We have a pipeline of 12 drug candidates, which are under research and development toward the submission of NDAs or ANDAs. Development progress and key milestones differ in these two regulatory pathways.
The following chart summarizes the development status, as of the Latest Practicable Date, of each of the nine drug candidates for which an NDA is required to be submitted:
(1) NDA is applicable to the application of new drugs and Category 5.1 imported drugs.
(2) Core Product.
(3) TAB008 is a bevacizumab biosimilar. Bevacizumab has been approved for the treatment of nsNSCLC and mCRC in China. Additional indications of bevacizumab approved in the United States or the EU include glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer and breast cancer.
(4) TAB014 is an ophthalmic formulation of bevacizumab.
(5) We licensed out the right of commercialization in China, Hong Kong and Macau.
(6) Recombinant protein.
(1) See “Regulatory Overview — Relevant Laws and Regulations of the PRC — Examination and Approval of New Drug” for details of each category.
(2) ANDA is applicable to the application of generic drugs or Category 5.2 imported drugs.