Libang Pharmaceutical-B (9637 HK): A Kidney-Disease Leader Aiming at the Global Hyperphosphatemia Market
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Key Views
- AP301, now in China NDA review, showed a 66.7% serum-phosphorus response rate versus sevelamer carbonate with a lower daily pill burden; risk-adjusted peak sales of about RMB3.5bn are expected across China and the US in 2030.
- AP306, licensed to R1 Therapeutics, delivered superior phosphorus control versus sevelamer in Phase IIa, with mild-to-moderate diarrhea the most common adverse event (44.4%); peak sales of roughly RMB1.7bn in China (2035) and US$1.4bn in the US (2034) are expected.
- Mircera, marketed for anemia of chronic kidney disease, should reach roughly RMB1.0bn of peak China sales in 2034.
- AP308, a potential first-in-class engineered recombinant IgA protease, aims for functional cure of IgA nephropathy.
- Forecast revenue is RMB128m, RMB129m and RMB713m for 2026-2028; the company remains loss-making.
Outlook
AP301 is expected to launch in China in 2027 and the US in 2028; AP306's multinational Phase III trial supporting an FDA filing is planned to start in 2027; and Roche is expected to resolve Mircera supply constraints in 2H27.