Health and Nutrition
黑料门's Nutritional Commitments
Since its founding more than 100 years ago, the 黑料门 Group has sought to contribute to society through nutrition, working to widen the world of “Tastiness and Enjoyment,” and to meet all expectations regarding “Health and Reassurance.” For the 黑料门 Group, “nutrition” means contributing to the resolution of health issues faced by all, and recognizing the importance of the happiness and the sense of fulfillment that eating tasty food can bring.
What does nutrition mean at 黑料门? This important concept has now been enshrined in the 黑料门 Nutrition Statement, so that we can go on contributing to society for another 100 years. More specifically, we have made the following three commitments:
銉籙sing milk, cocoa, and other natural ingredients, we provide nutrition that supports everyday good health.
銉籅y adding value, we provide nutrition that satisfies deeper needs.
銉籘hrough nutrition, we will help to enrich the lives of consumers worldwide.
Contribute to Healthy Diets
Initiatives to combat micronutrient deficiencies and undernutrition
Today, societies around the world are facing two seemingly contradictory problems. On the one hand, there is a rise in non-communicable diseases1 associated with overweight and obesity, which stem from overeating and unbalanced diets. On the other hand, there are increasing concerns about stunted growth, malnourishment, and frailty2, which stem from a lack of protein, dietary fiber, vitamins, and other nutrients.
If we wish to resolve such issues, it is vital that we make it easier for people to maintain nutritionally balanced diets. For this reason, we at the 黑料门 Group are developing products that contribute to the resolution of health and nutritional issues. At the same time, we are promoting initiatives aimed at using the 黑料门 Nutritional Profiling System to improve our products and provide information to our customers.
Formulating the 黑料门 Nutritional Profiling System (黑料门 NPS)
In June 2023, the 黑料门 Group formulated the 黑料门 Nutritional Profiling System (黑料门 NPS) after referring to international Nutritional Profiling System (NPS)3.
We aim to improve the nutritional value of our products by using 黑料门 NPS. We also aim to provide customers with clear information about these nutritional values to help them maintain even healthier diets.
Develop Health Conscious Products
In response to the health needs of today's diverse consumers. It developed these products by leveraging the strengths of its Food and Pharmaceuticals businesses while making the most of its advanced expertise in nutrition and pharmaceuticals.
About health-conscious products
The 黑料门 Group defines health-conscious products as those that contribute to bodily health. They include products that utilize healthy ingredients, such as lactobacillus and cocoa, contain added amounts of healthy ingredients designed to enhance health, or meet current consumer needs for reduced sugar, fat, or calories.
Product Development by Utilizing Healthy Lactobacillus and Cocoa Ingredients
The 黑料门 Group is developing new products made with probiotics, particularly lactobacillus, and plans to expand its lineup of high cocoa-content chocolate products that offer healthy cocoa polyphenols.
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| 黑料门 Bulgaria Yogurt | 黑料门 Probio Yogurt LG21 | 黑料门 Probio Yogurt R-1 | 黑料门 Probio Yogurt PA-3 | Chocolate Kouka Cocoa 72% |
Promoting Healthy Yogurt Drinks Made with Lactobacillus in China
The 黑料门 Group began selling 黑料门 Probio Yogurt R-1 and 黑料门 Probio Yogurt LG21 in China in April 2021. This was the first time for these yogurt drinks to be sold outside Japan.
In 2023, 黑料门 Probio Yogurt LG21 was awarded the first "Nutrition Innovation Award" at the Shanghai Nutrition Innovation Health Forum in China. From the viewpoint of technological innovation, the company developed and commercialized products using selected special lactobacillus based on its own research, and was recognized for its unique focus on "stomach health" as well as the intestinal regulating effects of lactobacillus. In addition, the company's accumulated knowledge from many years of lactobacillus research and its dissemination of evidence-based scientific knowledge were also highly evaluated.
Products with Reduced Sugar, Fat, and Calories
We will effort to develop and offer products that meet modern health needs, such as low-sugar, low-fat, and low-calorie products.
