Novartis Debuts Innovative Kidney Therapeutic Portfolio at CIIE, Strengthening Precision Treatment in Cardiorenal Diseases

China Finance Network, November 5th: The 7th China International Import Expo ("CIIE") officially opened today. Novartis, with multiple innovative drugs in the cardiovascular and renal treatment fields, is participating for the seventh consecutive year.

Among them, the innovative drug combination Atrasentan and Fehrda (Iptacopan Hydrochloride Capsules) for the treatment of IgA Nephropathy (IgAN) made their first joint appearance.

Atrasentan, an endothelin A receptor antagonist, is the first non-immunological, highly selective IgAN precision treatment drug submitted for marketing in China. Iptacopan hydrochloride capsules are currently the world’s first approved complement alternative pathway inhibitor for reducing proteinuria in primary IgA nephropathy (IgAN) patients at risk of rapid progression. Building on its already approved indication for paroxysmal nocturnal hemoglobinuria (PNH) in China, iptacopan has the potential to accelerate the expansion into IgAN and other renal indications, providing Chinese IgAN patients with more targeted treatment options and ushering in a new era of precision medicine.

Leo Li, President and Managing Director of Novartis China, stated that Novartis is also accelerating its strategic expansion in the renal treatment field. The new renal product portfolio showcased for the first time at the CIIE has the potential to provide more precise and safer solutions for kidney disease treatment in China. "We will actively promote the simultaneous launch of these innovative drugs in China and globally, benefiting more kidney disease patients with 'China speed.' In the future, Novartis will continue to focus on the needs of Chinese patients in core therapeutic areas such as cardiovascular, renal, and metabolic diseases, developing and introducing more innovative drugs to fill clinical treatment gaps and safeguard patients' cardio-renal health."

Data show that IgAN is a highly heterogeneous autoimmune disease caused by the immune system attacking the kidneys, leading to glomerular inflammation and proteinuria. It is characterized by a large number of patients, early onset, and rapid progression. IgAN is the most common primary glomerular disease in China, with approximately 4 million patients. The disease predominantly affects young and middle-aged adults, progressing insidiously and rapidly.

The iprocaptod sodium capsule, which made its debut at the CIIE, is an oral, selective B factor inhibitor and also the world's first approved IgAN therapy targeting the alternative complement pathway. Overactivation of the complement system in the kidneys is considered one of the pathogenic mechanisms of IgAN. The targeted inhibitory effect of iprocaptod sodium capsule on the alternative complement pathway can effectively reduce renal damage, providing clear and precise therapeutic benefits.

"Different from Europe and America, the incidence of IgA nephropathy is high in Asia, especially in China. Due to factors such as the characteristics of the disease itself and patients' treatment concepts, East Asian patients are more susceptible to the disease and have a poorer prognosis with faster decline in renal function. If not properly controlled, it can easily progress to uremia or even renal failure. Renal biopsy is the gold standard for diagnosing IgAN. Only by identifying the cause of the kidney disease as early as possible can patients receive timely personalized treatment and improve their prognosis," pointed out Professor Xie Jingyuan, Chief Physician of the Department of Nephrology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Currently, after receiving standard treatment, nearly half of persistent proteinuric IgAN patients still progress to renal failure within 10 to 20 years after diagnosis, facing maintenance dialysis and/or kidney transplantation. In clinical treatment, after clarifying the cause of IgAN, in addition to traditional CKD treatment plans, doctors can simultaneously initiate precision treatment strategies, grasping the best treatment opportunities with both hands, fully helping patients reduce and reverse proteinuria, delay disease progression—entering dialysis at 50 versus at 80 will be completely different life experiences."

Iptacopan Hydrochloride Capsules received accelerated approval from the US FDA in August 2024 for reducing proteinuria in adult IgAN patients at risk of rapid progression. The application for expanding its indications in the field of nephrology in China has also been accepted by the National Medical Products Administration, with the hope that Chinese patients will benefit from the most cutting-edge innovative treatment methods simultaneously with global patients.