The Kyorin Group’s main business is the development of ethical drugs under the guidance of holding company KYORIN Holdings Inc. The ethical drugs business is proactively engaged in proprietary drug discovery, while at the same time developing, manufacturing, and selling new drugs and generic drugs. It also handles environmental hygiene-related products and over-the-counter drugs.
New ethical drugs, etc.
New drugs business
We will seek to create new medicine that contributes to health worldwide, and establish a strong presence in the specific fields of respiratory, otolaryngology, and urology.
- Drug Discovery -
With the medical needs for people’s health today becoming increasingly diverse and complex, the degree of difficulty in creating innovative new drugs is higher than ever. In this environment, although the scientific and technological development efforts of drug manufacturers are resulting in many new drugs, numerous unmet medical needs still exist. Through our corporate activities, the Kyorin Group is using innovation to develop and provide safe products and services that benefit society, enabling the Company to continue to grow and contribute to resolving social issues. Under the new HOPE100 -Stage 3- medium-term business plan, we are focusing on strengthening our drug discovery capabilities to the greatest extent possible, aiming to become a company that is globally recognized as a company of innovative new drugs.
|New HOPE100 -Stage 3- Medium-Term Business Plan|
Strengthen drug discovery capability to create innovative new drugs
|Continue to add new layers to existing priority research domains and technologies and take on new research domains and technologies||Pursue R&D based on clarification of healthcare value of new drug candidates||Increase diversity by actively acquiring drug discovery seeds|
Initiatives under the new medium-term business plan
Continue to add new layers to existing priority research domains and technologies and take on new research domains and technologies
KYORIN Pharmaceutical’s WATARASE Research Center has technologies for analyzing disease models and low molecular weight drug discovery technologies, while ActivX has the KiNativ (broad and quantitative kinase analysis technology) platform. We have quantitatively and qualitatively reinforced our themes for initial-stage research and exploration in our priority research areas of fibrosis research and kinase research to make maximum use of the potential of these technologies and identify novel drug discovery targets. In terms of fibrosis research, we are working with academic institutions in proactive exploration of candidate compounds that have pharmacological activity for identified discovery targets using iPS cells and human tissue. In addition to our existing drug discovery platform based on low molecular weight, we are using new modality technologies (nucleic acids, etc.) to pursue the challenge of innovative new drug discovery.
Pursuing open innovation
To supplement and build on KYORIN Pharmaceutical’s proprietary drug discovery, we are proactively investigating external early-exploratory-stage drug discovery themes and candidate compounds, and using our evaluation technology platforms in areas including auditory function, bladder function, and infectious diseases to create a structure that can carry out speedy evaluations. This includes open innovation with academic institutions, venture capital start-ups, and domestic and overseas pharmaceutical companies, enabling us to approach drug discovery targets from various perspectives. We established the Department of Drug Discovery for Lung Diseases as a joint research program at the Graduate School of Medicine Kyoto University in fiscal 2017, integrating the academic institution’s pathological research and basic research capabilities with KYORIN Pharmaceutical’s drug discovery capabilities to search for new targets for drug discovery. KYORIN Pharmaceutical also concluded a strategic partnership with the technology transfer company of the Hebrew University of Jerusalem for drug discovery in the respiratory field in fiscal 2018, and began joint research with the Microbial Chemistry Research Foundation’s Institute of Microbial Chemistry to search for antibacterial drugs effective against multidrug resistant bacteria in fiscal 2018.
We are also acquiring early-stage drug discovery seeds from outside the Group to build new platforms for drug discovery, which will increase and expand our drug discovery seeds, diversify disease areas and modalities, and disperse risks.
Initiatives for innovative new drug discovery
KYORIN Pharmaceutical will take the following three approaches in its drug discovery activities:
Search for novel targets
We are strengthening our early-exploration- stage research to search quickly for novel drug discovery targets and create innovative new drugs effective against those targets. To strengthen our early-stage drug discovery research both quantitatively and qualitatively, we are using human (patients), disease model animal tissue or cells, and applying technologies including KiNativ and genome editing to enhance the quality of our target identification and validation. We are also stepping up our fibrosis research as a priority research area. Working with academic institutions with strengths in basic research, we are making maximum use of cutting-edge technologies like human disease-specific iPS cells for an enhanced level of drug discovery evaluation to select candidate compounds.