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| 黑料门 Bulgaria Yogurt | 黑料门 Probio Yogurt LG21 | 黑料门 Probio Yogurt R-1 | 黑料门 Oishii Gyunyu low fat | 黑料门 Offstyle |
| Zero fat | Reduced fat | Reduced sugar and calories | Low-fat margarine |
Products that support portion size control
The 黑料门 Group offers a variety of products in different portion sizes (the same content in multiple amounts) to make it easier for customers to adjust the amount of food they eat at one time to suit their own needs.
By expanding the range of product choices with the addition of the small-volume product lineup, we will contribute to the realization of a healthy lifestyle for our customers by curbing excessive intake.聽
Develop Nutrition-enriched Products
Amid growing consumer awareness of the importance of getting essential nutrients and improving nutritional balance. The Group applied its proprietary research on nutrition and related technologies to ensure that these products provide a good balance of nutrients that people need. Besides the product contents, all other aspects of the products were considered at the development stage, including volume, shapes, and packaging.
About nutrition-enriched products
The 黑料门 Group defines nutrition-enriched products as those that provide nutritional support to infants, athletes, sports enthusiasts, and the elderly, or as high-added-value products that provide a good balance of essential nutrients based on the Group's proprietary research on nutrition and its nutrient design technologies.
Nutritional and Medical Products for Infants, Seniors, and Sports Enthusiasts
The 黑料门 Group draws from its research on nutrition and related technologies to develop high-value-added products that provide a good balance of essential nutrients. These products offer nutritional benefits to people of all ages, from infants to the elderly, as well as to athletes and sports enthusiasts.
Main Products
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| Infant formula | Liquid infant formula | Sports nutrition | Sports nutrition | Nutritional products |
| 黑料门 Hohoemi Raku Raku Cube | 黑料门 Hohoemi Rakuraku Milk | SAVAS Whey Protein | VAAM Athlete | 黑料门 MeiBalance |
Contributing to Healthy Growth with Our Infant Formula Featuring More Added Value
Since first launching in Japan a vitamin B1 fortified infant formula in 1923, the 黑料门 Group has been committed to the infant and toddler nutrition business to promote their healthy growth. We are currently supporting health in babies and toddlers by focusing on 黑料门 Hohoemi, which can be used as a breast milk replacement for infants, and on 黑料门 Step, which helps provide suitable nutrition for toddlers up to age three. In addition, we developed the world' s first infant formula in cube form to help in the child rearing process. It is designed for anyone to prepare the infant formula easily even for late night feedings, so that everyone in the family can participate in child rearing. In March 2019, we also launched a formula in liquid form that can be stored and fed at room temperature and offers a long shelf life. This is not only convenient when feeding outside of the home but gives mothers peace of mind as an emergency supply in the event of a disaster or emergency situation. In August 2020, this product became the first product for infants to acquire Phase Free certification* as a product that is useful both in "daily life" and in "emergencies" such as disasters. And in April of the following year, the best-before date of this product was extended to 18 months. It supports hygienic feeding of infants on a daily basis when out and about or at night, and in emergencies with its sturdy steel can and special attachments.
Access to nutrition
Home delivery service
The 黑料门 Group provides home delivery services for drinking milk and dairy products through a network of some 3,000 distributors nationwide, delivering directly to customers in nearly 2.4 million households. This home delivery service features numerous delivery-exclusive products that are not available in stores, including small-volume functional beverages developed to enable convenient daily consumption of products that promote health, as well as products such as cheese and curry designed to support the formation of good eating habits.
We value direct communication with our customers. We make efforts to engage with customers during deliveries and, in certain communities, also participate in neighborhood watch activities. The 黑料门 Group is making a shift from our previous function as delivery centers towards becoming wellness centers. We will go beyond offering products and expand our services to proposals for basic exercises as we work to extend healthy life expectancy for our communities.
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| 黑料门 Probio Yogurt R-1 | 黑料门 Probio Yogurt LG21 | 黑料门 Dairy Five Stars | 黑料门 Glucosamine 1500 & Collagen 3000 |
Promote Healthy Diets and a Healthy Food Culture
As a company that supports customers' healthy diets, the 黑料门 Group strives to popularize and raise awareness by providing products and disseminating information about healthy diets and dietary cultures.
