Annual Review | Genuine Biotech Highlights in 2023

As the new year begins, let us also start anew. The coming 2024, like every new year, brings new beginnings and possibilities, ushering in the joy and hope of the New Year. Looking back on 2023, Genuine Biotech achieved our expected operational targets, with the company's development thriving and advancing steadily. Under the guidance of the corporate mission "improve human health through genuine innovation", Genuine Biotech has consistently unleashed the power of pharmaceutical innovation. With a pragmatic approach and a philosophy of gradual accumulation bringing breakthroughs, the company continuously hones its research and development capabilities. Several R&D projects have made encouraging progress, while the product pipeline has been further enriched and the product portfolio more comprehensively developed. All these achievements can address unmet clinical needs and accelerate the company's global development. In events such as negotiation for China's national medical insurance coverage, epidemic prevention and guarantee of supply, and charitable donations, we actively fulfill our social responsibilities, contributing a supportive force to the harmonious development of society and the well-being of the public.

Azvudine has officially been included in China’s national medical insurance, a balance between patients' financial capacity and the sustainability of the medical insurance fund

On January 18, 2023, the " National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2022)" was released. Azvudine has become the first Chinese-made COVID-19 small-molecule oral drug to be officially included in the National Health Insurance Drug List. The insurance payment price is set at only 175 yuan per bottle, a price that takes into consideration both the affordability of Chinese patients and the sustainability of the  healthcare security fund. At present, Azvudine has been included in the basic medical insurance networks of 31 provinces, autonomous regions, and municipalities of China, covering more than 40,000 medical institutions nationwide, effectively meeting the needs of the general population.

Clinical utility in surpassing ten million cases, multiple authoritative real-world studies have substantiated the safety and efficacy of Azvudine in treating COVID-19

Real-world studies serve as a further validation of the clinical effectiveness of marketed drugs. With a broader sample coverage, these studies provide a more genuine, objective, and comprehensive assessment. Since its marketing, Azvudine has been clinically utilized in over ten million cases. Multiple authoritative real-world studies have demonstrated the safety and efficacy of Azvudine in treating COVID-19. According to several related studies[1-3], Azvudine can accelerate the clearance of the virus in patients with mild to moderate COVID-19 and significantly shorten the time for nucleic acid to turn negative. It also significantly reduces the duration of clinical symptoms in moderate cases and substantially lowers the all-cause mortality.

Azvudine has been continuously included in both the 9th and 10th editions of the “Chinese Diagnosis and Treatment Guideline for COVID-19", and has also received high recognition and praise in the "Expert Consensus on Antiviral Therapy of COVID-19" authored by 34 leading experts in China.

Encouraging R&D progress and pouring good news, the product pipeline has become more enriched and comprehensive 

As a biopharmaceutical company driven by innovation, Genuine Biotech consistently prioritizes "innovative research and development" in our corporate growth. Several R&D projects have achieved promising progress: The dose escalation of the new-generation oral long-acting HIV candidate, CL-197, has been completed, demonstrating good safety. It is poised to enter the next stage of trials, with the goal of developing the world's first globally approved, entirely oral, and long-acting treatment for AIDS. Additionally, Dosimertinib, the promising Best-in-Class lung cancer candidate, is currently progressing smoothly through Phase I-II clinical trials, with an anticipated completion date in 2024. The results of animal experiments showed that Azvudine in combination with Dosimertinib exhibits a significant synergistic effect in treating non-small cell lung cancer, holding the potential to emerge as a more optimal treatment regimen for non-small cell lung cancer. In addition, there have been important new findings in animal experiments of Azvudine for anti-tumor treatment. Azvudine can selectively inhibit tumor cell DNA synthesis and effectively suppress the formation of myeloid-derived suppressor cells (MDSC), enhancing immune cells' intrinsic anti-tumor activity, and thereby improving the overall efficacy of cancer treatment. Animal experiments have also found that the combination of Azvudine and PD-1 inhibitors demonstrates significant advantages in the treatment of liver cancer and colorectal cancer, holding the potential to become the Best-in-Class (BIC) treatment regimen. The combination of Azvudine and the chemotherapeutic drug cyclophosphamide (CTX) has also demonstrated a significant synergistic effect in animal experiments for treating lymphoma, holding the promise of being a more effective treatment regimen. In the research and discovery of innovative drugs, several new candidates targeting solid tumors with significant market potential have been added, especially an innovative candidate that has been found effective against irinotecan resistance, addressing a substantial clinical need. These research achievements have further enriched the company's product pipeline, significantly boosting its market competitiveness.

Significant increase in productivity, an impressive annual capacity of 5 billion tablets

In 2022, the company's manufacturing site in Pingdingshan, Henan, successfully passed the GMP compliance inspection. Responding to the surge in market demand, we devoted full efforts to enhancing production capacity. In less than half a year, the annual production capacity was raised from 1 billion to 3 billion tablets, and now the company has achieved a leap to an annual capacity of 5 billion tablets. This significant enhancement in production capability has created an astonishing "acceleration" in the industry, laying a solid foundation for the commercialization of future innovative products. 

