Baorentang Pharmaceuticals: Pioneering a TCM-Based Oral Drug to Address the $10B+ OSA Market

Recently, obstructive sleep apnea (OSA) has gained wider public awareness due to advocacy by numerous high-profile individuals.

This condition causes intermittent hypoxemia during sleep and disrupts sleep architecture. Untreated obstructive sleep apnea (OSA) is highly likely to be complicated by multi-system and multi-organ diseases, including cardiovascular, cerebrovascular, and endocrine-metabolic disorders. It is closely associated with anxiety, depression, cognitive impairment, and reduced quality of life; in severe cases, it can lead to sudden death during sleep.

In 2019, The Lancet published an article for the first time to assess the global prevalence of OSA. The study results showed that approximately 936 million adults aged 30–69 years worldwide had mild-to-severe obstructive sleep apnea, among whom about 425 million had moderate-to-severe obstructive sleep apnea. China had the largest patient population, followed by the United States, Brazil, and India.

Currently, no specific drug for the treatment of obstructive sleep apnea (OSA) has been launched on the market. As public awareness of OSA continues to grow, this niche sector—boasting a multi-billion-dollar market potential—has attracted strategic investments from multinational corporations (MNCs) such as Eli Lilly, Bayer, and Johnson & Johnson, as well as emerging biotech companies.

In China, there is also a company that must be mentioned in the OSA sector—Zhejiang Baorentang Pharmaceutical Co., Ltd. Unlike many innovative pharmaceutical companies, Baorentang focuses on traditional Chinese medicine (TCM) research and development. Its Class 1.1 new TCM drug, Sanbeizhu Han Capsules, has stood out due to its unique advantages.

Zhejiang Baorentang Pharmaceutical Co., Ltd.Founded in 1886 with its ancestral home in Dongyang City, Zhejiang Province, Baorentang is a time-honored century-old brand of Traditional Chinese Medicine (TCM) in Zhejiang. Over the course of more than 100 years of development, Baorentang has adapted to the times and undergone multiple rounds of transformation to better meet the clinical needs of patients.

However, as a traditional Chinese medicine clinic, Baorentang has been able to benefit only a limited number of patients. To extend its benefits to more patients and enable the large-scale production of its prescriptions as pharmaceutical products, Baorentang aims to summarize the clinical experience of previous generations and translate it into tangible outcomes. In 2000, Dongyang Baorentang Pharmaceutical Co., Ltd. was established, dedicated to building a new drug research and development platform.

In 2008, Baorentang developed its ancestral formula for treating snoring, resulting in Sanbei Zhu Han Capsules, a traditional Chinese medicine used to treat obstructive sleep apnea.

In fact, the development of new traditional Chinese medicine (TCM) drugs is no less challenging than that of Western medicines; Zhejiang Baorentang Pharmaceutical Co., Ltd. has endured a remarkably arduous journey.

Wu Hao is the fifth-generation inheritor of Baorentang. In 2018, he took over the reins from his father, Wu Xunbang, continuing to lead Baorentang’s growth and development. Wu Hao stated, “My father was a clinician, so transitioning from clinical practice to new drug development presented an entirely new challenge. Furthermore, given that awareness of obstructive sleep apnea (OSA) emerged relatively late in China, the development of Sanbei Zhuhansnoring Capsules took a considerable amount of time, requiring substantial investment of both capital and effort.”

Nevertheless, Wu Hao’s takeover has infused Zhejiang Baorentang Pharmaceutical Co., Ltd. with greater innovative vitality, accelerating its traditional Chinese medicine (TCM) development. A graduate of the TCM program at Hong Kong Baptist University, Wu Hao has amassed extensive experience and insights in TCM drug development. He cited two main reasons for pursuing advanced studies in Hong Kong:

First, as the domestic pharmaceutical industry becomes increasingly standardized, the development paradigm for traditional Chinese medicine (TCM) has shifted. It is essential to maintain a clinical need-centric approach while ensuring the advancement of development technologies. This requires not only greater clarity in routes of administration and dosage forms but also optimization of manufacturing processes and clinical trials.

Meanwhile, the School of Chinese Medicine at Hong Kong Baptist University is a leading representative in promoting precision medicine and translational research in traditional Chinese medicine (TCM), as well as spearheading the standardization and globalization of TCM. Its research teams have gained widespread recognition for their work in translational research and drug discovery. The extensive network of clinics operated by the school, grounded in evidence-based medicine, enjoys deep trust among patients.

“Pursuing advanced studies in Hong Kong will better facilitate Zhejiang Baorentang Pharmaceutical Co., Ltd.’s efforts to advance the modernization and internationalization of traditional Chinese medicine,” said Wu Hao. This experience has enabled Sanbei Zhuhansnoring Capsules to be distinctly different from traditional Chinese medicines in their subsequent development.

In May 2022, Baorentang Pharmaceutical was introduced by the Hangzhou Xiaoshan Economic Development Zone, settled in the zone, and was officially renamed Zhejiang Baorentang Pharmaceutical Co., Ltd. Baorentang has entered a new stage of development, formally transforming from a family-owned business into a traditional Chinese medicine (TCM) pharmaceutical enterprise.

After settling in the Xiaoshan Economic Development Zone, Zhejiang Baorentang Pharmaceutical Co., Ltd. will have more abundant resources to improve the efficiency of new drug development and accelerate the clinical trial pace of Sanbeizhu Han Capsules.

