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
Sai Life Sciences Opens Dedicated Facility for Veterinary APIs in Bidar, India18.9.2025 18:22:00 CEST | Press release
Sai Life Sciences (BSE: 544306 | NSE: SAILIFE), an innovator-focused Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the opening of Unit VI, a dedicated facility for Veterinary Active Pharmaceutical Ingredient (API) production, in Bidar, India. Located alongside Unit IV, the company’s flagship API manufacturing site, Unit VI has been established exclusively for veterinary APIs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918612071/en/ Sai Life Sciences’ Veterinary APIs Unit in Bidar, India. The new facility is designed to meet the highest standards of safety, sustainability, and regulatory compliance, ensuring the production of high-quality APIs for veterinary applications. With this expansion, Sai Life Sciences aims to provide efficient and scalable manufacturing solutions to leading global animal health companies. Making the announcement, Krishna Kanumuri, CEO & Managing Direct
Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 202518.9.2025 17:45:00 CEST | Press release
Celltrion’s Omlyclo™, the first and only omalizumab biosimilar in Europe, will be commercially available starting in Norway, with subsequent rollouts in European countries Results from the global Phase III clinical trial of Omlyclo™ (CT-P39) for the treatment of chronic spontaneous urticaria (CSU), allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) will be presented at a satellite symposium during the 2025 European Academy of Dermatology and Venereology (EADV) Congress Celltrion highlights the strength of its expanding dermatology portfolio with positive clinical results for CT-P55, a biosimilar candidate referencing secukinumab With the launch of Omlyclo™, Celltrion underscores its commitment to advancing innovative and accessible treatments in immunology and dermatology Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereo
Andersen Consulting tilføjer samarbejdsfirmaet Charter18.9.2025 17:14:00 CEST | Pressemeddelelse
Andersen Consulting udvider sine digitale transformationskapaciteter gennem en samarbejdsaftale med Charter, et canadisk konsulentfirma, der er specialiseret i IT-strategi, managed services og applikationslevering. Charter blev grundlagt i 1997 og leverer teknologiprojekter med en forretningsorienteret tankegang og dyb teknisk ekspertise, herunder inden for IT-rådgivning, cloud-infrastruktur, cybersikkerhed, applikationsudvikling, projektlevering og forretningsarkitektur. Charter hjælper traditionelle virksomheder, offentlige institutioner, tjenesteudbydere og mellemstore kunder med implementering, netværksinfrastruktur og kundeorienterede applikationer – der leveres gennem en livscyklus-tilgang fra strategi til udførelse. "Vores mål hos Charter har altid været at fjerne kompleksiteten fra IT og hjælpe organisationer med at bevæge sig fremad med tillid," siger Kelly Michell, præsident for Charter. "Vores samarbejde med Andersen Consulting gør det muligt for os at bringe vores integrere
Andersen Consulting udvider sit udbud inden for cybersikkerhed og teknologi med tilføjelsen af Move18.9.2025 17:06:00 CEST | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Move, der er en førende virksomhed inden for it-infrastruktur, driftstjenester og digitale løsninger til virksomheder. Move befinder sig i Norge og Sverige. Move blev grundlagt i 1989 og leverer konsulentydelser, it-løsninger og driftstjenester. Virksomheden har ekspertise inden for cybersikkerhed, cloud-løsninger, server- og lagringsløsninger, netværkskommunikation og implementering af AI. Move samarbejder med mellemstore og store virksomheder om at designe, implementere og drive sikre, skalerbare og fremtidssikrede it-miljøer. "Dette samarbejde er en spændende mulighed for at skabe endnu større værdi for vores kunder," siger Roald Sannæs, der er administrerende direktør i Move. "Med vores kompetencer og Andersen Consultings globale rækkevidde og ekspertise kan vi levere mere helhedsorienterede løsninger, der hjælper organisationer med at løse nutidens udfordringer og forudse fremtidens muligheder." "Move har opbygget et godt ren
Setting the Standard: AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’18.9.2025 16:40:00 CEST | Press release
The inaugural ranking by TIME, in partnership with Statista, features AMRA as one of the world’s leading health technology companies that are “driving innovation, enhancing accessibility, and contributing to a more effective and sustainable health care system” AMRA Medical is proud to share its inclusion in the World’s Top HealthTech Companies list, published today by TIME in collaboration with Statista. This recognition positions AMRA among an elite group of global innovators that are leading healthcare transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918372780/en/ AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’ The selection, which comes just one week after celebrating AMRA’s 15 years of progress and innovation within the body composition space, highlights AMRA’s long-standing commitment to becoming a global leader in health informatics. By delivering detailed, reproduc
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