SOLASIA-PHARMA
30.6.2021 10:00:07 CEST | Business Wire | Press release
Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world.
Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year. If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.
Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows:
“No standard treatment has been established for relapsed or refractory PTCL as of yet. I firmly believe that darinaparsin, with its novel mechanism of action that differs from those of already approved drugs, will contribute to patients and healthcare providers at clinical sites as a new treatment option for relapsed or refractory PTCL. Since founding, Solasia has conducted R&D on five pipeline drugs. Of the five, we have successfully developed and brought to market two drugs, i.e., began providing them to patients, and today, we submitted an NDA for our first anti-cancer drug. Under our mission to provide patients with ‘Better Medicine for a Brighter Tomorrow’, we will continue aiming to contribute to patients’ treatment and enhanced quality of life. ”
About darinaparsin (SP-02)
Darinaparsin, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the US and EU.
For more information, please visit at https://solasia.co.jp/en/pipeline/sp-02.html
About Asian Multinational Phase 2 Study
The Asian Multinational Phase 2 Study was a multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in patients with relapsed or refractory PTCL conducted in Japan, Korea, Taiwan, and Hong Kong. (CT.gov Identifier: NCT02653976).
Solasia plans to present the results of the study at an international academic conference to be held in the near future.
About peripheral T-cell lymphoma (PTCL)
Please visit at https://solasia.co.jp/en/pipeline/sp-02.html
About Solasia
Please visit at https://solasia.co.jp/en/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210630005395/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
MultiBank Group and Universal Sign Agreement to Develop USDU Settlement Capabilities for Institutional Clients12.11.2026 13:02:00 CET | Press release
MultiBank Group, one of the world’s largest financial derivatives institutions, has signed a memorandum of understanding (MoU) with Universal Digital Intl Limited (“Universal”) to develop settlement capabilities using USDU, Universal’s US dollar-backed stablecoin, for eligible institutional digital asset transactions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112192767/en/ MultiBank Group, one of the world’s largest financial derivatives institutions, has signed a memorandum of understanding (MoU) with Universal Digital Intl Limited (“Universal”) to develop settlement capabilities using USDU, Universal’s US dollar-backed stablecoin, for eligible institutional digital asset transactions. The initiative will begin with a pilot for eligible Professional Clients on mb.io, the Group’s cryptocurrency and digital asset trading platform. It combines MultiBank Group’s trading infrastructure, institutional relationships and li
IFF Launches CONCEPT MUSE, an AI-Powered Platform Designed to Accelerate Food and Beverage Product Development12.11.2026 13:00:00 CET | Press release
From inspiration to conceptualization, accelerated by technology and shaped by human expertise. IFF (NYSE: IFF)—a global leader in flavors, fragrances and health and biosciences—today announced the launch of CONCEPT MUSE, a proprietary AI-powered tool for food and beverage concept generation. Drawing from IFF’s consumer insights, flavor expertise and market intelligence, CONCEPT MUSE helps identify market opportunities and uses simple prompts to generate differentiated concepts—complete with narratives, visual mockups and suggested technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111590865/en/ IFF's CONCEPT MUSE helps identify market opportunities and uses simple prompts to generate differentiated concepts. “Food and beverage innovation has always been a balance of art and science. Now digital transformation is adding a powerful new dimension to that equation,” said Benjamin Mattei, vice president of intellige
Carbon Measures Opens Singapore Office and Launches First In-Country Pilot to Advance Industrial Decarbonization in Hard-to-Abate Sectors12.11.2026 12:00:00 CET | Press release
Today, at COP31, Carbon Measures announced the establishment of its Singapore office, with support from the Singapore Economic Development Board (EDB). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112827071/en/ Carbon Measures opens Singapore office and launches first in-country pilot to advance industrial decarbonization in hard-to-abate sectors. The Singapore office will serve as Carbon Measures’ Asia-Pacific hub, expanding its technical expertise and knowledge capabilities while strengthening engagement with key stakeholders across the region. The office will focus on advancing industrial decarbonization policies for hard-to-abate sectors, convening companies, nonprofit organizations, academic institutions and other partners to guide the Pilot’s development and implementation. “We welcome Carbon Measures’ establishment of its first office in the region. By piloting new approaches for product-level carbon accounting,
Focused Support Delivers Link 16 to Royal Netherlands Air and Space Force MQ-9 Fleet With Cavok STRIKE12.11.2026 12:00:00 CET | Press release
Focused Support LLC today announced the successful deployment of Cavok® STRIKE to the Royal Netherlands Air and Space Force (RNLASF), providing its MQ-9 fleet with enhanced Link 16 participation capabilities without requiring modifications to the aircraft. The deployment represents a significant advance in integrating remotely piloted aircraft into the shared tactical picture, improving situational awareness, interoperability, and coordination across joint and coalition forces. The installation marks a key milestone for Focused Support as Cavok STRIKE expands into European military operations. Integrated within the Cavok Mission Ecosystem, STRIKE addresses a persistent tactical challenge: extending Link 16 to non-traditional participants without costly or complex aircraft modifications. Focused Support Founder and CEO, Jonathan Shill, remarked, “Two decades ago we asked for Link 16 on the MQ-1 Predator but were denied because the 8 lb. terminal represented a half hour of time on statio
Ahead of Frieze Abu Dhabi, 421 Arts Campus Spotlights Emerging Artistic Practices12.11.2026 11:15:00 CET | Press release
As Abu Dhabi prepares to welcome the international art community for the inaugural Frieze Abu Dhabi this November, 421 Arts Campus presents two exhibitions highlighting artistic experimentation, research, and emerging creative practices in the UAE and wider region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112518634/en/ Juma Alhaj, Revelation, 2026 at 421 Arts Campus. Courtesy of 421 and the artist. (Photography by: Ismail Noor, Seeing Things) On view until 10 January 2027, the exhibitions bring together distinct artistic approaches, from Juma Alhaj’s exploration of reflection and self-discovery to an examination of how knowledge is formed and shared through informal modes of communication. Revelation, the first institutional solo exhibition by Emirati artist Juma Alhaj, marks a significant evolution in his practice. Grounded in reading, journaling, and philosophical inquiry, the exhibition explores reflection, solit
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom