Yingqi Peng's questions to I-Mab (IMAB) leadership • Q4 2021
Question
Yingqi Peng asked for the latest update on the BLA submission for TJ202 (felzartamab) in China, questioning the difference between filing as an imported versus a domestic product and the expected timeline for completion.
Answer
Jingwu Zang, Founder, Chairman and Acting CEO, explained that the BLA submission for felzartamab was slightly delayed for two reasons. First, the company is in discussions with China's CDE regarding a new conditional approval policy. Second, they decided to submit a new BLA package that includes a localized manufacturing plan to significantly reduce costs and enhance commercial competitiveness. Dr. Zang stated they hope to submit the new BLA package soon within 2022.