Ardelyx Inc. (Nasdaq: ARDX), a biopharmaceutical company on a mission to revolutionize modern medicine, today announced that its New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA).
This milestone acceptance has resulted in a $2 million payment to Ardelyx along with the potential approval of the NDA submission in China by the end of 2024; a step toward treating adult patients with chronic kidney disease on hemodialysis to control their serum phosphorus levels.
Ardelyx has taken a significant stride forward with the acceptance of their novel therapy, tenapanor, for hyperphosphatemia in China. This was made possible through their successful partnership with Fosun Pharma, who generated impressive clinical results demonstrating the efficacy of tenapanor in treating this condition.
With this success, Ardelyx is now looking to make tenapanor available to patients and expand their reach internationally. Mike Raab, president and chief executive officer of Ardelyx, praised their collaboration partner on this impressive result and is enthusiastic about their unyielding commitment to bring new treatments to those with unmet medical needs.
Ardelyx has made a major deal with Fosun Pharma that gives them a $12 million upfront payment, as well as the potential for additional developmental and commercialization milestones of up to $110 million and tiered royalty payments from the mid-teens to 20 percent on net sales.
Not only that, but Fosun Pharma also has the exclusive rights to sell and market Ardelyx’s tenapanor in China, Hong Kong, and Macau. It’s a hugely exciting agreement for both parties involved.
About Ardelyx, Inc.
Ardelyx is on a mission to bring innovative, first-in-class medical solutions to those suffering from unmet medical needs. One of its revolutionary products, IBSRELA® (tenapanor), has already been approved and is available in the United States and Canada.
The groundbreaking XPHOZAH® (tenapanor) is in its final phases of development and, once approved, it will be used for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
Additionally, Ardelyx is investing in early-stage programs for the treatment of elevated serum potassium and metabolic acidosis. To welcome its ground-breaking treatments throughout the world, Ardelyx has partnered up with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.
About Fosun Pharma
Fosun Pharma, a global leader in the innovation-driven pharmaceutical and healthcare industry, has been forging ahead since 1994. By leveraging its strategic shareholder in Sinopharm Co. Ltd., Fosun Pharma continues to expand its reach, covering pharmaceuticals, medical devices, medical diagnosis, and healthcare services alongside its extensive distribution and retail business. Boasting a global presence and stock code (600196. SH, 02196. HK), Fosun Pharma is dedicated to enriching healthcare around the world.
At Fosun Pharma, we strive to develop innovative treatments tailored to the needs of patients. We prioritize independent research and development, cooperative development, license-in, and in-depth incubation strategies to continuously enrich our product pipeline and advance the research and clinical development of First-in-class and Best-in-class drugs as well as innovative technologies and products.
By doing so, we ensure that we remain at the forefront of medical advancement, and move ever closer to providing cutting-edge treatments that will improve the lives of countless people.
Fosun Pharma is on a mission to create maximum shareholder value. Guided by our 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), we are committed to transforming, expanding and growing together.
Through our top-notch independent research, strong external partnerships and expanding global presence, we are generating valuable product pipelines and all-encompassing business models that are sure to take the pharmaceutical and healthcare industries by storm.
With cutting-edge digital and physical platforms, Fosun Pharma is well on its way to becoming a leader in the global medical and health field.