GSK plc
British multinational pharmaceutical and biotechnology company, formed in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham; manufactures pharmaceuticals, vaccines, and consumer healthcare products across asthma, cancer, infections, diabetes, and mental health.
相关临床试验
3905
202 进行中
药物批准
131
批准总数
监管机构
1
监管机构数
成立时间
2000
尚未招募
41
1.1%
No Longer Available
5
0.1%
终止
241
6.2%
招募中
92
2.4%
暂停
2
0.1%
Available
3
0.1%
撤回
116
3.0%
进行中（未招募）
161
4.1%
Unknown
7
0.2%
已完成
3237
82.9%
- GSK has secured full global rights to Chimagen Biosciences' unnamed trispecific T-cell engager for multiple myeloma in a deal worth up to $750 million. - The preclinical asset is designed to bind T cells while targeting two tumor-associated antigens, aiming for deeper responses and better tolerability than existing engagers. - GSK plans to begin Phase 1 testing in 2027, adding to a myeloma portfolio anchored by the BCMA-directed antibody-drug conjugate Blenrep. - The deal is GSK's second with Chimagen, following the 2024 licensing of the CD19/CD20-targeted T-cell engager CMG1A46 for B-cell malignancies and autoimmune disease.
- In the Phase I/II ARROS-1 trial, zidesamtinib produced a 94% objective response rate in 94 TKI-naive patients with advanced ROS1-positive NSCLC by blinded independent central review. - Among 10 evaluable patients with CNS metastases, intracranial objective response rate reached 100%, including a 70% intracranial complete response rate. - GSK plans a supplemental new drug application to the FDA later this year seeking first-line approval, after Jideytro's July approval in previously treated disease. - Treatment-related adverse events led to dose reductions in 11% and discontinuation in 1%, with peripheral edema the most common event at 34%.
- The Phase III ARTEMIS-008 trial showed risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small-cell lung cancer. - Median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median follow-up of 12.2 months. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, mostly hematologic toxicities. - GSK, which holds ex-China rights to the B7-H3-directed antibody-drug conjugate, is advancing a global development program including the Phase III EMBOLD SCLC-301 trial.
- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer. - In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up. - Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.
- Yuhan registered a U.S. patent on July 21 covering bicyclic fused ring derivatives that inhibit the LOX enzyme family, a preclinical small-molecule anti-fibrosis candidate. - The patent lists idiopathic pulmonary fibrosis, MASH, chronic kidney disease and liver cirrhosis as target indications, positioning the asset across multiple organ fibrosis markets. - The LOX inhibitor differs mechanistically from Yuhan's disclosed MASH candidate YH25724, which acts on FGF21 and GLP-1 and entered domestic Phase 1 planning in May. - Industry analysts see potential licensing value as global fibrosis and MASH dealmaking accelerates, though Yuhan cautions the candidate remains preclinical and success is unproven.
- The US FDA has approved Moderna's mRNA-based seasonal influenza vaccine mFlusiva for people aged 50 to 64, the first flu vaccine using mRNA production. - mFlusiva encodes full-length viral hemagglutinin surface glycoproteins from three WHO-recommended influenza strains, delivered by lipid nanoparticles into cells. - In two clinical trials, mFlusiva outperformed GlaxoSmithKline's four-strain Fluarix in preventing influenza infection or eliciting antibody responses.
- Alteogen signed an exclusive option and license agreement with Novartis for its hyaluronidase ALT-B4, with maximum payments reaching $3.223 billion if all options and milestones are achieved. - Novartis secured multiple options to develop and commercialize subcutaneous formulations of biopharmaceuticals using ALT-B4, choosing it over Halozyme's Enhanze platform. - ALT-B4's patent protection extends into the early 2040s, while Halozyme's core composition-of-matter patents expire between 2027 and 2029, reinforcing Alteogen's long-term exclusivity position.
- AstraZeneca's IL-33 inhibitor tozorakimab reduced moderate-to-severe COPD exacerbations by 29% in OBERON and 34% in TITANIA among former smokers versus placebo. - Across more than 2,300 randomized patients, exacerbation reductions reached roughly 30% and 29% in the overall trial populations including current smokers. - Benefit extended across blood eosinophil counts, including a 23% reduction below 150 cells/microliter, a subgroup where COPD biologics have historically underperformed. - The FDA accepted the biologics licence application under Priority Review with a PDUFA date expected in Q1 2027, while EU and China reviews are also underway.
- The ISS National Laboratory has surpassed 1,000 sponsored payloads delivered to the orbiting laboratory since August 2011, a milestone reached during NASA's Northrop Grumman Commercial Resupply Services 24 mission. - The space-based research program has generated more than 675 peer-reviewed publications, with over 20% appearing in top-tier journals, underscoring its scientific impact. - Global pharmaceutical companies including Merck & Co., AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, and Sanofi have leveraged microgravity to advance drug discovery, vaccine development, and drug-delivery technologies. - Startups using the ISS National Lab have raised nearly $3 billion in funding after completing their spaceflight projects, highlighting the platform's role as a commercialization incubator.
- The U.S. FDA granted Fast Track Designation to BV100, BioVersys' lead clinical asset, for treating VABP and HABP caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). - BV100 is a novel intravenous formulation of rifabutin that uses the siderophore pathway to target the RNA-polymerase enzyme in Gram-negative bacteria, offering a non-β-lactam therapy option. - The designation follows a Phase 2 study showing a 50% reduction in mortality versus best available therapy, with BV100 now in a pivotal Phase 3 trial (RIV-TARGET). - CRABC is a WHO priority-1 critical pathogen with mortality rates reaching 50% globally, underscoring the urgent unmet medical need for new antimicrobials.
