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
Hitachi Joins Anthropic’s Critical Infrastructure Defense Program9.10.2026 02:32:00 CEST | Press release
Hitachi, Ltd. (TSE:6501, "Hitachi"), today announced that it has joined Anthropic, PBC’s (“Anthropic”) “Critical Infrastructure Defense Program,” launched on October 8, 2026, as a founding partner. The program is aimed at strengthening cyber defense for critical infrastructure, including control systems supporting power, water, manufacturing, and transportation services. Infrastructure systems that underpin society and the economy cannot tolerate prolonged downtime, making it difficult to implement certain security measures, such as system shutdowns for patch deployment. At the same time, advances in AI are significantly shortening the time between vulnerability disclosure and exploitation, creating an urgent need to redesign systems based on the assumption that cyberattacks will occur. The program seeks to strengthen cybersecurity through rapid vulnerability detection and remediation by integrating Anthropic’s advanced AI models, Claude, into the products and services of trusted syste
Lapmaster Wolters and Precision Surfacing Solutions Secures Strategic Minority Investment from The Cynosure Group and Fernweh Group to Accelerate Growth8.10.2026 22:49:00 CEST | Press release
Investment strengthens the balance sheet and brings long-term strategic partners to support continued growth and expansion across semiconductors, advanced materials, advanced packaging, and precision optics end markets. Lapmaster Wolters and Precision Surfacing Solutions (“Lapmaster Wolters”), a leading global supplier of high-precision machine systems and consumables to the semiconductor, advanced materials, precision optics, and advanced packaging industries, today announced the completion of a minority equity investment by affiliates of The Cynosure Group (“Cynosure”) and Fernweh Group (“Fernweh”). The investment strengthens the balance sheet and adds long-term, engaged partners to support the company’s next phase of growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008141876/en/ Positioned for growth Demand for ultra-high-precision surface finishing continues to grow as customers in semiconductors, advanced mater
Dubai Launches Global Create AI Agents Championship with Prize Pool Exceeding AED 2.5 Million8.10.2026 19:05:00 CEST | Press release
Dubai has launched the Create AI Agents Championship, a global competition inviting innovators to develop practical and scalable AI-agent solutions that address real-world challenges, with a total prize pool exceeding AED 2.5 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008883373/en/ Dubai has launched the Create AI Agents Championship as part of its efforts to accelerate the adoption and development of Agentic AI (Photo: AETOSWire) The launch of the championship was announced by H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai, who encouraged innovators from around the world to participate. Led by Dubai Chamber of Digital Economy, the championship aims to accelerate the adoption of Agentic AI and support the development of innovative AI-agent solutions with strong potential for
Seiden Law LLP issues statement: Prosecuted by Press Conference: Declared Guilty Without a Charge, Yim Leak Family Asks UN Human Rights Experts to Hold Thailand to Its Own Treaty Commitments8.10.2026 18:26:00 CEST | Press release
Urgent appeal to UN Special Rapporteurs cites the presumption of innocence, due process and protection of a child. The key facts are the Thai government's own words and files. Seiden Law LLP, chief global counsel to Cambodian businessman Yim Leak, announced today that Jared Genser, international counsel to Mr. Yim and his wife, has asked two UN Special Rapporteurs to send an urgent appeal to the Thai government. The request is made on behalf of the couple and their seven-year-old son. It says Thailand violated its international human rights commitments by announcing the family’s guilt before any court had tried them, and by freezing their assets, including their minor son’s savings, without a hearing. Six Official Statements in Nine Months. No Charge Filed in Any Court. Between December 2025 and September 2026, Thai officials described Mr. Yim as the center of a criminal network on six occasions: at two press conferences chaired by the head of the Thai government, in the House of Repre
Sam Altman-Backed Meanwhile Raises $37.5M as Families Across Asia, Europe and the Middle East Turn to Bitcoin Life Insurance8.10.2026 18:12:00 CEST | Press release
Existing investors, led by Bain Capital Crypto, back the first licensed Bitcoin life insurer after its single-premium policy for international clients drives a record year Meanwhile, the first life insurer licensed to operate entirely in Bitcoin, today announced $37.5 million in new funding from its existing investors. Bain Capital Crypto led the round, alongside Haun Ventures, Framework Ventures, Pantera Capital, Apollo, Northwestern Mutual Future Ventures, and Morgan Creek Digital. Meanwhile, whose backers also include Sam Altman, has now raised more than $180 million. The round follows a surge in international demand for Meanwhile’s Bitcoin life insurance policies, particularly in Asia, Europe and the Middle East amid broader macro instability. In early 2026, Meanwhile launched BTC Life 1-Pay, a single-premium whole life policy built for high-net-worth clients outside the United States. It is the company's second product line after BTC 10-Pay, which is purposely designed for US taxp
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