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
Poland's Galaxy Systemy Informatyczne Becomes First Private Enterprise to Buy Quantum Computer from IQM7.4.2026 15:00:00 CEST | Press release
IQM will deliver and install the 54-qubit quantum computer at Galaxy in the fourth quarter of 2026. The deployment builds Galaxy’s quantum capabilities, supporting talent development and innovation across sectors, while reinforcing Poland’s growing quantum ecosystem. This will be another Radiance 54-qubit computer deployed this time in Poland by IQM, following installations at LRZ in Germany, VTT in Finland, CINECA in Italy, and CESGA in Spain, underscoring the company’s leading market position. IQM Quantum Computers, a global leader in superconducting quantum computing, today announced a commercial milestone to deploy a hybrid integrated quantum computer at GalaxySystemy Informatyczne Sp. z o.o., marking its first deployment in a private enterprise worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407351934/en/ IQM Radiance quantum computer Galaxy has been implementing innovations in security, digitisation, and h
Variational AI Releases Enki 4: Major Update to Foundation Model for Small-Molecule Drug Discovery7.4.2026 15:00:00 CEST | Press release
Variational AI introduces Enki™ 4: an improved algorithm and architecture designed to scale, expanding the pre-trained target coverage from 592 to 760 and now applicable to proximity-based therapeutics and novel payloads for antibody drug conjugates Variational AI today announced the release of Enki™ 4, a major update to its generative AI platform for small-molecule drug discovery. The release of the fourth generation of Enki™ delivers significant improvements in algorithmic performance and target coverage through platform architecture design, as well as extending its application to degraders, PROTACs, glues, and novel payload design for antibody drug conjugates (ADCs) and related modalities. “Enki 4 is a massive step forward for our platform,” said Ali Saberali, Co-Founder & Head of Platform at Variational AI. “We’ve re-architected Enki and improved the underlying algorithms to expand target and modality coverage, while operating faster to deliver even better performance for our partn
Textron Aviation Receives First Military Order for Cessna SkyCourier, Launching the Aircraft Into Global Defense Market7.4.2026 15:00:00 CEST | Press release
Belgium selects SkyCourier fleet to boost special operations airlift for troop transport, logistics, casevac and crisis response Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Belgium has selected the Cessna SkyCourier as its newest special mission aircraft, awarding an order for five multirole aircraft to support the nation’s Special Operations Forces. The selection launches the SkyCourier into the global defense market for the first time and strengthens Belgium’s airlift capability through a rugged, flexible platform built for demanding missions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260309292194/en/ A new ally in the air: An artist’s rendering shows a Cessna SkyCourier configured for military operations, including a special operations paint scheme and mission equipment. The aircraft was selected by Belgium Special Operations Forces. Belgium’s SkyCourier fleet will enable rapid movement
Gurobi Defines Its Role as the Technology Behind Better Decisions in the AI Era7.4.2026 15:00:00 CEST | Press release
The decision intelligence leader emphasizes the critical partnership between AI-driven insights and optimized solutions. Gurobi Optimization, LLC, the leader in decision intelligence technology, today announced a renewed brand identity that reflects its role in empowering organizations to make better decisions in complex, high-stakes environments. As organizations increasingly rely on optimization to put their AI-driven insights into action, the Gurobi Optimizer is a foundational component of decision intelligence systems, where different approaches to AI—from prediction to optimization—work together to guide business outcomes. “AI has transformed how organizations generate insight, but insight alone does not drive outcomes—decisions do,” said Duke Perrucci, CEO, Gurobi. “We see optimization as the GPS for AI, enabling users to determine the best possible course of action in complex environments. Those decisions are what drive real outcomes, and we’re proud to be the technology behind
Cessna SkyCourier Strengthens Mission Versatility With New In‑Flight Operable Door Option7.4.2026 15:00:00 CEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced a new In-Flight Operable Door option for the passenger variant of its twin-engine, large-utility Cessna SkyCourier turboprop, expanding the aircraft’s Special Mission versatility for military, humanitarian and commercial operations. The functionality is expected to be available as a Special Mission factory-installed option in 2028. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407228562/en/ Mission flexibility starts at the Cessna SkyCourier door “An In-Flight Operable Door builds on the Cessna SkyCourier’s reputation for reliability and adaptability, reinforcing its role as a purpose-built solution for high-demand missions,” said Bob Gibbs, vice president, Special Missions Sales. “The option opens new opportunities for customers worldwide, including armed forces, smokejumpers, disaster relief groups and commercial skydiving operators.” The Cessna
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