Shibeikang's First-in-Class Mucolytic Drug SBK001 Achieves Success in Phase II Clinical Trial

Recently, the Phase II clinical trial of SBK001 Injection, a global first‑in‑class Category 1 new drug independently developed by Chengdu Shibeikang Biomedical Technology Co., Ltd. (hereinafter referred to as "Shibeikang"), was successfully completed. As the world's first MUC5AC‑specific inhibitor, SBK001 demonstrated dual breakthroughs in efficacy and safety in a head‑to‑head comparison with a classic positive control drug.

Global First-In-Class Innovation: Overcoming Therapeutic Limitations with a Novel Target
SBK001 is a global first‑in‑class MUC5AC‑specific inhibitor with a novel chemical structure and the first Category 1 innovative mucolytic drug in China targeting this target. It directly addresses the core challenge of difficult mucus clearance in patients with lower respiratory tract diseases. This Phase II trial employed a rigorous multi‑center, randomized, double‑blind, placebo‑ and active‑controlled parallel design to comprehensively evaluate the efficacy, safety, and pharmacokinetic profile of SBK001.

Superior Efficacy and Safety, Significantly Enhancing Patient Compliance
In terms of efficacy, the primary efficacy endpoint in the SBK001 treatment group showed a statistically significant improvement compared with the placebo group and was superior to Ambroxol Hydrochloride Injection, a classic mucolytic drug used in clinical practice.

In terms of safety, SBK001 demonstrated favorable overall safety and tolerability across all dose groups, with no drug‑related adverse events leading to subject withdrawal and an adverse reaction incidence comparable to placebo.

Additionally, SBK001 offers a convenient once‑daily dosing regimen, a notable improvement over Ambroxol Hydrochloride Injection, which requires 2–3 daily administrations, thereby substantially improving patient compliance.

Accelerating Market Launch: Phase III Clinical Trials to Begin Soon
The success of this Phase II trial fills a global gap in mucolytic therapy targeting this target. Shibeikang is now actively advancing preparations for the Phase III clinical trial of SBK001 in China to further validate its efficacy and safety, with the goal of bringing this first‑in‑class innovative therapy to patients as soon as possible.