In January 2021, Sanbeizhu Han Capsules received approval from the National Medical Products Administration (NMPA) to initiate Phase III clinical trials as a Class 1.1 innovative drug. This achievement is attributable not only to the substantial clinical experience accumulated by predecessors but also closely aligned with Wu Hao’s steadfast philosophy of developing new traditional Chinese medicine (TCM) drugs by integrating clinical efficacy and advanced technologies with the distinctive characteristics of TCM.

Wu Hao told VCBeat, “Currently, there are two major challenges in the research and development of new traditional Chinese medicine drugs: one is the issue of efficacy evaluation, and the other is the clarification of mechanisms of action.”

In terms of efficacy evaluation, traditional assessments of Traditional Chinese Medicine (TCM) are relatively subjective, relying primarily on TCM practitioners’ observations through the four diagnostic methods—inspection, auscultation and olfaction, inquiry, and palpation—to determine therapeutic effectiveness. Regarding the mechanism of action, TCM formulations are multi-component complex preparations containing numerous active ingredients, making pharmacokinetic studies even more challenging than those for chemical drugs.

In response to these challenges, Zhejiang Baorentang Pharmaceutical Co., Ltd. has provided innovative solutions, which form the foundation of Sanbei Ramie Snoring Capsules’ core competitiveness in the field of obstructive sleep apnea (OSA).

For efficacy evaluation, the diagnosis of obstructive sleep apnea (OSA) has an internationally unified gold standard. Using polysomnography, the diagnostic criteria for OSA include: an apnea-hypopnea index (AHI) ≥5 events/hour accompanied by typical symptoms such as daytime sleepiness, fatigue, insomnia, waking with a sensation of gasping or choking, loud snoring, or observed apneas; or an AHI ≥15 events/hour.

Therefore,The Phase III clinical trial of Sanbei Ramie Snoring Capsules will eschew subjective judgments and employ a more objective evaluation system to assess drug efficacy.“More than half of the participating centers in our clinical trials are Western medicine hospitals, which allows us to effectively address the challenges in evaluating the efficacy of traditional Chinese medicine,” Wu Hao stated.

To clarify complex mechanisms of action, Zhejiang Baorentang Pharmaceutical Co., Ltd. has identified core research strategies from the perspective of modern pharmacology. Much like the discovery journey of artemisinin,Zhejiang Baorentang Pharmaceutical Co., Ltd. is based on the clinical achievements of Sanbei Zhuhanti Capsules, seeking to identify and elucidate their active ingredients and mechanisms of action.Thereby facilitating process optimization for drug development and enabling scalable production.

In addition to making significant efforts in the development strategy of new traditional Chinese medicine (TCM) drugs, Sanbei Ramie Snoring Capsules, derived from an ancestral prescription with extensive accumulated clinical experience and outcomes, also demonstrate competitiveness in the treatment of obstructive sleep apnea (OSA).

Currently, the treatment modalities for obstructive sleep apnea (OSA) primarily include risk factor management such as dietary control and increased physical activity, positional therapy, non-invasive positive airway pressure ventilation, oral appliance therapy, and surgical intervention.

Among these, non-invasive positive pressure ventilation (NPPV) is currently the most recommended treatment regimen. This form of artificial ventilation provides ventilatory support by connecting the patient to a ventilator via a nasal or facial mask, with the device delivering positive pressure. While this approach can effectively improve clinical conditions, the bulky and non-portable nature of ventilators may adversely affect patients’ quality of life. If ventilatory support yields limited improvement, surgical intervention becomes the final option; however, surgery is not universally applicable to all patients, particularly those who do not meet the indications for surgical procedures.

Therefore, pharmacological treatment regimens, particularly oral medications, are urgently needed.

In terms of pharmacotherapy, modafinil is the only drug approved in China as an adjunctive treatment for obstructive sleep apnea (OSA). It is classified as a Category I psychotropic substance under China’s Catalogue of Psychotropic Substances, characterized by high addiction potential and strong tolerance, and may cause irreversible damage to the patient’s nervous system.

More new drugs are still in the research and development pipeline. Apart from tirzepatide, recently approved by Eli Lilly for the treatment of obesity-related obstructive sleep apnea (OSA), Sanbeizhen Han Capsules have demonstrated the most rapid clinical progress and boast a broader range of indications.

Wu Hao explained that, from the perspective of Traditional Chinese Medicine (TCM), obstructive sleep apnea (OSA) is closely associated with the syndrome of phlegm and blood stasis mutual accumulation. Sanbei Zhushen Han Capsules treat patients by resolving phlegm, detoxifying, and soothing the throat, thereby strengthening the body’s fundamental constitution.

Compared with other drugs,Sanbeizhu Han Capsules also feature other advantages: as an oral medication, it offers greater accessibility compared to injectable drugs; furthermore, its treatment course is relatively short, lasting only one month, which significantly improves patients' quality of life.

In addition to its flagship product, Sanbei Zhumu Snoring Capsules, Zhejiang Baorentang Pharmaceutical Co., Ltd. will continue to advance the translation of scientific achievements in traditional Chinese medicine (TCM) formulations for other disease areas. To this end, the company is continuously strengthening its drug R&D team and has actively initiated collaborative laboratory partnerships with universities. Looking ahead, Baorentang will accelerate the modernization and internationalization of its products, enabling TCM to benefit a broader patient population.