SHIN NIPPON BIOMEDICAL LABORATORIES, LTD.
2395・Prime Market・Services
Business
Shin Nippon Biomedical Laboratories, Ltd. is a long-established drug development support company founded in 1957, which launched Japan's first CRO business in 1960. In its core CRO business, the company has established itself as the largest domestic operator in non-clinical studies using experimental NHPs (non-human primates), and also undertakes international collaborative clinical trials through its joint venture with global clinical CRO PPD (Shin Nippon Biomedical Laboratories PPD). In its TR business, the company promotes drug discovery and development leveraging its proprietary nasal delivery platform technology (SMART), and in April 2025 launched "Atzumi™," a nasal migraine drug that became the first FDA-approved product developed using this technology. In its Medipolis business, the company operates geothermal and hot spring power generation as well as hospitality operations, leveraging the natural capital of its 1.03 million tsubo site in Ibusuki, Kagoshima. Its main customers are pharmaceutical and biotech companies both in Japan and overseas.
Business Model
In the CRO business, the core earnings model involves receiving orders for trials from pharmaceutical companies and other clients, with fees received upon completion of each trial. The order backlog stands at ¥40,920 million (an all-time high), providing high visibility. The TR business is in an upfront investment phase, targeting future revenue through licensing out and commercialization of SMART technology. The Medipolis business consists of stable electricity sales revenue under the FIT (Feed-in Tariff) system and hotel operation income. The CRO business maintained a high operating margin of 22.1%.
Company Strengths
As the only CRO in the world to have built an NHP breeding and supply system within its own group (Japan, Cambodia, China). The company also owns a quarantine facility (bonded warehouse) designated by the Minister of Agriculture, Forestry and Fisheries, ensuring stable quality and quantity. In FY2026 (ending March 2026), non-clinical business order intake reached a record high of ¥35,728 million, with an order backlog of ¥40,920 million, while orders from Europe and the US grew significantly, up 35.2% year on year to ¥13,225 million.
The company has established preferred outsourcing contracts (preferred agreements) with multiple pharmaceutical companies, securing a stable order base. In FY2026 (ending March 2026), a major domestic pharmaceutical company was added, bringing the total to four domestic pharmaceutical companies with preferred agreements. In addition, the company obtained preferred vendor certification from one global mega-pharma company. The establishment of a dedicated Global Sales Team (GST) for overseas clients and strengthened sales efforts across multiple US locations have contributed to order growth.
SMART, a proprietary intranasal administration platform technology developed continuously since 1997, produced its first FDA-approved product (Atzumi™) in April 2025. In the development of an intranasal mucosal vaccine, the company received the highest rating of "A" in the AMED/SCARDA interim evaluation, with achievement of non-clinical proof of concept (POC) certified and support extended through March 2029. As a platform technology with a track record of application to five or more drugs, it offers a wide range of options for commercialization.
ENVALITH's Perspective
Performance Trend
Revenue for FY2026 (ending March 2026) was ¥32,524 million (up 0.3% year on year), marking a record high for the fourth consecutive fiscal year; however, the completion of several large-scale studies in the CRO Business slipped into the following fiscal year, keeping the revenue increase marginal. Operating profit was ¥2,653 million (down 11.1% year on year), declining for the second consecutive fiscal year. The main causes of the cost increase were the expansion of Satsuma's operating loss (¥2,545 million) and strategic upfront investments in personnel and facilities. Ordinary profit was ¥5,833 million (down 9.6% year on year), impacted by a decrease in equity-method income (from ¥3,513 million to ¥2,780 million). Meanwhile, the order backlog in the Non-Clinical business reached a record high of ¥40,920 million, and for FY2027 (ending March 2027), revenue is forecast at ¥38,000 million (up 16.8% year on year) and operating profit at ¥3,000 million (up 13.0% year on year). The recovery in earnings hinges on the collection of deferred projects and the progress in working through the order backlog.
Growth Strategy
Three pillars: strengthening the company's global position in NHP non-clinical CRO, expanding the PPD clinical business, and monetizing SMART nasal delivery technology
Constructing a new "EU Experimental Building" specialized in EU-standard large breeding cages for NHP experimental facilities, at a total cost of approximately ¥10.0 billion. Aiming for a world-class facility equipped with a new MRI (3 Tesla), CT scanner, and other advanced equipment. Order intake from US and European clients grew sharply, up 35.2% year on year in FY2026 (ending March 2026), and the facility expansion aims to capture further orders.
Developing an AI-based automated final report generation system to shorten the period from the end of experiments to submission of the final report draft. A PoC was conducted in FY2026 (ending March 2026) with satisfactory results. Shortening lead times for non-clinical studies is an important value for pharmaceutical companies and serves as a differentiating factor.
For the FDA-approved intranasal migraine drug "Atzumi™ (STS101)", the company is promoting early market introduction in global markets including the Middle East, India, Asia, and Japan, while internalizing manufacturing and sales functions. In addition to traditional lump-sum licensing-out negotiations, the company is also proceeding in parallel with its own business development to realize business value at an early stage.
SNBL PPD, a joint venture with PPD (a subsidiary of Thermo Fisher Scientific), marked its 10th anniversary, and orders received in fiscal 2025 significantly exceeded the previous year. The company maintains a high operating margin of 44.3%, and the increase in orders is expected to contribute to growth in equity in earnings of affiliates from FY2027 (ending March 2027) onward.
The financial KPIs for fiscal 2028 include net sales of ¥50.0 billion, ordinary income of ¥20.0 billion, an ordinary income margin of 40%, and a dividend payout ratio of 30-40%. Net sales in FY2026 (ending March 2026) were ¥32,524 million, and achieving the target will require accelerating growth to a rate exceeding approximately 15% per year. Both ROE and ROIC are targeted at 10% or higher, with monthly reporting to the Board of Directors.
Last updated: July 19, 2026