Kobayashi Pharmaceutical's red yeast rice health products have caused 4 deaths, and a number of its Internet celebrity products are selling well in China|Focus Analysis
Text: Hu Xiangyun
Edited by Hai Ruojing
On March 28, Kobayashi Pharmaceutical said that the number of deaths from taking the company's red yeast rice ingredient health product "Red Yeast Cholesterol Granules" has reached 4.
The day before, the number had been two deaths and 106 hospitalizations. Details of the death were not released, "doctors said it was due to kidney damage." Hideaki Karaki, a professor emeritus at the University of Tokyo, believes that the number of hospitalizations may be "several times higher" than the current base.
According to CCTV News, citing Japanese media reports, in 2023, Kobayashi Pharmaceutical will produce about 18.5 tons of red yeast rice raw materials, of which 2.4 tons will be produced for self-use and health care products, and the remaining about 16.1 tons will be sold to other food, cosmetics companies and wholesalers. Among them, products that may cause damage to human health are concentrated in batches after September 2023.
Since March 22, Kobayashi Pharmaceutical announced for the first time that some consumers had poor kidney function after taking the company's health products containing red yeast rice ingredients, and recalled three products, including "Red Yeast Cholesterol Granules", "Red Yeast Rice Reduction + Cholesterol Reduction Granules with Red Yeast Yeast Rice as Raw Materials", and "Nattokinase Refreshing Granules GOLD", to domestic and foreign markets, including China, the recall incident has continued to attract attention.
Kobayashi Pharmaceutical's "Red Koji Cholesterol Granules" and other 3 products are being recalled
According to Kobayashi Pharmaceutical China, the recalled products are due to "possible unintended ingredients in some red koji raw materials"; none of the three products recalled are marketed in the Chinese mainland market, and the related products are "sold to Chinese mainland through cross-border channels."
So far, the cases have only occurred in Japan. However, the occurrence and fermentation of the recall incident may affect the recognition of Chinese consumers for this long-established Japanese Internet celebrity health brand. This Japanese "century-old store" that has expanded from pharmaceuticals to health care products, with the creation of popular products, will have sales of more than 173.455 billion yen (about 8.2 billion yuan) in 2023.
As early as 2015, taking advantage of the popularity of overseas daigou, Kobayashi Pharmaceutical's sales to Chinese tourists in Japan reached 4.3 billion yuan (about 200 million yuan). In 2023, its sales revenue in China will increase to 13.6 billion yen (about 600 million yuan), and China has become its second largest overseas market in terms of volume. In recent years, Kobayashi Pharmaceutical has also continued to increase its investment in China.
Red yeast yeast ingredient products are "basically safe", and it is not clear why Kobayashi Pharmaceutical is "thunderous".
The core ingredient of the product that caused the accident was "red yeast rice", which is a common food and health care product raw material. In China, the public is probably most familiar with red yeast wine and red yeast tofu.
For example, in 2022, the European Union issued management requirements for red yeast rice health products, saying that the daily intake of the active ingredients of related products should be controlled within 3 mg, and in China, the State Food and Drug Administration also issued a specification in 2010 requiring that the recommended daily amount of red yeast rice should not exceed 2g.
Some people in the industry engaged in the research and development of health care products introduced to 36Kr that the active ingredient of red yeast rice is a statin analogue, and its effects for health care include lowering sterols, lowering blood lipids, lowering blood pressure, etc. However, the production of red yeast yeast raw materials into products requires a one-step fermentation process, and the secondary metabolite citrin produced is renal toxic, and improper dosage may cause toxic side effects. Therefore, if there is contamination in the fermentation process, side effects may occur. But in most cases, the products are "basically safe". Since Kobayashi Pharmaceutical has not disclosed its production process to the public, it is still difficult to say which step led to the death of this otherwise safe raw material.
After the recall, the outside world criticized Kobayashi Pharmaceutical for receiving a doctor-patient report in mid-January this year and finding the first suspected health hazard case, but it did not recall the product until two months later, during which "no information was provided to the government". Kobayashi Pharmaceutical said in response that this is because it "takes time" to confirm whether its red yeast rice ingredient products are really harmful.
But so far, Kobayashi Pharmaceutical has only determined that the cases of kidney disease patients who have consumed "products made from the same batch of raw materials" may have an ingredient that the company did not anticipate, and although it has not been determined what the ingredient is, citrinkillin has not been detected.
