Nippon Shinyaku - Company History

In November 1911 Ichinose Hisomu opened a one-man shop in Kyoto, Kyoto Shinyakudo, wholesaling medicines imported from Europe and America to physicians and drug dealers. Most of what it handled was expensive because it came from abroad, and the most expensive of all was santonin, the standard treatment for roundworm: Russia held the plant that yielded it and forbade seed leaving the country, so Japan could only buy. Kyoto — an old capital, but also a university town — was the right place to think about answering that with research rather than with better purchasing. In October 1919 Ichinose and Naiki Seibei reorganized the shop into a joint-stock company with ¥500,000 of capital and renamed it Nippon Shinyaku, taking a head office and plant at Mibu in Shimogyo ward; by May 1920 it was manufacturing its own preparations there, and had stopped being a merchant.

From April 1926 the company went looking for a plant that carried santonin. In August 1929 it drew 2.4 grams of santonin crystals from the flower buds of a European variety raised at Mibu, and named the plant mibuyomogi. Cultivation and process then took another decade: the Nishioji plant followed in 1934, a medicinal-plant field at Yamashina in 1935. The point was not the molecule but the chain — seed, field, extraction, factory — all of it held in-house.

Domestic santonin finally went on sale in May 1940, fifteen years after the search began, and it made the company. An Osaka branch opened the same year; in October 1944 a Sapporo plant was built to grow and process the raw material closer to where it grew. The wartime three-site structure of Kyoto, Osaka and Sapporo, put up under a national policy of import substitution, was what the company still had to work with when the war ended.

The company listed in Kyoto in June 1949, in Osaka in 1956 and in Tokyo in 1962 — three markets in thirteen years, and a national funding base for a firm that still thought of itself as a Kyoto house.

What it did with that base was widen sideways. A 1960 tie-up with Kuroishi Pharmaceutical (today the consolidated subsidiary Shioe Pharmaceutical) filled out the drug line; in May 1961 it built a spice plant and launched a powdered seasoning, Spice Kenda, the first product of a functional-foods business that has run alongside pharmaceuticals ever since and, decades later, would quietly beat its targets while the drug side missed them. Research and related ventures were added on the same rhythm — a new laboratory in 1962, an Odawara plant for eastern Japan in 1964, a food plant at Morioka in 1966, a food technology laboratory in 1970, the Central Research Laboratory in 1982.

Less visible, and more consequential, was what the product list accumulated. From Eviprostat in 1967 to Estracyt capsules in 1984, urology and haematology drugs piled up in fields the large pharmaceutical companies did not treat as their main battlefield. Nobody called it a strategy at the time. Half a century later the company would declare it as one.

A Düsseldorf office opened in 1991, a New York office in 1997, incorporated in 1999 as NS Pharma, Inc. These were listening posts — places to gather development information — not sales organizations, and the distinction would decide the company’s next twenty years. Research capacity grew faster than commercial reach: a second western research building in 1994, an eastern research laboratory at Tsukuba in 1997.

Manufacturing was pulled the other way, into one place. In February 2001 a new formulation building went up inside the Odawara site, which was renamed the Odawara Integrated Formulation Plant and equipped with containment for highly potent compounds — a bet on what the pipeline was becoming rather than on what it then sold.

The consequence arrived in 2008. Nippon Shinyaku had created selexipag, a drug for pulmonary arterial hypertension, and had no way to sell it outside Japan; it kept the domestic rights and licensed the rest of the world to Actelion, taking macitentan for Japan in return in 2010. It was the clean expression of the company’s shape — strong enough to invent a global drug, too small to deliver one.

Capital spending through the 2010s went to modalities the company did not yet sell: a clinical-trial API building at head office in 2016, a highly potent solid-dosage building at Odawara in 2017. In 2019 the sixth mid-term plan put the strategy in words — concentrate research on intractable and rare disease, urology and haematology, which was less a new direction than a formal choice of the ground it had been standing on since the 1960s.

The proof came in 2020. Viltepso (viltolarsen), an exon-53 skipping antisense drug co-created with the National Center of Neurology and Psychiatry, was approved by the US FDA, and NS Pharma sold it in the United States on its own — the first time Nippon Shinyaku had ever marketed a product abroad without a partner. Where selexipag’s market was the world, Viltepso’s was a countable set of specialist centres, patient organizations and payers, and a mid-sized firm could reach it unaided. Chinese subsidiaries followed in Beijing and Tianjin in 2021, a move to the Tokyo Prime Market in April 2022, and a new NS Pharma office in Cambridge, Massachusetts in 2023.

The year ended March 2025 was the best in the company’s history: revenue of $1.1B (¥160bn) and operating profit of $236.6M (¥35bn). But the composition is worth reading. A large part of that profit is industrial-property income — royalties riding on the sales of the partner that took selexipag — and Viltepso’s US position still depends on confirmatory evidence the company owes the regulator. One hundred and fourteen years after a shop that resold other people’s imports, the question is the same one in a new form: how much of the chain from discovery to patient it can hold itself.