PK流感“神药”的国产创新药来了

Core Viewpoint - The article discusses the successful development and market entry of the innovative flu drug, Olanidavir, by Zhongsheng Pharmaceutical, which has managed to outperform the established flu medication, Oseltamivir, in clinical trials [3][4][7]. Industry Progress - Since the initiation of drug regulation reforms in 2015, China's biopharmaceutical industry has made significant advancements in drug development, achieving breakthroughs in several areas previously dominated by multinational companies [3]. - The emergence of valuable drug molecules from both new and established pharmaceutical companies is expected to create substantial economic and social value for China [3]. Company Development - Zhongsheng Pharmaceutical's Olanidavir is the first flu RNA polymerase PB2 protein inhibitor approved in China, marking a significant milestone in the company's innovation journey [4][17]. - The drug was developed over a decade, with a focus on addressing the limitations of existing treatments, particularly the resistance and side effects associated with Oseltamivir [6][19]. Clinical Trial Success - In head-to-head clinical trials, Olanidavir demonstrated a median symptom relief time and fever relief time shorter than that of Oseltamivir, with nearly a 10% reduction in illness duration [7]. - Olanidavir showed superior efficacy against flu viruses, including those resistant to Oseltamivir and the newer drug, Marbofloxacin [7][8]. Market Potential - The Chinese flu medication market is projected to reach approximately 20 billion yuan, with Olanidavir expected to capture a significant share [19]. - The overall market for flu medications in China is nearing 20 billion yuan in 2023 and is anticipated to grow to 26.91 billion yuan by 2028 [18][19]. Future Plans - Zhongsheng Pharmaceutical aims to explore licensing opportunities for Olanidavir in international markets, particularly in the U.S. and Belt and Road countries, despite facing challenges in conducting large-scale clinical trials abroad [18]. - The company is also preparing for negotiations regarding national health insurance coverage for Olanidavir [18].