The Hong Kong stock exchange has disclosed that LYB Medicine, a company specializing in renal diseases, has successfully passed its main board listing hearing. With Jefferies, BofA Securities, and Huatai Securities acting as joint sponsors, the firm is positioned to become a pioneering listed entity in Hong Kong's nephrology innovation drug sector.
Its core product, AP301, classified as a Class 1 new drug for treating hyperphosphatemia, has completed its Phase III clinical trial in China and is preparing to submit a New Drug Application (NDA). A global multi-regional Phase III clinical trial is also underway in both the United States and China. Notably, only two molecules are in the clinical stage for hyperphosphatemia globally, with LYB Medicine holding both.
The company's pipeline includes AP306, acquired from Japan's Chugai Pharmaceutical for treating refractory membranous nephropathy, which has received Breakthrough Therapy Designation. Other candidates are AP303 for polycystic kidney disease, which has secured FDA Orphan Drug designation, and AP308, an IgA protease for IgA nephropathy.
On the commercial front, LYB Medicine holds exclusive rights in mainland China for Mircera®, Roche's long-acting erythropoiesis-stimulating agent used for anemia in chronic kidney disease (CKD). Financially, the company reported a significant 368% surge in revenue to 30.556 million yuan in 2025, providing initial validation of its commercial strategy. Research and development expenses increased by 59% year-over-year, rising from 235 million yuan to 373 million yuan.
Market projections indicate the global hyperphosphatemia drug market will grow from $18 billion in 2025 to $64 billion by 2035. The corresponding market in China is expected to expand from 1.8 billion yuan to 10.7 billion yuan. As an innovator with one of the most comprehensive and advanced pipelines in the renal disease field, LYB Medicine's potential listing is anticipated to accelerate product commercialization, making it a distinctive investment opportunity in a promising market segment.