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
Prodalim Reports Q3 2026 Results, with Growth in its Specialty Ingredients & Solutions Business and Solos Activity Net Profit and Cashflow from Operating Activities9.11.2026 11:18:00 CET | Press release
Group revenues for the quarter grew 7% reaching US$98.4 million.SIS revenues (Specialty Ingredients & Solutions) grew 30% in Q3 reaching US$20 million.Adjusted EBITDA1 for the SIS grew 37% reaching US$4.3 million, reflecting an adjusted EBITDA margin of 21.4%.Juice Solutions revenues grew 2% in the quarter to US$78 million, improvement in adjusted EBITDA margin to 11.0%.Group’s adjusted net profit grew 34% reaching US$4.2 million.Cashflow from operating activities in the quarter was strong, increasing to US$16.7 million.Last week, the Company announced a strategic acquisition, of BOK, a South African company that produces natural ingredients, high value grape based specialty using circular economy principles. Regulatory News: Tsahi Barak, Chairman of the Board and CEO of the Company, commented: "We are pleased to report another quarter of growth across all key operating parameters, alongside an important strategic acquisition. We continue to make substantial investments in production i
Logistics Reply named a Leader in the IDC MarketScape: Worldwide Warehouse Management for Retail and Manufacturing9.11.2026 10:00:00 CET | Press release
Logistics Reply, the Reply Group company specialised in software solutions for supply chain execution and warehouse management, has been positioned in the Leaders Category of the IDC MarketScape: Worldwide Warehouse Management for Retail 2026 Vendor Assessment (doc #US53701926, October 2026) as well as in the IDC MarketScape: Worldwide Warehouse Management for Manufacturing 2026 Vendor Assessment (doc #US53013526, October 2026). The reports evaluate vendors based on strategy and product capabilities, looking at both quantitative and qualitative criteria. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109197861/en/ Logistics Reply, the Reply Group company specialised in software solutions for supply chain execution and warehouse management, has been positioned in the Leaders Category of the IDC MarketScape: Worldwide Warehouse Management for Retail and Manufacturing. LEA ReplyTM is Logistics Reply’s cloud-native warehouse
SWISSto12 passes critical design review of dual-band 5G antennas for UNIVITY satellites9.11.2026 09:00:00 CET | Press release
The milestone clears the way for flight hardware production, bringing UNIVITY closer to delivering both broadband and direct-to-device 5G services from a single satellite architecture. SWISSto12, a leading enabler of the new space economy, today announced it has passed the Critical Design Review (CDR) for the S- and Ka-band phased array antennas for UNIVITY’s 5G non-terrestrial network (NTN) demonstration satellites. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109823601/en/ SWISSto12's S- and Ka-band phased array antennas pass Critical Design Review SWISSto12 is developing two active antennas for UNIVITY: an S-band direct radiating array (DRA) for direct-to-device services, connecting standard 5G phones straight to the satellite, and a Ka-band DRA operating at 26 GHz for broadband services and feeder links. Both are built for 5G NTN applications, allowing one single satellite to carry both broadband and direct-to-devic
Arrow Electronics lancerer en ny forretning, Capstone, for at øge fokus på IP&E-løsninger9.11.2026 07:00:00 CET | Pressemeddelelse
Arrow præsenterer den nye forretning på electronica-messen i München (10.-13. nov) Arrow Electronics, Inc. (NYSE:ARW) annoncerede i dag lanceringen af Capstone, en global forretning dedikeret til interconnect, passiver og elektromekaniske (IP&E) produkter, løsninger og services. Med Capstone skaber Arrow en fokuseret og specialiseret go-to-market-tilgang for IP&E idet det teknologisegment bliver mere kritisk for systemets ydeevne, pålidelighed og forsynings sikkerhed. Capstone er designet til at gøre IP&E nem at specificere, indkøbe og skalere. Kunder vil få fordelen ved dedikeret IP&E ressourcer, hurtig beslutningstagning og bred teknisk viden, både på on-board og off-board produkter. Med et fokuseret brand kan Capstone tilbyde kunderne mere målrettet rådgivning og støtte gennem hele processen – fra de første designovervejelser til den færdige produktion. Det giver kunderne et bedre grundlag for at træffe de rigtige beslutninger, mindske risikoen undervejs og skabe de bedste skalerbar
Avanzanite Announces Exclusive Licence Agreement to Commercialise Zemcelpro® in Europe9.11.2026 07:00:00 CET | Press release
Zemcelpro is authorised in the European Union for eligible adults with blood cancers who need an allogeneic stem cell transplant and have no other suitable donor cells available. Avanzanite secures exclusive commercialisation rights to Zemcelpro across 32 countries covering the European Economic Area, UK and Switzerland including potential indication expansion. Avanzanite will become the EU marketing authorisation holder following regulatory transfer and support a planned Phase 3 trial. Zemcelpro becomes Avanzanite’s fifth rare disease launch and first advanced therapy medicinal product (ATMP). Avanzanite Bioscience B.V. (“Avanzanite” or “Company”) a European pharmaceutical company focused on rare diseases, today announced an exclusive licence agreement with Montreal-based Cordex Biologics, an ExCellThera company (“ExCellThera”), a leader in enhanced blood stem cell therapies, to commercialise Zemcelpro®. Zemcelpro received conditional marketing authorisation from the European Commissi
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