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
Enginzyme and AGC Create Scalable Process for Key mRNA Ingredient12.1.2026 06:00:00 CET | Press release
At the mRNA Health conference in Berlin, enginzyme and AGC Inc. presented a scalable process to produce a key mRNA vaccine and therapy ingredient, N1-methylpseudouridine-5'-triphosphate (m¹ΨTP). The rapid growth of mRNA-based vaccines and therapeutics has driven significant demand for modified nucleotides like m¹ΨTP, which enhances mRNA stability and expression, while reducing immunogenicity. Enginzyme is a deep-tech company delivering optimized biomanufacturing solutions through cell-free enzyme engineering technology. AGC Inc. is a leading global player in fields spanning from architectural glass to chemicals and life science. AGC Inc. provides services in a wide range of life science fields, from synthetic pharmaceuticals and agrochemicals, to biopharmaceuticals and leading-edge cell and gene therapies, as well as messenger RNAs. The presentation in November detailed the latest collaboration between the companies, with a focus on the biomanufacturing of nucleotides for mRNA therapy,
Ant International Partners with Google’s Universal Commerce Protocol to Expand AI Capabilities12.1.2026 02:15:00 CET | Press release
Ant International, a leading global payment, digitisation, and financial technology provider, is collaborating on the launch of Google’s Universal Commerce Protocol (UCP), a new open standard for agentic commerce that works across the entire shopping journey — from discovery and buying to post-purchase support. UCP establishes a common language for agents and systems to operate together across consumer surfaces, businesses, and payment providers to enable commerce. So instead of requiring unique connections for every individual agent, UCP enables all agents to interact easily. UCP is built to work across verticals and is compatible with existing industry protocols like Agent2Agent (A2A), Agent Payments Protocol (AP2), and Model Context Protocol (MCP). “For agentic commerce to scale, it’s critical for the industry to align on a common set of standards. We are proud to have Ant International endorse the Universal Commerce Protocol as the foundation for that future,” said Ashish Gupta, VP
Torq Secures $140M Series D at $1.2B Valuation to Lead the AI SOC and Agentic AI Era11.1.2026 17:59:00 CET | Press release
Fueled by Massive Customer Adoption of AI Agents, Torq Scales the World’s First True AI SOC Platform and Accelerates Expansion into the U.S. Federal Market Torq, the established Agentic AI security operations pioneer, today announced it has closed a massive $140 million Series D funding round, propelling its valuation to $1.2 billion and total funding to $332M. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112510774/en/ Led by Merlin Ventures—a leading cybersecurity fund renowned for its deep access to the U.S. commercial and Public Sector markets—with participation from all existing investors, including Evolution Equity Partners, Notable Capital, Bessemer Venture Partners, Insight Ventures Partners, and Greenfield Partners, this capital injection is a definitive investment in the future of security. Torq is driving the industry’s critical shift: the complete transformation of the Security Operations Center (SOC) through
Andersen udvider sine kompetencer med tilføjelsen af Scimitar9.1.2026 21:44:00 CET | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Scimitar, der er et firma med fokus på at accelerere innovation i biovidenskabsbranchen. Scimitar, der har hovedkvarter i USA, et førende konsulenthus inden for strategieksekvering for biovidenskabsbranchen. Virksomheden er specialiseret i design af driftsmodeller, digital transformation og organisatorisk forandring. Scimitar samarbejder med medicinal- og biotech-virksomheder om at accelerere innovation, styrke den driftsmæssige eksekvering og sikre compliance gennem hele produkters livscyklus. Deres praktiske og samarbejdsorienterede tilgang sikrer løsninger, der ikke blot er formålstjenlige, men også skalerbare. "Virksomheder inden for biovidenskabsbranchen befinder sig i en tid med hurtige videnskabelige fremskridt, stigende regulatorisk kompleksitet og et voksende behov for operationel agilitet, samtidig med at de holdes op mod de højeste standarder for patientsikkerhed og dataintegritet," udtaler Ramy Khalil, CEO i Scimitar.
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
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