Clinical Trials
52
9 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
8
15.4%
Completed
23
44.2%
No Longer Available
1
1.9%
Not yet recruiting
1
1.9%
Recruiting
10
19.2%
Terminated
7
13.5%
Withdrawn
2
3.9%
No approval data available
- 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.
- China's NMPA has approved the combination of sintilimab (TYVYT®) and fruquintinib (ELUNATE®) for second-line treatment of locally advanced or metastatic renal cell carcinoma patients who failed prior VEGFR-TKI therapy. - The FRUSICA-2 Phase III trial demonstrated a 63% reduction in disease progression risk, with median progression-free survival extending to 22.2 months versus 6.9 months for standard therapy. - This approval marks the 10th indication for sintilimab and addresses critical unmet medical needs in China's advanced renal cell carcinoma treatment landscape.
- HUTCHMED's sovleplenib, a novel oral Syk inhibitor, has received priority review and breakthrough therapy designation from China's NMPA for treating warm antibody autoimmune hemolytic anemia. - The NDA submission is supported by positive Phase III data showing the drug met its primary endpoint of durable hemoglobin response in patients with wAIHA who failed prior treatments. - Phase II results published in The Lancet Haematology demonstrated a 43.8% overall response rate versus 0% for placebo in the first 8 weeks, with 66.7% response during 24 weeks of treatment. - This represents the second indication for sovleplenib, following its development for immune thrombocytopenia, highlighting the drug's potential across multiple hematological conditions.
- HUTCHMED's Phase III ESLIM-02 trial of sovleplenib successfully met its primary endpoint of durable hemoglobin response rate in adult patients with warm antibody autoimmune hemolytic anemia in China. - The novel spleen tyrosine kinase inhibitor demonstrated rapid and durable responses in wAIHA, the most common form of autoimmune hemolytic anemia accounting for 75-80% of adult cases. - HUTCHMED plans to submit a New Drug Application to China's NMPA in the first half of 2026, marking a potential breakthrough for patients with limited treatment options. - The drug targets Syk, a key component in B-cell receptor and Fc receptor signaling, addressing the pathogenic mechanism of antibody-mediated red blood cell destruction in wAIHA.
- Hutchmed's HMPL-A251 represents the first antibody-targeted therapy conjugate (ATTC) to enter clinical development, targeting HER2 with a PI3K/PIKK inhibitor payload instead of traditional cytotoxic agents. - The Phase I/IIa trial will recruit 147 patients across 11 sites in the USA and China, with preclinical data showing superior or comparable efficacy to Enhertu in multiple tumor models. - Hutchmed plans to advance two additional ATTC candidates into clinical development within the next year, with HMPL-A580 expected in the first half of 2026 and HMPL-A830 in the second half. - The ATTC platform aims to address safety concerns associated with cytotoxic ADC payloads while potentially enhancing efficacy through targeted delivery of small-molecule inhibitors directly to tumor cells.
- HUTCHMED announced that three of its oncology drugs—ELUNATE, ORPATHYS, and SULANDA—will maintain coverage on China's National Reimbursement Drug List starting January 1, 2026. - TAZVERIK becomes the first drug included in China's newly established Commercial Insurance Drug List, expanding access for patients with relapsed or refractory follicular lymphoma. - The multi-layered reimbursement framework enhances patient access to innovative cancer treatments while supporting China's pharmaceutical innovation sector development. - China's basic medical insurance now covers 1.33 billion people, representing approximately 95% of the population, creating significant market access opportunities for approved therapies.
- DelveInsight's analysis reveals a robust acute myeloid leukemia pipeline with over 100 companies actively developing 150+ therapeutic candidates across various clinical stages. - Recent regulatory milestones include FDA approval of KOMZIFTI (ziftomenib) for relapsed/refractory NPM1-mutated AML and priority review acceptance for revumenib, both representing first-in-class menin inhibitors. - The pipeline features diverse therapeutic approaches including targeted therapies like isocitrate dehydrogenase inhibitors, immunotherapies, and novel mechanisms of action addressing unmet medical needs in this aggressive blood cancer.
- Merck KGaA appointed Kai Beckmann as CEO following Belén Garijo's departure after 15 years with the company, while also naming David Weinreich as global head of R&D and chief medical officer. - GSK concluded Emma Walmsley's eight-year tenure as CEO, appointing Luke Miels as her successor, who brings extensive experience from leadership roles at AstraZeneca, Roche, and Sanofi-Aventis. - The pharmaceutical industry experienced widespread executive changes across biotech companies, with multiple CEO transitions and senior leadership appointments spanning oncology, regenerative medicine, and rare disease therapeutics. - Major pharmaceutical companies including Sanofi and Bristol Myers Squibb strengthened their leadership teams with new chief medical officers and oncology medical affairs heads.
- HUTCHMED presented preclinical data for HMPL-A251, a first-in-class PI3K/AKT/mTOR-HER2 Antibody-Targeted Therapy Conjugate that demonstrated superior or comparable efficacy to trastuzumab deruxtecan in most tested models. - The novel ATTC platform addresses limitations of traditional toxin-based ADCs by combining selective PI3K/PIKK inhibition with precise HER2 targeting, achieving potent antitumor effects while maintaining a favorable safety profile. - HMPL-A251 showed robust antitumor activity across 130 tumor cell lines with synergistic and bystander killing effects, and plasma exposure of free payload was significantly lower with a mass ratio of less than 1:500,000. - The company plans to initiate global clinical trials for HMPL-A251 around the end of 2025, followed by multiple global IND filings for additional ATTC candidates in 2026.
- HUTCHMED will present updated clinical data for savolitinib, a selective MET tyrosine kinase inhibitor, at the 2025 World Conference on Lung Cancer, including results from SACHI, SAVANNAH, and Phase IIIb studies in non-small cell lung cancer patients. - The company will showcase first-in-human Phase I data for HMPL-653, a novel CSF-1R inhibitor for tenosynovial giant cell tumor, at the Chinese Society of Clinical Oncology Annual Meeting 2025. - Multiple investigator-initiated studies will be presented featuring fruquintinib and surufatinib combination therapies across various cancer types including colorectal, pancreatic, and biliary tract cancers. - The presentations span two major conferences from September 6-14, 2025, highlighting HUTCHMED's diverse oncology pipeline and collaborative research efforts.