In addition to our existing low molecular weight drug discovery, we are using new technologies to explore compounds including medium molecular weight compounds and nucleic acid medicines, and building on our work on fusion protein formulations begun in fiscal 2019 to pursue possibilities in new modalities and create new drugs with global potential that help address medical needs that cannot be met with low molecular weight drugs.
Restructure drug discovery research centers
All research centers, covering early-exploration- stage research to research and development, have been consolidated at the WATARASE Research Center, which is carrying out drug discovery research with a structure that is effective and cooperative in the areas of pharmacology, chemistry, safety, and pharmacokinetics, as well as formulation and analysis. Experts in all these fields work in teams that cross organizational divisions to conduct research and complete development with greater quality and speed for drug discovery research that is consistent with global standards.
System for Continuous Creation of Innovative New Drugs
- Development -
The Kyorin Group views the expansion of our pipeline to support medium-term growth as an important management issue. In addition to expanding our development pipeline in specific fields (respiratory, otolaryngology, and urology) as well as the fields of infectious diseases and rare and intractable diseases, we aim to globally roll out at an early stage compounds that we have created in-house.
|New HOPE100 -Stage 3- Medium-Term Business Plan|
Enhance pipeline to support medium-term growth
|Proactively invest in pipeline expansion to contribute to medium-term earnings through in-licensing for disease field including and peripheral to the three specialties of franchise customer fields (respiratory, otolaryngology, and urology), and infectious disease and rare and intractable diseases||
In principle, achieve proof of concept (POC)* ourselves and aim for early global out-licensing
* Proof of concept: Confirmation of the effectiveness and safety to humans of candidate substances for new drugs in the research and development stage
Promotion of proactive partnering activities
As per its management strategy, KYORIN Pharmaceutical Co., Ltd. expanded its product lineup through the in-licensing of the allergy treatment Desalex from an affiliate of MSD and the overactive bladder treatment Beova from Merck & Co. of the United States.
In January 2020, we concluded a licensing agreement with aTyr Pharma, Inc. of the United States for KRP-R120 (ATYR1923), a treatment for interstitial lung diseases. Having acquired the exclusive rights for development and sales in Japan, we will carry out development for interstitial lung diseases (including pulmonary sarcoidosis) in Japan.
Going forward, we will proactively work to expand the product pipeline to support the Group’s medium-term growth through worldwide partnering activities with the aim of establishing a strong presence in the Group’s priority fields of respiratory, otolaryngology, and urology.
Partnering with Companies in Japan and Overseas
Products under development
- Increasing overseas earnings Overseas out-licensing -
Promoting global out-licensing to increase overseas earnings
In November 2019, KYORIN Pharmaceutical Co., Ltd. concluded a licensing agreement with JEIL Pharmaceutical Co., Ltd. of South Korea for the overactive bladder therapeutic agent Vibegron (sales name in Japan: Beova), giving JEIL Pharmaceutical the development, manufacturing, and commercialization rights for the drug in South Korea. Going forward, we will continue to work proactively for the out-licensing of Vibegron in the ASEAN region and other countries.
KYORIN Pharmaceutical Co., Ltd. is also currently engaged in activities for the out-licensing of its original oral new quinolone synthetic antibacterial agent, Lascufloxacin (sales name in Japan: Lasvic).
Initiatives toward direct entry into Asia
In tandem with our licensing activities, we conducted market surveys and collected information on Southeast Asia, aiming to lay the foundation for a direct entry into overseas markets in the future, focusing on Asia.
We have also been selling our multipurpose disinfectant cleaner Rubysta since 2017 through PT. Meiji Indonesian Pharmaceutical Industries (PT. Meiji Indonesia), a subsidiary of Meiji Seika Pharma Co., Ltd., and continue to promote the product to local medical institutions as an environmental surface disinfectant.
