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Drug Discovery Research and
Product Development Research

Focus Therapeutic Areas

The Group remains committed to research and development by taking every available opportunity to assimilate cutting-edge technologies through combinations of a wide variety of avenues, including in-house research, technology in-licensing, and joint research with biotech companies and academia, with the aim of continually discovering excellent pharmaceutical products with Psychiatry & Neurology, Oncology, and Regenerative Medicine and Cell Therapy as its focus therapeutic areas.

Psychiatry and Neurology

In the early stages of research, the Company is working to apply cutting-edge scientific technologies including high-performance computer-based in-silico drug discovery technology and utilization of iPS cells to drug discovery.
Under our ONE TEAM operating structure for the Global Clinical Development linking our Japan and U.S. units, we focus on late-stage clinical development products to obtain fast approval.

Oncology

Under a global research and development framework comprising Boston Biomedical, Inc. (U.S.), Tolero Pharmaceuticals, Inc. (U.S.), and the DSP Cancer Institute (Japan), our fundamental research and development strategy is to deliver unique, previously unavailable products with a focus on cancer stemness inhibitors, cancer peptide vaccines, and kinase inhibitors.
We are also proactively forming external research collaboration with leading institutions, including universities both within and outside Japan.

Regenerative medicine/cell therapy

The Company aims to achieve early commercialization of regenerative medicine and cell therapy products. In order to overcome one of the greatest bottlenecks hindering this goal, namely, the development of a production system for such products, the Company completed the Sumitomo Dainippon Manufacturing Plant for Regenerative Medicine & Cell Therapy (SMaRT) in March 2018 as the world's first facility dedicated to the commercial manufacturing of regenerative medicine and cell therapy products derived from allogeneic iPS cells.
The Company will remain committed to promoting the regenerative medicine and cell therapy business using allogenetic iPS cells for age-related macular degeneration, Parkinson's disease, retinitis pigmentosa, and spinal cord injury.

Sumitomo Dainippon Pharma's major therapeutic areas of research

Fundamental Technologies

Technology enhancement for improving drug discovery ability or the probability of success in the clinical development stage is indispensable for the continual creation of excellent pharmaceutical products.

Among the wide range of technical foundations and general pharmaceutical expertise possessed by Sumitomo Dainippon Pharma, in the initial stage of research, Sumitomo Dainippon Pharma is working to apply leading-edge scientific technologies, including high-performance computer-assisted in silico methods and iPS cells, to drug discovery and regenerative medicine/cell therapy. Sumitomo Dainippon Pharma also proactively seeks external research collaboration with universities and other research institutions throughout the globe. During FY2016, the second term of the joint research project with Kyoto University (DSK Project), which aims to discover innovative anti-cancer drugs, was launched. Meanwhile, under the Partnership to Realize Innovative Seeds and Medicines (PRISM) framework, which is an open innovation program launched in FY2015 whereby research institutions and researchers in Japan are invited to submit ideas that meet Sumitomo Dainippon Pharma's drug discovery research needs, joint research agreements were signed on multiple ideas during FY2016.

Product Development Research

For continuously developing excellent pharmaceuticals and contributing to society, not only improvement in drug discovery ability or technology enhancement of clinical development but also enhancement of product development technology are indispensable.
We conduct research into the commercialization of promising drug candidate compounds found in drug discovery research so that they can be delivered to patients suffering from diseases as a "good medicine."

Product Development Research

Product Development Research Process

Universal design - Orally disintegrating (OD) tablet technology

Previous OD tablets have been disadvantageous in their fragility, which often caused destruction in the middle of preparation, in spite of smooth melting in the mouth. To deal with this problem, we developed the SUITAB and PEATAB technologies for manufacturing OD tablets with excellent melting and strength and, after them, the SUITAB-NEX technology for reducing bitterness and improving stability according to drug properties.

While traditional OD tablets have been positioned as barrier-free drugs for specific cases such as infants, aged patients and those with difficulty swallowing, the new OD tablets feature a "universal" design, which is easy to take for anyone who has been taking tablets. The new technologies described above have allowed us to release the Japan-first hypertension treatment OD tablets and long-acting anti-allergic OD tablets to the market.

Universal design - Orally disintegrating (OD) tablet technology

Nucleic acid drugs - Drug delivery system (DDS)

Nucleic acid drugs such as siRNA(*) are expected as candidates for next-generation drugs thanks to their excellent specificity and efficacy. Nevertheless, further technological innovation is required because the DDS technology for the specific introduction of the drug to the target cells is not established. At Sumitomo Dainippon Pharma, we are conducting joint research into DDS technology using atelocollagen. It is the most advanced research into practical applications for the delivery of nucleic acid drugs to the patients who need them. The atelocollagen DDS is one of the few nucleic acid DDS technologies that has been demonstrated to be effective in in vivo trials, and its high efficacy and safety have earned it a high reputation among various research institutions as well as overseas nucleic acid drug developers.

* Double-stranded RNA molecules composed of 21-23 nucleotides, which are involved in RNA interference (a technique

Nucleic acid drugs - Drug delivery system (DDS)

Lipiodolized drug

We developed the first platinum-based drug indicated as "adapting lipiodolization for hepatocellular carcinoma." This drug features increased suspensibility in the ethyl esters of the iodized fatty acids of poppyseed oil, thanks to the high lipophilicity of miriplatin molecules, which are its active ingredient, and its special formulation design. After having been administered in the hepatic artery, it is retained in the tumor to locally release the platinum ingredient for a long period while minimizing whole-body exposure.

Lipiodolized drug

Application of imaging analysis technology

To offer high-quality pharmaceuticals, we are positively tackling development and introduction of advanced analysis technologies. The imaging analysis technology that enables visual confirmation is one of such technologies. In our efforts for quality improvement, we actively use a near-infrared imaging device and X-ray CT scanner to measure and analyze the surface ingredient distribution and internal structure of a tablet without destroying it.

Application of imaging analysis technology

Drug stability prediction technology

In addition to stability prediction based on thermodynamic considerations, we are also challenging ourselves to make predictions of the future stability of drugs from the spectroscopic and physical information obtained through nonlinear analysis, represented by chemometrics, etc. For instance, with the aim of improving product quality, we are studying a stability prediction method using a near-infrared (NIR) analyzer.

Drug stability prediction technology