Table 2 Characteristics of unmatched sample. Values are counts (percentages).

Approval class

 Initial approval

137(72.5%)

155(79.1%)

 New indication supplement

52(27.5%)

66(29.9%)

0.600^c

Registration class

 NDA

116(61.4%)

148(67.0%)

 BLA

73(38.6%)

73(33.0%)

0.238^c

FDA priority review

 Yes

151(79.9%)

99(44.8%)

 No

38(20.1%)

122(55.2%)

<0.01***^c

FDA orphan designation

 Yes

102(54.0%)

59(26.7%)

 No

87(46.0%)

162(73.3%)

<0.01***^c

FDA accelerated approval

 Yes

39(20.6%)

19(8.6%)

 No

150(72.4%)

202(91.4%)

<0.01***^c

FDA boxed warning at approval

0.3(0.03)

0.3(0.03)

 Yes

52(27.5%)

69(31.2%)

 No

137(72.5%)

152(68.8%)

0.412^c

Pivotal trial type

 Domestical trial

41(21.7%)

136(61.5%)

 Overseas trial

69(36.5%)

35(15.8%)

 Global trial enrolling China-based sites

79(41.8%)

50(22.6%)

<0.01***^c

Therapeutic area

 Cancers

93(49.2%)

61(27.6%)

 HIV/HCV

16(8.5%)

13(5.9%)

 Others

80(42.3%)

147(66.5%)

<0.01***^c

FDA review times, days, mean(SD)

278.7(20.3)

369.5(17.6)

<0.01***^d

Launch delay, days, mean(SD)

1385.7(96.8)

2118.8(115.3)

<0.01***^d

Submission delay, days, mean(SD)

1284.7(99.3)

1898.6(112.7)

<0.01***^d

NMPA review time, days, mean(SD)

379.7(13.4)

583.1(21.4)

<0.01***^d