Pharmaceutical Business

Japan

Information Provision Activities

New drugs are delivered to patients after passing a long process that includes basic research, clinical studies and review by the government for regulatory approvals. Even after drug products are launched and used by a large number of patients, safety and efficacy are continually checked resulting in safe and secure, useful pharmaceuticals. It is only after proper usage has been established based on safety and efficacy information that the pharmaceuticals can fulfill their desired function of contributing effectively to human health requirements.
At Sumitomo Pharma, we collect and share safety information and provide the requisite and specialized information to medical professionals via our MRs (Medical Representatives) and multiple media outlets. Our aim is to earn greater confidence among medical professionals and to contribute to the betterment of healthcare and fuller lives of patients through daily information provision activities.

Focus Areas for the Japan Business

In Japan, we collect and provide professional information primarily in the Psychiatry & Neurology, Diabetes, and Rare diseases areas.
In the Psychiatry & Neurology area, we have therapeutic drugs for disorders such as schizophrenia and we aim to contribute to the treatment of psychiatric and neurological diseases as a medical partner.
In the Diabetes area, we offer several drugs with different mechanisms of action and respond to a wide range of medical needs.

Product Lineup

Major Pharmaceutical Products Therapeutic Indication
LATUDA® Atypical antipsychotic
XEPLION®, XEPLION TRI® long-acting antipsychotic medication
LONASEN® Tape Atypical antipsychotic
TWYMEEG® Therapeutic agent for type 2 Diabetes
Ozempic® Subcutaneous Injection Therapeutic agent for type 2 Diabetes
Equa® Therapeutic agent for type 2 Diabetes
EquMet® Therapeutic agent for type 2 Diabetes
METGLUCO® Therapeutic agent for type 2 Diabetes
Wegovy® Subcutaneous Injection Treatment for Obesity Disease
Agalsidase Beta BS I.V. Infusion [JCR] Therapeutic agent for Fabry disease
IZCARGO® Recombinant Therapeutic for Mucopolysaccharidosis Type II

Research and Development

With a focus on the Psychiatry & Neurology and Oncology disease areas, where unmet medical needs are high, the Sumitomo Pharma Group will make the utmost of the experience and knowledge that we have acquired so far to continue making active efforts for research and development of pharmaceuticals, regenerative medicine/cell therapy, and otherwise. In other areas, too, we will tap into assets at hand and make steady R&D efforts to deliver solid value to patients.

Oncology Area

Through our R&D activities to date, we have gained a variety of knowledge, strengthened our drug discovery capabilities, and created multiple development pipelines with distinctive features. Making use of these achievements, we continue to focus on research and development in the area of oncology, where there are high unmet medical needs.
In drug discovery, we aim to create innovative new drugs by enhancing our competitiveness through the development of modalities using our new technologies as well as initiatives, such as joint research with academia.
In the development stage, we aim to improve the probability of success by carefully evaluating data from short-term, small-scale studies to identify optimum cancer types and product value for multiple development pipelines undergoing initial clinical evaluation. In particular, we are concentrating our resources on enzomenib (DSP-5336) and nuvisertib (TP-3654) , aiming for obtaining early approval and maximizing their value.

Psychiatry & Neurology (CNS) Area

We promote competitive drug discovery research based on our proprietary drug discovery platform, which we have built up by incorporating cutting-edge technologies. In the CNS area, we are committed to continuous value creation by focusing on neurological disorders with high unmet medical needs, including neurodegenerative and rare diseases. In particular, we aim to develop innovative new drugs—such as disease-modifying treatments—by applying our proprietary small molecule drug discovery technologies with strong CNS penetration to targets closely linked to clinical pathology. We are also leveraging non-clinical models with high relevance, such as iPS cells, while further enhancing our accumulated translational technologies, including EEG and imaging, to improve the probability of R&D success. In FY2017, we introduced a new Research Project System, under which researchers who have devised project themes take the lead in their projects up to the initial clinical development stage as a general rule.

Other Areas

We tap into assets at hand and make steady R&D efforts to deliver solid value to patients.

  • To contribute to global health and pandemic preparedness, we are promoting research and development of a universal influenza vaccine and a drug for antimicrobial resistant bacterial infections.

