Celltrion started clinical trial phase 2b for comprehensive influenza antibody new drug CT-P27

- Influenza-infected subject’s efficacy and safety confirmation test ... Significant reduction of virus in the patient group in phase 2a - The flu vaccine can be produced and used immediately ... Innovative new drug prospect to replace Tamiflu if successful in development [Oct 12, 2016] Celltrion announced today that it has received approval by the Korean Ministry of Food and Drug Safety (MFDS) for the Phase 2b clinical trial of CT-P27, a comprehensive influenza antibody drug under development. CT-P27 is the first antibody drug developed by Celltrion. The study was conducted to assess the efficacy and safety of therapeutic agents after administration of CT-P27 to patients infected with influenza ‘A’. In Celltrion's phase 2a clinical trials, healthy subjects were injected with influenza virus, tested for infection, and administered a therapeutic drug. The results confirmed that the virus concentration in the body of CT-P27-administered group drastically decreased. Celltrion recruited patients with influenza ‘A’ infections to support participation in phase 2b clinical trials during the winter season, a high influenza incident rate season. The company plans to evaluate the efficacy and safety of the drug by collecting and analyzing CT-P27 and placebo in the target group, side effects, vital signs, electrocardiogram, and blood test results. CT-P27, developed by Celltrion, is a complex antibody treatment consisting of two antibodies. The antibody of CT-P27 binds to the stem part of hemagglutinin, the surface protein of the virus, to prevent the virus genome from penetrating into the cells. Since the axis of hemagglutinin is not mutated, CT-P27 is expected to have a therapeutic effect on most influenza, regardless of the mutation of the virus. Celltrion has already reported that in nonclinical and clinical trials conducted with the CDC in the US and Chinese government research institutes, CT-P27 has been shown to be effective against most influenza that has been transmitted to humans (H1, H2, H3, H5, H7 and H9), and it is anticipated that CT-P27 will replace existing drugs, such as Tamiflu. In general, it takes about six months or more to develop and produce a new vaccine that is effective when there is a new influenza is outbreak. For this reason, governments have been struggling with the initial treatment of the influenza epidemic. However, antibody therapy has the advantage that medicines can be stockpiled in advance to administer them immediately when there is a virus outbreak. If CT-P27 is commercialized, it will be an innovative anti-influenza drug that can be used worldwide. In the future, if CT-P27 is commercialized and selected as an antiseptic for government stockpile against a virus pandemic, the potential market size is expected to be considerable. Tamiflu and Relenza recorded sales of KRW 180 billion in Korea in 2009 when H1N1 influenza was prevalent. Roche sold more than KRW 3 trillion worldwide of Tamiflu in the same year. Celltrion Remsima exceeded cumulative export of KRW 1 trillion for the first time in the Korean pharmaceutical industry Celltrion Healthcare and Teva enters into exclusive business collaboration agreement for Truxima™ and Herzuma™ in the U.S. and Canada List

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