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SIM0335, Simcere's Investigational Drug for Psoriasis Entered Phase II Clinical Trial and has completed the first patient enrollment

Release time:2022-05-27

On May 27, 2022, Simcere Pharmaceuticals (2096.HK) announced that, SIM0335 (CKBA ointment), an innovative chemical drug candidate developed in-house by Simcere’s subsidiary BCY Pharm Co., Ltd. (hereinafter referred to as BYC Pharm ) for the treatment of mild to moderate plaque psoriasis has entered phase 2a clinical trial in China. The first patient has been enrolled in Wuxi Second People's Hospital.


This multi-centered, randomized, double-blinded phase 2 clinical trial was led by Prof. Jianzhong Zhang from Peking University People's Hospital to evaluate the safety, efficacy and pharmacokinetics of SIM0335 in patients with mild to moderate plaque psoriasis. This is another milestone following the completion of a phase I clinical study in healthy volunteers in 2021 which showed good safety and tolerability of CKBA .


Psoriasis is an immune-mediated chronic disease with no cure worldwide. It currently affects nearly 6.5 million people in China, with 80%-90% being plaque psoriasis. Among these patients, approximately 50% have mild to severe symptoms. Other than suffering from the painful symptoms, the patients are also under enormous psychological distress and possible social ostracization. Though many drugs have been developed to manage the symptoms, there are still huge clinical demands for safer and more effective new treatments.


SIM0335 is a topical ointment with 3-O-cyclohexanecarbony1-11-keto-β-boswellic acid (CKBA) being the active ingredient. CKBA is a novel compound derived chemically from acetyl-11-keto-β-boswellic acid (AKBA) with optimized structure and higher biological activity. Preclinical studies suggests that CKBA can regulate the differentiation of helper T cells 17 (Th17) by affecting the de novo synthesis of fatty acids, thereby inhibiting the secretion and expression of the inflammatory factor interleukin-17A (IL-17A) in psoriatic skin lesions.

Simcere will keep making efforts in advancing the clinical research of CKBA in hope of bringing new options for clinical psoriasis patients in China soon.