Regenerative medicine / Cell therapy

The regenerative medicine/cell therapy business aims to provide new value that can only be created through regenerative medicine by utilizing our strengths in networking through open innovation with academia, startup companies, and other industries; accumulated technologies for the practical application of iPS cells, as represented by the differentiation induction technology from pluripotent stem cells; and abundant manufacturing capabilities and manufacturing methods, infrastructure, and human resources related to cell production. We have been engaged in research activities in regenerative medicine and cell therapy since the 1990s, drawing on foundational knowledge and intellectual property obtained through Sumitomo Chemical’s basic research using human ES cells, as well as Sumitomo Chemical’s joint research with RIKEN in the ophthalmology area. In FY2024, to accelerate business development in this area, Sumitomo Chemical and Sumitomo Pharma established a joint venture company, RACTHERA . Together, we are promoting efforts to rapidly commercialize iPS cell-derived products, with the goal of becoming the first in the world to launch iPS cell-derived dopaminergic neural progenitor cells for the treatment of Parkinson’s disease.

Pharmaceuticals Production

We have built a stable supply structure for our products, which are manufactured mainly at our own plants in Japan and also in collaboration with partners in Japan and other countries. Our plants have worked hard to increase the precision of their production plans by strengthening collaboration with the Sales & Marketing Division, the Business Development & Management, overseas subsidiaries, and business partners. We have also made proactive efforts such as double sourcing of active pharmaceutical ingredients and optimizing the supply chains regarding the formulation and packaging of products. To further strengthen our competitiveness, we continuously work on cost reduction activities, as well as actively striving to increase productivity in our plants, such as by reducing lead times.

Suzuka Plant

The Suzuka Plant is Sumitomo Pharma's core formulation plant, equipped with integrated pharmaceutical manufacturing facilities capable of a full range of operations from the production of active pharmaceutical ingredients to the formulation and packaging of products. It includes a state-of-the-art solid dosage formulation facility fully compliant with cGMP (the latest U.S. GMP) and supplies products globally.

Oita Plant

The Oita Plant is Sumitomo Pharma's principal facility for the production of active pharmaceutical ingredients and its equipment is cGMP-compliant. It operates 24 hours a day, 365 days a year to ensure stable production of active pharmaceutical ingredients.

Key initiatives for the Japan business under Reboot 2027

Secure revenues through our strengths and key products, and make regenerative medicine and cell therapy our core business

Maximize the value of key products and new products

  • Maximize product value by leveraging the sales base and relationships in the areas of strength (CNS/diabetes/rare diseases)
  • Prepare for the launch of the oncology business
  • Improve customer satisfaction through omni-channel information and conduct evidence-based medical activities

Focus on launching and expanding the regenerative medicine and cell therapy business

Adapt operations to change

  • Build and operate a system that adapts to changes in product and workforce mix
  • Respond flexibly to changes in healthcare policy
  • Strategic alliances to ensure business continuity

USA

Sumitomo Pharma America, Inc. is engaged in R&D, manufacturing and sales of pharmaceuticals.
Sumitomo Pharma America, Inc. launched in July 2023, through consolidation the functions and human resources of seven U.S. group companies, Sunovion Pharmaceuticals Inc., Sumitomo Pharma America Holdings, Inc., Sumitomo Pharma Oncology, Inc., Sumitovant Biopharma, Inc., Myovant Sciences, Inc., Urovant Sciences, Inc., and Enzyvant Therapeutics, Inc.

Sumitomo Pharma America, Inc. Product Lineup

Major Pharmaceutical Products Therapeutic Indication
ORGOVYX® Therapeutic agent for advanced prostate cancer
MYFEMBREE® Therapeutic agent for uterine fibroids and endometriosis
GEMTESA® Therapeutic agent for overactive bladder (OAB)
RETHYMIC® Cultured thymus tissue for pediatric congenital athymia

Key initiatives for the North American business under Reboot 2027

Maximizing the value of existing products

  • Three key products: Maximizing sales and product profitability through the execution of strong sales strategies with excellent return on investment
  • RETHYMIC®: Enhancing product supply to patients through the establishment of in-house processing facilities

Pursuing continuous operational efficiency improvements

  • Continuing rigorous cost management
  • Simplifying the governance structure
  • Maintaining efficient commercial structure to support approval and launch of enzomenib