SBP GROUP (01177): KYLO-11 "LPA SIRNA" announces Phase I clinical data at ESC 2026 and in The Lancet.

SBP GROUP (01177) announced that its wholly-owned subsidiary, Hangzhou Hejiya Biomedical Co., Ltd. (Hejiya Bio), has independently developed the national class 1 innovative drug Kylo-11 LPA siRNA. The final results of its phase I clinical study will be presented as a Late-Breaking Clinical Science (LBCT) oral report at the 2026 European Society of Cardiology (ESC) Annual Congress; simultaneously, the full research paper will be published in the top-tier journal The Lancet (IF: 109) by Xi'An International Medical Investment. This research is a randomized, double-blind, placebo-controlled, single ascending dose first-in-human clinical study involving 70 subjects who actually received either Kylo-11 or a placebo. In the study, cohorts 1-6 included subjects with baseline Lp(a) levels of 75-200 nmol/L, who received single subcutaneous injections of 9 mg, 30 mg, 75 mg, 225 mg, 450 mg, and 600 mg of Kylo-11, respectively. Cohort 7 included subjects with baseline Lp(a) levels >200 nmol/L, who received a single injection of 225 mg of Kylo-11 to further evaluate its safety and efficacy in reducing Lp(a) levels in a high Lp(a) population. Final data showed that a single administration of Kylo-11 significantly and durably reduced Lp(a). In the mid-to-high dose groups, the median reductions in Lp(a) levels at 48 weeks compared to baseline were: 94.6% for the 225 mg dose group (cohort 4), 95.6% for the 225 mg dose group (cohort 7 - higher baseline group), 96.3% for the 450 mg dose group (cohort 5), and 97.0% for the 600 mg dose group (cohort 6). Notably, for cohort 7, the median baseline Lp(a) level was 217.7 nmol/L, and following a single 225 mg dose, the median Lp(a) level decreased by an absolute 207.7 nmol/L to a median of 10.5 nmol/L at 48 weeks. It is noteworthy that in the 225 mg and higher dose groups, Lp(a) approached its maximum reduction about 4 weeks after administration and maintained this level until 48 weeks. These results demonstrate that Kylo-11 has the potential for profound and lasting reductions in Lp(a) after a single dose, providing important clinical evidence for further validation of an "annual administration" strategy in subsequent clinical studies. Safety was the primary endpoint of this study. Within 24 weeks post-administration, among the 70 subjects, 37 reported adverse events mainly classified as grade 1-2, with the vast majority deemed unrelated to the study drug by researchers; by the end of the 48-week study, no significant trend was observed for increased adverse event rates with rising dosages; there were no serious adverse events, injection site reactions, or deaths observed, nor were there adverse events leading to drug discontinuation, medication withdrawal, or subject dropout from the study, indicating that Kylo-11 has good overall tolerability.