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
Samsung Biologics Strike: Labor Union Warns of CDMO Supply Chain Risks Following Overwhelming Vote30.3.2026 11:52:00 CEST | Press release
Union members overwhelmingly approve strike action with 95.52% voting in favor on a 95.38% turnout, clearing the final legal hurdle after mediation ceased.Union emphasizes this is a fight against structural corporate governance issues, citing unresolved allegations concerning unfair labor practices and ESG compliance risks.Management adhered to a group-level wage guideline rather than bargaining on the basis of Samsung Biologics' own performance, exposing a lack of independent bargaining authority. The Samsung Biologics Labor Union (President: Jaesung Park), representing approximately 75% of the company's total employees, announced today that its members have overwhelmingly voted in favor of a strike, with 95.52% voting in favor on a 95.38% turnout during a voting period from March 24 to March 29. Following the Incheon Regional Labor Relations Commission's decision to cease mediation, the union has now secured the legal mandate to strike. The union stressed that this strike is not mere
The Premier Jumping League (PJL) Launches with a Record-Breaking $300 Million Guaranteed Prize Pot, Defining a New Era for Showjumping30.3.2026 11:00:00 CEST | Press release
The PJL empowers riders to compete as full-time professional athletes while working towards a sustainable economic model for the sport. Backed by McCourt Global and shaped by a leadership team with decades of experience in equestrian competition, sport, and entertainment, the PJL sets a new, sustainable, and globally relevant standard for elite jumping. Sixteen teams will compete across fourteen iconic international venues throughout Europe, North America, and the Middle East when the inaugural season opens in March 2027. The Premier Jumping League (PJL) launches with a record-breaking $300 million guaranteed prize pot, defining a new era for showjumping. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330990938/en/ Photography credits: Daniel Benson for The Premier Jumping League/ Wieden+Kennedy London Backed by McCourt Global and its Executive Chairman, Frank McCourt, the PJL is a groundbreaking global competition that e
Dompé Announces First Patient Enrolled in New Study of Intranasal NGF in Cerebral Palsy30.3.2026 11:00:00 CEST | Press release
Cerebral Palsy (CP) refers to a group of permanent disorders in the development of movement and posture, which causes activity limitations, and is attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.1 Nerve growth factor (NGF) is a naturally-occurring protein that supports damaged nerve cells and improves nervous system signaling, Dompé is investigating whether intranasal NGF has the potential to improve movement and neurodevelopment and address underlying brain damage in people with CP. Dompé’s intranasal NGF platform builds on the Nobel Prize-winning discovery of neurobiologist Professor Rita Levi-Montalcini and biochemist Dr. Stanley Cohen. Dompé, a leading biopharmaceutical company with operations in Italy and in the U.S., announced that the first patient has been enrolled at the Agostino Gemelli IRCCS University Hospital in Rome, Italy, in a Phase 2 investigational study of an intranasal form of Nerve Growth Factor (NGF) (Cenegermin-bkb
IQM Secures €50M Financing to Accelerate Global Growth30.3.2026 08:00:00 CEST | Press release
€50 million financing package from funds and accounts managed by BlackRock will support IQM to scale operations, accelerate product development, and strengthen its market position. The facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing as IQM prepares for public listing. IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), today announced it has secured a €50 millionfinancing package from funds and accounts managed by BlackRock. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329996942/en/ IQM Radiance quantum computer is located in IQM's showroom in Espoo, Finland. This facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing. This
Bureau Veritas and Trade Technologies Join Forces to Streamline Global Trade Operations30.3.2026 07:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), through its Swiss branch Government Services Division, is pleased to announce a strategic agreement with Trade Technologies, the leading provider of trade finance automation, connectivity and transaction management services. This collaboration is a significant step toward reducing the complexities of international trade operations, particularly in regions where regulatory and inspection controls remain stringent. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329411683/en/ Addressing Critical Trade Finance Challenges The agreement comes at a pivotal time for global trade. Letters of Credit (LCs) continue to serve as essential instruments in international commerce, particularly across the Middle East and Africa, where counterparty risk, foreign exchange controls, sanctions exposure, and regulatory oversight face ongoing challenges. In
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