Recently, for Kylo-11 (LPA-siRNA), independently developed by Hygieia Pharma, a wholly-owned subsidiary of Sino Biopharm (1177.HK), the enrollment of all subjects in the China region for a Phase II clinical trial has been successfully completed. The trial is being conducted simultaneously in China and the US for atherosclerotic cardiovascular disease (ASCVD) with elevated lipoprotein (a) [Lp(a)]. Patient enrollment in the US is still ongoing. Leveraging its proprietary core delivery technology, Kylo-11 has the clinical potential for potent lipid-lowering, ultra-long-acting administration, and excellent safety. It is expected to fill the global gap in Lp(a)-targeted therapy and bring new treatment options to high-risk cardiovascular patients. 

Atherosclerotic cardiovascular disease (ASCVD) is a group of diseases caused by atherosclerosis, including coronary heart disease, cerebrovascular disorder, and peripheral artery disease, and has become a major cause of death worldwide. Lipoprotein(a) [Lp(a)], a genetically determined cholesterol-rich particle, has been established as an independent risk factor for ASCVD, with dual risks of atherogenesis, pro-inflammatory responses, and thrombosis ^{[1, 2]}. Currently, there are no effective treatments specifically for lowering Lp(a) levels worldwide, representing a significant unmet clinical need. 

Kylo-11 was developed based on Hygieia Pharma's proprietary MVIP delivery platform and has best-in-class (BIC) potential. As the first siRNA delivery technology platform in China to receive global patent authorization, MVIP utilizes the world's first dual-conjugate siRNA delivery technology for liver-derived diseases. It can effectively prevent exonuclease degradation of the antisense strand's terminal fragments and reduce the degradation of the antisense strand in plasma, thereby achieving efficient delivery and long-term stability. This technological breakthrough gives Kylo-11 the ultra-long-acting potential for "once-a-year dosing", which is expected to significantly improve patient medication compliance and quality of life. 

The ongoing Phase II clinical study (Kylo-11-II-C01) aims to evaluate the efficacy and safety of Kylo-11 administered semi-annually or annually in patients with ASCVD and lipoprotein (a) increased. Previously, Phase I clinical data^[3] announced at the American Heart Association (AHA) Scientific Sessions 2025 showed that Kylo-11 demonstrated a significant and durable reduction in serum Lp(a) levels after a single dose:

● At 24 weeks, the reductions for cohorts 1-7 (9 mg, 30 mg, 75 mg, 225 mg, 450 mg, 600 mg, and 225 mg) were maintained at 83.5%, 88.9%, 95.2%, 96.7%, 97.2%, 97.4%, and 98.4%, respectively. 

● In subjects with baseline Lp(a) of 75-200 nmol/L, the Lp(a) reduction in the 30 mg group (cohort 2) was still maintained at 77.6% at Week 48, the reduction in the 75 mg group (cohort 3) was maintained at 88.8% at Week 44, and the reduction in the 225 mg group (cohort 4) was maintained at 96.7% at Week 40. 

● In subjects with baseline Lp(a) >200 nmol/L who received a single 225 mg dose, the Lp(a) reduction was still maintained at 98.4% at Week 28. 

● In dose groups of ≥30 mg, subjects' serum Lp(a) levels dropped below 75 nmol/L from week 4 post-dosing and remained below this level throughout the follow-up period. 

Meanwhile, Kylo-11 demonstrated good safety and tolerability. Most treatment-emergent adverse events were Grade 1-2 and not related to the study drug. No serious adverse events, adverse events leading to study discontinuation, or injection site adverse reactions occurred during the trial. 

References:

[1] PAMIR N, FAZIO S. Lipoprotein (a)gets worse [J].Circ Res,2020,126(10): 1360-1362.

[2] Wu Danrong, Lin Xiankao. Role of lipoprotein(a) in atherosclerotic cardiovascular disorder and new progress in its treatment[J]. Frontiers of Medicine, 2026, 16(08):38-41+45. 

[3] Xiaolin Du, et al.Dose-Dependent and Sustained Reduction in Lipoprotein(a) levels after single-dose of Kylo-11, a LPA-targeted Small Interfering RNA, in Healthy Volunteers: A First-in-Human Phase I Study.2025 AHA.#4390197.

Declaration:

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

Forward-Looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expected clinical benefits and advantages, commercialization prospects, the possibility of clinical benefit to patients, and potential commercial opportunities for [Kylo-11]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.