At the same time, due to the company's extensive supply of raw materials, the scope of the main body affected by the recall incident has been expanding.
According to official figures, about 1 million pieces of "red koji cholesterol granules" have been sold by pharmacies and Yogo Den nationwide since April 2021, and a total of 170 companies are selling products made from kobayashi pharmaceutical yeast yeast, and officials are considering whether to involve the National Institute of Health Sciences in an investigation to determine what to do with these products.
According to Japanese media statistics, as of 7 p.m. on the 26th, the number of other companies that have voluntarily recalled red yeast yeast ingredient products has reached 25, involving food, seasonings, alcohol and other fields.
On March 27, after the second death was disclosed, Kobayashi Pharmaceutical issued a statement on its official website that it was under investigation whether the death was related to the product, and "sincerely expressed condolences to the bereaved family".
China has become the second largest overseas market
In China, Kobayashi Pharmaceutical's name is not actually a household name, but this Japanese company, which has achieved take-off by virtue of its strategy of creating explosive products in a niche market, is actually a veritable "century-old brand". By 2023, Kobayashi Pharmaceutical's sales will exceed 173.455 billion yen (about 8.2 billion yuan), a year-on-year increase of 4.3%, and its operating profit will be 25.78 billion yen (about 1.2 billion yuan), achieving 26 consecutive years of growth.
Domestic consumers' perception of Kobayashi Pharmaceutical began with the rise of overseas purchasing agents. In this way, in 2015, Kobayashi Pharmaceutical's sales revenue to Chinese tourists in Japan reached 4.3 billion yen (about 200 million yuan), and in recent years, the rise of cross-border e-commerce has made more of Kobayashi Pharmaceutical's health care products that are not sold in China well-known to more Chinese people, such as the recall of three cholesterol-improving health products and hormone conditioning product "Mother of Life".
In addition, the brand's disposable stove series "Warm Baby", antipyretic cold paste series "Bingbao Sticker", toilet cleaning product "Bo Yueqing", etc., are also popular among Chinese consumers.
Illustration of Kobayashi Pharmaceutical products (Source: Kobayashi Pharmaceutical official website)
With strong purchasing power, China has become one of the overseas markets that Kobayashi Pharmaceutical has been eager to expand in recent years.
In 2017, Kobayashi Pharmaceutical began to plan to invest in China, planning to spend 30 billion yen (about 1.4 billion yuan) in three years to acquire local companies in overseas markets dominated by China to expand overseas sales of products;In 2018, Kobayashi Pharmaceutical officially established a pharmaceutical head office in China at the same time, announced the acquisition of Zhongdan Pharmaceutical, planning to increase the sales of drugs in China to 4 billion yen (about 100 million yuan) in the next 10 years.
In terms of actual performance, according to Kobayashi Pharmaceutical's financial data, in the five years from 2019 to 2023, its sales revenue in China increased from 8.4 billion yen to 13.6 billion yen (400 million yuan to 600 million yuan). Although the company did not specify the specific sales category, in terms of volume, China has become Kobayashi's second largest overseas market outside the United States. In order to further expand sales, Kobayashi Pharmaceutical continues to increase its investment in China.
In mid-March this year, the completion ceremony of the second phase of Kobayashi Pharmaceutical's largest production base in China, Xiaolin daily necessities green and intelligent production base, has just been completed in Hefei High-tech Zone, which is mainly used for the production of medical antipyretic patches, disposable heating tablets to warm babies, aromatic products and other single products, and is expected to reach annual sales of about 340 million yuan after production.
However, under the influence of the recall, there may be a question mark over whether domestic consumers will still trust Kobayashi Pharmaceutical's series of products as they did in the past. 36Kr noticed that at present, in official online sales channels such as Tmall Xiaolin Pharmaceutical's overseas flagship store, although the aforementioned three recalled products have been removed from the shelves, in some online platforms where red yeast rice health products are sold, some consumers have been leaving messages saying that they are worried about the safety of such products.
This time, some Japanese media also mentioned in the analysis of the fermentation of the recall incident that the purchase demand of tourists represented by China and South Korea contributed a lot to Kobayashi Pharmaceutical's domestic revenue (referring to Japan), which affected its domestic business performance.
On March 27, Kobayashi Pharmaceutical issued a statement on its official website saying that the impact of the recall on its performance was under review. Kobayashi Pharmaceutical will hold a board meeting on March 28 and a press conference in Osaka, Japan, on March 29.