Table 4. Mean changes in peripheral CD19+ and CD20+ B lymphocyte following HLX01 and reference rituximab administration (phase 1b study).
| Time point | Statistics | CD19+ B cell (count/µL) | CD20+ B cell (count/µL) | |||
| HLX01 (N=43) | Reference rituximab (N=43) | HLX01 (N=43) | Reference rituximab (N=43) | |||
| Reference rituximab was sourced from China (MabThera®; rituximab-CN); 375 mg/m2 of HLX01 or reference rituximab was administered. | ||||||
| Baseline | n (miss) | 43 (0) | 42 (1) | 43 (0) | 42 (1) | |
| Mean | 114.7 | 132.8 | 112.0 | 132.7 | ||
| Median | 55.0 | 94.6 | 54.0 | 96.5 | ||
| Min, Max | 0.1, 591.1 | 0.1, 632.7 | 0, 522.9 | 0, 629.1 | ||
| 5 min after infusion | n (miss) | 43 (0) | 42 (1) | 43 (0) | 42 (1) | |
| Mean | 1.8 | 0.9 | 0.1 | 0.1 | ||
| Median | 0.3 | 0.7 | 0.0 | 0.1 | ||
| Min, Max | 0, 32.3 | 0, 4.1 | 0, 0.7 | 0, 0.6 | ||
| 24 h after infusion | n (miss) | 43 (0) | 42 (1) | 43 (0) | 42 (1) | |
| Mean | 1.5 | 1.4 | 0.1 | 0.1 | ||
| Median | 0.6 | 1.0 | 0.0 | 0.0 | ||
| Min, Max | 0, 17.5 | 0, 6.4 | 0, 0.3 | 0, 0.7 | ||
| 14 d after infusion | n (miss) | 42 (1) | 42 (1) | 42 (1) | 42 (1) | |
| Mean | 0.6 | 0.6 | 0.1 | 0.1 | ||
| Median | 0.4 | 0.3 | 0.0 | 0.1 | ||
| Min, Max | 0, 4.6 | 0, 5.5 | 0, 0.7 | 0, 0.8 | ||
| 56 d after infusion | n (miss) | 42 (1) | 42 (1) | 42 (1) | 42 (1) | |
| Mean | 2.0 | 0.5 | 1.7 | 0.3 | ||
| Median | 0.4 | 0.3 | 0.2 | 0.2 | ||
| Min, Max | 0, 58.4 | 0, 2.9 | 0, 59.0 | 0, 1.1 | ||
| 91 d after infusion | n (miss) | 42 (1) | 42 (1) | 42 (1) | 42 (1) | |
| Mean | 4.2 | 1.2 | 4.1 | 1.0 | ||
| Median | 0.3 | 0.3 | 0.3 | 0.2 | ||
| Min, Max | 0, 142.4 | 0, 34.1 | 0, 142.4 | 0, 34.1 | ||