Further strengthening the executive team , accelerating the company's global development

Genuine Biotech has consistently placed a strong emphasis on team construction, attracted global top-tier talents, and reinforced the comprehensive capabilities of the management team to accelerate the company's global development. In 2023, the company strategically brought in experienced management professionals for core positions in R&D and commercialization, including the significant appointment of Dr. James He as Senior Vice President and Chief Medical Officer, who will lead the clinical and registration teams, and assume the responsibility for the product pipeline strategy, clinical project planning and operations, product registration and team construction. With more than 20 years of experience in the pharmaceutical industry, Dr. He is familiar with the registration environments in China, the United States, and the European Union and has led and participated in the development and launching of multiple globally significant products. Before joining Genuine Biotech, Dr. He held executive positions leading clinical teams at several global pharmaceutical companies, including Pfizer, GlaxoSmithKline, Novartis, Amgen, and Boehringer Ingelheim. In October of this year, Mr. Sun Guorui joined Genuine Biotech as Vice President, overseeing the company's marketing management. With over 25 years of experience, Mr. Sun has previously worked at companies such as Novartis, Bayer, and MSD, where he played a key role in core market expansion in China, managed various business activities, and led teams to win a large number of prestigious national and international awards.

Successful entry into international markets of Azvudine representing China's contribution to the global fight against the COVID-19 pandemic

In Feb. 2023, 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. This milestone signifies Azvudine's successful entry into international markets and represents China's contribution to the global fight against the COVID-19 pandemic, which will provide China's regimen to the world to consistently protect the health of patients.

Repeatedly honored, widely recognized

Leveraging the outstanding innovation capabilities and breakthrough R&D achievements, Genuine Biotech and its major  product Azvudine garnered multiple prestigious honors in 2023, earning recognition from various sectors of society. At the corporate level, Genuine Biotech received notable honors in 2023. In May, the company was granted the 2022 Henan Annual Enterprise Social Responsibility Award, jointly presented by Henan Daily, the State-owned Assets Supervision and Administration Commission of Henan Province, the Local Financial Supervision and Administration Bureau of Henan Province, the Department of Industry and Information Technology of Henan Province, and the Henan Charity Federation. The following month, Genuine Biotech was once again featured on the list of "Top 30 Innovative Small-Molecule Pharmaceutical Enterprises in China" in the "2022 Top 100 Innovation List Series for Biopharmaceutical Enterprises in China". In November, Genuine Biotech was honored with "Top 10 Innovative Biotechnology Companies of the Year" at the 2023 Golden Cane Awards by China Times. At the product level, the project "Development and Application of Azvudine for the Treatment of COVID-19" won the first prize in the Henan Provincial Technical Invention Award issued by the Henan Provincial Government in March 2023; in May, Azvudine won the BEYOND Awards Life Science Innovation Award in the special awards of the BEYOND International Science and Technology Expo, which is sponsored by the Macau Technology General Association and jointly organized by the Trade Development Bureau of the Ministry of Commerce, the Planning and Development Bureau of the State-owned Assets Supervision and Administration Commission of the State Council, the Center for International Economic and Technical Cooperation Ministry of Industry and Information Technology.

Various awards demonstrate a high recognition of the social and innovative value of Genuine Biotech and Azvudine. These awards will further inspire the company's innovation drive, motivating the company to steadfastly advance on the path of "innovation driving the future".

Charitable drug donation, actively fulfilling social responsibility

As a company with devotion and pursuits, Genuine Biotech has always been committed to the well-being of the people during its development. During the critical period of the COVID-19 pandemic, the company actively engaged in charitable drug donations, fully committing to its social responsibilities. In January 2023, Genuine Biotech together with Fosun Pharma donated Azvudine worth 100 million RMB to rural areas, covering 250 cities and counties across the country, building a solid defense line for people's health with concrete actions, catering to the need for drugs in primary-level areas.

Ample coverage by authoritative media, significant enhancement of brand reputation

In 2023, Genuine Biotech captured significant attention with noteworthy events such as "proactive price reduction in  negotiation for China's national medical insurance coverage, benefiting the public", "overtime work during the Spring Festival to ensure supply and production", and "charitable drug donation worth 100 million Yuan". These events garnered widespread coverage and attention from various media outlets, including authoritative national media such as CCTV, Xinhua News Agency, and People's Daily, as well as local official media and numerous social media platforms. As a result, the brand's reputation saw a significant enhancement.

References

1、Composite Interventions on Outcomes of Severely and Critically Ill Patients with COVID-19 in Shanghai, China

https://www.mdpi.com/2076-2607/11/7/1859

2、Oral azvudine for mild-to-moderate COVID-19 in high risk, nonhospitalized adults: Results of a real-world study

https://onlinelibrary.wiley.com/doi/10.1002/jmv.28947

3、Real-world effectiveness of Azvudine in hospitalized patients with COVID-19: a retrospective cohort study

https://www.medrxiv.org/content/10.1101/2023.01.23.23284899v1