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HANGZHOU, China, July 02, 2021 (GLOBE NEWSWIRE) – Hangzhou Chance Pharmaceuticals (“Chanceâ€), a clinical-stage biotechnology company focused on the discovery, development and commercialization of transformative inhalation therapies for the most debilitating diseases worldwide, announced that the National Medicines 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 studies identifying formulation, process development and in vitro studies, including a full comparison to the reference medicine for each of its attributes. quality reviews, a stability study of over 2 years, and more importantly, the bioequivalence (BE) study.
“The NMPA Marketing Authorization Application for CXF11 is the first important step in product development for Chance. With a business strategy that emphasizes both external collaborations and internal development, a recent innovation for a global standard commercial manufacturing facility, and a unique VFC technology platform, we are well positioned to deliver the CXF11 and other innovative drugs in China and the rest of the world, â€commented Donghao Chen, Founder and CEO of Hangzhou Chance Pharmaceuticals.
About CXF11
CXF11 is Chance’s tiotropium bromide inhalation medicine for the prevention of bronchospasm in adults with chronic obstructive pulmonary disease (COPD). It uses Chance’s proprietary inhaler with improved ease of use and visual effect compared to the benchmark product. CXF11 is the first drug of its kind in China to be proven in bioequivalence (BE) and stability studies.
The global tiotropium bromide market peaked at US $ 3.5 billion in 2015 and gradually declined due to the expiration of Spiriva’s patent. The Chinese market is around 1.8 billion RMB in 2020 and is growing by around 15%.
About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a group of chronic diseases that cause blocked airflow and breathing problems. It includes emphysema and chronic bronchitis. There is currently no cure for COPD, but its symptoms can be treated.
About Hangzhou Chance Pharmaceuticals Co. Ltd.
Chance Pharmaceuticals is a clinical-stage biotechnology company focused on the discovery, development and commercialization of transformative inhalation therapies for the world’s most debilitating diseases. For more information, please visit http://www.chancepharmaceuticals.com.
Contact information:
Hangzhou Chance Pharma
Guobao Zhao
Zhaoguobao@chancepharmaceuticals.com
+ 86 571-8630-9565
Solebury Trout
Bob ai
bai@soleburytrout.com
+1 646-389-6658
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