According to the evening announcement issued today by Humanwell Healthcare Group Co., Ltd., the Company recently received the Drug Clinical Trial Approval for Budesonide Cream approved and issued by the China Food and Drug Administration (CFDA). The application for this drug was jointly submitted by Humanwell Healthcare, its wholly‑owned subsidiary Hubei Humanwell Chengtian Pharmaceutical Co., Ltd., and its holding subsidiary Hubei Bio‑pharmaceutical Industrial Technology Research Institute Co., Ltd. (with a shareholding ratio of 54.81%).
Budesonide Cream is indicated for the treatment of skin inflammation and pruritus associated with a variety of corticosteroid‑responsive dermatoses, including contact dermatitis, neurodermatitis, seborrheic dermatitis, eczema, psoriasis, lichen planus, lichen simplex, and dyshidrosis.
According to statistics from Menet, the main domestic manufacturer of Budesonide Cream is Chongqing Huapont Pharmaceutical Co., Ltd. In 2016, the sales of Budesonide Cream in China's three major terminal public hospitals (urban, county and township) amounted to approximately RMB 300 million. According to Thomson Reuters Newport data, the global sales of the drug in 2017 were approximately USD 200 million.
It is reported that Humanwell Healthcare submitted the clinical registration application for Budesonide Cream in December 2016, which was accepted. Up to now, the cumulative investment in the project has reached approximately RMB 4 million.
