An Attempt to Scientifically Standardize Traditional Medicine

The Phase 2 clinical trial (NCT05665777) of Qingyan Lihou Decoction, led by the Chinese University of Hong Kong, represents a significant effort to validate the efficacy of a traditional Chinese medicine formulation using a Western-style randomized, double-blind, placebo-controlled design. In the past, natural product-based drugs or traditional remedies have been limited by their reliance on subjective symptom improvement, preventing them from gaining proper recognition in the global pharmaceutical market. This study aims to demonstrate the objective efficacy of a traditional medicine through a modern Phase 2 clinical trial, presenting a new research and development (R&D) milestone for the natural product biotech market in Asia. The researchers plan to systematically verify long-term drug safety and recurrence inhibition through 8 weeks of treatment and 8 weeks of follow-up observation.

Unmet Needs and Limitations in the Treatment of Chronic Pharyngolaryngitis

Patients with chronic pharyngolaryngitis experience a significant reduction in their quality of life due to symptoms such as globus sensation, chronic cough, and pain. However, there are currently no targeted therapies available to fundamentally treat this condition. In clinical practice, nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetic sprays, and even antibiotics, which carry a risk of misuse, are often prescribed indiscriminately, posing a significant risk of adverse effects. Qingyan Lihou Decoction has been developed with the clear objective of overcoming the limitations of existing standard treatments by controlling this chronic inflammatory state without causing systemic adverse effects. We are confident that if a safe, naturally derived treatment is successfully introduced to the market, it will become a valuable alternative for healthcare professionals and patients who desire long-term treatment options.

Multi-Target Mechanism and Differentiated Pipeline Value

Qingyan Lihou Decoction is a complex formulation consisting of 22 natural medicinal ingredients. Unlike synthetic drugs that target only a single protein receptor, it adopts a multi-target approach. During the clinical trial, changes in inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and white blood cell (WBC) count will be tracked to demonstrate the molecular biological pharmacological mechanism. Because it simultaneously blocks multiple inflammatory pathways, it has the significant advantage of being free from the drug resistance problems commonly associated with single-mechanism drugs. The objective data obtained from this multi-component formulation can be used as a key value-demonstration material in future technology licensing (L/O) negotiations with global pharmaceutical companies.

Overcoming Regulatory Barriers and Global Market Prospects

The global pharyngitis treatment market is estimated at approximately USD 2.5 billion in 2025 and is projected to grow to as much as USD 6 billion by 2030-2035. Although this formulation is currently in Phase 2 clinical trials and has no prior approval from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), the study is being conducted in accordance with the standards of the Hong Kong Department of Health. In particular, with the strengthening of regulations to prevent antibiotic misuse, the growth of the safe, natural product-based treatment segment, which can replace existing throat lozenge markets such as Reckitt (RKT)'s Strepsils, is very rapid. If this clinical trial is successfully completed, it is expected that it will lay the foundation for replacing a portion of the global throat lozenge market, which is worth over USD 5 billion annually, with prescription (Rx) or high-functionality over-the-counter (OTC) products.