Annual Review | 2022 Annual Highlights of Genuine Biotech

Ten years of perseverance with uncompromising dedication.No effort will go in vain, and success only comes through hard work!
The year of 2022 marks a significant milestone in the development of Genuine Biotech.All of the extraordinary moments and unforgettable memories etched in the firm steps forward have had a profound impact on the development of Genuine Biotech, contributing to China's fight against the COVID-19 pandemic. Looking back on the year's highlights, each and every one of them was made possible by the diligence and hard work of our colleagues and scientists, as well as the steadfast support of our partners.
Genuine Biotech is grateful to have you!

TOP 1: Azvudine, the first homegrown oral drug for COVID-19 was approved for marketing in China, included in the Diagnosis and Treatment Guideline for COVID-19, and covered by temporary medical insurance

Azvudine tablets is the first oral small-molecule drug developed in China for the treatment of COVID-19 infection with fully independent intellectual property and was conditionally approved for marketing by the NMPA on Jul. 25, 2022.On Aug. 9, Azvudine tablets was officially included in the Diagnosis and Treatment Guideline for COVID-19 (9th Edition) as the only domestic oral drug recommended for COVID-19. Since Aug. 12, Azvudine has been covered by temporary medical insurance. As of now, Azvudine tablets has been included in the basic medical insurance networks of 31 provinces, autonomous regions, and municipalities of China.

TOP 2: Azvudine tablets successfully commenced and expanded production with an annual production capacity of over 3 billion tablets

Genuine Biotech has a modern manufacturing site in Pingdingshan, which has successfully passed the GMP compliance inspection in May 2022. On Aug. 2, Azvudine tablets were successfully manufactured in mass production, and the production expansion was completed in November, increasing the daily production from 70,000 bottles to 300,000 bottles, and achieving an annual production capacity of more than 3 billion tablets, thereby securing the market supply.
TOP 3: Strategic collaboration with Fosun Pharma provided critical support for commercialization of Azvudine
On Jul. 26, Genuine Biotech entered into a strategic collaboration with Fosun Pharma. The two companies will jointly develop Azvudine tablets, which will be exclusively commercialized by Fosun Pharmaceutical Industrial, a subsidiary of Fosun Pharma, and the areas of partnership include treatment and prevention of COVID-19 and HIV.The strategic collaboration provides crucial support for the rapid launch and sales of Azvudine tablets. At present, Fosun Pharma has entered into strategic collaborations with a number of business partners in China, including Sinopharm Group and China Resources Pharmaceutical, to fully leverage their respective assets and to accelerate the coverage of terminals of the channel network.

TOP 4: Azvudine accessibility has been greatly improved by the availability of online consultations and prescriptions
Recently, with the release of the Notice on Provision of Internet Medical Services for COVID-19 by the Joint Prevention and Control Group of the State Council, online medical platform channels such as Fosun Health, WeDoc, and Fangzhou Jianke are now available for Azvudine, improving the accessibility of Azvudine, further addressing the home treatment demand of patients with COVID-19 infection, so as to consistently benefit more patients and safeguard people's health.
TOP 5: CL-197 was successfully approved for clinical trial, which is likely to be developed into the first fully oral long-acting anti-HIV drug in the world

On Oct. 8, the clinical trial application for CL-197, a next-generation oral long-acting HIV drug candidate independently developed by Genuine Biotech, was formally approved by the Center for Drug Evaluation of the NMPA. The combination of CL-197 and Azvudine meets the requirements of HIV cocktail therapy, which is equivalent to having three drugs with different mechanisms of action acting simultaneously. The cocktail treatment can effectively prevent the occurrence of drug resistance and is expected to be developed into the first fully oral long-acting anti-HIV drug in the world.

TOP 6: Successful submission of listing application to the Hong Kong Stock Exchange promotes the listing process step by step
On Aug. 4, Genuine Biotech successfully submitted an application for listing on the main board of the Hong Kong Stock Exchange.According to the prospectus, the proceeds will be used mainly for enhancing the R&D platforms, expanding the product pipelines, clinical development of investigational drug candidates, manufacturing, and commercialization of Azvudine tablets, and potential acquisition or introduction of other drug candidates, etc. Genuine Biotech will follow the requirements of the Hong Kong Stock Exchange to proceed with the listing process step by step.

TOP 7: Successful completion of Series B financing raised RMB 563 million

Genuine Biotech successfully completed its Series B financing in April, raising RMB 563 million that provides a strong impetus for the company's development. It will further enhance the R&D efficiency by comprehensively accelerating the R&D process of each innovative drug and strongly strengthening the company's competitive advantage in the field of innovative drugs.

TOP 8: Important patents were granted, further strengthening the protection of intellectual property

Since the beginning of this year, a number of invention patents declared by Genuine Biotech have been accepted by the China National Intellectual Property Administration, marking the further strengthening of the protection of the company's intellectual property. Among them, the domestic invention patent of oral drug for COVID-19 was granted on Oct. 14. Patents are the cornerstone of business development and the embodiment of innovative exploration. Since its establishment, the company has obtained more than 40 invention patents in China and overseas, and has progressively established a scientific patent layout and intellectual property protection system.

TOP 9: Charity drug donation for Tibet represents the company's fulfillment of its social responsibility

On Aug. 19, 5,000 bottles of Azvudine tablets donated by Genuine Biotech and Fosun Pharma arrived in Lhasa. This batch of drugs was received by the Health Commission of Tibet Autonomous Region and distributed to designated hospitals on the same day to meet the needs of first-line pandemic prevention and control. This is part of the company's efforts to support the tough fight against the COVID-19 pandemic, fulfilling its corporate social responsibility.

TOP 10: Multiple coverage by authoritative Chinese central media significantly boosts the brand value

In 2022, Genuine Biotech had been repeatedly recognized and reported by China Central Television (CCTV), Xinhua News Agency, People's Daily, and other authoritative Chinese central media, significantly enhancing the company's brand value. Consistently driven by R&D, Genuine Biotech will further improve its R&D team, recruit international talents, enhance the R&D platforms, and expand product pipelines to address unmet clinical needs with newer and better treatment options, so as to improve human health through genuine pharmaceutical innovation.