In 2020, the Ministry of Health and Welfare’s National Research Institute of Chinese Medicine (NRICM) came up with the formulation for NRICM101 and embarked on a program of research while also pursuing licensing of the formula to manufacturers. The institute subsequently authorized eight GMP-certified TCM drug makers to produce and sell the formulation. Overseas markets caught wind of NRICM101 early, triggering a buying frenzy that saw acupuncturists, doctors of Chinese and Western medicine, and Chinese communities in Europe and the US enthusiastically sharing information both on the product’s efficacy and on where to purchase it.

The reason for NRICM101’s unusual progress from development in Taiwan, to sales abroad, and then back again to Taiwan was that Taiwan was managing the pandemic quite well in early 2020. NRICM director Su Yi-chang initially decided not to distribute it domestically because, given that we weren’t struggling with Covid when the formulation was finalized in late January 2020, he anticipated little local demand for the product.
 

Sun Ten Pharmaceutical sells its version of NRICM101 as a water-soluble preparation, adding extra mint to make the product more palatable for non-Chinese users.
 

A broad solution

NRICM advanced its research on the formulation in early 2020. In April of that year, Tri-Service General Hospital treated a critically ill Covid patient in its care with a combination of Western and Chinese medicine. When the decoction that Su and the TCM department at the hospital prescribed proved effective, with the consent of patients and of doctors in the infectious disease department and patients, they began to provide complementary TCM treatments to other Covid patients at the hospital. Their efforts resulted in a dozen or so patients being cured and released from the hospital, providing an initial clinical demonstration of the effectiveness of NRICM101.

With the emergence of a major outbreak of Covid-19 in Taiwan in 2021, 15 hospitals and a NRICM research group created a platform for clinical trials. These institutions then conducted a study that ran from May to early August of that year and involved 524 patients, including more than 100 who were critically ill. The research found that patients given NRICM101 were 80% less likely to progress to serious illness than patients who did not receive the formulation. It further found that NRICM102, a variation on NRICM101, lowered the mortality rate of critically ill patients by more than 50%. 

NRICM101 is based on a 470-year-old TCM formulation known as jingfang baidusan, which NRICM adapted to address the variability of Covid-19 and its differences from SARS, as well as the preparation’s clinical performance. While some TCM practitioners argue for individualized treatment of every patient, Su notes that we are in the midst of a pandemic, and that doctors of TCM have long made broad use disease-specific formulations during epidemics as a means of treating people more quickly.

Scientific evidence

NRICM101 contains ten TCM ingredients. Research conducted by five NRICM laboratories has shown it to be effective against Covid-19 in the areas of relieving fever, improving overall health, and strengthening immunity. Biomedicine & Pharmacotherapy published the results of these studies in its January 2021 issue.

In Su’s analysis, NRICM101 is more effective than simple antiviral treatments because it is a multi-target treatment that inhibits the ability of the Delta and Omicron variants to infect, replicate and cause inflammation. In other words, it reduces the symptoms of the disease while also disrupting its transmission and stabilizing cardiopulmonary function.

Tsai Keng-chang, an associate research fellow at NRICM, explains that NRICM101 inhibits the virus’ spike protein-ACE2 interactions, preventing the virus from infecting host cells. In the event that the virus does enter a cell, the formulation also inhibits 3CL protease activity, interfering with the virus’ ability to replicate.

Covid attacks alveolar macrophages in the lungs. In critically ill patients, this can initiate cytokine storms that severely damage the patient’s tissues and organs and even cause death. NRICM101 and NRICM102 inhibit IL-6 and TNF-α in alveolar macrophages, which helps stop the formation of cytokine storms, reducing injury to the lungs and lowering the risk of pulmonary fibrosis.

The NRICM102 formulation, which targets critically ill patients, offers even greater support for the lungs. NRICM’s Pulmonary Embolism and Stroke Laboratory has conducted experiments with NRICM102 that have identified a mechanism which inhibits the formation of pulmonary fibers.
 

NRICM101 and NRICM102 are multi-target formulations that are designed to treat Covid-19 and help prevent severe illness.
 

Starting overseas

In May of 2020, while Covid was rapidly spreading around the world, GMP-certified drug makers Sun Ten Pharmaceutical Co. and Chuang Song Zong Pharmaceutical Co. acquired licenses to make NRICM101 and immediately began developing production processes. They converted the original decoction used in the clinical trails into an easy-to-consume soluble powders, and quickly acquired licenses to manufacture them for export.

According to Winnie Hsueh, a manager in the international trade department at Sun Ten, traditional Chinese medicines are seen as health foods or supplements overseas and regulated accordingly. In October of 2020, the company acquired the registrations and permissions it needed to sell its NRICM101 formulation, branded as “Respire Aid,” in Luxembourg, the UK, Singapore, the US and Canada. It then worked with local doctors of Western and Chinese medicine and acupuncturists in these countries to introduce the preparation to patients with confirmed diagnoses. By the time of 2021’s Delta and Omicron outbreaks, Taiwanese communities abroad were buzzing about the formulation, and you could even buy it on Amazon.

NRICM was able to get the formulation approved for sale in Europe and the US because Su excluded ingredients in the original TCM prescription that are banned overseas, such as ephedra, Manchurian wildginger, and gypsum.

Sun Ten recognized that people outside of Taiwan often have trouble taking Chinese medicines because they find them to be bitter, and the powdered forms earthy and hard to swallow. To get around these issues, foreign users often mix them with water. Hsueh says that Sun Ten improved its version’s flavor and mouthfeel by adding extra mint, and then packaged it in convenient instant packets. “The goal was to make a ‘good medicine that tastes good.’”

But NRICM101 remains a Chinese medicine, and still has that Chinese medicine taste even when you mix it with water to make a drink. On the other hand, what matters to sick patients isn’t flavor, but effectiveness. As of the end of January 2022, Sun Ten had sold 100,000 boxes of the formulation to 55 countries. While ethnic Chinese account for 60% of the purchases, many others, including even the King of Eswatini, a diplomatic ally of Taiwan, have also benefited from the preparation.

In addition, even after recovering from Covid many people in the US and Europe have continued to have difficulty breathing or struggled with exhaustion so severe that they’ve had to take sick leave or even quit their jobs. Sun Ten has therefore introduced “RestorAid,” a product aimed at the needs of these convalescent patients. Hsueh expects demand for the product to remain high for at least five years.

A contribution to world health

In Taiwan, NRICM101 requires an examination and prescription from a doctor of TCM and the cost is borne by the National Health Insurance system. Overseas, the cost is about US$60 per box, with a ten-day course requiring roughly two boxes. But even so it is very inexpensive when compared to Western Covid drugs that can cost US$100-140 per day.

Liaw Chia-ching, an assistant research fellow at the NRICM and curator of its herbarium, says that the roughly NT$3000 cost a course of NRICM101 is much more affordable than the NT$70,000-80,000 cost of a course of injections of Western pharmaceuticals. This low price makes NRICM101 much more accessible to patients in developing nations.

As Su points out, Taiwan’s integration of Western and TCM healthcare and education is the best in the world. More, our medical system’s patient-oriented approach and quality of integrated care also lead the world. Taiwan’s development, clinical testing, and international distribution of NRICM101 demonstrate to the international community that we have the capability to pioneer new R&D breakthroughs in TCM and natural pharmaceuticals.

For more pictures, please click《A TCM Prescription for Covid: Taiwan’s NRICM101》