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
IonQ and QuantumBasel Expand Long-Term Partnership in Next-Generation Quantum Systems17.12.2025 22:10:00 CET | Press release
Extension solidifies QuantumBasel as IonQ’s Innovation Center in Europe; adds IonQ Tempo and next-generation system to advance quantum commercialization IonQ (NYSE: IONQ), the world’s leading quantum company, today announced an expanded agreement with QuantumBasel, the quantum initiative of uptownBasel, Switzerland’s innovation campus. The extended contract grants QuantumBasel ownership of its existing IonQ Forte Enterprise system and secures ownership of a next-generation Tempo system. This new agreement brings the total deal value of the QuantumBasel and IonQ partnership to over $60 million and extends IonQ’s on-site presence in Switzerland four more years, continuing through 2029. QuantumBasel is IonQ’s official Innovation Center in Europe, serving as a hub for European industry, academia, and research institutions to explore practical quantum computing applications and access IonQ’s latest enterprise-grade systems. “Our extended partnership with QuantumBasel represents a cornerston
Suzano Starts Up New Production Line, Boosting Its Fluff Pulp Capacity by 400%17.12.2025 21:50:00 CET | Press release
A R$490 million investment expands the supply of raw material used in the production of absorbent items Suzano, the world’s largest pulp producer, has commenced operations this week at its new fluff pulp production line located in its Limeira unit in Brazil’s São Paulo state. This R$490 million investment increases Suzano’s total fluff pulp production capacity by more than 400%, from 100,000 to 440,000 tonnes per year. The project involved converting the existing pulp line at the Limeira unit into a flexible machine, capable of producing both Eucafluff® and market pulp. Eucafluff® is used in the production of absorbent and personal hygiene products, such as baby and adult diapers, sanitary pads and pet pads. Then market pulp is supplied for making products including toilet paper, printing and writing papers, and paper packaging. Launched in 2015, Eucafluff® is the world’s first fluff pulp made from eucalyptus, delivering unique advantages like enhanced softness and flexibility, which t
SES Acknowledges Moody’s Rating Action and Reiterates Deleveraging Commitments17.12.2025 21:36:00 CET | Press release
SES S.A. (“SES” or the “Company”), a leading space solutions company, acknowledges the credit rating action announced by Moody’s Investor Service today, which follows the release of SES’ Q3 2025 results and Intelsat integration update. SES management reiterates that the Company continues to execute on its strategy with a clear plan to strengthen its key credit metrics over time. Consistent with this plan, it remains management’s intention to de-lever and return to credit metrics that are commensurate with investment grade, with a policy objective of reducing adjusted net leverage1 to at least 3.0x or below. Today’s rating action does not change the Company’s ability to operate its business, serve customers, or execute its strategic plan. SES maintains a balanced weighted average debt maturity profile of approximately five years, and the rating action from Moody’s is not expected to have a material impact on the interest payable under the Company’s existing debt facilities. SES also ben
Picsart and Zazzle Power the Creator-to-Commerce Evolution with Print-On-Demand Integration17.12.2025 20:47:00 CET | Press release
Partnership Gives Creators an End-to-End Solution to Create A Range of Products in the $205 Billion Creator Economy Picsart, the world’s leading digital creation platform with over two billion downloads and more than 100 million monthly active users, is partnering with Zazzle, the global leader in customized products and designs, to deliver an end-to-end printing solution for Picsart users. The new “vibe-design-to-print” integration works seamlessly with Picsart’s recently expanded suite of AI products, including AI Assistant and Flows, enabling creators to ideate, iterate, design, and bring their work to life as physical art and products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217882832/en/ Picsart and Zazzle Power the Creator-to-Commerce Evolution with Print-On-Demand Integration “At Picsart, our mission has always been to give creators the tools they need to bring their ideas to life,” said Hovhannes Avoyan, Fo
Inspiring Leadership Recognised: Anna Byrne Named Finalist at CIPD 2026 HR Awards17.12.2025 19:58:00 CET | Press release
ProAmpac, a global leader in flexible packaging and material science, is proud to announce that Anna Byrne has been selected as a finalist in the “Most Inspirational and Impactful Leader” category at the CIPD 2026 HR Awards in Ireland. This recognition highlights Anna’s exceptional leadership, her unwavering commitment to people-first practices, and her meaningful influence across the organisation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251217690526/en/ The CIPD HR Awards in Ireland The CIPD HR Awards highlight the people profession’s crucial role in driving strategy, leading transformation, and enabling organisations to thrive. Overseen by CIPD Ireland and supported by independent academic expertise, the awards celebrate innovation, integrity, and impact within modern HR practice. This year, the awards introduce four new categories, including the “Most Inspirational and Impactful Leader” award, reflecting the evolvi
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