Fungal infections have become an urgent challenge in the global healthcare field, posing a particularly severe threat to immunocompromised patient groups, including those with cancer, organ transplants, and HIV. However, the progress of innovative drug development for antifungal infections in China has been relatively slow. Coupled with the limitations on the use of antifungal drugs and the increasing resistance of fungi, there is an urgent need to explore and develop new treatment strategies to address this global medical challenge.
Against this development background, Sungening Biological (Sungening) has successfully obtained an implicit permission from the National Medical Products Administration for clinical trials (acceptance number: CXHL2400203) for its first innovative drug, SG1001. Additionally, Sungening has signed an agreement with Livzon Pharmaceutical Group, regarding the rights to SG1001 in the Greater China region. This not only highlights the potential of SG1001 and the high market recognition it has received but also brings new treatment strategies to the field of antifungal infections. It significantly advances China's innovation process in the development of antifungal drugs. Medicilon as a partner of Sungening Biological, relies on its technical strength and rich experience in the field of biopharmaceutical preclinical research and development to provide pharmacokinetics and GLP safety evaluation research services for the research and development of SG1001, and fully ensures its efficient and high-quality research and development.
The successful approval and licensing collaboration of Sungening's SG1001 is attributable to its exceptional innovation capabilities and profound scientific research strength. In order to deeply analyze the innovative achievements and R&D experience of Sungening in the field of antifungal infections, Medicilon has invited Dr. Chenguang Yuan, co-founder and Chief Scientist of Sungening, to share his unique insights and cutting-edge practices in antifungal drug development.
Chenguang Yuan, an expert in medicinal chemistry, graduated with a bachelor's degree from Xiamen University and a Ph.D. from Colorado State University. He previously served as a principal researcher in the innovative drug development departments at GD Searle and Amgen in the United States, an adjunct professor at the School of Life Sciences at Xiamen University, and a senior vice president at Hyperway Pharmaceuticals. He is a specially-appointed expert in Sichuan Province, a high-level innovative talent under Fujian Province's "Hundred Talents Program," and a leading entrepreneurial talent in Xiamen's "Double Hundred Plan." With over 30 years of experience in innovative drug research, Dr. Yuan specializes in innovative drug development and design, particularly excelling in the field of Class 1.1 small molecule innovative drugs. He has unique and keen insights into organic chemistry and drug synthesis and is the inventor of several innovative drug compounds. Dr. Yuan has published 28 papers in renowned journals both domestically and internationally. He has been awarded 25 compound invention patents in the United States and has applied for over 20 patents in China in recent years.
Dr. Yuan: SG1001 is a selective inhibitor targeting the fungal enzyme dihydroorotate dehydrogenase (DHODH), exhibiting significant antibacterial activity against Aspergillus, Candida, Penicillium, Fusarium, and Malassezia. The fungal DHODH is a key enzyme involved in the intracellular biosynthesis of pyrimidines. By inhibiting the activity of fungal cell DHODH, it interrupts the pyrimidine biosynthesis pathway, thereby exerting antifungal effects. This mechanism of action differs from all antifungal drugs already on the market and holds significant promise for the treatment of drug-resistant Aspergillus infections. After more than four years of effort and with the assistance of sister companies, Sungening overcame many challenges and submitted the Investigational New Drug (IND) application in February of this year as planned. The successful IND approval of the SG1001 oral tablets marks Sungening's entry into the clinical stage, laying a solid foundation for the company's further development.
Dr. Yuan: We are about to initiate the overseas IND application for SG1001, preparing for future international expansion. At the same time, we have initiated preclinical research on another cyclic peptide compound, SG5035, for the treatment of invasive candidiasis. We plan to submit simultaneous IND applications in China and the United States for SG5035 in 2025. In addition to the field of antifungal infections, we have shifted our focus in early drug discovery to oral cyclic peptide innovative drugs. Potentially promising drug candidates will gradually enter preclinical research, and we hope to share more news in this regard with everyone in the near future.
Dr. Yuan: Invasive fungal infections pose a serious threat to immunocompromised individuals, with high mortality rates resulting from secondary infections. The global development of innovative drugs for invasive fungal infections has been slow, failing to meet the significant clinical demand brought about by the rapid growth of immunocompromised populations, with China's situation being particularly evident. Currently, commonly used drugs in clinical practice, such as fluconazole, amphotericin B, and azoles, have been on the market for over a decade, even two decades. However, these drugs no longer meet the clinical demands in terms of safety and clinical compliance. Particularly concerning is the prevalence of drug-resistant fungi against these medications, posing a severe threat to the lives of immunocompromised individuals. There are very few domestically developed innovative antifungal drugs in China, and most are still in the early stages of discovery. Clinical treatment largely relies on generic drugs and the importation of innovative drugs from overseas, which is not commensurate with the current level of drug innovation and the development of the national economy in China. We hope that through the efforts of Sungening, we can raise awareness among relevant government departments and the public, work together to accelerate the development of domestically developed innovative antifungal drugs in China to meet the health needs of our people.
