Kexing Biopharmaceutical(688136) announced on March 4 that its wholly-owned subsidiary, Shenzhen Kexing Biopharmaceutical Co., Ltd., has independently developed an innovative drug targeting BDCA2 (blood dendritic cell antigen 2).The drug "GB19 Injection" received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, which approved it to conduct clinical trials for the indication of cutaneous lupus erythematosus (CLE).

According to the announcement, GB19 injection targets BDCA2, a target specifically expressed on the surface of plasmacytoid dendritic cells (pDCs), and its mechanism of action differs significantly from existing clinical drugs targeting the B cell pathway. By specifically binding to BDCA2, it can inhibit the production of type I interferon by pDC cells, intervening in the abnormal activation loop between innate and adaptive immunity. Preclinical studies have shown that GB19 possesses good in vitro activity, immunogenicity, high bioavailability, and maintains target inhibition for over 90 days, exhibiting excellent safety profile.

As of the date of this announcement, GB19 injection has received approval from the National Medical Products Administration to conduct clinical trials for both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus. The announcement states that if successfully launched in the future, it will provide the market with more diverse product options, enrich the company's product portfolio, and further enhance its market competitiveness. This approval will not have a significant impact on the company's recent financial condition or operating results.

https://finance.eastmoney.com/a/202603043661276558.html