Cell Therapy

Seoul – October 18, 2026 -- XellSmart's off-the-shelf Parkinson's cell therapy XS411 improved OFF-state motor scores by an average of more than 30 points at six months in all nine Phase I participants, and its 30-patient Phase II trial in China has completed enrollment.

The data were presented at the International Congress of Parkinson's Disease and Movement Disorders (MDS). The company says the results showed no dose-limiting toxicities, serious adverse events or adverse events related to XS411.

Phase I data show motor and imaging gains in nine patients

The single-arm, open-label trial used a 3+3 dose-escalation design across three cohorts. Participants had moderate-to-advanced disease, a mean duration of about 10 years, end-of-dose wearing-off and OFF-state Hoehn-Yahr stages of 3 to 4. Cells were transplanted into the bilateral posterior putamen.

Shanghai – October 17, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to GT801, the lead in vivo CAR-T candidate of Vivacta Biotechnology (Shanghai) Co., Ltd., for autoimmune hemolytic anemia (AIHA). Vivacta Bio was spun out of Beijing Grit Biotherapeutics' in vivo CAR-T platform on June 25, 2025.

Designation opens tax credits, fee exemption and seven-year exclusivity

Sponsors of designated products may be eligible for tax credits on qualified clinical trial expenses and an exemption from marketing application user fees. They may also receive seven years of orphan drug market exclusivity after marketing approval, subject to applicable requirements.

Beijing – October 12, 2026 -- T-MAXIMUM PHARMACEUTICAL has received FDA clearance to start a Phase 2 study of MT027, its B7-H3-targeted allogeneic CAR-T therapy, in patients with brain metastases from lung and breast cancer. It is the second Phase 2 program for the asset to clear the agency.

MT027 now has two FDA-cleared Phase 2 programs in intracranial solid tumors

The FDA previously cleared a Phase 2 study of MT027 in recurrent glioblastoma. The therapy holds Orphan Drug Designation and Fast Track Designation. The two programs give T-MAXIMUM a dual-indication portfolio covering both primary and metastatic intracranial solid tumors.