Dr. Yuan: The development of innovative anti-infection drugs requires the collective efforts and promotion of the entire society. We are an innovative drug development company focused on anti-infection and oral cyclic peptide. In addition to fully leveraging the benefits of our established platform, we also need to collaborate with large pharmaceutical companies and various CROs and CDMOs in different fields to expedite the clinical development and market entry of our discovered innovative drugs. Sungening proactively reaches out to embrace available resources and capital, striving to carve out its own place in the biopharmaceutical field.
Dr. Yuan: I agree with this viewpoint. In October 2022, the World Health Organization (WHO) released a report that introduced the first-ever "Essential Pathogens List for Fungi" (WHO FPPL), highlighting 19 fungi posing the greatest threat to public health. The WHO's list of essential fungal pathogens represents the first global effort to systematically prioritize fungi based on unmet research needs and anticipated public health significance. Its aim is to raise awareness among governments and organizations worldwide about the threat posed by fungal infections, particularly emphasizing the importance of monitoring of fungal infections and the development of treatment drugs, to prevent major public health crises. During the COVID-19 pandemic, the outbreak of mucormycosis infections among COVID-19 patients in India, as well as the significant increase in mortality rates among severe COVID-19 patients due to fungal co-infections, are all indicating that we must prepare for potential infectious public health crises in the future.
Dr. Yuan: New mechanisms of action (MOA), new formulations, new molecular modalities, and broader spectrum antibacterial effects are needed for new antibiotics. Overcoming resistance and addressing safety concerns will be the future trends.
Dr. Yuan: The development of innovative antifungal drugs is progressing very slowly, severely lagging behind clinical demand, and failing to meet the public health security crisis that fungal infections may cause. We need to pay more attention to the development of this field, broaden our thinking, and strengthen collaboration. I believe that with the development of the innovative pharmaceutical industry, there will definitely be more new antifungal drugs emerging to combat the threat of super fungi that endanger human health.
Dr. Yuan: Funding. Currently, China's industrial chain for innovative drug development is relatively well-established, but the investment in innovative drug research and development is still significantly lower than that of Western developed countries. Sufficient funding will greatly enhance the level of innovation in drug development and the pharmaceutical industry in China, making it a pillar industry in China's economy.
Dr. Yuan: Focused on developing new drugs to address clinical needs and safeguarding human health.
Dr. Yuan: Success in scientific research depends on the accumulation of professional knowledge and dedicated exploration. Drug development is a complex system engineering that requires continuous innovation, advanced technology, high investment, long cycles, and involves multiple departments. It presents both surprises and challenges. Designing and synthesizing entirely new molecules that do not exist in the world, screening innovative drugs that can treat certain diseases, and benefiting humans, animals, and plants is a very cool pursuit in life. Utilizing AI technology to aid in biopharmaceutical research and development is a future trend. I hope interested students will diversify their skills and grow into the forefront of drug development as the new generation.
Dr. Yuan: China has made tremendous progress in the field of innovative drugs over the past decade! As talents continue to gather and more and more innovative drug intellectual property rights are transferred overseas, successful cases of innovative drug globalization are constantly being refreshed. While generating significant economic value, it also contributes to the health and well-being of people worldwide. In the future, China can continuously strengthen its investment in funding, talent cultivation, and policy guidance. I believe that China's innovative drug research and development has great potential. In the near future, it will become a high ground for innovative drug research and development worldwide.
Founded in 2021, Sungening is an innovative drug company focusing on innovative antifungal infection drugs and oral cyclic peptides. It has a fully independent drug pipeline and mature commercialization capabilities. With the vision of "focusing on developing new drugs to address clinical needs and safeguarding human health", Sungening strives to develop innovative drugs that can address clinical needs.
Based on its complete independent innovation capability, the company has developed several innovative drug pipelines for global use in just a few years. Among them, one pipeline has received IND approval, two pipelines are in the clinical application stage, and two pipelines are in the preclinical candidate compound (PCC) stage. It is one of the few companies domestically and internationally that focuses on the development of innovative drugs for antifungal infections and oral cyclic peptides.
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