相关临床试验
151
140 进行中
药物批准
44
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
137
90.7%
已完成
3
2.0%
尚未招募
3
2.0%
招募中
8
5.3%
- The EMA's CHMP recommended approval of intravenous Ocrevus (ocrelizumab) for patients aged 10 years and older with relapsing forms of multiple sclerosis. - The positive opinion rests on the Phase 3 OPERETTA 2 trial, which tested Ocrevus against fingolimod, the current standard treatment for pediatric MS. - Ocrevus was non-inferior to fingolimod on relapse control and cut relapse risk by 48%, with 48% fewer new or enlarging T2 lesions. - The safety profile in children and adolescents matched the established adult profile, and no OPERETTA 2 participants discontinued treatment for adverse events.
- Roche will pay Dualitas Therapeutics $36.5 million upfront under a research collaboration and license agreement to discover novel bispecific antibodies for immunology and inflammation diseases. - Dualitas will use its DualScreen Bispecific Discovery Engine to functionally screen more than 300,000 novel bispecific combinations, described as one of the largest-scale bispecific discovery endeavors. - The deal carries research, development and commercial milestone payments plus tiered royalties, for a potential total value of up to $1 billion, with Roche handling all later development. - Dualitas' lead internal program DTX-102 for rheumatoid arthritis is expected to enter the clinic in 2027, alongside DTX-103 in allergic disease and DTX-101 in dermatologic and gastrointestinal autoimmune disease.
- Genentech reported that Lunsumio plus lenalidomide significantly improved progression-free survival versus rituximab plus lenalidomide in relapsed or refractory follicular lymphoma. - The Phase III CELESTIMO trial met its primary endpoint at interim analysis, showing a statistically significant and clinically meaningful reduction in disease progression risk. - CELESTIMO is a confirmatory study intended to convert Lunsumio's accelerated third-line approval to full approval and secure a second-line or later indication. - Overall survival data were immature, no new safety signals emerged, and full results including the hazard ratio are awaited at an upcoming medical meeting.
- Novo Nordisk has entered a collaboration with Anthropic to apply artificial intelligence across its drug discovery and development workflows, with no financial terms disclosed. - The Danish drugmaker will initially test Anthropic's Claude Science on selected R&D workflows where the partners expect the greatest scientific impact. - Novo will also use Anthropic's frontier models to strengthen AI-driven software development, which it calls a key enabler for scaling AI company-wide. - The deal extends Novo's 2026 AI partnerships, following agreements with OpenAI in April and Amazon Web Services in August.
- 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.
- Interim results from the randomized phase III TAISHAN-302 trial show Tam-Peli reduced the risk of death by 54% versus topotecan in relapsed small-cell lung cancer. - Median overall survival reached 13.3 months with Tam-Peli versus 9.4 months with topotecan, with median progression-free survival of 7.4 versus 2.8 months. - Grade 3 or higher treatment-related adverse events occurred in 46.4% of Tam-Peli patients versus 74.7% of those receiving topotecan. - The B7-H3-targeting antibody-drug conjugate is the second positive phase III readout for Tam-Peli, following the TAISHAN-301 trial in nasopharyngeal carcinoma.
- The FDA approved Isembyld (apitegromab-mstn) for SMA patients aged two and older already receiving an SMN2-targeted therapy, marking Scholar Rock's first product approval. - Isembyld is the first and only muscle-targeted SMA therapy, blocking myostatin activation to increase muscle mass and strength rather than targeting motor neurons. - In the Phase 3 SAPPHIRE trial, Isembyld produced a statistically significant 2.2-point HFMSE motor function improvement over placebo after 52 weeks of treatment. - The approval follows a prior complete response letter tied to manufacturing compliance issues, and Scholar Rock plans European and Japanese filings plus development in FSHD and obesity-related muscle loss.
- The FDA extended its review of Exelixis' NDA for zanzalintinib plus atezolizumab in metastatic colorectal cancer by three months, setting a new PDUFA date of March 3, 2027. - The extension followed Exelixis' submission of updated safety and efficacy data in response to an FDA information request, which the agency classified as a major amendment. - The filing is based on the Phase 3 STELLAR-303 trial, where the combination reduced the risk of death by 20% versus regorafenib in the intent-to-treat population. - William Blair said the rejection risk remains low given the overall survival benefit, though a second pre-specified analysis in patients without liver metastases missed statistical significance.
- Amgen's phase III DeLLphi-305 trial met its primary overall survival endpoint for tarlatamab plus durvalumab versus durvalumab alone as first-line maintenance in extensive-stage small-cell lung cancer. - The 563-patient randomized study enrolled patients whose disease had not progressed after induction with durvalumab, platinum chemotherapy and etoposide, with PFS and ORR also significantly improved. - No numerical survival data, hazard ratios or safety tables were disclosed, and the full dataset is slated for presentation at an upcoming medical meeting and regulatory submission. - Tarlatamab, a DLL3-directed bispecific T-cell engager already approved in second-line ES-SCLC, could move earlier into the maintenance setting if the benefit is confirmed.
- Teitur Trophics reported positive Phase I results for TT-P34, a first-in-class neuroprotective peptide tested in 55 healthy volunteers and 12 patients with early-stage Parkinson's disease. - Once-weekly subcutaneous dosing was well tolerated at all levels tested with no dose-limiting findings, and pharmacokinetics confirmed dose-dependent exposure in the brain and central nervous system. - Early biomarker signals were consistent with lysosomal pathway engagement, supporting a planned Phase II trial in Parkinson's disease patients in 2027. - Teitur is now raising a Series B round to fund the Phase II study, which will explore TT-P34's therapeutic benefit and disease-modifying potential.
