CMS(00867): The innovative drug phosphorylated Lutkenib cream has been accepted for application for market approval in China for the treatment of atopic dermatitis (AD) and has been included in the priority review.

date
17:49 24/02/2026
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GMT Eight
Kangzhe Pharmaceutical (00867) announced that its subsidiary, Demei Pharmaceutical Co., Ltd. ("Demei Pharmaceutical"), a innovative pharmaceutical company focusing on skin health, is applying for independent listing on the main board of the Hong Kong Stock Exchange. On February 24, 2026, it received acceptance from the China National Medical Products Administration (NMPA) for the new drug listing application (NDA) for phospho-ruzatinib cream ("product") for the treatment of mild to moderate atopic dermatitis (AD).
CMS (00867) issued an announcement that its subsidiary, Termez Pharmaceuticals Limited ("Termez Pharmaceuticals"), an innovative pharmaceutical company specializing in skin health, is applying for an independent listing on the Main Board of the Hong Kong Stock Exchange. On February 24, 2026, the company obtained the acceptance of a New Drug Application (NDA) for the market approval of phospholipid luteinidin cream ("product") for the treatment of mild to moderate atopic dermatitis (AD) from the National Medical Products Administration (NMPA) of China. The product is intended for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in children aged 2 and above and adults who have poor control with other topical medications or are not recommended for use. This NDA has been approved by the NMPA Drug Evaluation Center to be included in the priority review list due to the "novel variety, dosage form, and specifications suitable for children". This is expected to expedite the approval process for the product for the indication of AD. Additionally, the phospholipid luteinidin cream was approved for marketing by the NMPA in January 2026, becoming the first and only targeted therapy approved in China for the treatment of vitiligo. The acceptance of the NDA for the indication of AD is a key milestone in expanding the product into multiple therapeutic areas.