BEIJING, June 28 (China Economic Net) -- Beijing Wenfeng TianjiPharma Ltd.(BWTL), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative drugs for the treatment of psoriasis and eczema, announced that the National Medical Products Administration (NMPA) has approved, under priority review, the use of its proprietary new drug Benvitimod cream, a therapeutic aryl hydrocarbon receptor modulating agent (TAMA), in patients with mild-to-moderate plaque psoriasis.
Dr. Genhui Chen, co-inventor of Benvitimod and CEO of BWTL, said “We are very excited about NMPA’s approval for the use of Benvitimod, prior to this, as patients with psoriasis had limited options available to help treat their conditions and this accelerated decision from the NMPA means patients now have an innovative, efficacious medicine available to help manage this challenging disease. I am grateful to the NMPA for this approval, as this NMPA decision will make a significant impact on the patient community suffering from this disease and will benefit millions of people in China.”
Professor Jianzhong Zhang, principle investigator of clinical study and chairman of the department of dermatology, Peking University People’s Hospital commented, “plaque psoriasis is a chronic disease that affects over 8 million people in China. For the first time in close to 30 years, patients with this hard-to-treat condition now have a novel topical treatment option for their disease. As a research community, we all share in the excitement as it highlights our dedication to bringing novel treatments to patients living with dermal conditions such as psoriasis.”
Dr. Qianjin Lu, President of the Chinese Society of Dermatology, commented on this approval by the NMPA, “the use of Benvitimod in patients is great news for a community serious for more treatment options. As the first-line novel topical treatment for the disease, now physicians will have another much-needed tool for treating their psoriasis patients.”
The approval of Benvitimod is supported by a comprehensive clinical trial program evaluating the efficacy and safety in more than 1,200 patients with mild-to-moderate plaque psoriasis. Benvitimod demonstrated significant efficacy as indicated by the primary end points of percentage of patients with a reduction of PASI ≥75% and with PGA score of clear or almost clear at the end of the treatment, as well as by the sustained efficacy over a follow-up period of nine months. The most common side effects reported in the clinical trials were adverse events at the application site. The majority were mild to moderate in intensity and transient, generally resolved without treatment.
This approval signifies the first TAMA agent for medical use in any country. Benvitimod is a first-in-class, convenient therapy that could meet the need for topical treatment in one of the most common and chronic medical conditions that affects around 100 million people with plaque psoriasis world-wide.
Benvitimod (3,5-dihydroxy-4-isopropyl-trans-stilbene, WBI-1001, tapinarof) is a non-steroid small molecule isolated from symbiotic bacteria of entomopathogenic nematode. Benvitimod has anti-inflammatory and immune-modulating activities related with cytokines that are involved in Th1 and Th17 type autoimmune inflammatory and in Th2 type allergic diseases. In addition to therapeutic activities in treating psoriasis, Benvitimod, currently, has been shown to have efficacy in a Phase 3 clinical trial in patients with eczema, a skin condition that affects over 400 million people world-wide; indicating, Benvitimod would be the first NSAID approved topical therapy that could treat both psoriasis and eczema.
About Beijing Wenfeng TianjiPharma
BWTL is a commercial-stage, research-based biotechnology company focused on therapeutics of inflammatory and auto-immune diseases. With its first dermal product on the market in China, BWTL is advancing a pipeline consisting of novel small molecules for several hard-to-treat, auto-immune diseases and dermatological disorders.