Japanese pharmaceutical company best known for originating Crestor; specializes in pharmaceuticals and biotechnology with particular expertise in antimicrobial and antibiotic development.
相关临床试验
219
24 进行中
药物批准
3
批准总数
监管机构
1
监管机构数
成立时间
1878
进行中（未招募）
24
11.0%
已完成
78
35.6%
招募中
11
5.0%
- Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream 0.5% (tapinarof) in atopic dermatitis patients under 12 years of age. - The approval rests on a domestic Phase 3 trial in children aged 2 to under 12 in which once-daily tapinarof for 8 weeks beat vehicle cream on the primary endpoint. - Long-term safety was assessed for up to 60 weeks of treatment, with the companies reporting favorable tolerability in the pediatric population. - Shionogi said the financial impact on consolidated results for the fiscal year ending March 2027 is expected to be minimal.
- China's NMPA has approved Jiangsu Hengrui Pharma's oral TPO receptor agonist hetrombopag for chemotherapy-induced thrombocytopenia in patients with solid tumours. - Hengrui says the clearance makes hetrombopag the first oral TPO agonist approved for chemotherapy-induced thrombocytopenia anywhere in the world. - The NMPA also granted hetrombopag second-line use in paediatric patients aged six and over with immune thrombocytopenia, expanding its existing indications. - Injectable TPO options such as 3SBio's Tpiao and off-label romiplostim biosimilars currently require multiple clinic visits for CIT patients in China.
- Shionogi and StemRIM reported that redasemtide met the primary endpoint of refractory ulcer closure in 3 of 4 patients in an additional Phase 2 trial in dystrophic epidermolysis bullosa. - The global Phase 2b trial in acute ischemic stroke did not achieve its primary endpoint, with no statistically significant improvement in 90-day modified Rankin Scale versus placebo. - Exploratory subgroup analysis suggested an mRS improvement trend in redasemtide-treated patients with higher stroke severity at onset who did not undergo endovascular recanalization therapy. - No new safety concerns were identified in either trial, and adverse event incidence in the stroke study was comparable between redasemtide and placebo groups.
- 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.
- A peer-reviewed study in Scientific Reports shows an annealing quantum computer improved a generative AI model's output for drug discovery, producing chemically valid molecules 97% of the time versus 73% for a classical-only model. - The quantum-assisted model generated drug-like molecules (QED ≥ 0.7) at 66.79%, more than double the 31.61% rate in the training data and about 55% higher than the best classical model's 43.15%. - The research, a collaboration between D-Wave and Shionogi & Co., Ltd., used a neural hash function to bridge classical and quantum networks, with the D-Wave Advantage2 system serving as the model's sampling engine. - The findings suggest annealing quantum computing could act as a general-purpose stochastic generator in generative AI, extending beyond drug discovery into broader optimization and sampling applications.
- Verrica Pharmaceuticals announced the first U.S. patient has been dosed in the COVE-3 pivotal Phase 3 trial evaluating YCANTH (VP-102) for the treatment of common warts. - Development partner Torii Pharmaceutical simultaneously dosed the first Japanese patient in the same COVE-3 study, marking a key milestone in the global Phase 3 program. - Common warts affect an estimated 22 million people in the U.S. alone with no FDA-approved therapies, representing one of the largest unmet needs in dermatology. - The Phase 2 COVE-1 trial showed 51% of subjects achieved complete clearance of all treatable warts at Day 84 with no serious adverse events observed.
- Shionogi completed the acquisition of global rights to RADICAVA (edaravone) from Tanabe Pharma for $2.5 billion, establishing the company as a commercially viable rare disease player. - RADICAVA, approved for amyotrophic lateral sclerosis treatment, has treated over 22,000 ALS patients in the U.S. and generates approximately $700 million in annual global sales. - The acquisition includes both oral suspension and intravenous formulations of edaravone, along with an established rare disease team and ALS treatment platform. - The transaction is expected to be immediately accretive in fiscal year 2026 and supports Shionogi's 2030 Vision to address unmet medical needs in rare diseases.
- Apnimed's Phase 2 FLOW study of sulthiame, an oral carbonic anhydrase inhibitor, met its primary endpoint across all doses in treating moderate to severe obstructive sleep apnea. - The 15-week trial enrolled 298 patients across 28 European sites and demonstrated significant dose-dependent reductions in breathing disturbances and improved nocturnal oxygenation. - Sulthiame was generally well-tolerated with a favorable safety profile, offering a distinct mechanism of action from other investigational OSA treatments. - The positive results were published in The Lancet, marking a potential breakthrough for the estimated 80 million Americans and nearly one billion people worldwide suffering from OSA.
- Genentech announced its first Direct-to-Patient program for Xofluza, offering a $50 cash pay option that is 70% lower than the list price for uninsured and underinsured patients. - The program provides same-day home delivery in select U.S. markets through partnerships with Alto Pharmacy, Amazon Pharmacy, and Mark Cuban Cost Plus Drug Company. - This initiative addresses the severe 2024-25 flu season, which CDC data shows was the most severe since 2017-18 with an estimated 47-82 million illnesses and up to 130,000 deaths. - Xofluza is a first-in-class, single-dose oral antiviral that blocks viral replication by inhibiting cap-dependent endonuclease protein, approved for treatment and prevention in patients five years and older.
- 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.
