On the 27th, it was learned that just four months after the approval of the US Food and Drug Administration (FDA), the innovative drug Feiheda ® Iprocopam hydrochloride capsules have been successfully approved in China for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor treatment.



PNH is a rare chronic, progressive, and life-threatening hematological disorder characterized by clinical manifestations such as anemia, paroxysmal hemoglobinuria, bone marrow hematopoietic failure, and thrombosis. PNH can occur at any age, but is more common in the 30-40 age group, causing a lifelong heavy burden on young adults. It is reported that the current standard treatment for PNH is anti complement C5 therapy. However, after receiving treatment, most patients still suffer from residual anemia, fatigue, and transfusion dependence.



It is reported that Feiheda ® Iprocopam hydrochloride capsules act on the proximal pathway of the complement pathway in the immune system, comprehensively controlling intravascular and extravascular hemolysis, compensating for the shortcomings of anti C5 antibody therapy, and ushering in a new era of PNH targeted therapy.



Zhang Ying, President and Managing Director of a multinational pharmaceutical company in China, said, "Thanks to China's support for prioritizing the evaluation of innovative drugs, Feiheda ® Iprocopam Hydrochloride Capsules were quickly approved only 10 months after submitting their marketing approval application, greatly reducing the time difference with global synchronous approval. In the future, we will continue to adhere to the concept of "patient-centered" and accelerate the promotion of Feiheda ® Implementing nationwide to meet the most urgent health needs of Chinese PNH patients.



Professor Han Bing from the Department of Hematology at Peking Union Medical College Hospital emphasized that "the development of PNH diagnosis and treatment in China has undergone significant exploration and progress. Although existing anti complement C5 therapies can inhibit intravascular hemolysis, they cannot effectively inhibit extravascular hemolysis, leading to long-term anemia in some patients who cannot escape transfusion dependence. The injection administration method also causes patients to frequently travel to medical institutions, affecting their normal lives. We are pleased to see Feiheda." ® The rapid approval of ipracopam hydrochloride capsules in China not only provides a new option for PNH patients with this innovative mechanism of oral medication, but also has the potential to change the overall treatment of PNH in China.



It is reported that ipracopam hydrochloride capsules can improve treatment compliance, improve medication experience, and improve quality of life. This approval in China is based on the results of a critical phase III APPOINT-PNH global and Chinese subgroup clinical study (50% of participants enrolled in China). This study confirms the efficacy, safety, and tolerability of ipracopam hydrochloride capsules in adult PNH patients who have not previously received complement inhibitor treatment. After 24 weeks of treatment, most patients have hemoglobin levels of 12 g/dL or above, and almost all patients have achieved avoidance of transfusion. Patient reported fatigue and mania have also improved.



Jia Jia, the founder of PNH Friends Home, said, "PNH patients are mainly young and middle-aged, but the disease makes them tired of seeking medical treatment at the best age of life, and they also have to deal with the risk of fatal complications such as thrombosis and kidney failure. We hope that more and more innovative treatment methods and drugs can help PNH patients better control their condition, no longer be trapped in pain, and regain a healthy life like an ordinary person.".