来凯医药-B早盘涨超5% LAE002预计26年上半年提交NDA

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) rose over 5% following the announcement of an exclusive agreement with Qilu Pharmaceutical for the research, development, and commercialization of LAE002 in China [1] Group 1: Financial Details - Lai Kai Pharmaceutical is set to receive a non-refundable upfront payment of up to 530 million RMB and milestone payments related to clinical development [1] - The total potential upfront and milestone payments could reach up to 2.045 billion RMB, in addition to a tiered sales revenue share of over 10% to 20% from future net sales in the licensed region [1] Group 2: Clinical Development - The company is responsible for completing the Phase III clinical trial for HR+/HER2- breast cancer until the first indication receives new drug application approval in China [1] - According to Yongxing Securities, LAE002 is expected to submit its New Drug Application (NDA) in the first half of 2026 [1] Group 3: Pipeline Progress - The company’s pipeline is progressing smoothly, with promising data for LAE102 and FDA approval for the IND application of LAE103 [1] - Yongxing Securities has initiated coverage on LAE102 using the DCF valuation method and has given the company a "buy" rating [1]