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 Parkinson's disease and 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 |
|---|---|
| TRERIEF® | Therapeutic agent for Parkinson's disease |
| LATUDA® | Atypical antipsychotic |
| LONASEN® Tape | Atypical antipsychotic |
| Equa® | Therapeutic agent for type 2 Diabetes |
| EquMet® | Therapeutic agent for type 2 Diabetes |
| SUREPOST® | Therapeutic agent for type 2 Diabetes |
| METGLUCO® | Therapeutic agent for type 2 Diabetes |
| TWYMEEG® | Therapeutic agent for type 2 Diabetes |
| AmBisome® | Therapeutic agent for systemic fungal infection |
| REMITCH® | Therapeutic agent for pruritus |
| 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, non-pharmaceutical products, 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.
Psychiatry and Neurology
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 area of psychiatric disorders, including schizophrenia, depression, and peripheral symptoms of neurological disorders, we aim to create breakthrough therapeutic drugs that satisfy unmet medical needs through drug discovery based on neural circuit pathology. In the area of neurological disorders, including dementia, Parkinson’s disease, and rare diseases, we aim to create disease modifying therapies for neurodegenerative diseases by focusing on abnormal cell functions. We also use insights gained from clinical data of products and development assets in translational research to select appropriate drug discovery targets and biomarkers from big data, such as genome information, EEG, and imaging, thereby improving 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.
Oncology
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 nuvisertib (TP-3654) and enzomenib (DSP-5336), aiming for obtaining early approval and maximizing their value.
Other Areas
We tap into assets at hand and make steady R&D efforts to deliver solid value to patients.
- For GEMTESA®, we make efforts to pursue a Phase 3 clinical study and prepare an application for approval for overactive bladder in China.
- 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.
Non-pharmaceutical modalities
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. Specifically, we will expand our therapeutic areas from the central nervous system and ophthalmology fields to peripheral organs, expand into overseas markets with Japan as a foothold, and transition from supplying single cells to supplying 3D tissues and organs.
In the regenerative medicine/cell therapy business, we aim to achieve sales revenue of approximately 10 billion yen through the launch of allogeneic iPS cell-derived dopaminergic neural progenitor cells (DSP-1083) in Japan, the expansion of the contract manufacturing business at S-RACMO Co., Ltd., and the development of the “RETHYMIC® (allogeneic cultured thymus tissue)” business under the Mid-term Business Plan 2027. Furthermore, in the early 2030s, we aim to achieve a global business scale of over 100 billion yen by launching DSP-1083 in North America and other iPS cell-derived products in Japan.
Frontier Business
Anticipating the advent of an era in which it will be difficult to achieve the required level of well-being through pharmaceuticals alone, the Company's consolidated subsidiary FrontAct Co., Ltd. is promoting frontier business with the aim of providing new healthcare solutions other than pharmaceuticals while also utilizing digital transformation (DX) technologies. In a bid to create synergies with our pharmaceuticals business, we will focus on the areas of mental resilience (preventing deterioration of neuropsychiatric disorders by detecting the signs at an early stage) and active aging (improving, maintaining, and enhancing the health of the elderly from their state of mind). We will build business platform consisting of key technologies (including ICT and engineering) and external networks (including partnership with startups and venture capitals).
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 International Business Management Department, 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.
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) |
| APTIOM® | Antiepileptic |
| RETHYMIC® | Cultured thymus tissue for pediatric congenital athymia |
China
Sumitomo Pharma (Suzhou)Co., Ltd. is engaged in manufacturing (subdivided packaging) and sales of pharmaceuticals.
Sumitomo Pharma (Suzhou)Co., Ltd. Product Lineup
| Major Pharmaceutical Products | Therapeutic Indication |
|---|---|
| MEPEM® (Brand name in Japan: MEROPEN®) | Carbapenem antibiotic |
| ALMARL® (Brand name in Japan: Arotinolol Hydrochloride) | Therapeutic agent for hypertension, angina pectoris and arrhythmia |
| LONASEN® | Atypical antipsychotic |
| LATUDA® | Atypical antipsychotic |