SOLASIA-PHARMA
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
The Coca-Cola Company Names New Leader for Europe Operating Unit18.7.2025 21:00:00 CEST | Press release
The Coca-Cola Company today announced that Luisa Ortega will become president of the Europe operating unit effective Sept. 1, succeeding Nikos Koumettis, who will retire in 2026 after a 25-year career with the company. Koumettis will remain with the company through Feb. 28, 2026, as a senior advisor. He will also serve on the board of directors of Hindustan Coca-Cola Beverages Pvt. Ltd., a company-owned bottler in India. Ortega joined Coca-Cola in 2019 and currently serves as president of the Africa operating unit. In this role, she leads a complex business that operates across 54 markets. Koumettis has led the Europe operating unit since it was created in 2021. “Luisa has done an outstanding job leading our African business, where our system has continued to make major investments to serve growing markets on the continent,” said Henrique Braun, Executive Vice President and Chief Operating Officer of The Coca-Cola Company. “As head of Europe, she will bring great international experien
NFL Running Back Derrick Henry Joins Amazfit as Athlete Ambassador18.7.2025 15:00:00 CEST | Press release
Henry to utilize Amazfit products to optimize health, recovery and performance as he enters his 10th NFL season Amazfit, a leading global smart wearables brand owned by Zepp Health (NYSE: ZEPP), announced Baltimore Ravens running back Derrick Henry as the newest elite athlete to join its growing roster of ambassadors. Known for his rare combination of speed and strength, Henry will utilize Amazfit wearables to power every phase of his training, recovery and sleep as he prepares for his 10th NFL season. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250718322498/en/ Derrick Henry is the newest elite athlete to join Amazfit's growing roster of ambassadors. As one of the most prolific running backs of his generation, Henry has amassed an impressive array of accolades during his career, including NFL Offensive Player of the Year, two rushing titles, and five Pro Bowl selections. With Amazfit as his official smart wearable partne
Qualcomm Announces Quarterly Cash Dividend18.7.2025 15:00:00 CEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on September 25, 2025, to stockholders of record at the close of business on September 4, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensin
MultiBank Group Confirms $MBG Token Listings on MEXC and Gate.io on TGE Day in Addition to MultiBank.io and Uniswap18.7.2025 14:34:00 CEST | Press release
MultiBank Group, the world’s largest & most regulated financial derivatives institution, is proud to announce that its highly anticipated $MBG Token will be listed on two new major global cryptocurrency exchanges — MEXC and Gate.io — on the day of its official Token Generation Event (TGE), July 22, 2025, in addition to MultiBank.io and Uniswap. The $MBG Token will go live on: MultiBank.ioGate.ioMEXCUniswap This new dual listing will allow millions of users across both exchanges to seamlessly access and trade $MBG using their existing accounts, ensuring immediate market participation at launch. The Token Generation Event (TGE) is now approaching following the successful completion of two pre-sale rounds, where MultiBank Group issued 7 million tokens in Round 1 and 3 million tokens in Round 2 — both of which sold out within minutes. Naser Taher, Chairman and Founder of MultiBank Group said “With $MBG, we’re introducing a utility token built to deliver real-world value, transparency, and
SLB Announces Second-Quarter 2025 Results18.7.2025 12:50:00 CEST | Press release
Revenue of $8.55 billion increased 1% sequentially and decreased 6% year on year GAAP EPS of $0.74 increased 28% sequentially and decreased 4% year on year EPS, excluding charges and credits, of $0.74 increased 3% sequentially and decreased 13% year on year Net income attributable to SLB of $1.01 billion increased 27% sequentially and decreased 9% year on year Adjusted EBITDA of $2.05 billion increased 2% sequentially and decreased 10% year on year Cash flow from operations was $1.14 billion and free cash flow was $622 million Board approved quarterly cash dividend of $0.285 per share SLB (NYSE: SLB) today announced results for the second-quarter 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250716727689/en/ The exterior of the SLB headquarters in Houston, Texas. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2025Mar. 31, 2025Jun. 30, 2024SequentialYear-on-yearReve
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