Clinically urgently needed PDE4 inhibitors in China to declare the listing of Amjin's $13.4 billion acquisition acquisition

On February 3rd the Drug Review Center (CDE) of China's State Drug Administration announced that applications for the listing of new drugs for apremilast, co-submitted by Amgen and Celgene, had been accepted.
public information shows that Apust in China has been included in the first batch of clinically urgent need for new drugs abroad, is an oral, non-biological treatment drug.
the product was originally developed by BMS's new base company, Amson announced in August 2019 that it had acquired a global interest in Apuster for up to $13.4 billion.
Screenshot Source: CDE Official Website Public information shows that April is a new type of oral small molecule phosphate disterase 4 (PDE4) inhibitor, through dose dependence inhibition of human membrane cells release tumor necrosis agent (TNF)-α to play a role.
PDE4 is a cyclophosphate adenosine (cAMP) specific PDE, which is the main PDE in inflammatory cells.
PDE4 inhibition leads to elevated intracellular camp levels, which are thought to indirectly regulate the production of inflammatory media.
was first approved for listing in the U.S. in March 2014.
Currently, its approved adaptations in the United States are: 1) moderate to severe plaque psoriasis patients suitable for light therapy or systemic therapy; 2) adult patients with active psoriasis arthritis; and 3) adult patients with mouth ulcers associated with white plug disease.
August 2019, AMSM announced that it would buy Otezla for $13.4 billion, complementing its existing inflammatory innovative biologics.
Apster's sales reached $1.6 billion in 2018, according to an earlier press release from Amjin, and with new adaptations and global expansion, April is on track to achieve an average double-digit annual sales growth over the next five years.
according to CDE's earlier publicity, Apust has a brand new target, has been shown to have therapeutic effect and good tolerance in studies outside China.
In treating patients with psoriasis, a multi-center, randomized, placebo-containing control group of Phase 3 clinical results showed that Apt's treatment of patients with mild and moderate plaque-like psoriasis reached the main endpoint of the trial.
in the static physician general assessment (sPGA) in week 16 compared to the placebo group, the candidate drug resulted in a statistically significant improvement in the patient's skin condition.
another study, estEEM 1, showed that patients treated with Abster prevention had a 75 percent improvement in psoriasis area and severity index (PASI-75) compared to placebo, significantly more than placebo (33.1 percent vs. 5.3 percent) at 16 weeks.
has conducted a number of clinical studies in the treatment of patients with psoriasis arthritis.
a study called PALACE 1 showed that the Proportionte 20mg, 30mg and placebo groups reached the American Rheumatology Society's 20 percent mitigation standard (ACR20) at 16 weeks, 30.4 percent, 38.1 percent, and 19 percent, respectively.
65% and 68% of patients in the Aptster 20mg and 30mg group reached ACR20 at 156 weeks, respectively, and 35.8% and 31.9% reached PASI-75, meaning that long-term use of Apt treatment still had better results.
In treating oral ulcers caused by white congestion, a randomized, placebo-controlled, double-blind Phase 3 clinical study called RELIEFTM showed that When Appster measured the pain level of mouth ulcers with visual simulation scoring (VAS) in week 12, it was 42.7 points lower than the baseline compared to the placebo group.
12 weeks, the proportion of patients with complete remission of oral ulcers (no mouth ulcers) was 52.9% (vs 22.3%).
psoriasis is a chronic, relapsed, immuno-mediated multi-system disorder.
to severe psoriasis can reduce quality of life and even disability, and traditional drugs (methotrexate, aveia, cyclosporine and other drugs) are limited in effectiveness and have a variety of potential toxicity.
psoriasis arthritis is a disabling chronic disease with symptoms in multiple parts of the body.
inflammation of the immune system in patients with psoriasis arthritis, which can lead to skin lesions, joint pain, fatigue and stiffness associated with psoriasis.
progress has been made in treating the disease, many patients' symptoms are not sufficiently alleviated.
is a rare chronic multi-system inflammatory disease that is difficult to treat.
is associated with abnormal immune systems and inflammation of blood vessels.
are relapsed oral and genital ulcers, skin damage, staphylococcitis, arthritis, vascular, central nervous system and gastrointestinal injuries.
more than 98% of patients with white plug disease have mouth ulcers, which seriously affect the daily life of patients.
the acceptance of Abster's application for listing in China and hoped that the product would be approved in China at an early time, benefiting more Chinese patients.