About Us

Genuine Biotech

Genuine Biotech is an innovation- and R&D-driven biotech company established in 2012, dedicated to the development, manufacturing and commercialization of novel drugs for the treatment of viral infections, oncological and cardio-cerebrovascular diseases. We have built a comprehensive drug portfolio primarily consisting of seven drug candidates, including three Core Products. In particular,centered on azvudine (brand name: 捷倍安®), our Core Product, a conditionally approved drug for the treatment of HIV infection and COVID-19 in China, we are developing a monotherapy for the treatment of multiple myeloma, lymphoma and acute leukemia, a monotherapy for the treatment of immunological non-responders (INRs) in HIV-infected patients, as well as four combination therapies including azvudine + anti-PD-1 for the treatment of liver cancer and colorectal cancer,azvudine + dosimertinib for the treatment of non-small cell lung cancer (NSCLC), azvudine/CL-197 for the treatment of HIV and azvudine + CTX for the treatment of lymphoma. Our other six drug candidates include CL-197, our Core Product, for the long-acting treatment of HIV infection;dosimertinib, our Core Product, for the treatment of NSCLC; ZSSW-136 for the treatment of malignant tumor; MTB-1806 for the treatment of acute ischemic stroke (AIS); ZS-2004 for the treatment of solid tumors; and ZS-1004 for the treatment of solid tumors.

Genuine Biotech has an in-house R&D management team composed of senior experts in the field of international drug research and development. Dr. Du Jinfa, the chairman of our Board,executive Director, chief executive officer, chief scientific officer of our Company, recognized as“State Specially Recruited Experts ” by the PRC government, is one of the inventors of sofosbuvir, drug for treating hepatitis C which won the Prix Galien Award, and one of the inventors of azvudine (for the treatment of COVID-19), CL-197 and dosimertinib, our Core Products. Cell has commented that sofosbuvir is one of the most significant public health accomplishments of our generation. Our senior management personnel, such as Dr. Dang Qun, Dr.Guo Chang Yue and Dr. Li Pan, all have served in internationally-renowned biomedical companies with an average of nearly 30 years of extensive experience in the fields of innovative drug research and development, translational medicine, and clinical trial management, which has laid a solid foundation for our continuous innovation and global competitiveness.

Leveraging our extensive experience in drug research and development, we have established comprehensive research and development platforms, including a highly selective novel nucleoside broad-spectrum anti-tumor drug R&D platform, a TOPO1 inhibitor and XDC drug R&D platform, a drug target discovery and validation platform, and an innovative drug design and optimization platform. These platforms cover the entire drug development process, from early target screening to preclinical research, to clinical trials and subsequent optimization, providing strong technical support and systematic safeguards to accelerate the discovery and development of innovative drugs.


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 was established in September 2012.

2012

• Submitted an IND clinical trial application for azvudine for treatment of HIV infection and received approval from the NMPA for the commencement of a Phase I clinical trial for azvudine for treatment of HIV infection in the PRC in April 2013.

2013

• Commenced the Phase I clinical trial for azvudine for treating HIV in the PRC in July 2014.

2014

• Completed the Phase I clinical trial for azvudine for treating HIV in the PRC in June 2015 .

• Received approval from the NMPA to conduct a Phase II clinical trial forazvudine for treating HIV in the PRC in December 2015.

2015

• Commenced the Phase II clinical trial for azvudine for treating HIV in the PRC in October 2017.

2017

• Completed the Phase II clinical trial for azvudine for treating HIV in the PRC in January 2019.

2019

• Received approval from the NMPA to conduct a Phase I/Phase II clinical trial for dosimertinib for treating advanced EGFR mutation-positive non-small cell lung cancer (NSCLC) in the PRC in April 2020.

• Submitted an IND application to the NMPA to directly initiate a Phase Ⅲ clinical trial for azvudine for treating COVID-19 in the PRC, received approval in April 2020 and commenced the Phase Ⅲ clinical trial in 2020 June .

2020

• We 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 in 2020, and received an IND approval in January 2021 and commenced the Phase Ⅲ clinical trial in June 2021.

• Completed the Series A Investment in February 2021 and raised approximately RMB149.5 million.

• Authorized Beijing Union and an Independent Third Party agent to submit an IND application to the Brazilian Health Regulatory Agency for initiating a Phase Ⅲ clinical trial of azvudine for treating COVID-19 in Brazil and received approval in March 2021 and commenced the Phase Ⅲ clinical trial in June 2021.

• Obtained a conditional approval of azvudine from the NMPA for treating HIV in the PRC in July 2021.

2021

• Completed the Phase Ⅲ clinical trial for azvudine for treating COVID-19 in the PRC in March 2022 .

• Completed the Series B Investment in April 2022 and raised approximately RMB563.3 million.

• Obtained a conditional approval from the NMPA of azvudine for treating common COVID-19 in adults in the PRC in July 2022.

• Entered into a strategic cooperation agreement with Fosun Pharmaceutical Industrial in July 2022 and launched the commercial sales of azvudine for the treatment of COVID-19 in the PRC in August 2022.

• 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 (《新型冠状病毒感染诊疗方案》) in August 2022.

• Initiated the Phase Ⅲ clinical trial of azvudine for the treatment of HIV infection in August 2022.

• Received an IND approval from the NMPA for CL-197 for the treatment of HIV infection in October 2022.

2022

• Azvudine, was included in the NRDL in April 2023.

• Commenced the Phase I clinical trial of CL-197 for the treatment of HIV infection in the PRC in August 2023.

2023

• As of January 2024, 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, in March 2024.

• Obtained the IND approval from the NMPA for the clinical trials of azvudine in patients with advanced solid tumors in September 2024.

• 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 in September 2024.

• Completed the NRDL renewal regarding azvudine, with the scope and price of payment remaining unchanged, in November 2024.

• Submitted IND application for the combination therapy of azvudine anddosimertinib for the treatment of NSCLC in November 2024.

• In December 2024, 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

• Obtained the ethical committee approval over the Phase IIa clinical trial of CL-197 for the treatment of HIV in September 2025. CDE reviewed the Phase IIa trial design in October 2025 and expressed no objection.

• Obtained the IND approval of azvudine + dosimertinib for the treatment of NSCLC in September 2025 and initiated a Phase I/IIa trial in November 2025.

• Submitted the IND application for the Phase II clinical trial of azvudine monotherapy for the treatment of blood cancers, received acceptance notification in September 2025 and obtained the IND approval in December 2025.

• Completed the last visit of the last patient under the Phase Ⅲ clinical trial of azvudine for the treatment of HIV in June 2025.

• Completed the Phase I clinical trial of dosimertinib for the treatment of NSCLC in May 2025 , and initiated the Phase II clinical trial in June 2025.

• Completed the Phase I clinical trial of CL-197 for the treatment of HIV in March 2025.

• Initiated Phase I clinical trial of azvudine in patients with advanced solid tumors in the PRC in January 2025 and completed such trial in June 2025.

• In January 2025, submitted a communication application to the CDE for the conversion of the conditional approval for the COVID-19 indication to regular approval. We submitted the conversion application in July 2025.

2025

• Submitted an application for a conversion from conditional approval for the HIV indication of azvudine to a regular approval in April 2026.

• Obtained the IND approval of azvudine + anti-PD-1 for the treatment of liver cancer and colorectal cancer in February 2026.

2026

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. Guo Chang Yue

Senior Vice President,Chief Medical Officer

Dr. Li Pan

Senior 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