2026：或许是决定创新药国运的一年

Core Viewpoint - The article discusses the potential impact of AK112, a PD-1×VEGF dual antibody developed by Kangfang, on the future of innovative drugs in China, suggesting it could lead to significant changes in the market dynamics over the next 3-5 years [1][16]. Group 1: AK112's Market Performance - AK112 has been approved for the Chinese market and shows promising results in treating EGFR mutation patients with non-small cell lung cancer (NSCLC), with a progression-free survival (PFS) of 7.06 months compared to 4.8 months for chemotherapy, and a hazard ratio (HR) of 0.46 [2][17]. - The overall survival (OS) data for AK112 is less impressive, with a median survival of 16.8 months for the combination therapy versus 14.1 months for chemotherapy, resulting in a risk ratio of 0.74 (p=0.019) [2][17]. Group 2: Challenges and Concerns - A small issue is identified regarding the limited market size for EGFR TKI resistant treatments, which constitutes only 4% of the total NSCLC market, suggesting limited impact on overall sales [2][18]. - A significant concern arises from the OS data being statistically insignificant (HR=0.79, p=0.057), which could hinder the drug's acceptance and market potential [3][18]. Group 3: Future Trials and Implications - The success of future trials, particularly Harmoni-2 and Harmoni-6, is crucial for AK112's market position. Harmoni-2 has already been approved, while Harmoni-6 is critical for first-line treatment of squamous NSCLC [6][21]. - If Harmoni-6 fails to demonstrate significant OS benefits, it could jeopardize the global clinical value of AK112 and lead to negative repercussions for other companies involved in PD-1×VEGF dual antibodies [6][22]. Group 4: Market Trends and Investment Opportunities - The innovative drug sector has seen a resurgence in the secondary market, particularly in Hong Kong, with the Hang Seng Innovation Drug Index showing over a 10% increase in 2026 [13][25]. - The index offers unique advantages, including a focus on pure innovative drugs, a high concentration of leading companies, and controlled risks through liquidity management [14][28].