Merz Therapeutics GmbH and China-based Jiangxi Kvvit Pharmaceutical Co., Ltd, announced an exclusive license and collaboration agreement covering Inbrija (levodopa inhalation powder) and its proprietary inhalation device for mainland China, Hong Kong, and Macao. Under the deal, Kvvit will take responsibility for local development, regulatory submissions, and commercialization under a jointly agreed China Development Plan. Financial terms were not disclosed.
Inbrija is an inhaled dry-powder formulation of levodopa indicated for the intermittent treatment of episodic motor fluctuations — known as OFF episodes — in adult patients with Parkinson’s disease who are already receiving a levodopa/dopa-decarboxylase inhibitor regimen. The product received US FDA approval in 2018 and European Medicines Agency approval in 2019, but it is not currently approved in mainland China, Hong Kong, or Macao. Any approval in the licensed territory will depend on the completion of local clinical development and regulatory review. The deal covers both the levodopa inhalation powder and the proprietary inhaler device through which it is administered, with no manufacturing rights transferred to Kvvit.
Under the agreement’s regulatory structure, Merz will act as Overseas Holder of the Drug Registration Certificate while Kvvit will serve as Domestic Responsible Person. Kvvit will fund local clinical development and regulatory submissions, and Merz will retain responsibility for global product quality and key regulatory activities. Merz will continue to supply Inbrija to Kvvit under the arrangement, and will receive an upfront payment alongside development and commercial milestone payments, as well as tiered supply and royalty arrangements linked to commercial performance, specifics no disclosed.