Immunogenicity
The immunogenicity analysis set included a total of 87 subjects. Among the 44 subjects in the test drug group, only 1 subject (random number 039) tested positive for ADA on day 71. The test results of this subject at other time points and the other 43 subjects were tested negative. Two of the 43 subjects in the reference group (random numbers 005 and 051) tested positive for ADA (005 on day 29 and 051 on day 43). The test results of these 2 subjects at the remaining time points and the test results of the other 41 subjects at all time points were negative. In the three cases above, the titers corresponding to positive ADA test results were all 1:50, and the corresponding NAb results were negative. In both treatment groups, the incidence of ADA was low, and subjects with positive ADA had little effect on overall PK parameters.