SBP GROUP (01177.HK): Kylo-11 Phase I data published in The Lancet; single dose reduces Lp(a) by up to 97% at week 48

NewTimeSpace News: On 31 August 2026,Sino Biopharmaceutical Limited (stock code: 01177) announced that the final results of the Phase I clinical study of Kylo-11 ("LPA siRNA"), a Class 1 innovative drug independently developed by its wholly-owned subsidiary Hangzhou Hejiya Biomedical Co., Ltd., were presented as a Late-Breaking Clinical Science (LBCT) oral presentation at the 2026 Congress of the European Society of Cardiology (ESC), with the full study concurrently published in The Lancet (IF: 109).

According to the announcement, the study was a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose clinical study in which 70 subjects actually received Kylo-11 or placebo. Final data showed that a single dose of Kylo-11 significantly and durably reduced Lp(a): at week 48, the median percentage reductions from baseline in Lp(a) in the mid-to-high dose groups were 94.6% in the 225 mg group (cohort 4), 95.6% in the 225 mg group (cohort 7, higher baseline group), 96.3% in the 450 mg group (cohort 5) and 97.0% in the 600 mg group (cohort 6); in cohort 7, subjects had a median baseline Lp(a) of 217.7 nmol/L, and after a single 225 mg dose, Lp(a) fell by a median absolute reduction of 207.7 nmol/L from baseline at week 48, with median Lp(a) declining to 10.5 nmol/L. In the 225 mg and above dose groups, Lp(a) approached its maximum reduction approximately 4 weeks after dosing and was maintained through week 48, providing important clinical evidence supporting the "once-a-year" dosing strategy.

In terms of safety, within 24 weeks after dosing, 37 of the 70 subjects reported adverse events, predominantly of grade 1-2, most of which were judged by investigators to be unrelated to the study drug; by the end of the 48-week study, no clear trend of increasing adverse event rates with dose was observed, and no serious adverse events, injection site reactions or deaths occurred, with Kylo-11 generally well tolerated.

Kylo-11 is a long-acting siRNA drug targeting the LPA gene, which lowers serum Lp(a) by targeting hepatic LPA mRNA and inhibiting apolipoprotein(a) synthesis; unlike conventional GalNAc-siRNA structures, Kylo-11 adopts a non-canonical siRNA molecular design with two GalNAc groups conjugated at the 3' end of the sense strand and another two GalNAc groups at the 5' end of the antisense strand. Kylo-11 is currently undergoing a Phase II clinical study in China and the United States in patients with atherosclerotic cardiovascular disease (ASCVD) and elevated Lp(a).

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