Two in-house drugs expecting approval in 2021, says TOT Biopharm

China’s TOT Biopharm International (HK: 1875) today announced its financials and provided a review of its clinical milestones and pipeline achievements.

Key milestones of pipeline products:

-- TAB008 (anti-VEGF MAb): Phase III clinical results were published. The clinical results show that TAB008 has similar efficacy, safety, immunogenicity and pharmacokinetics profiles with the brand-name formulation of bevacizumab. The new drug application under the new version of the Administrative Measures for Drug Registration was submitted, and was accepted by NMPA [China’s regulator]. in September 2020 (Pre-approval registration inspection was completed in January 2021). It is expected to be approved for marketing in 2021.

-- TAA013 (anti-HER2 ADC): It is the first T-DM1 ADC product entering Phase III clinical trial in China. The first participant was enrolled in July 2020. Clinical recruitment is progressing smoothly.

-- TAB014 (anti-VEGF MAb): Phase III clinical trial application (IND) was submitted to the Food and Drug Administration. Upon receiving FDA's approval, it would be exempted from the Phase II clinical trial and would directly carry out Phase III clinical trial (IND authorized by FDA in January 2021, and would directly carry out Phase III clinical trial).

-- TOZ309 (temozolomide capsule): Pre-approval registration inspection was completed, and it is expected to be approved for marketing in the first half of 2021.

Achieved multiple targets during the year