LONGBIO-B (01779.HK): LP-005 hits Phase II endpoints in PNH
- The multicentre, randomised, open-label trial (CTR20242478) tested 900 mg, 1,200 mg and 1,500 mg cohorts dosed intravenously every four weeks for 48 weeks.
- The trial enrolled 30 PNH patients, 27 of whom completed 24 weeks of treatment, with all three cohorts reaching 100% transfusion avoidance and no breakthrough haemolysis.
NewTimeSpace News: On 21 October 2026, LongBio Pharma (Suzhou) Co., Ltd. (stock code: 01779) released Phase II data for LP-005, a bispecific antibody fusion protein targeting C5 and C3b, in paroxysmal nocturnal haemoglobinuria (PNH). The multicentre, randomised, open-label trial in China tested 900 mg, 1,200 mg and 1,500 mg cohorts dosed every four weeks for 48 weeks, enrolling 30 PNH patients, 27 of whom completed 24 weeks of treatment.
At week 12, haemolysis control, defined as LDH below 1.5 times the upper limit of normal, reached 100% in the 1,200 mg and 1,500 mg cohorts, all three cohorts had 100% transfusion avoidance and no breakthrough haemolysis. At week 24, 85.7% (6/7) of the 1,500 mg cohort had haemoglobin rise by at least 2 g/dL without transfusion and 71.4% (5/7) reached 120 g/L or above. No treatment-related serious adverse events were reported. The Board said the data support further development and reflect the long-acting four-weekly profile.
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