In Vietnam, we concluded a licensing agreement for generic drug manufacturing technologies with BinhDinh Pharmaceutical and Medical Equipment JSC in 2017, and in Mongolia, we concluded an agreement giving generic drug sales rights in that country to Monospharm Trade Co., Ltd. in 2019.
Going forward, we will continue to consider directly entering overseas markets on the basis of locally collected information and take steady steps in that direction.
- Marketing -
Japan’s pharmaceutical industry is undergoing structural market changes, caused by moves to curtail drug costs through promotion of the use of generics, a review of the price maintenance premium system, and price revisions for long-listed drugs. The Kyorin Group formulated the new HOPE100 -Stage 3- medium-term business plan in the face of this challenging market environment. Fiscal 2020, the first year under the plan, is being positioned as the beginning of a period of growth, and we will work to accelerate promotion of the new drugs group as much as possible. As a new marketing style, in fields related to infectious disease, we will move beyond medical treatment alone and develop activities that provide total solutions including prevention and diagnosis. In addition, to keep up with the needs of the times, we will provide information by proactively adding digital formats and artificial intelligence to our core format of face-to-face interaction.
|New HOPE100 -Stage 3- Medium-Term Business Plan|
Shift to business based on the proposal of solutions and accelerate growth of the new drugs group
|Make a uniquely Kyorin contribution to medical practitioners by shifting to a solution-based approach that integrates the ethical drugs business and the infection-related business||Accelerate the growth of the new drugs group as much as possible (Flutiform, Desalex, Beova, Lasvic, etc.)||Consolidate healthcare businesses to focus on infection-related businesses|
Shift in marketing style to solution-based approach
We are starting solution-based activities that integrate the infection-related business to make a uniquely Kyorin contribution to medical practitioners. Specifically, we aim to make a unique contribution that highlights Kyorin’s originality by providing doctors, pharmacists, and nurses, especially those who are part of infection control teams (ICTs) and antimicrobial stewardship teams (ASTs), with complete information including that for Milton and Rubysta for prevention, GeneSoC® for diagnosis, and Lasvic® Tablets and KRP-AM1977Y (scheduled for release during fiscal 2020) for treatment.
The Kyorin Group’s Initiatives to Combat Infectious Disease
Under the new HOPE100 -Stage 3- medium-term business plan, the Kyorin Group aims to build an infection-related business model around prevention, diagnosis, and treatment. We will build a marketing structure that cuts across the Group and address the international issue of antimicrobial resistance by proactively promoting the appropriate use of treatments through a uniquely Kyorin approach that contributes to medical practitioners.
* Drug-resistant bacteria that threaten people’s lives around the world
The improper use of antibacterial drugs is leading to a global increase in drug-resistant bacteria, while at the same time the development of new antibacterial drugs is declining, creating a major problem for international society. Estimates are that if this situation continues, the annual global number of deaths from infectious disease caused by drug-resistant bacteria could grow to roughly 10 million people by 2050, from roughly 700,000 in 2013. Measures to counter antimicrobial resistance are therefore being pursued globally.
(Adapted from Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations; The Review on Antimicrobial Resistance, Chaired by Jim O’Neill; December 2014)
Contributing to the treatment of respiratory and otolaryngological infectious disease
The oral antibacterial drug Lasvic Tablets was developed as a quinolone antibacterial agent that has sufficient antibacterial properties against pathogenic bacteria targeted in treatment while suppressing full-body exposure, and is also unlikely to develop resistant bacteria. Going forward, the Kyorin Group will strive to educate and promote the appropriate use of antimicrobial drugs by sharing information with physicians, pharmacists, clinical technicians, other members of infection control teams (ICTs), and antimicrobial stewardship teams (ASTs), while also cooperating with surveillance of drug-resistant bacteria based on antimicrobial resistance action plans and academic surveillance programs, and through cooperation with and support of infectious disease-related academic conferences.