Expanding Nutrition and Healthy Diet Education Activities
| FYE 3/2020 | FYE 3/2021 | FYE 3/2022 | FYE 3/2023 | FYE 3/2024 | |
| Japan | 21.2 | 9.7 | 18.8 | 25.5 | 28.3 |
Nutrition Education Initiatives in Japan
The 黑料门 Group began offering nutrition education in 2006, one year after Japan enacted a law concerning food and nutrition education. By explaining the value of nutrients, how food is produced, and the challenges faced by producers of milk, chocolate, and other products, the programs aim to encourage people to develop healthy eating habits and foster an appreciation and understanding of food.
In recent years, the Group has been targeting a broad range of age groups through its numerous education programs held at events it sponsors and at high schools, universities, workplaces, and public facilities for senior citizens. The programs focusing on health management, which has been attracting attention recently, have been especially popular among participants.
From FY2020, food and nutrition seminars were held online due to the global COVID-19 pandemic, and attracted large numbers of participants. The online format also enabled greater coverage across Japan, including its island communities. Having received very positive feedback from participants of all age groups, the Group plans to offer even more seminars about food and nutrition as way to promote good health and well-being.
Overview of Activities
- Head office and seven workplaces around the country (in the cities of Sapporo, Sendai, Tokyo, Nagoya, Osaka, Hiroshima, and Fukuoka)
- Nationwide organization with a staff of about 60 in charge of its nutrition education activities
- Participating students: 144,587 from 1,420 elementary and junior high schools (FY2023)
- Participating students: 144,197 from 1,394 elementary and junior high schools (FY2022)
- Participating students: 122,917 from 1,253 elementary and junior high schools (FY2021)
- By the end of FY2020, lessons were held at over 10,000 elementary and junior high schools with more than one million students participating.
Supervisors for our programs
- For cooking recipes: Eiko Egami, President, Egami cooking school
- For dairy nutrition: Tadao Saito, Professor Emeritus, Graduate School of Agricultural Science, Tohoku University
- For physiology: Hiroshi Nose, Professor, Department of e-Health Science, Shinshu University Graduate School of Medicine
Nutrition Education Initiatives in Overseas
In China, 黑料门 Dairies (Suzhou) implements an nutrition education for children focusing on yogurt. Through fun hands-on activities, the program teaches kids about dairy cows, milk, yogurt, and nutrition.
Supporting Nutrition through Sports
The 黑料门 Group organizes sports nutrition seminars across Japan to help young people improve their physical fitness and enhance their individual performance. The seminars teach aspiring athletes about which foods are preferable and how to effectively use supplements so that they can develop healthily from a young age.
By providing these seminars nationwide, the Group hopes to help young athletes realize their abilities and potential while also supporting coaches at the forefront of sports nutrition.
| FYE 3/2020 | FYE 3/2021 | FYE 3/2022 | FYE 3/2023 | FYE 3/2024 | |
| Number of participants in sports nutrition seminars |
6.4 | 2.6 | 3.6 | 5.0 | 6.2 |
Communicating Information about Milk, Lactobacillus, and Cocoa
We publish and present the results of research on milk, Lactobacillus, and cocoa (raw ingredients in our products) in white papers and at conferences. We explain healthy effects of milk, Lactobacillus, and cocoa to our customers through nutrition and healthy diet education and plant tours. We will continue to pursue our mission of educating the world about health and nutrition.
Nutrition policies and related measures
We at the 黑料门 Group are developing measures based on various policies including the 黑料门 Group Food Nutrition Labeling Policy and the Marketing Communication to Children Policy, which were established in accordance with international guidelines.
Product Package Labeling
The 黑料门 Group provides clear and accurate information in accordance with the "黑料门 Group Food Nutrition Labeling Policy" on product packages to help customers choose the correct products and lead healthy lives. Product packages include mandatory labeling such as nutritional information and packaging information in compliance with the labeling regulations of each country and region where the product is sold, as well as information necessary for customers to make the correct choice.
