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Highlights:
- CORXEL’s Aficamten NDA accepted by China’s NMPA for obstructive hypertrophic cardiomyopathy (HCM) treatment.
- Aficamten, a next-in-class cardiac myosin inhibitor, is a breakthrough therapy for a common but underserved heart disease.
- RTW Biotech portfolio company CORXEL advances towards commercialization in Greater China after FDA and NMPA designations.
RTW Biotech Opportunities Ltd (LSE:RTW), a London-listed investment company focused on transformative life sciences assets, is pleased to announce the significant milestone achieved by its portfolio company, CORXEL Pharmaceuticals (“CORXEL”). The National Medical Products Administration (NMPA) of China has accepted CORXEL’s New Drug Application (NDA) for Aficamten, an investigational selective small molecule cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). This marks a pivotal step for CORXEL, further solidifying its leadership in addressing unmet medical needs within the cardiometabolic disease space.
Aficamten has garnered Breakthrough Therapy Designation from both the U.S. Food & Drug Administration (FDA) and the NMPA, affirming its potential as a next-generation treatment for symptomatic obstructive HCM, a condition that leads to abnormal thickening of the heart muscle, impairing its pumping function. HCM is the most common inherited cardiovascular disorder, affecting approximately 132,000-330,000 patients in China alone, with a significant number of undiagnosed cases. The acceptance of the NDA by the NMPA is a critical step toward bringing Aficamten to the large, underserved patient population in China, as well as providing a pathway for future commercialization in the region.
CORXEL, originally founded as Ji Xing Pharmaceuticals in 2019, is dedicated to developing innovative treatments for cardiometabolic diseases, a class of disorders that affect the heart, blood vessels, and metabolism. In 2020, CORXEL entered into a collaboration with Cytokinetics, a California-based late-stage biopharmaceutical company, securing an exclusive license to develop and commercialize Aficamten in Greater China. The NDA acceptance by the NMPA comes after Aficamten’s success in clinical trials in the U.S. and global recognition of its potential to revolutionize the treatment of HCM.
The milestone of the NDA acceptance follows a series of strategic steps by CORXEL, which includes rigorous clinical testing and regulatory filings. Aficamten has shown strong promise in clinical trials, particularly in patients with obstructive HCM, demonstrating its potential to significantly improve heart function and patient quality of life. With the NMPA’s acceptance, CORXEL is now positioned to continue advancing the development of Aficamten in China, with the goal of delivering a much-needed treatment for a significant patient population.
Roderick Wong, Managing Partner and Chief Investment Officer at RTW Investments, the Investment Manager for RTW Biotech, commented on the news: “We are thrilled to see the acceptance of the NDA for Aficamten by the NMPA. This is a major milestone for CORXEL and a testament to their dedication to bringing innovative therapies to patients with cardiometabolic diseases. The achievement highlights the commitment of the CORXEL team to improving patient outcomes, and we look forward to continuing our support as they work to deliver this groundbreaking treatment to a global patient population.”
The successful acceptance of the NDA for Aficamten is expected to be a key driver for CORXEL’s growth in the coming years. With its innovative approach to treating obstructive HCM, the company is poised to meet a critical need within the cardiovascular field, benefiting millions of patients in China and beyond. As CORXEL advances towards commercialization, RTW Biotech Opportunities Ltd continues to be a strategic partner in its mission to transform patient care in the cardiometabolic space.
