Citrine Medicine to Bring Pitolisant to Market in China

Citrine Medicine has acquired exclusive rights to develop, register, market, and manufacture pitolisant in China. Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist that has been approved in the European Union (2016) and the US (2018) for the treatment of adults with narcolepsy with or without cataplexy. Harmony Biosciences has also announced a phase II clinical trial in the US to determine the safety and efficacy of pitolisant as a treatment for Prader-Willi Syndrome (PWS).

Patients with rare diseases in China face many barriers to accessing knowledge about and treatments for rare diseases. For example, currently there are no drugs that have been officially approved by the National Medical Products Administration (NMPA) in China for the treatment of narcolepsy. Regulatory reforms and policy changes in China, however, have now allowed for expedited approval for rare disease drugs in the country.

Launched in 2019, Citrine Medicine is a China-based rare disease therapeutics company intent on developing the first rare disease support system in China with a focus on bringing validated medicines to patients in need. They are joining the global orphan drug development effort and will work with NMPA, healthcare providers, advocacy organizations, and other stakeholders.

Citrine is headquartered in Shanghai and has offices in Beijing, China and Cambridge, Massachusetts. Citrine was founded by Eight Roads, F-Prime Capital, and Vivo Capital and closed an $80 million series A financing earlier this year.