Spotlight on kidney disease drugs
Two of the in-licensing deals in July are for treatments aimed at kidney diseases.
Alebund Pharmaceuticals and Peking University First Hospital entered a strategic partnership to develop the pre-clinical product PKU308/AP308, a novel and specific treatment for IgA Nephropathy (IgAN). Peking University First Hospital will receive an undisclosed amount in an upfront payment as well as royalty payments after PKU308/AP308 is commercialized.
This compound was designed and developed by Peking University First Hospital. It has an innovative mechanism of action compared to currently available treatment options, directly targeting on the pathology of the the disease.
In addition, Unicycive announced an exclusive license and development agreement with Lee’s Pharmaceutical for Renazorb (lanthanum dioxycarbonatein) in China and certain other Asian markets. Lee’s Pharmaceutical is a well-known company in China that focuses on generic drugs.
In this deal, Unicycive will receive an upfront payment of $1.0 million and up to $1.0 million in milestone payments upon the product launch in China. It will also be eligible for tiered royalties upon achievement of prespecified regulatory and commercial achievements.
Renazorb is being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). It has potential benefits over currently available treatment options as it requires smaller and fewer number of pills per dose and is swallowed instead of chewed. Renazorb has been in phase III clinical studies in the United States.
Improved enthusiasm for kidney disease drugs R&D in China
The incidence of kidney disease in China is increasing every year.China has about 130 million chronic kidney disease patients, reported a 2020 piece published in The Lancet.
It was predicted that the incidence and prevalence of end-stage renal disease in China would increase by 1.19% and 1.95% each year through model calculations, stated a BMC Nephrology article.
But the drugs for treating kidney disease are few and far between in the market. IgA nephropathy is the most common type of primary glomerulonephritis worldwide and a leading cause of end-stage kidney disease. However, currently available treatments are limited, and nearly one-third of patients with IgA nephropathy require dialysis 10 to 20 years after the onset of the disease.
In recent years, more companies in China have participated in the research and development of new drugs for kidney disease. There are many biotech companies such as Alebund Pharmaceuticals, Kind Pharmaceuticals and KBP Biosciences that are focused on the field of kidney disease.
KBP-5074 is the lead product by KBP Biosciences. It is in a global phase III clinical study for chronic kidney disease patients with refractory hypertension. In addition, KBP Biosciences’pipeline also has candidates for renal fibrosis and glomerulosclerosis.
AND017 is a phase II clinical product developed by Kind Pharmaceuticals, which targets anemia caused by chronic kidney diseases. Kind Pharmaceuticals is also developing a drug to treat kidney cancer.
Alebund Pharmaceuticals has a more abundant pipeline for kidney disease. AP301 is its lead candidate for hyperphosphatemia caused by chronic kidney disease. It also has other compounds developed for IgA nephropathy, diabetic nephropathy, and autosomal dominant polycystic kidney disease.
These three companies are the new kids on the block for the R&D scene for kidney disease drugs in China. The indications of their products have almost no overlap, so this may be a sign that there is still plenty of room in the kidney disease pool.