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Hangzhou Changxi Pharmaceutical Co., Ltd. (Changxi Pharmaceutical), a clinical-stage biotechnology company, announced that it has entered into an exclusive commercialization collaboration in mainland China for Changxi Pharmaceutical’s product CXG87 (modified budesonide/formoterol inhalation powder) with Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (000963.SZ, Huadong Medicine).
CXG87 is a Class 2.2 new drug independently developed by Changxi Pharmaceuticals for the treatment of respiratory diseases such as asthma. Currently, the Phase III clinical trial for this drug for asthma has completed enrollment of all subjects, and the New Drug Application (NDA) is expected to be submitted in the first half of 2026.
According to the terms of the agreement, Changxi Pharmaceutical, as the MAH holder, will be responsible for the research and development, registration, production and supply of the CXG87 product; after the signing of the agreement, Changxi will receive an initial payment, as well as corresponding registration milestone and sales milestone payments; Huadong Medicine will be responsible for the commercial promotion of the CXG87 product in mainland China.
Dr Donghao Chen, founder and CEO of Changxi Pharmaceuticals, said: "CXG87 is the first product developed based on Changxi's unique VFC platform and is one of Changxi's important differentiated products. It also fully verifies the scientific nature and commercial value of the VFC platform. Compared with the original research product, CXG87 has many significant advantages, such as lower flow rate dependence. The commercial cooperation with Huadong Medicine, on the one hand, highlights the recognition of the huge commercial potential of CXG87 products; on the other hand, relying on Huadong Medicine's strong commercialization capabilities in the respiratory field, it can maximize the commercial and clinical value of CXG87. Changxi Pharmaceuticals will work closely with Huadong Medicine to bring the product to market as soon as possible to benefit the majority of patients with respiratory diseases.
Dr Lan Chen, co-founder and head of R&D at Changxi Pharmaceuticals, stated, "Symbico Turbuhaler is an excellent inhaled product. We are fortunate to have further refined and enhanced it through pharmaceutical, Phase I, and phase III clinical trials, striving to achieve a 'closed-loop' demonstration of its superiority. We look forward to this collaboration enabling CXG87 to further benefit a vast number of asthma patients with inspiratory airflow limitation in the future, providing Chinese asthma patients with a superior treatment option."
Lv Liang, chairman and general manager of Huadong Medicine, stated, "We highly recognize the potential of CXG87 in respiratory therapy. This collaboration will further strengthen Huadong Medicine's strategic presence in the respiratory pipeline. Leveraging our nationwide commercial network and professional marketing team, CXG87 is expected to achieve rapid, efficient market access and widespread coverage upon launch. We will collaborate deeply with Changxi, integrating our respective resources to accelerate the launch of this innovative product with significant clinical value in China, bringing it to the benefit of patients as soon as possible."
CXG87 (modified budesonide/formoterol inhalation powder) is a Category 2.2 novel drug independently developed by Changxi Pharmaceutical. Compared to the original product, Symbicort Turbuhaler, CXG87 has lower flow rate dependence, making it more suitable for patients with inspiratory flow limitation. Furthermore, CXG87 utilizes a simple, single-dose powder inhaler, resulting in a lower rate of misuse and more stable therapeutic performance. CXG87 has completed enrollment in its Phase III clinical trial in China, and anticipates submitting a marketing application in the first half of 2026.
Changxi Pharmaceuticals is a clinical-stage biotechnology company focused on the development of innovative dry powder inhaler (DPI) therapies. The company has built a diversified product pipeline based on two core technology platforms: pulverization and mixing, and spray drying.
Huadong Medicine Co., Ltd., founded in 1993 and headquartered in Hangzhou, Zhejiang, adheres to the corporate philosophy of "research-based, patient-centric." After more than 30 years of development, the company's business covers the entire pharmaceutical industry chain, with four major business segments: pharmaceutical industry, pharmaceutical commerce, medical aesthetics, and industrial microbiology.
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