相关临床试验
31
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1921
已完成
10
32.3%
招募中
3
9.7%
暂无批准数据
- Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream 0.5% (tapinarof) for atopic dermatitis in pediatric patients under 12 years of age. - The approval was based on a domestic Phase 3 trial in children aged 2 to under 12 in which the drug met its primary efficacy endpoint versus vehicle cream. - Pooled Phase 3 ADORING data showed consistent vIGA-AD and EASI75 improvements across pediatric age groups, with responses observed as early as week 2. - Tapinarof is a first-in-class nonsteroidal topical aryl hydrocarbon receptor agonist, offering a steroid-free option for a disease that frequently develops in childhood.
- Shionogi received a "Notice of Non-issuance of Cease and Desist Order" from Japan's Fair Trade Commission on May 28, 2025, clearing regulatory hurdles for its tender offer to acquire Torii Pharmaceutical. - The company is conducting a tender offer at 6,350 yen per share to make Torii Pharmaceutical a wholly-owned subsidiary, with Japan Tobacco holding 54.78% of shares agreeing not to tender in the offer. - The acquisition aims to create synergies in domestic pharmaceutical sales, accelerate global development capabilities, and establish flexible manufacturing structures through integration of both companies' complementary strengths.
