About Us-GenuineBiotech-真实生物⎢ Improve Human Health Through Genuine Innovation

Genuine Biotech

Founded in 2012, Genuine Biotech Limited is a R&D-driven biotech company dedicated to the development, manufacturing, and commercialization of innovative drugs for the treatment of viral infection, tumors, and cerebrovascular disorders. Our mission is to improve human health through genuine innovation. Through steadfast pursuit of innovation, we aim to find newer and better treatment options to address unmet medical needs, with a particular focus on the antiviral field, and become a competitive biopharmaceutical company.

Leveraging our advanced technology platform and strong R&D capabilities, we have built broad and competitive product pipelines, especially in the field of antiviral drugs. Azvudine, our core product, is an innovative drug with broad-spectrum antiviral activity, which was conditionally approved by the NMPA for the treatment of HIV infection and COVID-19 in Jul. 2021 and Jul. 2022, respectively.

Industrial layout

R&D

Shenzhen R&D subsidiary

Nucleoside drug discovery platform
R&D of novel macromolecular drugs
ADC drug discovery and synthesis

Shanghai R&D subsidiary

FIC-BIC R&D of novel drugs
Computer-aided design platform
AI-aided R&D of novel drugs (external cooperation)
New ADC payload discovery

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
MAH management
Marketing management
Operation center

Shenzhen

Wholly owned subsidiary
Capital operation center
Securities affairs management

Development history

• The company was founded in 2012.

2012

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

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

2013

• Conducted 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.

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

2015

• Conducted 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. and Shenzhen R&D Center.

• 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.

• Approval granted by the NMPA to conduct Phase III clinical trials of Azvudine for the treatment of COVID-19.

2020

• The application for Phase III clinical trials of Azvudine for the treatment of COVID-19 in Russia and Brazil was approved, and clinical trials started in Jun. 2021.

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

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

2021

• Completed Phase III clinical trials of Azvudine for treating COVID-19 in China.

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

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

• Entered into a strategic cooperation agreement with Fosun Pharmaceutical Industrial.

• Azvudine tablets was the only domestic oral drug included in the Chinese Diagnosis and Treatment Guideline for COVID-19 (9th Edition).

• The IND application of CL-197, the next-generation oral long-acting HIV drug candidate, was approved by the NMPA.

2022

• Azvudine was approved for marketing by the Ministry of Health of the Russian Federation (registration certificate no.: ЛП-008750) and officially became a drug for the treatment of COVID-19 in Russia.

• Genuine Biotech jointly with Fosun Pharma donated 100 million yuan's worth of Azvudine to rural areas in Midwestern China, covering 180 counties.

• Azvudine was officially included in the national reimbursement drug list.

• Azvudine was included in the Chinese Diagnosis and Treatment Guideline for COVID-19 (Tentative 10th Edition).

2023

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