Qianjiang pharmaceutical and TnI company of the United States launched the new drug application of "Zhongzhu 1018" in China

On the evening of March 10, Hubei Qianjiang Pharmaceutical Co., Ltd., a subsidiary of China Pearl holdings, signed a supplementary cooperation agreement with TnI Biotechnology Co., Ltd (TnI company for short) Both parties confirm that: we will immediately start the basic and clinical trials of new drug application of "Zhongzhu 1018" in China, and Qianjiang pharmaceutical will inject start-up funds into the joint management account within one month after the supplementary agreement takes effect, At the same time, TnI company of the United States provides all research materials, data and achievements of "Zhongzhu 1018" in China for its registration and application in the United States The use of the funds in the joint management account is signed off by Qianjiang pharmaceutical and the authorized person of TnI company of the United States In the process of Qianjiang pharmaceutical's registration and application of new drugs in China, TnI company of the United States arranges research experts for technical guidance at any time, "Zhongzhu 1018" The latest research progress and achievements in the United States are shared with Qianjiang pharmaceutical without reservation and serve as the test basis for registration and application in China; when Qianjiang pharmaceutical applies for registration in China, the indications are the same as those in the United States; after obtaining the production approval, Qianjiang pharmaceutical is responsible for the production and sales of "Zhongzhu 1018" in mainland China "Zhongzhu 1018", a TnI company in the United States, has been used to treat pancreatic cancer in phase I and phase II clinical trials The FDA review meeting of the United States agreed that TnI company of the United States should develop freeze-dried dosage forms, take the form of intravenous injection, agree with the results of phase I and phase II clinical trials, agree to hold phase II clinical summary meeting again after the relevant pharmaceutical and pharmacological toxicology test data are supplemented and improved, and approve "Zhongzhu 1018" to conduct phase III clinical trials in the United States In October 2012, Qianjiang pharmaceutical, a subsidiary of China Pearl holdings, signed a cooperation agreement with TnI Biotechnology Co., Ltd (US) to jointly develop preclinical research on blood, bone marrow hematopoietic system cancer and cancer patients' immune recovery anticancer drugs In order to avoid risks, both parties agree to determine further cooperation after the US enters phase III clinical In principle, after TnI is admitted to phase III clinical practice, China and the United States will further promote phase III clinical practice in China In view of the cooperation agreement between China food and Drug Administration and FDA, the drugs approved by the us to enter phase III clinical will enjoy a green channel in China At present, the cooperation project between the two sides in China is still in the laboratory stage Previously, it was rumoured that once TnI bio obtained the approval of FDA's phase III plan for pancreatic cancer, TnI bio will give the final budget to Hubei Qianjiang pharmaceutical Under the agreement of both parties, Hubei Qianjiang pharmaceutical will be responsible for the preparation of the fund It is estimated that the cost of phase III plan will be 30 million to 40 million US dollars, and Hubei Qianjiang pharmaceutical will also get the exclusive franchise of the drug in China It is understood that TnI company has possessed the new drugs (including the intellectual property rights, patent technology and license currently possessed by "Zhongzhu 1018") for the treatment of cancer in blood and bone marrow hematopoietic system and the immune recovery of cancer patients, and obtained the results in preclinical stage, and has conducted preclinical research with Qianjiang pharmaceutical Zhongzhu holding said that the purpose of holding hands with TnI of the United States is to let Qianjiang pharmaceutical obtain the exclusive license of "Zhongzhu 1018" technology in China, and obtain the new drug certificate and production approval of "Zhongzhu 1018", a national first-class chemical, issued by China food and drug administration At the same time, the cooperation between the two sides is also conducive to strengthening the research and development of drugs and increasing the drug reserves of Qianjiang pharmaceutical