Ascletis Pharma Awarded Zhejiang Provincial Science and Technology Progress First Prize for Pioneering Domestic Oral HCV Therapy

This was a “feast” of technological innovation. On July 11, 2022, the Provincial Conference on Scientific and Technological Innovation was held at the Zhejiang Provincial People’s Great Hall. After multiple rounds of evaluation, the project “Development and Industrialization of Class 1 New Drug Technology for All-Oral Direct-Acting Anti-Hepatitis C Virus Agents,” jointly submitted by Ascletis Pharma Inc. (hereinafter referred to as “Ascletis”) and leading experts in the field of liver diseases, was awarded the First Prize of the 2021 Zhejiang Provincial Science and Technology Progress Award. Yuan Jiajun, Secretary of the Provincial Party Committee, presented the award certificate to Dr. Wu Jinzi, Founder, Chairman of the Board, and Chief Executive Officer of Ascletis.

Chronic Hepatitis C Infection in China Is a Major Public Health Issue. Yang Xizhong, Executive Vice Chairman and Secretary-General of the China Hepatitis Prevention and Control Foundation, stated, “China has a large base of hepatitis C patients and multiple transmission routes, with approximately 10 million affected individuals.” Hepatitis C symptoms are often subtle, making early detection difficult; hence, it is known as the silent “killer.” If not treated promptly, there is a 55% to 85% chance of progressing to chronic infection, which is more likely than other viral hepatitis types to develop into liver cirrhosis or even liver cancer.

Xinlilai® (ravidasvir hydrochloride) and Genuo Wei® (danoprevir sodium) are two Class 1 innovative direct-acting antiviral agents against hepatitis C virus (HCV), independently developed by Ascletis Pharma. The all-oral, domestically produced HCV treatment regimen composed of these two drugs was included in the 2021 updated National Reimbursement Drug List of China. With complete independent intellectual property rights covering key technologies throughout the entire process from active pharmaceutical ingredients to finished formulations, it is currently the only locally developed, all-oral HCV treatment regimen in China that is not restricted by Gilead’s sofosbuvir patents. The regimen was incorporated into the 2019 edition of China’s “Guidelines for the Prevention and Treatment of Hepatitis C.” It addresses the substantial unmet clinical needs of a large population of patients with chronic hepatitis C, reduces the incidence of liver cirrhosis and hepatocellular carcinoma, significantly improves patients’ quality of life and long-term health outcomes, recovers productivity losses attributable to chronic hepatitis C amounting to tens of billions of yuan, and effectively alleviates the societal and economic burden.

Ascletis’s hepatitis C treatment regimen has significantly enhanced antiviral activity and overcome the resistance barrier of the hepatitis C virus, breaking the technological and market monopoly held by U.S. pharmaceutical companies in this field. It has filled the gap in China’s development of small-molecule direct-acting antivirals (DAAs) against hepatitis C and contributed to a substantial reduction in the pricing of imported drugs in China. The 100% domestic production ensures the security of national drug supply and has significantly elevated the value contribution of Chinese innovative drugs in the treatment of major infectious diseases. The regimen has been granted four patents, resulted in the publication of 21 academic papers both domestically and internationally, and its research findings have been presented as poster sessions and oral reports at annual conferences of multiple leading professional societies worldwide, effectively enhancing China’s international standing in the field of virology research.

Ascletis’ research findings have been presented as poster presentations and oral reports at the annual meetings of top international societies, including the American Association for the Study of Liver Diseases (AASLD), the European Association for the Study of the Liver (EASL), and the Asian Pacific Association for the Study of the Liver (APASL). The Phase II clinical study of Danoprevir received the highest honor at the 24th APASL Annual Conference—an invited plenary lecture by the Congress President. The Phase III clinical study of Danoprevir was awarded the First Prize at the 15th National Conference on Infectious Diseases of the Chinese Medical Association.

Ascletis Pharma served as the lead institution for the hepatitis C projects under the National Major Science and Technology Special Project on New Drug Innovation during China’s 13th Five-Year Plan period, undertaking a total of three national hepatitis C projects within this special initiative. Academician Chen Kaixian, Deputy Chief Technical Officer of the National Major Science and Technology Special Project on New Drug Innovation, stated, “Ganovo®, the anti-hepatitis C virus drug, is the first major achievement fostered by the ‘New Drug Innovation’ special project during the 13th Five-Year Plan period, and the hepatitis C projects serve as a model implementation of the major special initiatives in this period.”

For a long time, China’s scientific research talent has been predominantly concentrated in research institutes, higher education institutions, and large state-owned enterprises, which have contributed the vast majority of technological innovation achievements. However, with the implementation of more policies encouraging market entities to engage in scientific and technological innovation, an increasing number of tech enterprises are now developing “hardcore” capabilities in technological innovation and assuming the role of “problem posers.” As President Xi Jinping emphasized, “We should leverage the role of enterprises as problem posers, promote collaboration on key projects and integrate research and development activities, and accelerate the establishment of innovation consortia led by leading enterprises, supported by universities and research institutes, and characterized by mutual coordination among all innovation stakeholders.”

This honor marks a new starting point for Ascletis. Building on its successful technologies and experience in the development of anti-hepatitis C virus (HCV) drugs, Ascletis will continue to strive for innovative breakthroughs in the field of antiviral therapy. Recently, Ascletis’s Phase IIb clinical trial results for ASC22, an investigational subcutaneous PD-L1 antibody for hepatitis B, presented at the 2022 EASL Congress, have garnered attention from the international academic and industrial communities, offering promise toward achieving a functional cure for hepatitis B. With firm conviction, Ascletis will press forward on the path of technological innovation. Once the direction is set, it will uphold the spirit of perseverance—“willing to endure solitude and dedicate years to perfecting a single breakthrough”—to benefit more patients in China and around the world with original innovative drugs. In fulfilling its social responsibility as a leading Chinese antiviral enterprise, Ascletis is fully committed to advancing the R&D pipelines for COVID-19, hepatitis B, and HIV/AIDS, thereby realizing its mission and vision: “Freedom Through Cure.”

Ascletis Pharma (1672.HK), listed on The Stock Exchange of Hong Kong, is an innovation-driven biotechnology company covering the entire value chain from new drug R&D to manufacturing and commercialization.

Ascletis’ management team possesses deep professional expertise and a strong track record of achievement. Under its leadership, Ascletis focuses on three therapeutic areas with significant unmet clinical needs—viral diseases, non-alcoholic fatty liver disease (NAFLD), and oncology—and adopts a global strategic perspective. Leveraging exceptional execution capabilities, Ascletis rapidly advances its drug pipeline to secure a leading position in international competition. Ascletis currently has three commercialized products: ritonavir tablets, Ganovo®, and Xinlilai®, as well as 20 drugs in development. Its most advanced candidate drugs include ASC22 (for functional cure of hepatitis B), ASC10 and ASC11 (oral small-molecule anti-SARS-CoV-2 agents), ASC40 (for recurrent glioblastoma), ASC42 (for primary biliary cholangitis), and ASC40 (for acne).

For more information, please visit www.ascletis.com.