On October 11, the NMPA website showed that Hemei Pharmaceutical's Class 1 new drug "Momisite" was approved for marketing for the treatment of plaque psoriasis (Acceptance Number: CXHS2400033), becoming the first approved domestic PDE4 inhibitor.
Momisite (Hemay005) is a phosphodiesterase 4 (PDE4) small molecule inhibitor. According to the Insight database, the drug's clinical trial application was filed as early as 2013, the first clinical trial was initiated in 2016 for the treatment of psoriasis, and the first marketing application was submitted in April 2024 with plaque psoriasis as the initial indication.
The Phase III clinical results of Momisite for moderate-to-severe chronic plaque psoriasis were presented at the 2023 American College of Rheumatology (ACR) Annual Meeting. This was a randomized, multi-center, double-blind, placebo-controlled clinical study (NCT04839328/CTR20210660) that enrolled 306 patients in China. The primary endpoint was the proportion of patients achieving a PASI score ≥ 75% (PASI assesses psoriasis area and severity index) at week 16. Secondary endpoints included the proportion of subjects achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) with a ≥2-point improvement from baseline at week 16.
The results showed that the PASI75 response rates were 53.6% for Momisite vs. 16.0% for placebo, and sPGA 0/1 rates were 31.3% vs. 6.4%, respectively.
Beyond the approved indication, Hemei Pharmaceutical is currently extensively exploring Momisite for other indications. A Phase III clinical trial for Behçet's disease has been advanced, Phase II clinical trials for atopic dermatitis and ankylosing spondylitis have been completed, a Phase II clinical trial for ulcerative colitis is underway, a Phase I clinical trial for COPD has been initiated, and IND approvals have been obtained for Crohn's disease and psoriatic arthritis.
The Insight database shows that previously two PDE4 inhibitors had been approved for marketing in China: apremilast (Sun Pharma/Amgen) and crisaborole cream (Pfizer). Hemei Pharmaceutical's Momisite (Hemay005) becomes the first domestic PDE4 inhibitor.
Additionally, in China, companies including Hengrui, China Biopharmaceutical, Huadong Medicine, Jumpcan Pharmaceutical, and Joincare are actively pursuing the PDE4 space, either through self-development or licensing, with a total of five PDE4 inhibitors having entered Phase III clinical trials.