Enables quick, accurate, and simple identification of pathogenic microorganisms, prevents the spread of infectious disease, and achieves appropriate use of antimicrobial drugs
Proactive screening for pathogenic microorganisms is needed to address problems like the novel coronavirus pandemic and antimicrobial resistance. We also believe it is important to establish an in-house system that can effectively prescribe and discontinue medicines, including accurate decision making of the necessity of antimicrobial drug use based on examination results.
The microchannel-based genetic measurement device GeneSoC® is a real-time PCR system that enables quick, accurate, and simple identification of pathogenic microorganisms. SARS-CoV-2 GeneSoC ER Kyorin is currently being sold as a novel coronavirus detection reagent used with GeneSoC®. Going forward, we will develop reagents for research and the “GeneSoC® mini” dedicated automated preprocessing device, and work to commercialize the system for use in extracorporeal diagnosis at an early date, to contribute to the appropriate selection of medications through point-of-care testing (POCT), while also working on further improvements to enable use in hygiene management including the food field and other fields.
* Point of Care Testing：testing performed by medical practitioners at the bedside of patients
Rubysta and Milton
Contributing to controlling infections in medical institutions
Many types of microbes are present in medical institution environments, and in recent years we have learned that microbes are transmitted through environments. Because much of this transmission takes place via fingers, it is important to keep environment surfaces clean and to disinfect fingers.
Kyorin is contributing to the control of infections with its lineup of the multipurpose disinfectant cleaner Rubysta and the disinfectant Milton, as infection countermeasures in medical institutions.
Achieving a growth trend in the new drugs group
We believe the new drugs group, which includes Flutiform, the combination drug for asthma treatment, Desalex, the treatment of allergic diseases, Beova, the treatment of overactive bladder, and Lasvic, an oral quinolone antibacterial agent, will be the growth drivers for Stage 3, which starts with fiscal 2020.
Fiscal 2019 sales of Flutiform grew to ¥14.6 billion. After a temporary stop of supplies, sales of Desalex resumed in November 2019 and totaled ¥2.6 billion. With the limit on the prescription period for Beova lifted in December 2019, sales totaled ¥4.3 billion, with the pace of prescriptions surpassing our initial estimate. Sales of Lasvic Tablets, which commenced in January 2020, have been solid, totaling ¥1.1 billion.
We are forecasting a sales increase of more than ¥10 billion for these four products in fiscal 2020 compared with fiscal 2019. We will place a maximum focus on these products as Stage 3 growth drivers, aiming for the new drugs group to account for more than 50% of our net sales target in the plan’s final year.
Establishing a presence in the franchise customer fields
KYORIN Pharmaceutical Co., Ltd. aims to establish a presence in designated fields focusing on respiratory, otolaryngology, and urology (a franchise customer strategy). We are placing importance on relationships of trust with medical practitioners and carrying out activities to provide, gather, and transmit information regarding the proper use of pharmaceutical products.
KYORIN Pharmaceutical Co., Ltd. has also introduced a marketing team structure whereby multiple medical representatives are responsible for a designated area. With this structure, entire teams cultivate an area, for swift and systematic responses to increasingly diverse medical needs. Going forward, we will build on this initiative to foster a culture in which teams help each other achieve their targets.
Prioritize marketing activities directed at regularly visited doctors centered on the specific fields(respiratory, otolaryngology, and urology)
Main products and pipeline
Strengthen the new drugs business by expanding the pipeline in the specific fields areas and by building strong relationships of trust with healthcare professionals.
Providing information using digital channels and artificial intelligence
With the Guidelines for Prescription Drug Marketing Information Provision having taken effect from April 2019 and the spread of novel coronavirus infections, traditional methods of providing information are changing drastically, and transformations are being sought in the content of information and the ways it is provided. In response to this major shift, KYORIN Pharmaceutical Co., Ltd. is looking beyond its traditional focus on face-to-face interaction with physicians and providing information using digital channels in various ways. In our proactive use of digital channels as media for providing, gathering, and transmitting information, in addition to advances in the media we possess in-house, we are optimizing the providing of information via third-party platforms. We are also aggregating our marketing data to enhance the quality of the information we provide to physicians.
