Jul 12, 2017
Mycenax receive NDA approval for TuNEX from TFDA
Mycenax announced on 12 July 2017 that NDA for TuNEX from TFDA is approved. This is the first time for a Taiwan biotech company receive NDA for biologics, which marks a new milestone for Taiwan biopharmaceutical industry.
TuNEX is Mycenax’s lead product and alleviates the devastating inflammtory symptoms caused by rheumatoid arthritis (RA). TuNEX has shown statistical significance on the primary endpoint of efficacy. As the product owner of TuNEX, Mycenax have completed the development of development, pre-clinical trials including in vivo and in vitro efficacy trials, pharmacokinetics analysis and toxicology test, and phase I/II clinical trials in Taiwan in accordance with international regulations. In 2011 Mycenax have partnered with TSH Biopharm, for TSH to be responsible for phase III clinical trial and NDA submission. Based on the current strategy for TuNEX, TSH pharma is the partner for marketing and sales in Taiwan and China, Mycenax will be in charge of manufacturing TuNEX based on state-of-the-art technology under CMC guidance.
Chen Deli, Mycenax chairman noted that TuNEX is the first domestic biotech to develop its own biological drug. Mycenax holds the right of TuNEX for global market: In addition to the market in Taiwan, Mycenax have authorized TSH as exclusive distributor, and Mycenax have entered drug distribution agreement with OEP to explore the Southeast Asian market for TuNEX, there are possible partners are discussing the detail for cooperations in Latin America and other emerging markets. Furthermore, Mycenax is actively looking for licensees or co-developers who have capability of local trial management, and welcomes new business partnership.
In view of establishing a complete portfolio for RA, Mycenax expands and develops its pipelines to LusiNEX (reference medical product Actemra®/RoActemra®), a biosimilar acting as IL-6R antagonist. By binding IL-6R, it blocks the inflammatory response and alleviates joint erosion. The process development of LusiNEX has been completed and successfully scale-up to 2000L scales and aims to enter clinical study in the end of 2017. CTA/IND submission for LusiNEX in Europe and Taiwan are expected in 2017.
Source：Mycenax Biotech Inc.
http://www.mycenax.com.tw/en/news.php?act=view&no=27
TuNEX is Mycenax’s lead product and alleviates the devastating inflammtory symptoms caused by rheumatoid arthritis (RA). TuNEX has shown statistical significance on the primary endpoint of efficacy. As the product owner of TuNEX, Mycenax have completed the development of development, pre-clinical trials including in vivo and in vitro efficacy trials, pharmacokinetics analysis and toxicology test, and phase I/II clinical trials in Taiwan in accordance with international regulations. In 2011 Mycenax have partnered with TSH Biopharm, for TSH to be responsible for phase III clinical trial and NDA submission. Based on the current strategy for TuNEX, TSH pharma is the partner for marketing and sales in Taiwan and China, Mycenax will be in charge of manufacturing TuNEX based on state-of-the-art technology under CMC guidance.
Chen Deli, Mycenax chairman noted that TuNEX is the first domestic biotech to develop its own biological drug. Mycenax holds the right of TuNEX for global market: In addition to the market in Taiwan, Mycenax have authorized TSH as exclusive distributor, and Mycenax have entered drug distribution agreement with OEP to explore the Southeast Asian market for TuNEX, there are possible partners are discussing the detail for cooperations in Latin America and other emerging markets. Furthermore, Mycenax is actively looking for licensees or co-developers who have capability of local trial management, and welcomes new business partnership.
In view of establishing a complete portfolio for RA, Mycenax expands and develops its pipelines to LusiNEX (reference medical product Actemra®/RoActemra®), a biosimilar acting as IL-6R antagonist. By binding IL-6R, it blocks the inflammatory response and alleviates joint erosion. The process development of LusiNEX has been completed and successfully scale-up to 2000L scales and aims to enter clinical study in the end of 2017. CTA/IND submission for LusiNEX in Europe and Taiwan are expected in 2017.
Source：Mycenax Biotech Inc.
http://www.mycenax.com.tw/en/news.php?act=view&no=27