TNI BioTech and Hubei Qianjiang Pharmaceutical have collaborated to develop new cancer therapeutics.
The cancer drugs will be based on TNI BioTech’s patents involving Methionine Enkephalin, which when approved is expected to be marketed under the brand name IRT-101 and IRT-102 in China.
Methionine Enkephalin exhibited encouraging antitumor efficacy and a positive toxicity profile during Phase I and Phase II trials.
Hubei Qianjiang Pharmaceutical president Ye Jige said the alliance with TNI BioTech validates Hubei Qianjiang Pharmaceutical’s business model of co-developing novel compounds as therapies for Chinese markets with a US biotech company.
"The initiation of the pre-clinical trials for IRT-101 and IRT-102 in China is a significant achievement for the development of Hubei Qianjiang Pharmaceutical Co Ltd, and it represents both an important development milestone for this promising cancer drug and illustrates the benefits of Chinese and Western biopharmaceutical companies working together to efficiently carry out drug development," Jige said.
TNI BioTech will be responsible for pre-clinical and clinical trials in China meeting the FDA and SFDA standards while Hubei Qianjiang will provide around RMB 10m ($1.6m) for pre-clinical work.
The pre-clinical trials will evaluate the safety, tolerability and antitumor activity of Methionine Enkephalin.
After the completion of the pre-clinical studies, TNI BioTech will seek SFDA approval for clinical trials, which will be funded by Hubei Qianjiang.
TNI BioTech CEO Noreen Griffin said; "This agreement illustrates TNI BioTech’s ability to draw upon its patents to build alliances that help biopharmaceutical companies navigate the approval process of new therapies and further illustrates our strategy to maximize the potential of biopharmaceutical development and innovation for the benefit of patients and our shareholders."
Image: Hubei Qianjiang Pharmaceutical and TNI BioTech have signed co-development agreement. Photo: TNI BioTech.