In addition, we are working to enhance the marketing skills (the ability to grasp needs) of medical representatives, using artificial intelligence to logically analyze their sales presentations.
We are addressing diversifying health needs by offering over-the-counter drugs that can be used safely.
Over-the-counter drugs addressing diversifying health needs
With the Japanese government’s introduction of a “self-medication tax system” (special tax deductions for medical expenses) in January 2017, people have become more aware of their health. The Kyorin Group sells the COOL ONE series of over-the-counter drugs that apply active ingredients used in ethical drugs. This series is highly regarded because we are able to provide accurate information regarding the products’ effectiveness and safety gained at the ethical drugs business. We will continue to work to provide products that address diversifying health needs.
* COOL ONE Cough Medicine GX tablets and syrup and COOL ONE expectorant capsules are applicable under the self-medication tax system.
Subcontracted drug manufacturing business
- Manufacturing -
Drug price revisions implemented under the government’s basic policy of comprehensively reforming the NHI’s drug pricing system have had a major effect on the Kyorin Group’s manufacturing structure. With sales of long-listed drugs declining and the market for generics growing, the domestic pharmaceutical market is undergoing drastic structural changes that we expect to impede profitability. The Group has therefore consolidated its three internal manufacturing functions for overall optimization, creating a manufacturing structure that will be able to pursue low-cost operations with a greater sense of speed. Under the new HOPE100 -Stage 3- medium-term business plan, we will build on initiatives implemented to date, creating a competitive Group manufacturing structure that will provide a stable supply of low-cost, high-quality products and also be able to increase subcontracted manufacturing for non-Group customers.
|New HOPE100 -Stage 3- Medium-Term Business Plan|
Enhance cost competitiveness
|Establishing a manufacturing structure to achieve stable supply and low cost while also enabling expansion of subcontracted manufacturing|
Initiatives under new medium-term business plan
Striving for greater cost competitiveness
Under the new medium-term business plan, businesses involved in pharmaceutical manufacturing will share human resources and information across plants, while also creating and operating a human resources management system to cultivate and implement technologies and a mindset for improvement. They will also work to pursue a higher level of Good Manufacturing Practices (GMP), increase manufacturing capabilities (both capacity and efficiency), including the construction of a new manufacturing center, and create a stable supply structure that uses outside parties. Through these initiatives, we will establish a stable manufacturing structure that is highly competitive and able to provide a stable supply of quality products at a low cost. We will then focus on increasing subcontracted manufacturing for non-Group customers and establishing a solid manufacturing base.
Supply chain management（SCM）
With the aim of establishing solid earnings strength in the face of environmental changes, the Kyorin Group is working to build a structure for more efficient manufacturing that offers stable supplies, with flexibility to address changes in demand, by comprehensively addressing the Group’s entire supply chain. We are pursuing supply chain management that manages (makes visible) the entire process- from domestic and overseas procurement of raw materials to manufacturing (production management and drug manufacturing), warehousing, and supply (shipping) - on an individual product basis. By quickly addressing issues like reducing lead times from orders to delivery as they arise, we are working to ensure stable supplies and reduce risks, for reliable, stable supplies of products.
Features of KYORIN Pharmaceutical Group Facilities’ Plants
Noshiro Plant：Low-cost, high-volume manufacturing through automation
The Noshiro Plant uses automated transport of pharmaceutical ingredients and intermediate products, as well as robotic arms for labor savings. Automation makes it possible to manufacture large volumes at a low cost with high productivity. In addition to new drugs, the facility is currently using these strengths to manufacture generic drugs in large volumes, focusing on tablets and capsules. The plant’s advanced manufacturing activities have also been approved in GMP inspections carried out by overseas regulatory authorities and global companies headquartered overseas.