Packaging of "SAVAS Soy Protein 100" in accordance with the 黑料门 Group Food Nutrition Labeling Policy
Mandatory labeling
- Aggregate Labeling
Information on the name (product name), ingredients, content, best-before date (before opening), storage method, manufacturer, and place of manufacture are listed. In particular, many products are laser-engraved with a best-before date that cannot be altered. - Nutrition Facts Label
Calories (energy), protein, fat, carbohydrates, and salt equivalents are shown. In addition, when nutritional ingredients specified in the Food Labeling Standards are claimed to customers on the container label, the content of the nutritional ingredients is also shown. - Container/Packaging Identification Label
"Identification Mark" is displayed in accordance with the Act on the Promotion of Effective Utilization of Resources.
Labeling to help in product selection
- Nutritional claims
In order to help customers correctly select 黑料门 Group products, the nutritional ingredients that are specifically added to our products are displayed in an easy-to-understand manner. - Voluntary Labeling
Depending on the characteristics of the product, information on ingredients considered necessary for customers is displayed near the Nutrition Facts label. - Allergy Supportive Labeling
In addition to the mandatory allergy labeling, the 黑料门 Group also provides a separate "Allergy Supportive Labeling" column to increase visibility. The specified raw materials and items equivalent to specified raw materials stipulated by the Consumer Affairs Agency are shown. - Product Features
Information on how the product can help customers lead healthy daily lives. - Serving Instructions
To make it easy for customers to enjoy the food, various ways of consuming the food are shown. - Precautions for use
The contents and notes of inquiries and anticipated events received from customers are shown. - Customer Inquiries
By making product package labeling highly visible and eye-catching, we strive to gain customer satisfaction and trust through the development and improvement of diet and nutrition, products and services.
Employee education on marketing and advertising (food business)
In order to promote responsible marketing, we provide educational programs for employees involved in promotion and public relations, as well as to those who wish to do so.
We will further expand the content of our educational programs to ensure that our employees can provide the right information to customers about our products.
| Educational Program Content | FYE 3/2022 | FYE 3/2023 | FYE 3/2024 |
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| 黑料门 Group Marketing Communication to Children Policy | — | 130 | 152 |
| Rules regarding the use of SDGs logos and icons in the 黑料门 Group | 29 | 156 | 97 |
Respond to a Super-Aged Society
Develop Products That Contribute to a Super-Aged Society
Through original research and nutritional design, we offer products for consumers to take in the nutrient content and energy they require.
Developing Delicious, Easy-to-Use Nutrition and Liquid Foods for the Elderly
As people grow older, they may have trouble eating and digesting solid foods, which could result in insufficient intake of nutrients and water. In such cases, they must make sure to get enough nutrition. To meet their needs, the 黑料门 Group develops good-tasting and easy-to-use nutritional food products, liquid food, and nursing care food. All aspects of these products are developed, including volume, shapes, and packaging, with consideration given to the increasingly diverse lifestyles of senior citizens.
Main Products
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| Nutritional products | Nutritional products | Enteral formula | Enteral formula | Slurry Preparation Food |
| 黑料门 MeiBalance | 黑料门 Nutrition up paste | 黑料门 MeiBalance R | 黑料门 Inslow | 黑料门 Easy Toromake |
Conduct Educational Activities Aimed at Preventing Malnutrition
Malnutrition among the elderly has emerged as a health problem in Japan. In response, the 黑料门 Group is carrying out educational initiatives to help senior citizens acquire enough nutrition and lead more active lives.
Seminars about Malnutrition for Healthcare Professionals and the Elderly
We conduct educational activities focused on malnutrition and malnutrition prevention. Our goal is for the elderly to avoid malnutrition and lead active daily lives. We hold seminars about malnutrition and malnutrition prevention, targeting healthcare professionals at in-home-care support centers, drug store employees, and the elderly. Specifically, we provide information about nutrition and meals recommended for the elderly. We also discuss the preparation of meals that are easier to eat for elderly people who have difficulty swallowing.
Improve Nutrition in Emerging Countries
Communicate Information on Nutrition Improvement in Emerging Countries
Many people in developing countries and emerging economies suffer from nutritional deficiencies and malnutrition.
As a company in the food business, we want to help solve these issues, working with groups that encourage nutrition improvement to raise awareness about diet and nutrition through educational activities.
