Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 10

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 10
---
=13) n (%)
  
    CR
     
    1 (14.3)
     
    — 
     
    1 (7.1)
  
    PR
     
    1 (14.3)
     
    — 
     
    1 (7.1)
  
    SD
     
    5 (71.4)
     
    5 (83.3)
     
    10 (76.9)
  
    PD
     
    —
     
    1 (16.7)
     
    1 (7.1)
  
    ORR (%) [95% CI]
     
    28.6 [3.7 – 71.0]
     
    0.0 [0.0 – 45.9]
     
    15.4 [1.9 – 45.4]
  
    DCRR (%) [95% CI]
     
    100.0 [59.0 – 100.0]
     
    83.3 [35.9 – 99.6]
     
    92.3 [64.0 – 99.8]

Note: A hyphen (-) indicates no events were reported. n = number
of patients with an event; N = number of patients; NR = non-resectable. Percentages are based on the number of patients. CR = complete
response; PR = partial remission; SD = stable disease; PD = progressive disease; ORR = objective response rate (CR and PR);
DCR = disease control rate (CR, PR, and SD).

In this study, we assessed clinical response using several measures,
including progression-free survival (PFS) and overall survival (OS). PFS ranged from 9 to 366 days, with a median PFS of 0.8 months
in the 107 CFU dose group and 2.6 months in the 106 CFU dose group. OS ranged from 67 to 416 days,
with a median OS of greater than 14 months in the 106 CFU group and 7.6 months in the 107 CFU
group.

For the 3 patients who entered the prolongation phase, PFS ranged between