Mycenax Biotech Inc.


Chairperson: Mr. Rong Jin Lin
President: Dr. Karen Wen
Est.: 2001/09/28 
Tel: +886-37-586988
Fax: +886-37-586188 
          Address: 2F, No. 8, Kedung 3 Rd., Jhunan Miaoli, Taiwan 35053
          Website: http://www.mycenax.com.tw/


 

Company Profile:

Mycenax Biotech Inc. (MBI) was established in 2001, located in Jhunan base, Hsinchu Science Park, Taiwan. MBI equipped itself a platform for developing and manufacturing biologics. The core competency of MBI is the strategy and execution of CMC (Chemical, Manufacturing and Controls) for biologics. In addition, MBI featured in utilizing the most advanced single-use technology in its USFDA DMF registered and TFDA cGMP certified biomanufacturing facility. Today, MBI installed and operated 2,000 L single use bioreactor, which is the largest one so far.

TuNEX®, MBI’s first in-house pipeline, is in phase III clinical trial, and MBI is in discussion with foreign companies for oversea development and marketing. More than TuNEX®, MBI is currently developing TuNEX’s liquid formulation and sustained release one. Based on its experience and capacity, MBI provided total solution and one-stop service to other developers or sponsors of biologics. MBI’s capacity covered the demand from bench to bed. MBI’s services encompassed clone, bank, process, production, product, and quality. In sum, MBI can provide optimized clone, characterized cell banks, process development, finished product (inclu. liquid in vial, lyophilized powder in vial, and liquid in prefilled syringe), blinding operation (labeling and packaging), and CMC writing for regulatory filing.

MBI has proven its capacity for planning and executing process development in a GMP-complaint, cost-effective, and time-efficient fashion, by passing IND and supplying clinical drug. In the near future, MBI will focus biobetters or bionovels as the target of development or co-development.

The goal of MBI is to be a competitive biopharmaceutical, based on international regulation and targeting global market.

Pipeline:

Item

Indication

Mechanism

Status

TuNEX®

Rheumatoid Arthritis

Inhibiting TNF binding to TNFR

TW PIII

GranNEX®

Neutropenia

Stimulating proliferation of neutrophil

TW IND