To rebuild the foundation of our core new drugs business and put it on a growth trajectory, we must urgently expand our development pipeline. In fiscal 2023, our newly established Business Development Headquarters will work with the Licensing Department and the Alliance Department to swiftly introduce a development pipeline.
By stabilizing our existing alliances and creating new businesses, we will generate stable earnings and create new business opportunities, thereby fostering the sustainable growth of our new drugs business.
Under Vision 110 –Stage1–, we have set a guideline for expected sales based on our business strategy “expanding the development pipeline through in-licensing” while being conscious of medium- to long-term profits.
Our aim is to secure six or more in-licensed items. We recognize that the eff orts of the Business Development Headquarters will be truly appreciated only when in-licensed products are commercialized and generate profits, and will continue working proactively to achieve those goals.
In fiscal 2023, we will acquire at least one in-licensed product in the late-stage development phase and at least one in-licensed product in the early-stage development phase. Those acquisitions will enable us to expand our development pipeline, which is our most important priority.
Changing environment(internal and external)
- Growing needs for diagnosis and prevention in addition to treatment
- Advances in digital transformation in medicine
- Increasing sophistication and difficulty of drug discovery
- Diversification and complexity of drug discovery modalities
- Depleted development pipeline
- Strong financial base
Opportunities
- Expansion of technological innovation through open innovation
- Increase in opportunities to collaborate with partners from different industries
- Significant increase in capital and personnel
- Portfolio of therapeutic drugs and products related to diagnosis and prevention
- Growing value of innovative new drugs for rare and intractable diseases
Risks
- Surging investments in in-licensing contracts
- Earlier-than-normal recruitment by megapharmaceutical manufacturers
- Lack of human resources with multiple perspectives
Medium-term business plan
Vision 110 –Stage1– initiatives
Business strategyExpanding development pipeline through in-licensing
Significantly strengthen our ability to acquire in-licensed products
- Expand modalities and disease areas targeted for in-licensing and pursue wide-ranging in-licensing activities
- Increase in-licensing investments and boost investments in organizational reforms and human resources
Promote development of digital therapeutics (DTx)
- Develop a therapeutic application in the field of otolaryngology
Initiatives under the medium-term business plan
Search and evaluate through organizational reforms and deployment of personnel
To achieve the objectives of Stage 1, we must work closely with relevant departments to promote speedy and accurate evaluations since we are always searching and evaluating aspects of multiple projects in progress.
With this in mind, we established the Licensing Department (licensing activities) and the Alliance Department (contract negotiations and management of alliances) under the Business Development Headquarters and will provide personnel for those entities to the maximum extent possible.
To strengthen the headquarters function, we will step up collaboration within the headquarters and develop human resources. At the same time, we will activate our organization to enable one-stop in-licensing services, ranging from exploration to evaluation, negotiation of terms and conditions, and conclusion of contracts.
By building a system of collaboration with relevant departments to allow speedy responses, we will work Companywide to achieve our performance targets.
Expand in-licensing target modalities and disease fields
To broaden our development pipeline, we need to expand target modalities and disease fields and pursue in-licensing initiatives in a wide range of areas.
In addition to small molecule drug discovery, where we have been actively engaged, we will work to quickly secure development candidates that will enable us to demonstrate our strengths in new modalities and disease fields outside the franchise customer (FC) field (respiratory, otolaryngology, and urology), as well as in-licensed products with viable commercial prospects.
Promote DTx development
Amid advances in recent years in digital transformation (DX) in the medical field, we have also taken on the challenge of engaging in R&D on digital therapeutics (DTx).
In November 2022, we concluded an agreement with SUSMED, Inc. to conduct joint R&D and sales related to DTx as software for medical devices. In collaboration with relevant departments, the Business Development Headquarters will steadily develop a therapeutic application in the field of otolaryngology (target disease: tinnitus).
It will also gather information on the development of new therapeutic applications in a wide range of fields.
Pursue proactive partnering activities
Under the medium-term business plan “Vision 110 –Stage1–,” KYORIN Pharmaceutical’s Alliance Department and Licensing Department will work closely with other relevant departments to pursue proactive partnering activities. In line with the business strategy of the medium-term business plan, we have expanded our development pipeline in various ways.
In September 2020, for example, we concluded an agreement with ASKA Pharmaceutical Co., Ltd. for the joint development and sales of AKP-009, a benign prostatic hyperplasia treatment, and in April 2021, we signed an agreement with MSD K.K. for the exclusive distribution rights in Japan for Lyfnua (launched in April 2022), a treatment for intractable chronic cough.
Regarding the licensing agreement concluded in January 2020 with U.S.-based aTyr Pharma, Inc. for KRP-R120 (interstitial lung disease treatment), we decided to conduct multiregional clinical trials with aTyr Pharma and started Phase 3 clinical trials in Japan in September 2022. In June 2022, we signed an agreement with CellGenTech, Inc. for the joint development of a genetically modified human adipocyte as an in-licensed product in its early-stage development phase for the treatment of Fabry disease.
Promote global out-licensing activities to increase overseas earnings
Under our medium-term business plan, we will continue to aggressively pursue out-licensing activities with global companies to maximize the value of drugs discovered inhouse. We have already made good progress under the previous medium-term business plan. In October 2020, for example, we concluded an agreement for the transfer of intellectual property rights for the immunomodulator KRP-203 to Ireland-based Priothera Limited.
In March 2021, we signed a licensing agreement with Eisai Co., Ltd. for the development and sales in four ASEAN countries of the overactive bladder treatment Vibegron (sales name in Japan: Beova). In March 2023, we signed a licensing agreement with Sumitomo Pharma Co., Ltd. for the development, manufacture, and sales of Vibegron in Taiwan and elsewhere. Going forward, we will continue to actively pursue worldwide partnering activities to expand our product pipeline, which will support medium-term growth and bolster overseas earnings.
Partnering with Companies in Japan and Overseas
