Shares of ALEBUND-B (09637) rallied sharply in the afternoon, climbing more than 17% at one point. At the time of writing, the stock was up 12.96% to HK$25.98, with turnover reaching HK$36.28 million.

The surge comes after the company recently announced that its investigational new drug (IND) application for AP308, a therapeutic candidate for IgA nephropathy, has been cleared by the US Food and Drug Administration (FDA). The company plans to initiate the first-in-human clinical trial for AP308 in the near term.

The IND clearance for AP308 marks a significant milestone, transitioning this first-in-class drug candidate from preclinical research into the clinical development stage. According to the company's announcement, IgA nephropathy is the most common primary glomerulonephritis worldwide, with approximately 9.5 million patients globally in 2025, of whom about 5.1 million are in China, representing more than half of the global patient population.

Notably, around 60% of Chinese patients progress to end-stage kidney disease within 15 years of diagnosis. AP308 offers a differentiated therapeutic approach by directly cleaving and clearing pathogenic IgA and IgA immune complexes deposited in the glomeruli, potentially addressing the current unmet clinical needs in this disease area.

Where to begin with investment considerations? The FDA approval underscores the company's research capabilities in the nephrology space, but investors should closely monitor the progress of early-stage clinical trials and the drug's safety and efficacy profile in human subjects.