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ARTICLE | Company News

May 28 Company Quick Takes: Viela finds China partner for rare CNS disorder mAb; plus Santhera, Juvenescence’s Souvien and more

May 28, 2019 11:31 PM UTC

Viela partners with Hansoh on mAb for rare CNS disorder in China
Viela Bio Inc. (Gaithersburg, Md.) granted Hansoh Pharmaceutical Group Co. Ltd. (Lianyungang, China) rights to develop and commercialize Viela's humanized anti-CD19 mAb inebilizumab in China for neurosyelitis optica spectrum disorder (NMOSD), as well as other inflammation/autoimmune indications and other hematologic cancers. Viela will receive up to $220 million, comprising an upfront payment and milestones, plus tiered royalties. Viela plans to submit a BLA to FDA mid-year for inebilizumab to treat NMOSD (see "Viela Planning Detailed Phase II/III Data for Rare CNS Disorder Therapy").

Santhera submits MAA for DMD therapy
Santhera Pharmaceutical Holding AG (SIX:SANN) submitted an MAA to EMA seeking conditional approval of Puldysa idebenone to treat respiratory dysfunction in Duchenne muscular dystrophy patients who are not using glucocorticoids. Santhera plans to submit an NDA to FDA for Puldysa after it completes the Phase III SIDEROS trial; it expects to complete enrollment in 4Q19...