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Simcere and Idorsia enter into a licensing agreement for daridorexant in China

Release time:2022-11-16

Nanjing, China  & Allschwil, Switzerland &  – November 16, 2022

Simcere Pharmaceutical Group Ltd (2096.HK, “Simcere”), an innovation and R&D-driven pharmaceutical company, and Idorsia Ltd (SIX: IDIA, “Idorsia”), specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options, announced today that they have entered into an exclusive licensing agreement for Idorsia’s daridorexant in China.

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Jinsheng Ren,Chairman and CEO of Simcere commented:

"This licensing agreement represents an important and exciting step in pursuing Simcere’s mission of providing today’s patients with medicines of the future. There are over 200 million people in China who suffer from chronic insomnia that may benefit from daridorexant. Patients are eager for a better treatment option that improves quality of sleep and next day functioning. Simcere has a proven track record of successfully developing and marketing innovative Central Nervous System therapies in China. In collaboration with Idorsia, we hope to bring another impactful medicine to millions of people.”

 

Under the agreement, Simcere will be granted an exclusive right to develop and commercialize daridorexant in the Greater China region (Mainland China, Hong Kong, and Macau), one of the world's largest pharmaceutical markets. Simcere will be responsible for the funding and conducting of a local development program with Chinese patients. Simcere successfully commercializes Sanbexin for acute ischemic stroke and daridorexant will expand Simcere’s pipeline of Central Nervous System (CNS) products in China.

 

According to the terms of the agreement, Idorsia will receive a US$ 30 million upfront payment, and will be eligible to receive an additional milestone payment of US$ 20 million upon regulatory approval by the National Medical Products Administration, as well as commercial milestone payments and low double-digit tiered royalties based upon future sales.

 

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia commented:

“Daridorexant is on track to becoming a global success, helping the millions of sufferers of insomnia around the world. Marketed as QUVIVIQ, we expect daridorexant will soon be the leading branded insomnia medication in the US in terms of new prescriptions. It is also the first dual orexin receptor antagonist available to patients in Europe, and recent positive data in Japan gives me confidence that we can make it available there too. We have been convinced of Simcere’s shared enthusiasm for daridorexant, and I am confident that they are the right partner to join us on our mission of bringing an optimal treatment approach to patients with insomnia around the world by developing and commercializing daridorexant in China.”

 

About daridorexant

Idorsia’s research team has been working on the science of orexin and orexin receptors since they were first described in 1998. The team’s initial work led to the conclusion that antagonism of the orexin system was the key to preserving a natural sleep architecture for patients with insomnia. With this as the target, the team designed a dual antagonist with the goal of a rapid onset of effect and a duration of action sufficient to cover the night but short enough to avoid any negative next-morning residual activity at optimally effective doses.

 

Daridorexant is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins. Rather than inducing sleep through broad inhibition of brain activity, daridorexant blocks only the activation of orexin receptors. Consequently, daridorexant decreases the wake drive, allowing sleep to occur, without altering the proportion of sleep stages. The results of a Phase 3 clinical development program have been reported by Mignot, E., et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials, in The Lancet Neurology 2022;21:125–39.


About Simcere

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes.

 

For more information, please visit: http://en.simcere.com/

Media contact:  simcere.mediarelations@simcere.com

 

About Idorsia

Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

 

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

 

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,200 highly qualified specialists dedicated to realizing our ambitious targets.

 

For further information, please contact

Andrew C. Weiss

Senior Vice President, Head of Investor Relations & Corporate Communications

Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil

+41 58 844 10 10

investor.relations@idorsia.com

media.relations@idorsia.com

www.idorsia.com

 

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