Hangzhou Chance Pharmaceuticals Announces NMPA Acceptance of Marketing Authorization Application for CXF11
HANGZHOU, China, July 02, 2021 (GLOBE NEWSWIRE) -- Hangzhou Chance Pharmaceuticals (“Chance”), a clinical-stage biotechnology company focusing on discovering, developing, and commercializing transformative inhalation therapies for the world’s most debilitating diseases, announced that the National Medical Products Administration (NMPA) of China has accepted its Marketing Authorization Application for CXF11 for the treatment of chronic obstructive pulmonary disease (COPD).
The application is based on the results of a series of well-designed and successful formulation identification, process development and in vitro studies including a comprehensive comparison to the reference drug at each of its critical quality attributes, a more than 2 years stability study, and more importantly, the bioequivalence (BE) study.
“The NMPA Acceptance of Marketing Authorization Application for CXF11is the first important milestone in product development for Chance. With a corporate strategy that emphasizing both external collaborations and internal development, recent groundbreaking for global standard commercial manufacture facility, and unique VFC technology platform, we are well positioned to bring CXF11 and other innovative drugs to China and rest of the world,” commented Donghao Chen, Founder and CEO of Hangzhou Chance Pharmaceuticals.
CXF11 is Chance’s tiotropium bromide inhalation drug intended for prevention of bronchospasm in adults with chronic obstructive pulmonary disease (COPD). It uses Chance’s proprietary inhaler with improved usability and visual effect compared to reference product. CXF11 is the first drug of its kind in China that has demonstrated success in bioequivalence (BE) and stability studies.
The global market for tiotropium bromide peaked at US$3.5 billion in 2015 and has decreased gradually due to Spiriva’s patent expiration. The Chinese market is about RMB 1.8 billion in 2020 and growing at about 15%.
Chronic obstructive pulmonary disease (COPD) is a group of chronic diseases that cause airflow blockage and breathing problems. It includes emphysema and chronic bronchitis. Currently there is no cure for COPD, but its symptoms can be treated.
About Hangzhou Chance Pharmaceuticals Co. Ltd.
Chance Pharmaceuticals is a clinical-stage biotechnology company focusing on discovering, developing and commercializing transformative inhalation therapies for the world’s most debilitating diseases. For more information, please visit http://www.chancepharmaceuticals.com.
Hangzhou Chance Pharma
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