Tonghua Dongbao Protamine Recombinant Human Insulin mixed injection Ganshulin R40 (40 / 60) obtained the approval of new drug

As the first product of this specification in the domestic insulin market, it not only marks the strong rise of domestic brands in the insulin market, but also the company will soon put this product on the market The company expects that the market sales volume of Ganshulin 40R is expected to exceed 50R In addition to Gan Shulin R40, many of Tonghua Dongbao's biopharmaceutical products are in clinical use or about to be put on the market At present, Tonghua Dongbao has formed two R & D platforms, the company headquarters and Xiamen Tebao At the end of last year, Xiamen Tebao was identified as the "first group of national intellectual property advantage enterprises" At present, there are 8 first-class biopharmaceutical varieties in Xiamen Tebao, which are in clinical practice or will end clinical practice Among them, the third phase clinical study of y-pegylated recombinant interferon chronic hepatitis C has been completed, and the new drug production application was submitted in December last year, and it can be put on the market after being approved The third phase of chronic hepatitis B with y-pegylated interferon A2B approved in December 2012 is nearly over In addition, y-pegylated recombinant human interferon A2B injection is in the third phase of clinical research; y-pegylated recombinant human interferon A2A injection is in the second phase of clinical research; y-pegylated recombinant human granulocyte stimulating factor injection is in the second phase of clinical research; y-pegylated recombinant human long hormone injection is in the second phase of clinical research At present, only Roche produces y-pegylated recombinant human interferon for the treatment of hepatitis B and C in the world, with a price of more than 1000 RMB each Xiamen Tebao is expected to become the second manufacturer in the world At the same time, y-pegylated recombinant human interferon A2B is not only an exclusive patent in China, but also a European patent authorization, and has been approved by FDA to synchronize clinical practice in the United States, and the special technology has been exclusively authorized by the world Tonghua has become the research and development base of human insulin In addition to the second-generation insulin, the company's R & D team has mastered the structure of the third-generation insulin, i.e insulin analog The company's executives said recently that the existing human insulin companies in the market can develop and produce, and are currently focusing on the research of the four most cutting-edge analogues, namely, insulin glargine API, injection (changshulin), asparagus API, injection (ruishulin), insulin Di te (pingsulin), and insulin Lai Pro (Shulin), with a total of 20 specifications Process study According to the new drug application status of the State Food and drug administration, the six specifications of insulin glargine API, injection, aspartic insulin API and injection declared by the company are under review, and relevant testing has been carried out.