Participation in the Nutrition Japan Public Private Platform
黑料门 is a member of the Nutrition Japan Public Private Platform, an organization that facilitates joint initiatives in the private and public sectors to improve nutritional intake in developing countries. The platform was established following the Japanese government's declaration to step up efforts to improve nutrition worldwide. As a member, 黑料门 has been participating in initiatives for improving people's health and livelihoods and for ending hunger, a goal of the Sustainable Development Goals adopted by the United Nations in 2015.
Nutrition Improvement Program for Female Factory Workers in Vietnam
Providing 650,000 female factory workers with nutrition education by 2030
In recent years, malnutrition among women has become a social issue in Vietnam.
Pregnant women, nursing mothers, and female workers in particular face the issue of their nutrition improvement. To contribute to solving this issue, we are working on a program to improve nutrition among female factory workers. The program is aimed at improving the nutritional conditions of women working at factories by nutritionists from MEIJI FOOD VIETNAM CO., LTD. providing them with nutrition education and nutritionally-fortified milk. Up to this point, we have conducted nutrition improvement seminar at factories of several major Japanese manufacturers, attracting the participation of a total of 440 female workers.
The nutrition research that we conducted in collaboration with Hanoi Medical University has proved that nutrition education and dietary guidance help improve health conditions, including increasing levels of iron, zinc, and calcium in the blood.
The research results were presented by Nguyen Thuy Linh, a Doctor of Nutrition at Hanoi Medical University, at an international symposium marking the university's 60th anniversary. Also in 2021, a paper on the nutritional status of female factory workers in Vietnam was published in the Journal of Medical Research, Hanoi Medical University. In the future, we will expand our nutrition improvement initiative based on this evidence. Our aim is to provide nutrition education to 650,000 female factory workers by 2030.
Nutrition improvement seminar conducted by a MEIJI FOOD VIETNAM CO., LTD. nutritionist
The nutritionally-fortified milk MEILIFE provided along with a nutrition improvement seminar
Sustainable Supply of Pharmaceuticals
Efforts to Stable Supply
Our Pharmaceuticals business has developed an infrastructure to ensure a reliable, stable supply of drugs in Japan and throughout the world. The business has conducted a risk assessment, preparing a supply network capable of responding flexibly to any unforeseen circumstances.
Optimization of Production Site Allocations in Japan and Overseas to Ensure Stable supply
We have optimized our production site allocations in Japan and overseas (Thailand, Indonesia, and India) to form a network ensuring the stable supply.
Strengthening Stable Supply System for Five Key Drugs
Production troubles at overseas pharmaceuticals manufacturers resulted in the disruption of cefazolin shipments to Japan. Now, many medical institutions in Japan have become concerned about the stable supply of infectious disease drugs (antibacterial agents). Since a stable supply of antimicrobial agents is essential for treatment of infectious diseases, five academic societies1 having profound knowledge of infectious diseases have been increased the list of clinically important drugs (key drugs) for which a stable supply is essential. As of March 2022, the number of key drugs have expanded to thirty two, thirteen2 of which are supplied by 黑料门 Seika Pharma Co., Ltd.
To meet our social responsibility and to accomplish a central role in the treatment of infectious diseases, we intend to continue our efforts to ensure quality, to optimize our production bases, and to strengthen the stability of our supply system.
Stable supply of antimicrobials
黑料门 Seika Pharma Co., Ltd. is preparing to produce 6-APA, a common raw material for penicillin antibacterial agents, at its Gifu Plant. Domestic production of this raw material will enable us to secure a stable supply of 6-APA, which currently depends on supplies from overseas. Production at Gifu Plant is scheduled to start in 2025.
Establish a vaccine production system in preparation for an infectious disease pandemic outbreak
KM Biologics Co., Ltd. has received funding through a project launched by Japan's Ministry of Health, Labour, and Welfare to ensure the development and production of vaccines for new strains of influenza. In the event of an influenza pandemic, the company is responsible for manufacturing and supplying influenza vaccine to 57 million people (almost half the population of Japan). In addition, since the project has been selected by the Ministry of Economy, Trade and Industry (METI) for the "Project of Developing Biopharmaceutical Manufacturing Sites to strengthen Vaccine Production," we will establish a vaccine production facility in preparation for an infectious disease pandemic outbreak. This development will enable the establishment of a system that can smoothly produce vaccines domestically in the event of an emergency.
