Member Profile
TaiRx, Inc.
Established in 2011, TaiRx, Inc. is focused on the development of new drugs which aim to cure severe diseases including cancer and sepsis. The product pipeline covers new chemical compound, innovative antibody and formulation improvement drugs. Several products are under development and entering clinical trials to ensure their safety and efficacy. In 2018, a new drug (Zelnite®) has been approved by TFDA and launched in Taiwan. With Taiwan as a home base, TaiRx has set up its US and China subsidiaries and recruited experts and experienced consultants in various fields worldwide. TaiRx adds value to the product line by rapidly moving the progress of drug products forward. TaiRx is committed to pursuing high quality and scientific excellence and establishing global collaboration and partnering with a goal to become a global drug development company.
Product Pipelines
Company Milestones
| 2011 | TaiRx, Inc. founded under strategic alliance between Formosa Laboratories and Efficient Pharma Corp. focusing on small molecule anti-cancer treatment with an initial. |
| 2014 | In accordance with the “Act For the Development Of Biotech And New Pharmaceuticals Industry” issued by the Ministry of Economic Affairs, CVM-1118 qualifies as a new chemical entity for anti-cancer treatment. |
| 2015 | TaiRx’s new cancer drug CVM-1118 approved by the US FDA to initiate Phase I clinical trial. |
| 2015 | TFDA approved the IND of the oral cancer drug CVM-1118 via Fast Track review to start Phase I clinical trial in Taiwan. |
| 2016 | Rexis® approved by TFDA to start Phase III multi-center clinical trial as an add-on therapy for Sepsis. |
| 2016 | TaiRx IPO approved by the Taipei Exchange. |
| 2017 | In-licensed from Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago for global development and market rights using Nodal as a new target for treatment and diagnosis of cancers. |
| 2018 | Zelnite® Solution for Injection received NDA approval from the Taiwan FDA. |
| 2018 | Oral cancer drug CVM-1118 received US FDA and TFDA approvals to start a multi-center phase II clinical trial in advanced hepatocellular carcinoma and a multi-center phase II clinical trial in advanced NET (Neuroendocrine tumors) cancer. |
| 2018 | TaiRx was approved by TFDA for Good Distribution Practice (GDP). |
| 2018 | TaiRx US, Inc., a new joint venture between TaiRx and BioHealth Innovation, established in Maryland, USA. |
| 2018 | TaiRx (Kunahan), Inc. established in China. |
| 2019 | TaiRx was approved by Ministry of Economic Affairs as an Innovative Enterprises. |
| 2020 | New extended-release(ER) form of CVM-1118 recieved TFDA approval to start Phase I dose-escalating study in advanced cancers in Taiwan. |
| 2020 | Market registration submission of Zelnite® Solution for Injection to China NMPA. |
| 2021 | TaiRx signed a cooperation agreement with Gongwin Biopharm Co., Ltd. for China market development to treat lung cancer with CVM-1118. |
| 2021 | Oral cancer drug CVM-1118 received US FDA and TFDA approvals to start a phase II clinical trial in combination with Nivolumab for unresectable advanced hepatocellular carcinoma. |
| 2022 | TaiRx’s sodium selenite pentahydrate SelenOne® awarded the Symbol of National Quality (SNQ) in 2022 for its affirmed safety and quality for use as a food additive. |
| 2022 | Oral cancer drug TRX-920 received US FDA approval to initiate Phase I clinical trial. |