Citrine Medicine Secures Exclusive Rights to Wakix® (Pitolisant) for Narcolepsy in China Through Strategic Partnership with Bioprojet

(Shanghai/Boston, October 29, 2020) LanHua Pharma, a Chinese pharmaceutical company focused on rare diseases, today announced that it has entered into a strategic collaboration and exclusive licensing agreement with the French company Bioprojet, securing rights to the latter’s narcolepsy treatment drug, Wakix.^®Exclusive rights to develop, register, commercialize, and manufacture (pitolisant) in China. Wakix^®(Pitolisant), developed by Bioprojet, has been approved for the treatment of narcolepsy, with indications currently under clinical development including obstructive sleep apnea.

Narcolepsy is a rare neurological disorder primarily characterized by recurrent, irresistible daytime sleepiness, cataplexy, and nighttime sleep disturbances. Currently, the National Medical Products Administration (NMPA) has not formally approved any medications for the treatment of narcolepsy with or without cataplexy. There remains a significant unmet medical need in the treatment of patients with narcolepsy in China.

Wakix^®The active ingredient, pitolisant, is a selective histamine-3 (H3) receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons, increases the synthesis and release of wakefulness-promoting neurotransmitter histamine in the brain, and improves patients’ wakefulness and alertness. Pitolisant was developed over decades by Dr. Jeanne-Marie (J.M.) Lecomte and Professor Jean-Charles Schwartz, co-founders of Bioprojet, and has been approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.

Dr. Chen Zhaorong, Chief Medical Officer (CMO) of Langhua Pharma“It stated: ‘Narcolepsy is a rare, chronic neurological disorder that significantly impairs patients’ ability to learn, live, and work, as well as their physical and mental health. Currently, there are no drugs officially approved by the National Medical Products Administration (NMPA) in China for the treatment of narcolepsy with or without cataplexy. Chinese physicians have very limited therapeutic options for managing narcolepsy, resulting in a substantial unmet medical need for patients. Wakix® will provide a new treatment option for both patients and physicians in China.’”

Ms. Lin Rui, Partner at Sidao Capital and Board Member of Langhua Pharmastated: “While supporting corporate growth, STOA Capital is also committed to generating positive social impact. This vision underpins our investment in the establishment of Langhua Pharmaceuticals. We believe Langhua has the capability to build a patient-centric rare disease ecosystem in China, significantly improving the lives of patients with rare diseases. The collaboration with Bioprojet marks Langhua’s first step in introducing safe and effective drugs already approved abroad to patients in need. We look forward to continuing to provide strong support for Langhua’s capabilities and pipeline, while accelerating the development of rare disease therapies both in China and globally.”

Dr. Dong Dandan, Managing Director at Vivo Capital and Board Member of Langhua Pharmastated: “Vivo Capital has long supported the global research and development of drugs for rare diseases, with the aim of bringing more and better disease solutions to patients with rare conditions. We are delighted to have founded Langhua Pharmaceuticals and to support Langhua in introducing new rare-disease therapies to patients in China. We believe that bringing Wakix^®"Bringing it to China can provide new and effective treatment options for patients with narcolepsy in China."

Professor Jean-Charles Schwartz, Bioprojetstated, “We are delighted to partner with Langhua Pharmaceutical to bring Pitolisant to more patients in need. Through our close collaboration, we aim to provide much-needed relief to the hundreds of thousands of patients suffering from sleep-related disorders.”

As a rare disease treatment platform, Langhua Pharma aims to introduce rare disease medications to the Chinese market and establish the nation’s first rare disease ecosystem, providing support to patients and their families, healthcare professionals, and the broader rare disease community. The company is committed to building a patient-centric service platform, raising public awareness of rare diseases, assisting in improving screening efficiency and early diagnosis capabilities, and providing comprehensive disease management for patients with rare diseases.

Langhua Pharmaceuticals was co-founded by Shidao Capital, F-Prime Capital, and Vivo Capital. This July, the company completed an $80 million Series A financing round, led by Spring Capital, with participation from Sanzheng Health Investment, Shuanghu Capital, and the three founding institutional investors.

Langhua Pharma is a platform company focused on the treatment of rare diseases, co-founded by globally leading healthcare funds FSD Capital, F-Prime Capital, and Vivo Capital. It is committed to providing sustainable solutions for patients with rare diseases in China by developing and introducing effective and affordable drugs, combined with innovative business models.

Langhua Pharma leverages digital tools and internet technologies to establish a patient-centric service platform dedicated to the entire rare disease community. Its mission is to enhance public awareness of rare diseases, assist in improving screening efficiency and early diagnosis capabilities, and provide comprehensive disease management for patients with rare diseases.

Bioprojet SCR is a research-based pharmaceutical company. Headquartered in Paris, France, Bioprojet operates a research center in Rennes, France. The company specializes in the design, synthesis, and development of innovative medicines to address unmet medical needs.

Pitolisant is a selective histamine H3 receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons. The drug was approved by the European Medicines Agency (EMA) in 2016 for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and has been marketed in major European countries; it subsequently received approval from the U.S. Food and Drug Administration (FDA) in 2018. Cataplexy is characterized by sudden episodes of muscle weakness or paralysis. Pitolisant has been granted orphan drug designation for the treatment of narcolepsy in both the European Union and the United States. In the EU and the US, pitolisant is marketed under the brand name WAKIX^®Marketed under a brand name for the treatment of symptoms associated with narcolepsy in adult patients (with or without cataplexy).

Narcolepsy is a chronic, debilitating, and rare neurological disorder. Patients present with excessive daytime sleepiness, often accompanied by other symptoms such as cataplexy (sudden loss of muscle tone triggered by emotions), sleep paralysis, and hypnagogic hallucinations. According to the ICSD-3 diagnostic criteria, two types of narcolepsy are currently recognized: Type 1 and Type 2. Type 1 narcolepsy is characterized by the presence of cataplexy and reduced orexin-1 levels, whereas Type 2 narcolepsy occurs without cataplexy.

In clinical trials conducted in patients with narcolepsy, the most common adverse reactions to pitolisant were insomnia (8.4%), headache (7.7%), nausea (4.8%), anxiety (2.1%), irritability (1.8%), dizziness (1.4%), depression (1.3%), tremor (1.2%), sleep disorder (1.1%), fatigue (1.1%), vomiting (1.0%), vertigo (1.0%), dyspepsia (1.0%), weight gain (0.9%), and upper abdominal pain (0.9%). Pitolisant is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) and in breastfeeding women.

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