Core Insights - The company Aiyang Pharmaceutical (06855.HK / AAPG.OQ) has several key business milestones to watch for in 2026, focusing on core product commercialization, global clinical advancements, and breakthroughs in its innovative pipeline [1] Performance and Operations - The product APG-2575, China's first domestic Bcl-2 inhibitor, is set to participate in the national medical insurance catalog negotiations in 2026, which, if successful, could enhance market penetration [2] - The third-generation BCR-ABL inhibitor, Nilotinib, is expected to accelerate sales following the expansion of medical insurance coverage, with a target to cover over 1,500 hospitals, thereby increasing patient accessibility [2] Project Progress - The POLARIS-1 study, a global Phase III clinical trial for Ph+ acute lymphoblastic leukemia (Ph+ ALL), is planned to initiate patient enrollment in Europe and the U.S. in 2026, laying the groundwork for a 2028 submission to the FDA/EMA [3] - The POLARIS-2 study, targeting third-line and above chronic myeloid leukemia (3L+ CML), is expected to complete enrollment in 2026, with primary endpoints including 6-month cytogenetic response (CCyR) and major molecular response (MMR), potentially becoming the first domestically developed third-generation BCR-ABL inhibitor submitted overseas [3] Research Developments - The GLORA series studies, including the GLORA Phase III trial for first-line CLL/SLL, aims to complete enrollment in 2026, with a new drug application (NDA) submission planned for 2027 [4] - The GLORA-4 study for high-risk myelodysplastic syndromes (MDS) is set to release key data in 2026, addressing a treatment gap that has persisted for nearly 20 years without new drug approvals [4] - APG-2449, a third-generation ALK-TKI for resistant non-small cell lung cancer (NSCLC), is expected to present preliminary data in 2026, with potential to become a best-in-class product [4] Product Development Progress - APG-3288, a BTK degrader based on PROTAC technology, received clinical trial approval in China and the U.S. in February 2026, with a global multi-center Phase I study initiated, aiming to obtain preliminary pharmacokinetic and safety data in 2026 [5] - APG-115, an MDM2-p53 inhibitor, is in the second stage of global development, with critical data expected in 2026 that could influence its competitive landscape [6] - APG-5918, an EED inhibitor, is expanding into the anemia field, with clinical trials in oncology and non-oncology indications planned for 2026 in China and the U.S. [7]
亚盛医药2026年关键业务里程碑：核心产品商业化与全球临床进展