对话｜港大医学院邝沃林：用了20多年做出香港首款自主研发的抗癌新药产品，创新药研发环境正在变好

Core Viewpoint - The development of ARSENOL, an oral arsenic trioxide drug for treating acute promyelocytic leukemia (APL), marks a significant milestone as the first cancer treatment drug developed and manufactured by a local Hong Kong team, receiving preliminary certification from regulatory agencies in the US and Europe for clinical research [1][5][14]. Group 1: Drug Development Journey - The research on arsenic trioxide for leukemia treatment began over 20 years ago, with initial studies tracing back to the 1950s in Hong Kong [4][5]. - The drug ARSENOL was successfully developed into an oral formulation in 2010, but it took over a decade to transition from hospital preparation to obtaining market approval [5][10]. - The drug's development faced numerous challenges, including funding difficulties and the need for collaboration with GMP-certified manufacturers [10][14]. Group 2: Clinical and Economic Impact - ARSENOL significantly reduces the financial burden on patients, with treatment costs dropping from approximately HKD 2.6 million for traditional therapies to around HKD 4,000 per week for the oral drug [5][14]. - The new oral formulation allows patients to return to normal life, requiring only two weeks of hospitalization compared to over 100 days for intravenous treatments [5][14]. Group 3: Regulatory and Market Environment - The Hong Kong government is enhancing the drug development and approval process, aiming to position the region as an international hub for medical innovation [14]. - The establishment of the Guangdong-Hong Kong-Macao Greater Bay Area International Clinical Trial Center is expected to streamline clinical trials and drug approvals [14]. - Increased interest from local investors in innovative drug development is noted, indicating a positive shift in the investment landscape for the pharmaceutical industry in Hong Kong [6][14]. Group 4: Future Prospects - Ongoing collaborations with international institutions, such as Cardiff University, aim to expand the use of ARSENOL and explore its application in treating other diseases [15]. - The drug has received rare disease drug designation from the FDA and EMA, highlighting its potential for broader therapeutic applications [14][15].