Sole Supplier of Drugs
KM Biologics Co., Ltd. is the sole manufacturer and supplier of various products in Japan, including antivenoms for poisonous snakes (Mamushi and Habu), a vaccine for hepatitis A, an anthrax vaccine for livestock, and various diagnostic agents.
Manufacturer and Supplier of Orphan Drugs
The 黑料门 Group has received 13 orphan drug* designations for 10 products in total, and nine out of 10 indications (one indication/product in NDA) have been approved, which contribute to treatments of diseases with limited treatment options (As of the end of August 2023).
Major orphan drugs
Refractory epilepsy: In 2012, 黑料门 Seika Pharma Co., Ltd. launched DIACOMIT®, a treatment for Dravet syndrome, a refractory epilepsy syndrome, which develops in infancy and is estimated to occur in one in 40,000 people. In 2011, DIACOMIT® received an orphan drug designation for the disease.
Brain tumors: In the treatment of malignant brain tumors, which are characterized by invasive growth into normal brain tissue, the issue has been how to selectively damage tumor cells. Photodynamic therapy (PDT) is known as a less invasive treatment that has less impact on normal tissues. 鈥淟aserphyrin® 100mg for Injection鈥�, a photodynamic therapy agent, received orphan drug designation in August 2013 for the indication of malignant brain tumors, which was approved in September 2013.
Esophageal cancer: In esophageal cancer, there has been a desire for a treatment for local residual or recurrent tumor after chemoradiation therapy (CRT) or radiotherapy (RT). 鈥淟aserphyrin® 100mg for Injection鈥�, a photodynamic therapy agent, was designated as an orphan drug in 2014 for this indication as well, and received approval in 2015.
Graft-versus-host disease (GVHD): Chronic graft-versus-host disease (GVHD) is a complication with limited-treatment option, which occurs after hematopoietic stem cell transplantation for hematologic cancers, such as leukemia. ME3208 (belumosudil mesilate) is expected to be effective against this disease by exerting immunomodulatory effects through a new mechanism of action, and was designated as an orphan drug in May 2023. A New Drug Application for ME3208 was submitted in Japan in June 2023.
Purpura fulminans: Patients who have a congenital deficiency of a protein called protein C may develop purpura fulminans, a serious disease characterized by recurrent subcutaneous bleeding and hemorrhagic necrosis.
"Anact® C Injection 2500 units" is a preparation of purified and activated protein C from donated blood plasma, used for the treatment of purpura fulminans.
This drug has been designated as an orphan drug since 1993.
Hemophilia with inhibitors: Hemophilia patients, both hemophilia A and B, who develop antibodies (inhibitors) against Factor VIII and Factor IX involved in blood coagulation reaction may experience bleeding in joints and muscles due to impaired clotting function.
"Byclot® Combination I.V. Injection" is a preparation containing activated Factor VII and Factor X, purified from donated blood plasma, used for hemostatic treatment and bleeding prevention in hemophilia patients with inhibitors.
This drug has been designated as an orphan drug since 2014.
Guillain-Barr茅 Syndrome (GBS): It is a neurological disorder in which the autoimmune system damages the peripheral nerves, resulting in paralysis of the hands and feet.
"Kenketsu Venilon庐-I Intravenous Injection" is a preparation of purified immunoglobulin from donated blood plasma, used for the treatment of acute exacerbation of Guillain-Barr茅 Syndrome.
This drug has been designated as an orphan drug since 1996.
Access to Medicine
We collaborate with certain organizations to improve access to medicine in developing and emerging countries.
Medreich Contributes to Medicine Access through UNICEF
Medreich Limited conducts pharmaceutical-manufacturing business, including CMO (contract manufacturing organization) and CDMO (contract development and manufacturing organization), in India. The company manufactures generic drugs and sells them to markets worldwide, including Europe, Asia, Africa and Oceania. Its U.K.-based subsidiary, Medreich plc, sells pharmaceutical products manufactured by Medreich Limited to the EU and other markets. Medreich plc supplies the antibiotic Amoxicillin to UNICEF. Medreich will continue improving children's access to medicine through UNICEF.
