Investor Presentaiton
35
International Leading Capabilities on Manufacturing and Quality Management
Xuhui Site
24,000L
Songjiang
1st Plant
24,000L
Songjiang
2nd Plant
36.0001 +60,000
Manufacturing capacity optimization:
The scale of commercial GMP batches has
reached a new high
⚫ "Henlius Quality" with international
standard: obtained GMP certification from
China, the EU and PIC/S members
(Indonesia, Brazil)
⚫ Global expansion: Products available in
Europe, Australia, South America and
Southeast Asia
Continuous
Improvement
Increasing supply of HANQUYOU
(Trastuzumab): Over 100 batches in total,
manufacturing successful rate > 98%
Global GMP standards: completed Pre-
License Inspections (PLI) by FDA
Improving the laboratory infrastructure:
Strengthen downstream and formulation
process optimization and scale-up
capabilities
Aligned Quality
& Efficiency
O 2024 Henlius.
Plant construction for Phase I & II trials:
two main manufacturing buildings were
completed and accepted; the engineering
batch for the 2nd generation process of
HANSIZHUANG has completed; PFS
production line has been validated, ADC
manufacturing workshop has put into use
The improved application of stainless
steel equipment: Costs reduction by
process automation
Intelligent Drug
Manufacturing
2 HenliusView entire presentation