On October 18, 2012 TNI BioTech and Hubei Qianjiang Pharmaceutical reported an agreement to co- develop new cancer drugs based on TNI BioTech’s patents involving Methionine Enkephalin which when approved will be marketed in China under the band name IRT-101 and IRT-102 (Press release TNI BioTech, OCT 18, 2012, View Source [SID:1234501361]).
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Under the Supervision of Dr. Ronald Herberman, Chief Medial Officer, and Professor Fengping Shan, Chief Science Officer, TNI BioTech, Inc. will maintain oversight responsibility for pre-clinical and clinical trials in China complying with both FDA and SFDA standards. The companies believe this joint development will fast track the drugs for the Chinese pharmaceutical markets.
Hubei Qianjiang Pharmaceutical Co., Ltd., has committed a minimum of 10 million yuan, approximately $1,600,000 dollars, for pre-clinical work. The pre-clinical trials, designed to assess safety, tolerability and antitumor activity of Methionine Enkephalin, are required in China as Methionine Enkephalin is a new drug.
Once the companies complete pre-clinical studies, TNI BioTech, Inc. will apply for clinical trials with SFDA. Hubei Qianjiang Pharmaceutical Co., Ltd.will provide the funding for clinical trials in China to have Methionine Enkephalin approved as a new drug for the treatment of cancer. Methionine Enkephalin potential in fighting cancer was identified in completed Phase I and early phase II trials in the United States. During Phase I and Phase II trials, Methionine Enkephalin exhibited encouraging antitumor efficacy and a favorable toxicity profile.
"This alliance with TNI BioTech validates Hubei Qianjiang Pharmaceutical Co., Ltd.’s business model of co-developing novel compounds as therapies for Chinese markets," in conjunction with a U.S. biotech company" said Mr. Ye Jige, President of Hubei Qianjiang Pharmaceutical Co., Ltd. "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. This important step will expedite the clinical development process of IRT-101 and IRT-102 in China".
Noreen Griffin, CEO of TNI BioTech, at the signing ceremony in Qianjiang China 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."