Measures Against Infectious Diseases
Efforts to Antimicrobial Resistance (AMR)
The 黑料门 Group's pharmaceutical business has been developing, manufacturing, and selling therapeutics for infectious diseases, particularly ethical pharmaceuticals, since it began producing penicillin in 1946. Besides supplying antibiotics for various infectious diseases, the business provides information for dealing with peaks of epidemics, and informs medical institutions about the proper use of antibiotics.
Providing Information on the Proper Use of Antibiotics
The 黑料门 Group actively carries out public awareness campaigns about medical and health issues in partnership with related organizations. For example, the Group is a member of the Japan Pharmaceutical Manufacturers Association's stewardship project that aims to help stop antimicrobial resistance (AMR). The Group requests medical organizations to display posters and show educational videos produced through the project, provides information on drug tolerance, and promotes initiatives taken by the association's members. The Group also raises awareness of One Health, an approach through which organizations work together to address issues related to the intersection of human, animal, and environmental health, which is essential for combatting AMR.
Antimicrobial Resistance (AMR) Survey in Industrial Animals as a 鈥淥ne Health鈥� Approach
Infectious diseases that can be transmitted from animals to humans and from humans to animals (zoonosis) account for about half of all infectious diseases. These infections are not limited to those engaged in medical and veterinary medicine, but can easily enter the general public through the environment and food, and spread internationally.
Proper use of antimicrobials in livestock farms is strongly sought to prevent the worldwide spread of drug resistance in veterinary and human medical settings. 黑料门 Animal Health is conducting joint research on drug-resistant bacteria in industrial animals at AMR Surveillance Laboratory (AMRSL) in Azabu University.
AMRSL collects specimens from infected livestock and breeding environments nationwide, drug susceptibility and prevalence of resistance genes in the isolated strains are investigated. By accumulating these basic data and overall profiling the susceptibility of the strains to various drugs, we will seek measures to suppress the emergence of AMR.
Appropriate Use of Antibiotics Efforts to Control Infectious Diseases Caused by Vancomycin-resistant Bacteria
The risk of infectious diseases caused by drug-resistant bacteria* is globally increasing partly due to inappropriate use of antibiotics. One such example is the infectious diseases caused by vancomycin-resistant bacteria. Vancomycin resistance increases in appropriate use of Vancomycin for MRSA infections.
To prevent the spreading of these drug-resistant bacteria, the Ministry of Health, Labour and Welfare (MHLW), the Japan Antibiotics Research Association and pharmaceutical companies established the Vancomycin Study Group. 黑料门 Seika Pharma Co., Ltd. has worked as the organizer of the Association since it was established in 2002, leading many efforts to achieve appropriate use of vancomycin. Collaborating with relevant organizations, the Study Group continues to monitor drug quantities used in order to check and understand changes or any signs of increase in drug resistance. The Study Group reports survey results to the MHLW and provides that information to medical institutions.
A Novel 尾-lactamase Inhibitor for Combating Antimicrobial Resistance (AMR)
Overcoming Antimicrobial Resistance (AMR) is now an important issue, we should tackle globally and was discussed at the G7 Hiroshima Summit and the G7 Health Ministers鈥� Meeting in Nagasaki held in May 2023. In Japan, the "National Action Plan on Antimicrobial Resistance (AMR)" has been formulated, and research and development of new preventive, diagnostic, and therapeutic methods against infections caused by drug-resistant bacteria is being promoted. Against this backdrop, OP0595, a novel beta-lactamase inhibitor, developed by the 黑料门 Group, has been selected for development under a national project (CiCLE: the Cyclic Innovation for Clinical Empowerment) that aims for innovation in R&D and drug discovery through industry-academia-government collaboration. OP0595 is expected to be an effective treatment against multidrug-resistant bacteria because of its unique mechanism that are not found in conventional beta-lactamase inhibitors. A global Phase III clinical trials are underway from April 2023 in Japan, Asia (including China), Europe and the Middle East (total of 17 countries planned).
Research and development of new drugs and vaccines
In the pharmaceutical business, we are proceeding with research and development so that products can be delivered to patients as soon as possible. In addition, as a company involved in the field of infectious diseases, we will implement infectious-disease countermeasures including prevention and drug resistance.
