Frequently Asked Questions

A.Kampo is a medical tradition that has developed independently in Japan over the course of more than 1,400 years since the fifth or sixth century, when it was introduced from China via the Korean peninsula and through Japanese cultural missions to Sui China and Tang China. It is different from the traditional medicine that is practiced in China today.
Kampo was systematized during the Edo period. Western medicine introduced by the Dutch was called "Rampo," so the word "Kampo" was adopted to distinguish Japanese medicine from Western medicine. Traditional medicine from China is called "Chuigaku (Chuyaku)."

In general, we follow classic literature such as the Shang Han Lun and Jin Gui Yao Lue in deciding the crude drugs combined and their compounding ratios in our Kampo medicines.
The standards of use with each medicine (physical symptoms) are also described in those classics.

A characteristic of Kampo treatment is its proper use of various medicines in accordance with the patient's physical condition, illness, etc. This is why Kampo is referred to as tailor-made medicine.

Take a cold, for example: The proper medicines are used after an overall diagnosis is made based on the patient's condition, such as physical strength, period of affliction, and symptoms (fever, runny nose, joint pain, and cough).

• Standards of selection for the prescription vary by disease.

Synthetic drugs (Western medicinal treatment) have only one ingredient and a single medicine is given per symptom. As a result, although the effects are great, the varieties of medicine tend to increase as multiple illnesses build up and symptoms complexify.

On the other hand, a characteristic of Kampo medicines is that they are multicomponent products consisting of multiple crude drugs combined together. Thus, there are cases when a single medicine can treat multiple symptoms.

According to a survey taken in 2011 by the Japan Kampo Medicines Manufacturers Association, 89.0% currently use Kampo medicine; a 5.5% increase from the 83.5% reported in a previous survey in 2008, showing a rise in doctors prescribing Kampo medicine.

Some reasons for prescribing it are that acknowledgement of further efficacy of Kampo medical treatment with symptoms unaffected by Western medical treatment have soared to a maximum of 57%, while cases of its being requested by patients, evidence being reported at academic and other conferences, doctors feeling limitations with only Western medicine, and its allowance of holistic treatment improving quality of life continue.

• Holistic treatment places importance on individual physical condition and characteristics, and emphasizes promoting harmony throughout the body on the premise that the body and mind are one.

There are reports of Yokukansan's therapeutic effects in improving behavioral and psychological symptoms without impeding daily activities such as eating, dressing, or walking.
Improvements in the behavioral and psychological symptoms of those with dementia not only reduce their need for treatment but also mitigate the burden on the families and medical professionals who provide nursing care.

Rikkunshito is used against indefinite complaints regarding the upper abdomen brought on by functional dyspepsia (FD), gastroesophageal reflux disease (GERD), and other conditions.

During the US's Digestive Disease Week (DDW), Rikkunshito use was acknowledged as promoting appetite through secretion of the peptide hormone ghrelin in addition to an effect heightening the gastric excretion of food as well as retentive function in the stomach.

Daikenchuto is widely used in the field of surgery against the sense of abdomen distension brought on by postoperative ileus (paresis of the intestine), etc.

Anticipation with Daikenchuto also increases as clinical and basic research with its effects promoting enterokinesis enhancement and improved intestinal blood flow move forward.

Approximately 90% of Tsumura's sales are prescription Kampo medicines prescribed by hospitals.
At present, there are 148 Kampo medicine products that are NHI price-listed and covered by health insurance, and 129 of those products are sold by Tsumura.

Tsumura's prescription Kampo preparations were NHI price-listed for the first time in 1976. Since then, they have come to be widely used at hospitals for reasons that include the increase in Kampo popularity due to their perceived safety and the wide use of shosaikoto for treating chronic hepatitis. Our sales peaked in 1991, when our medicinal product had net sales of more than 100 billion yen. Shosaikoto accounted for 30 billion yen of that.

However, sales started trending downward after interferons hit the market as a drug treatment for chronic hepatitis and adverse drug reactions related to chronic hepatitis were reported for shosaikoto. A large-scale report of adverse drug reactions, including instances of death, was published in 1996, and the shock of deaths occurring due to Kampo medicines, which had previously been considered safe, caused a further decline in sales.

In light of these circumstances, we undertook a review of our sales strategy. The results of our strategy to promote the widespread adoption of Kampo medical science itself resulted in a recovery trend after bottoming out in 1999.
Sales have increased even further since we began collecting evidence through the "Kampo drug fostering and evolution program" in 2004.

The size of the market for Kampo products (prescription Kampo preparations) reached 158.3 billion yen in fiscal 2019.

The market has steadily grown after hitting bottom in 2000. Tsumura's share of the prescription Kampo preparation market was 83.5% as of the end of March 2019.

The compositions of Kampo medicines and their target diseases (symptoms) were compiled and published in medical texts over 1,800 years ago, so there are no patents. Nevertheless, there are high barriers to entry in the business of Kampo medicines.

1. If a company intends to release a Kampo medicine already sold by another manufacturer to market, they need to scientifically demonstrate that it is equivalent in terms of safety, efficacy, and so on (biological equivalence).
2. Selling new products, which would become the 149th and 150th Kampo medicines on the market, would require conducting clinical trials similar to those conducted for Western medicine. However, due to issues of cost effectiveness, such as recouping R&D investments, no new Kampo medicines are being developed at present.

