.


Industrial layout

R&D

Shenzhen, Shanghai R&D subsidiary

Highly selective novel nucleoside broad-spectrum anti-tumor drug R&D platform
Innovative drug design and optimization platform
TOPO1 inhibitor and XDC drug R&D platform
Drug target discovery and validation platform

Pingdingshan research institute

Henan Modern Pharmaceutical Industry Research Institute
Fundamental research laboratory

Operation

Pingdingshan

Registered place
Manufacturing site

Beijing

Clinical management
Submission for registration approval
Marketing management

Shenzhen

Capital operation center
Securities affairs management
Branding and PR

Development history

• Henan Genuine Biotech Co., Ltd. was founded in 2012.

2012

• Submitted IND clinical trial application for Azvudine for the treatment of HIV infection.

• Received approval granted by the NMPA to conduct Phase I clinical trials of Azvudine for the treatment of HIV infection in China.

2013

• Commenced Phase I clinical trials of Azvudine for the treatment of HIV infection in China.

2014

• Completed Phase I clinical trials of Azvudine for the treatment of HIV infection in China.

• Received approval granted by the NMPA to conduct Phase II clinical trials of Azvudine for the treatment of HIV infection in China.

2015

• Commenced Phase II clinical trials of Azvudine for the treatment of HIV infection in China.

2017

• Completed Phase II clinical trials of Azvudine for the treatment of HIV infection in China.

2019

• Established Shenzhen Genuine Biotech Co., Ltd.

• Received approval granted by the NMPA to conduct Phase I/II clinical trials of dosimertinib for the treatment of advanced EGFR mutation-positive non-small cell lung cancer in China.

• Received approval granted by the NMPA to conduct Phase III clinical trials of Azvudine for the treatment of COVID-19 and commenced the Phase III clinical trial.

2020

• Authorized Beijing Union to submit an IND application to the Ministry of Health of the Russian Federation for initiating a Phase III clinical trial of azvudine for treating COVID-19 in Russia and received approval in January 2021 and commenced the Phase III clinical trial in June 2021.

• Completed the Series A Investment and raised approximately RMB 149.5 million.

• Obtained a conditional approval for Azvudine from the NMPA for treating HIV infection in China.

2021

• Completed the Phase III clinical trial for azvudine for the treatment of COVID-19 in China.

• Completed the Series B Investment and raised approximately RMB 563.3 million.

• Obtained a conditional approval for indication expansion of Azvudine from the NMPA for treating common COVID-19 in adults in China.

• Entered into a strategic cooperation agreement with Fosun Pharmaceutical Industrial and launched the commercial sales of azvudine for the treatment of COVID-19 in China.

• Azvudine became the only domestic oral drug for the treatment of COVID-19 that has been listed in the Diagnosis and Treatment Plan for COVID-19 Infection.

• Initiated the Phase III clinical trial of azvudine for the treatment of HIV infection.

• Received IND approval from the NMPA for CL-197 for the treatment of HIV infection.

2022

• Azvudine has been listed in the National Reimbursement Drug List of China published by NHSA.

• Commenced the Phase I clinical trial of CL-197 for the treatment of HIV infection in China.

2023

• The terminal sales of azvudine exceeded 10 million bottles and azvudine became one of the top-selling drugs for treating COVID-19 worldwide.

• Completed an investigator-initiated open-label clinical trial of azvudine to evaluate its efficacy and safety for the treatment of various late-stage solid tumors, including, among others, NSCLC, liver cancer and colorectal cancer.

• Obtained the IND approval from the NMPA for the clinical trials of azvudine in patients with advanced solid tumors.

• Regained the complete commercialization right over azvudine for the treatment of COVID-19 and HIV infection in the PRC through an amendment agreement entered into with Fosun Pharmaceutical Industrial.

• Completed the NRDL renewal regarding azvudine, with the scope and price of payment remaining unchanged.

• Submitted IND application for the combination therapy of azvudine and dosimertinib for the treatment of NSCLC.

• The 240 mg dose group of the clinical trial of single-drug dosimertinib therapy showed significant efficacy and non-target lesions disappeared in the tested subjects.

2024

• Initiated Phase I clinical trial of azvudine in patients with advanced solid tumors in the PRC with three patients enrolled as of February, 2025.

• Submitted a communication application to the CDE for the conversion of the conditional approval for the COVID-19 indication to full approval.

2025

Leadership team

  • Core Leadership Team

Dr. Du Jinfa

Executive Director, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer

Dr. Dang Qun

Executive Director, President, and Chief Business Officer

Dr. Luo Feng

Senior Vice President, Chief Development Officer

Dr. Guo Chang Yue

Vice President

Dr. Li Pan

Vice President

Wang Lin

Executive Director and head of our Board office

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  • Corporate Mission

  • IMPROVE HUMAN HEALTH

    THROUGH GENUINE INNOVATION

  • Corporate Vision

    Driven by innovation and committed to becoming an globally competitive biopharmaceutical company

  • Core Values

    Pragmatic  Innovative  Pioneering  Responsible