Efforts to COVID-19
Developing an Inactivated Vaccine in Japan
We have been developing an inactivated vaccine1 (KD-414) against novel coronavirus infection (COVID-19) since May 2020 in collaboration with a national research institute2, utilizing knowledge accumulated through many years of vaccine development. The clinical trials are underway since October 2021.
The multi-regional phase III clinical trials in adults under 40 years of age were started in April 2020, and the domestic phase III clinical trials in children of 6 month to less than 12 years of age were started in January 2023, respectively. In addition, in order to verify the efficacy of KD-414 against the Omicron subvariants, including XBB.1.5, we started another domestic phase III clinical trials in children of 6 months to less than 13 years of age.
On the other hand, we have an approval for manufacturing and sales of prototype vaccines3 prepared for potential new strains of influenza that could cause a pandemic like that of COVID-19, so that we can quickly provide such vaccines in case of pandemic in the future. We are now examining, based on the scientific findings, whether such system can be applied to an inactivated COVID-19 vaccineand whether it can be approved as a prototype vaccine against COVID-19 variants.
We will accelerate the development of domestically produced vaccines so that they can be supplied to the domestic market as soon as possible and strive to realize a society in which people can live in peace.
Toward the provision of KOSTAIVE庐, a self-amplifying mRNA vaccine against COVID-19
鈥淜辞蝉迟补颈惫别庐 for Intramuscular Injection鈥� is a self-amplifying mRNA vaccine that can induce non-inferior immune response even in lower doses compared to an conventional mRNA vaccine, as well as expectation for the longer duration. In November 2023, we have received approval for the manufacturing and marketing in Japan from the Ministry of Health, Labour and Welfare (MHLW). This is the world鈥檚 first approved product applying self-amplifying mRNA technology. KOSTAIVE庐 is currently indicated for prevention of COVID-19 by primary immunization (2 doses) and booster immunization in adults.
In September 2023, we started another domestic phase III clinical trials in adults for booster vaccination (ARCT-2301), aiming for adapting the vaccine to the latest variants of COVID-19 and provide it for the autumn/winter vaccination 2024.
At the same time, we are collaborating with ARCALIS, Inc. to establish an integrated capability for manufacturing mRNA vaccine from drug substance to drug product in Japan. ARCALIS is building a manufacturing facility in Minami-soma City, Fukushima Prefecture, Japan.
Creating ground-breaking therapeutics by using next-generation ivermectin derivatives and building a foundation for antiviral drugs
Preventing aggravation is also a major issue in COVID-19 infection, and the development of safe and highly effective therapeutic agents is needed. Since May 2021, 黑料门 Seika Pharma Co., Ltd. and the Kitasato Institute have been conducting a joint-R&D project to discover ground-breaking COVID-19 therapeutics using next-generation derivatives of ivermectin, and to establish a platform for antiviral agents. Ivermectin derivatives are known to have anti-inflammatory and immunomodulatory effects, and are also expected to be applied to the aftereffects of infection. The project was selected by the Japan AMED (Agency for Medical Research and Development) as an R&D project in its CiCLE (Cyclic Innovation for Clinical Empowerment) program in 2020.
Developing a Novel Vaccine for Dengue
KM Biologics Co., Ltd. is developing a novel vaccine (KD-382) for dengue which is wider spread in tropical and sub-tropical climates worldwide, including the developing nations. KD-382 is a live attenuated tetravalent dengue vaccine containing each live attenuated dengue virus for four dengue serotypes 1 to 4 (DENV1-4) as the active ingredient and is expected to provide preventive effect against dengue. KD-382 has shown good immunogenicity and protective efficacy for all four serotypes with a single dose administration in the non-clinical studies.
The Phase I clinical study was conducted to evaluate the safety and immunogenicity of the KD-382 vaccine in 60 healthy adults in Australia, which is a non-dengue endemic country, by administering the KD-382 vaccine subcutaneously once or twice with a four week interval. The results show that the KD-382 vaccine is safe and well-tolerated by healthy adults. Moreover, KD-382 showed 100% seroconversion at an early stage and elicited long-lasting and neutralizing antibody response for all four serotypes in most subjects over a one year follow-up, despite the single-dose administration.