Shiga Plant：Focusing on subcontracted manufacturing incorporating global GMP
For many years the Shiga Plant was a manufacturing base for a non-Japanese pharmaceutical manufacturer, and in addition to manufacturing the Group’s main products, the plant is unique for its high portion of manufacturing subcontracted from outside the Group, including for pharmaceutical products to be sold in Japan by overseas manufacturers. The plant is able to keep pace with the needs of the times, using the latest equipment for manufacturing that incorporates global GMP, with an awareness of issues including the prevention of cross contamination. Using its abundant experience and expertise gained from subcontracted manufacturing for global companies headquartered overseas, the facility is bolstering its manufacturing equipment and working aggressively to increase its manufacturing subcontracted from outside the Group.
Inami Plant：Manufacturing numerous types of products with focus on generic drugs
With a focus on generic drugs, the Inami Plant manufactures products in a variety of forms, including solid formulations taken internally, sterilized formulations for injections, eyedrops, and nose drops. Taking advantage of flexibility that enables it to manufacture many types of products, the facility handles various products that newly appear on the drug price list twice a year, manufacturing more than 200 products including those subcontracted from outside the Group. Through frequent visits from drug manufacturers ordering subcontracting, the facility has gained a wealth of expertise in providing a stable supply of high-quality products. In addition to investing in equipment for new pharmaceutical production, the facility is proactively pursuing improvement activities to raise productivity and working to reduce costs.
The Kyorin Group’s generic drugs business is primarily carried out by KYORIN Rimedio Co., Ltd. Even in the era when generic drugs account for 80% of drugs used, we are addressing changes in our operating environment by using the combined advantages of our development, manufacturing, and sales functions, while also proactively working to handle authorized generics as a manufacturer of new and generic drugs, and making our marketing structure more efficient to enhance cost competitiveness.
|New HOPE100 -Stage 3- Medium-Term Business Plan|
|Business strategy▶ Enhance cost competitiveness|
|Make the generics’ marketing structure more efficient to enhance the generic business’s cost competitiveness||Strengthen ability to create new generics|
Initiatives under new medium-term business plan
Address authorized generics
The Kyorin Group has achieved a certain degree of recognition for its steady market penetration using its ability to handle, within the Group, both original drugs and authorized generics that meet the diverse needs of medical practitioners and patients. We released Montelukast Tablets “KM,” our authorized generic version of Kipres, in September 2016, followed by Mometasone Nasal 50μg “KYORIN,” our authorized generic version of Nasonex, in August 2019, and currently both have gained more than a 50% share of their respective generic markets. We also received approval for the manufacture and sales of Imidafenacin Tablets “KYORIN,” OD tablets 0.1 mg, our authorized generic version of Uritos, in August 2019, and began sales in June 2020.
Strengthen ability to create new generics
To provide generic drug products that can be used safely, KYORIN Rimedio has been carrying out pharmaceutical manufacturing and packaging from the perspectives of medical practitioners and patients, ensuring that products are easy to use in medical institutions and meet the needs of patients taking drugs. The Takaoka Pharmaceutical Technology Innovation Center, which commenced operations in July 2017, is further working to increase the products it develops to improve the quality and speed of pharmaceutical development, with the aim of making KYORIN Rimedio a generic drug company that provides attractive, distinctive generic drug products. As of June 2020, the company had launched eight new ingredients and 15 new products.
Make generics’ marketing structure more efficient to enhance the business’s cost competitiveness
KYORIN Rimedio has been strengthening its sales through a balanced approach using multiple sales channels, and going forward, it will build on that strength while also working to make its generics’ marketing structure more efficient, enhancing its sales capabilities and cost competitiveness through selection and concentration.
Strengthen overseas business
To date, KYORIN Rimedio has been exporting finished products, primarily eyedrops, to Taiwan, Hong Kong, and South Korea. Going forward, in line with economic development and rising incomes across Asia, we anticipate a trend of requests for a higher level of medical care leading to increased demand for Japanese high-quality drugs. KYORIN Rimedio is working to address this demand as quickly as possible by strengthening its businesses of providing technologies and products to countries including Vietnam, Taiwan, Hong Kong, and Mongolia.