Orphalan, a Paris-headquartered pharmaceutical company specializing in orphan drug development, has achieved a significant milestone by launching its Wilson's disease treatment "Ke Pei Ou" (科佩欧®) in China. This historic achievement makes Orphalan the first European pharmaceutical company to introduce an orphan drug to the Chinese Wilson disease market.
The launch comes through a strategic partnership with Kyuan Xinhai (Beijing) Medical Products Trade Co., Ltd ("SPH Kyuan Trade"), a leading pharmaceutical distributor and subsidiary of Shanghai Pharma Group, one of China's largest healthcare conglomerates.
Addressing Critical Unmet Needs in Wilson Disease Treatment
Wilson's disease is a rare, life-threatening genetic disorder that impairs the body's ability to eliminate excess copper. Without proper management, patients face severe neurological and hepatic complications that can be debilitating or fatal.
For years, penicillamine has been the standard therapy for Wilson's disease in China. However, many patients cannot tolerate this treatment, leaving them with limited therapeutic options. Orphalan's trientine tetrahydrochloride, marketed as "Ke Pei Ou" (科佩欧®), represents the first trientine-based treatment approved by China's National Medical Products Administration (NMPA).
The drug is already available in more than 20 countries under different brand names: Cuprior® in the European Union, United Kingdom, Saudi Arabia, Switzerland, Colombia, and New Zealand, and as Cuvrior® in the United States. Its introduction to China brings new hope to thousands of patients who previously had no alternative treatment options.
Strategic Expansion into the Chinese Market
Recognizing China's strategic importance in its global mission, Orphalan has established a local entity in Shanghai and appointed Ms. Grace Li as General Manager. Supported by a team of scientific and medical experts, Li will lead initiatives to:
- Engage with leading healthcare professionals to ensure access to the latest clinical data on Wilson's disease management
- Facilitate knowledge-sharing and medical education for informed decision-making by physicians and patients
- Strengthen Orphalan's presence in the Chinese healthcare landscape
Dr. Naseem Amin, CEO of Orphalan, emphasized the significance of this achievement: "This is more than a market expansion—this is a breakthrough for rare disease patients in China. Our collaboration with SPH Kyuan Trade represents a pivotal moment in Orphalan's journey. We are not just bringing a treatment to market; we are revolutionizing access to care for those who need it most."
Implications for Global Rare Disease Treatment
This milestone reflects Orphalan's broader commitment to advancing rare disease treatments worldwide. By successfully entering the highly regulated and competitive Chinese pharmaceutical market, the company is strengthening its position as a leader in orphan drug innovation and global patient access.
The launch of "Ke Pei Ou" in China sets a new standard for what is possible in orphan drug development and global accessibility. For Chinese patients living with Wilson's disease, this development represents access to a treatment option that has already proven beneficial in numerous other countries.
About the Treatment
Trientine tetrahydrochloride works as a copper chelating agent, binding to excess copper in the body and allowing it to be excreted. This mechanism of action provides an essential alternative for patients who cannot tolerate penicillamine due to its side effects or who have not responded adequately to first-line treatment.
Founded in 2011, Orphalan focuses on developing and delivering innovative therapies for people living with rare and debilitating diseases. The company works collaboratively with rare disease and scientific communities to develop evidence-based treatments in areas of unmet need.
With this launch, Orphalan continues to push the boundaries of scientific excellence and therapeutic innovation while ensuring that patients and healthcare providers in China have access to the latest advancements in Wilson's disease treatment.
