|
Statement
| 1.Date of occurrence of the event:2022/03/11
2.Company name:TaiMed Biologics Inc.
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):head office
4.Reciprocal shareholding ratios: N/A
5.Cause of occurrence:
TaiMed Biologics (TaiMed) announced today that its board approved a plan to
expand its business model from biologic drug innovator to Contract
Development and Manufacturing Organization (CDMO).
In response to the international market demand for biologic drugs and
commissioning of its Zhubei cGMP production plant last year, TaiMed has the
capability and capacity to produce monoclonal antibodies meeting clients'
needs.
According to statistics from Global Information Inc., the market size of
biologic medicines is growing at a compound annual growth rate of 8.3%, and
is expected to reach a scale of US$394.2 billion in 2026. In the past two
years, the COVID-19 epidemic accelerated the trend, which boosted the global
demand for CDMO services. Considering this trend, TaiMed has decided to
enter the CDMO business.
Since its establishment in 2007, TaiMed has devoted itself as the developer
and manufacturer of innovative biologic drugs. The company successfully
developed a first-in-class anti-HIV antibody drug TMB-355 (trade name
Trogarzo) which the US FDA and EU EMA approved in 2018 and 2019,
respectively. Recently, TaiMed also completed a Phase 3 label extension
clinical program in the United States and submitted an sBLA marketing
application to the FDA at the end of last year. In addition, TaiMed has
additional novel antibody drugs in clinical trials in the United States.
In 2017, TaiMed invested US$35 million to construct a cGMP monoclonal
antibody manufacturing facility in Zhubei Biomedical Park in Taiwan. The
construction of the Zhubei Plant was completed last year, and the design
complies with the cGMP requirements of the US FDA, the EU EMA, and the
latest ICH guidances. The 60,000 square foot plant is equipped with
state-of-the-art cell culture bioreactors, purification skids, and
analytical instruments. The manufacturing capacity is one of the largest
in Taiwan.
TaiMed has more than 10 years of experience in monoclonal antibody
development and production and has successfully produced supplies from
this facility for clinical studies conducted in the United States. The
facility utilizes single-use technology to maximize manufacturing
flexibility cost-effectively. It is also equipped with qualified
single-use bioreactors at 200L to 2000L sizes, adequately sized AKTA
downstream purification systems, and UF/DF skids to handle production
needs. The available CDMO services include process development and
scale-up, analytical method development and validation, formulation
development, GLP/GMP production, and regulatory services. The preparation
of regulatory CMC documents is one of the strengths of TaiMed. Over the
years, TaiMed prepared multiple global IND and BLA regulatory filings.
TaiMed strives to provide customers with high-quality contract services
at a competitive cost.
6.Countermeasures:None
7.Any other matters that need to be specified:None
|
