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China and the United States are expected to apply for listing! Yifan Pharmaceutical's Class 1 new drug F-627 Phase III clinical success in China

Release date: 2020-01-07 Views: 0

Source: Medical Rubik's Cube  

On January 6, Yifan Pharmaceutical announced the results of its Phase III clinical trial of recombinant human granulocyte colony-stimulating factor-Fc fusion protein (F-627) in the breed under development.

The results of this multi-center, randomized, open, and positive-control phase III clinical trial show that the effectiveness results of the F-627 China Phase III clinical trial have fully reached the clinical trial preset evaluation standards. Human granulocyte colony-stimulating factor) is equivalent. In addition, the overall safety of F-627 is good, and there are no significant differences in the incidence and severity of adverse events compared with the control drug. The adverse reactions associated with F-627 are mostly mild to moderate, indicating that F-627 has good safety. And tolerance. At the same time, the screening, confirmation and neutralizing antibody detection methods of this clinical trial were developed and validated in accordance with the latest FDA guidelines. The final results of this immunogenic neutralizing antibody test were negative.

Recombinant human granulocyte colony-stimulating factor (G-CSF) is a synthetic cytokine that promotes the production, release, or survival of neutrophils. Neutropenia is one of the most common dose-limiting toxicities in the chemotherapy of tumor patients. Therefore, G-CSF is often given to reduce the risk of infection, improve the compliance of chemotherapy, and avoid the decrease of chemotherapy drugs or the delay of treatment to reduce the clinical efficacy. G-CSF currently in clinical use includes short-acting G-CSF drugs used daily and long-acting G-CSF drugs used every chemotherapy cycle.

F-627 is an innovative biopharmaceutical product developed based on Shanghai Jiannenglong's existing Di-KineTM bi-molecular technology platform with independent intellectual property rights. Different from the existing recombinant human G-CSF, F-627 is a rhG-CSF dimer expressed by CHO cells based on Fc fusion protein technology and has long-lasting and potent biological characteristics. At present, it is mainly used for the treatment of granulocytopenia caused by tumor patients during radiotherapy and chemotherapy to prevent patients from dying from infection or other complications. It is a routine clinical treatment. Shanghai Jiannenglong launched F-627 Phase III clinical trials in China and the United States at the same time. It is also the first company in China to enter the US Phase II and Phase III clinical trials of innovative macromolecules.

According to IMS data statistics, G-CSF has a global market size of about 5 billion U.S. dollars in 2018. It is mainly based on PEGylated recombinant human granulocyte colony-stimulating factor developed by Amgen, namely Neulasta. 80% market share. According to statistics from Minnet.com, China's G-CSF has a market size of about 5 billion yuan in 2018.There are many companies producing short-acting G-CSF drugs and three Chinese companies' polyethylene glycol modified long-acting G-CSF drugs. However, so far no G-CSF produced by a Chinese company has been approved for sale in foreign markets.

F-627 has conducted pre-clinical and clinical stage studies in many countries around the world including China, the United States, and Europe. Among them, the first U.S. phase III clinical trial (04-program, controlled trial with placebo) has reached the main The clinical endpoint was obtained and the expected evaluation criteria were obtained; the second international phase III clinical trial (05 protocol, a controlled trial with the original research product, Neulasta), selected Amgen's Neulasta as a positive control drug for a head-to-head comparison test, and the protocol has been reached with the FDA The binding agreement agreed that Shanghai Jiannenglong will use this "special protocol evaluation" to carry out the second phase III clinical trial, and the trial has now entered the final visit stage.

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