Merz Therapeutics GmbH and Jiangxi Kvvit Pharmaceutical Co. Ltd., announced an exclusive license and collaboration agreement. The partnership brings INBRIJA (levodopa inhalation powder) and its proprietary inhalation device to new markets. These markets include mainland China, Hong Kong, and Macao. The treatment addresses episodic motor fluctuations in adult patients with Parkinson’s disease. Eligible patients must already use a levodopa/dopa-decarboxylase inhibitor.
Kvvit will manage local development and regulatory activities. The Chinese company also handles commercialization under a joint China Development Plan. Furthermore, Kvvit acts as the Domestic Responsible Person. This role requires funding local clinical development and regulatory submissions. Merz Therapeutics will receive upfront, development, and commercial milestone payments. Merz also secures tiered supply and royalty arrangements linked to commercial performance.
Details of the Pharmaceutical Partnership
Merz retains global product quality responsibility and key regulatory activities. The German firm acts as the Overseas Holder of the Drug Registration Certificate. However, the agreement grants no manufacturing rights to Kvvit. INBRIJA (levodopa inhalation powder) lacks approval in China, Hong Kong, and Macao currently. Therefore, future approval depends entirely on successful local clinical development and regulatory review.
“We are pleased to partner with Kvvit to potentially bring INBRIJA to people living with Parkinson’s disease in Greater China,” said Andrea von der Lippe, President, Region International Markets. “Kvvit’s local development and commercial capabilities, combined with Merz’s experience with INBRIJA, create a strong foundation to expand access to an additional treatment option for patients experiencing OFF episodes.”
“Kvvit is always committed to providing outstanding services for human health. Based in China and with a global perspective, it hopes to offer patients more valuable and innovative treatment plans for neurological diseases. Based on this cooperation opportunity with Merz for the development, registration, and subsequent commercialization of INBRIJA, we will closely cooperate with medical professionals to facilitate its rational application in clinical practice,” said Mr. Yang Lizhen, VP of Jiangxi Kvvit Pharmaceutical Co. Ltd.
The U.S. Food and Drug Administration approved INBRIJA (levodopa inhalation powder) in 2018. The European Medicines Agency granted approval in 2019. Because patients inhale the medication directly into the lungs, meals do not affect drug absorption. Gastrointestinal conditions associated with Parkinson’s disease also do not impact the treatment.
Merz Therapeutics maintains its headquarters in Frankfurt am Main, Germany, and operates in over 80 countries. The privately held, family-owned Merz Group has built a 117-year legacy. QF Pharmaceutical Group Co., Ltd. established Kvvit as a controlled subsidiary in 2021. The company focuses heavily on the central nervous system therapeutic area.
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News Source: Businesswire.com
