Part of Ipsen SA
Clinical Trials
50
26 active
Approvals
3
Total approvals
Agencies
2
Regulatory bodies
Founded
2007
Active, not recruiting
26
52.0%
Completed
13
26.0%
No Longer Available
2
4.0%
Recruiting
2
4.0%
Terminated
5
10.0%
Withdrawn
2
4.0%
- 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.
- Adaptimmune's TECELRA (afamitresgene autoleucel) becomes the first engineered cell therapy approved in the U.S. for solid tumors, specifically targeting synovial sarcoma. - The approval represents the first new treatment option in over a decade for synovial sarcoma, a rare soft tissue cancer primarily affecting young adults. - Adaptimmune's second T cell therapy, lete-cel, achieved its primary endpoint in a pivotal Phase II trial for advanced synovial sarcoma and myxoid/round cell liposarcoma. - The company plans to submit a rolling Biologics License Application to the FDA by the end of 2025 for lete-cel, positioning for a potential second sarcoma approval.
- Hengrui Medicine's Zemetostat received conditional approval from China's NMPA, becoming the country's first EZH2 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma. - The drug demonstrated a 34% objective response rate in Phase II trials for patients with relapsed/refractory follicular lymphoma and EZH2 mutations, addressing a critical unmet medical need. - Hengrui's regulatory milestone positions the company to capture significant market share in the global EZH2 inhibitors market, projected to reach $9.59 billion by 2034. - The approval represents a strategic breakthrough for Hengrui's transition from generic drugs to innovative therapies, with innovative drug revenue accounting for 61% of total income.
- China's National Medical Products Administration (NMPA) has granted conditional approval to tazemetostat (Tazverik) for adult patients with relapsed or refractory EZH2-mutated follicular lymphoma who have received at least two prior systemic therapies. - Tazemetostat is the first and only EZH2 inhibitor approved in China, representing HUTCHMED's fourth approved product and its first in hematological malignancies, following previous approvals in the US and Japan. - The approval was supported by a Phase II bridging study in China and international clinical trials, with the ongoing SYMPHONY-1 trial serving as the confirmatory study to validate clinical benefits.
- China's National Medical Products Administration (NMPA) has conditionally approved Tazverik (tazemetostat) for adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation who have received at least two prior systemic therapies. - The approval marks the first nationwide regulatory approval for Tazverik in China, following its priority review status granted by the NMPA. - Hutchmed will handle the research, development, manufacturing and commercialization of Tazverik in mainland China, Macau, Taiwan and Hong Kong as part of a 2021 strategic collaboration with Epizyme.