Furthermore, because the crude drugs are natural products, and Kampo medicines are multicomponent products consisting of multiple crude drugs combined together, a fairly high degree of expertise is needed to achieve stable production of Kampo medicines while maintaining a certain level of quality at all times.

At present, Tsumura is not developing any new Kampo medicines. Our goal is to expand the use of our 129 prescription medicines that have already been approved.

Tsumura handles 119 different crude drugs that are the raw materials used for making our 129 Kampo products. Roughly 80% of them are imported from China. The plants that serve as raw materials for our crude drugs are grown in the local soil and environment that they have been adapted to since ancient times and from which they derive their value as medicinal ingredients. These traditional crude drugs survive to this day as distinctive botanical substances that exhibit moderate yet reliable effects.

About 90％ of crude drugs come from China and the remaining approx. 10% are from Japan, Laos and other countries.
Additionally, with respect to new procurement countries, we have plans to cultivate crude drugs in Laos, and we established a local subsidiary, LAO TSUMURA CO., LTD., in FY2009.
In order to standardize the cultivation methods and cultivation management used in each of these regions and to ensure a stable supply of crude drugs, we will continue to expand cultivation under long-term contracts and will expand the acreage devoted to cultivation in China and Japan.

Even the same crude drug used as a raw material for Kampo products can vary in its constituents due to factors such as location and cultivar.
At Tsumura, in order to produce and sell products that exhibit consistent quality and consistent medicinal efficacy at all times, we have developed an integrated system in which everything from securing the availability of the crude drugs used as raw materials to establishing production methods and equipment that are suited to Kampo extract products, carrying out product control and quality control, and shipping is conducted in-house.
As one method of quality control, we have put effort into researching quality control using 3D-HPLC (three-dimensional high-performance liquid chromatography).

We have six locations in Japan (Hokkaido, Iwate, Gunma, Kochi, Wakayama, and Kumamoto) where we grow crude drugs. Going forward, we will be boosting our cultivation in Japan.
In Hokkaido, we have established a production, processing, and storage center for crude drugs in the city of Yubari. We established a subsidiary (Yubari Tsumura Co., Ltd.) for controlling the operations of our production, processing, and storage center for crude drugs in Yubari in July 2009, and we plan to expand our crude drug cultivation.

Due to the problem of adverse drug reactions related to shosaikoto, it seems that we need to take not only direct measures related to Kampo medicines, but also indirect measures related to Kampo medical science.
In order to promote Kampo medical science, there are three activities we are targeting.

1. Support for more comprehensive Kampo medical science education aimed at students who want to become doctors and pharmacists in the future
2. Kampo seminars aimed at doctors who examine patients
3. Public lectures and other Kampo seminars for sharing correct Kampo-related knowledge with the general public and media

Our past sales activities didn't present doctors with enough evidence, so we were focused on making visits to doctors who were already using Kampo.
However, today, we have created a framework for steady, sustained growth of Kampo through sales activities targeting every level of medical institutions.

As for our medical representative system, we introduced a dedicated university system in 2006 and a partially dedicated system for designated clinical training hospitals afterward, in 2007.

There are 82 university medical departments and medical universities in Japan. With regard to Kampo medical science education, we are supporting the introduction of a faculty development system (FD) at each university.

We also support the creation of standardized Kampo medical science textbooks in each domain that follow evidence-based medicine.

In addition to classroom lectures, we provide support for the establishment of Kampo outpatient clinics at 82 universities in order to provide practical training in clinical settings.

The number one reason given by clinical physicians who don't prescribe prescription Kampo preparations is that "Kampo products have no scientific basis." Accordingly, after looking at disease patterns in recent years, we have selected certain diseases in fields that are in serious need of treatment and that are difficult to treat with new drug therapies, but that prescription Kampo preparations have demonstrated particular efficacy for. In 2004, we launched an initiative called "Drug Fostering" in order to establish an evidential scientific basis for Kampo products.

Currently, out of our 129 prescription products, we have selected five for the Drug Fostering program: Daikenchuto, Rikkunshito, Yokukansan, Goshajinkigan, and Hangeshashinto. We have been promoting foundational and clinical research in order to establish an evidential basis for these products.

Tsumura's Kampo products have been accepted as a research subject at Digestive Disease Week (DDW), which is hosted in the US.

DDW is one of the world's largest medical conferences attended by numerous medical professionals and researchers from countries around the world each year. Interest in Kampo is growing not only in Japan but overseas as well.

A new domain for our "Drug Fostering" program is the cancer domain, and we are targeting Kampo products that are effective at treating the adverse drug reactions caused by cancer drugs.
Two prescription preparations were added in November 2009.

One of them, Tsumura Goshajinkigan, is the target of research that aims to reduce the symptoms of peripheral neuropathy (e.g., numbness) caused by cancer drugs. Another, Tsumura Hangeshashinto, is the target of research that aims to reduce the symptoms of mucosal disorders (diarrhea and mouth ulcers) caused by cancer drugs.

We believe that the adverse drug reactions caused by cutting-edge therapeutic drugs can be effectively reduced by administering Kampo products without compromising the efficacy of those drugs.

Tsumura promotes the internationalization of Kampo by selecting diseases that are difficult to treat in the US, but that Kampo products have demonstrated particular efficacy for.

We are developing a system for linking the latest research results achieved within Japan through the Daikenchuto Forum in particular with the US clinical trial process and are promoting the exchange of information between leading doctors in Japan and the US in order to build a more effective development framework.