Table 1.
Summary of anticancer drugs approved by the year of first approval in China.
| Year of first approval in China | 2005–2007 | 2008–2010 | 2011–2013 | 2014–2017 | 2018–2021∗ | Overall |
|---|---|---|---|---|---|---|
| Total number | 258 | 140 | 57 | 44 | 161 | 660 |
| Registration type, No. (%) | ||||||
| New drug | 13 (5.0%) | 7 (5.0%) | 7 (12.3%) | 13 (29.5%) | 54 (33.5%) | 94 |
| Generic | 241 (93.4%) | 130 (92.9%) | 50 (87.7%) | 31 (70.5%) | 99 (61.5%) | 551 |
| Modified new drug | 1 (0.4%) | 2 (1.4%) | 0 | 0 | 2 (1.2%) | 5 |
| Biosimilar | 3 (1.2%) | 1 (0.7%) | 0 | 0 | 6 (3.7%) | 10 |
| Drug type, No. (%) | ||||||
| Chemical | 250 (96.9%) | 137 (97.9%) | 57 (100.0%) | 44 (100.0%) | 140 (87.0%) | 628 |
| Biologicals |
8 (3.1%) |
3 (2.1%) |
0 |
0 |
21 (13.0%) |
32 |
| New drugs | ||||||
| MOA type, No. (%) | ||||||
| Cytotoxic | 5 (38.5%) | 3 (42.9%) | 2 (28.6%) | 2 (15.4%) | 5 (9.3%) | 17 |
| Targeted | 5 (38.5%) | 4 (57.1%) | 5 (71.4%) | 11 (84.6%) | 39 (72.2%) | 64 |
| Immuno-oncology | 1 (7.7%) | 0 | 0 | 0 | 8 (14.8%) | 9 |
| Miscellaneous | 2 (15.4%) | 0 | 0 | 0 | 2 (3.7%) | 4 |
| Drug origin, No. (%) | ||||||
| Domestic | 4 (30.8%) | 1 (14.3%) | 2 (28.6%) | 2 (15.4%) | 18 (33.3%) | 27 |
| Imported | 9 (69.2%) | 6 (85.7%) | 5 (71.4%) | 11 (84.6%) | 36 (66.7%) | 67 |
| NDA review length (months) |
14.8 (10.8–20.3) |
18.7 (17.5–25.6) |
17 (11.6–36.6) |
15.3 (10.6–25.6) |
12.5 (10.0–17.2) |
13.5 (11.2–20.0) |
| Generics | ||||||
| MOA type, No. (%) | ||||||
| Cytotoxic | 166 (68.9%) | 82 (63.1%) | 38 (76.0%) | 25 (80.6%) | 54 (54.5%) | 365 |
| Targeted | 11 (4.5%) | 4 (3.1%) | 7 (14.0%) | 2 (6.5%) | 40 (40.4%) | 64 |
| Immuno-oncology | 0 | 0 | 0 | 0 | 0 | 0 |
| Miscellaneous | 64 (26.6%) | 44 (33.8%) | 5 (10.0%) | 4 (12.9%) | 5 (5.1%) | 122 |
| Drug origin, No. (%) | ||||||
| Domestic | 237 (98.3%) | 127 (97.7%) | 49 (98.0%) | 29 (93.5%) | 94 (94.9%) | 536 |
| Imported | 4 (1.7%) | 3 (2.3%) | 1 (2.0%) | 2 (6.5%) | 5 (5.1%) | 15 |
| NDA review length (months) | 10.8 (8.5–13.9) | 35.0 (29.0–38.7) | 33.8 (22.7–44.2) | 38.4 (31.3–53.4) | 31.5 (22.1–57.0) | 22.2 (11.5–36.0) |
Note: MOA, mechanism of action; %, calculated by each period; NDA, new drug application. NDA review length and total development length are presented with median (IQR).
∗
Data until 31 May 2021 was included.