Core Insights - Novo Nordisk announced new data from the phase III FRONTIER clinical program for its investigational candidate, Mim8, as a prophylaxis treatment for hemophilia A, showing promising results in switching from Roche's Hemlibra treatment [1][2][4] Group 1: Study Results - The phase IIIb FRONTIER5 study indicated that switching from Hemlibra to Mim8 was well-tolerated with no safety issues reported in adults and adolescents, regardless of inhibitor status [2][4][7] - Patient-reported outcomes showed a strong preference for the Mim8 pen-injector, which was easier to use compared to the Hemlibra injection system, suggesting high potential for patient compliance [2][4] - Mim8 maintained clotting activity without adverse events or antibody detection, with no thromboembolic events or treatment-related adverse events leading to discontinuation [4][7] Group 2: Treatment Administration - Patients received their first Mim8 maintenance dose on the scheduled day of their next Hemlibra dose, with options for weekly, biweekly, or monthly dosing [6] - Steady-state levels of Mim8 were achieved by week 16, and Roche's Hemlibra was fully cleared by week 26, indicating a smooth transition [6] Group 3: Future Outlook - Novo Nordisk plans to submit Mim8 for regulatory review in 2025, with additional data from the phase III FRONTIER program expected in 2025 and 2026 [8] - Currently, Mim8 is not approved by regulatory authorities anywhere in the world [8] Group 4: Industry Context - Hemophilia A affects approximately 1.1 million people globally, with up to 30% of those with severe hemophilia A developing inhibitors that reduce the effectiveness of replacement therapies [9]

Japan Equity Research June 20, 2025 Pharmaceutical Sector Data Book – Valuation, Product Sales Trend Biotechnology & Pharmaceuticals/ Medical Technologies & Services Seiji Wakao, Ph.D. AC seiji.wakao@jpmorgan.com (81-3) 6736-8612 | | | | | P/E(x) | | | | | | P/B(x) | | | | | | EV/EBITDA(x) | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | FY25E | FY26E | FY27E | FY28E | FY29E | FY35E | FY25E | FY26E | FY27E | FY28E | FY29E ...

Core Insights - Roche announced positive phase I/II data for NXT007, a next-generation bispecific antibody for haemophilia A, supporting its progression to phase III clinical development [1][2] - NXT007 demonstrated a tolerable safety profile with no thromboembolic events reported, indicating its potential for haemostatic normalization in patients without factor VIII inhibitors [1][4] Company Overview - Roche has over 25 years of experience in developing medicines for blood diseases and is committed to advancing care for patients with haemophilia A [9] - The company aims to provide innovative treatment options, including NXT007, to enhance therapeutic choices and reduce treatment burdens for patients [2][6] Clinical Development - NXT007 is currently undergoing a robust clinical development program, with ongoing phase I/II trials and additional phase II data expected later this year [3] - Three phase III studies are planned for 2026, including a head-to-head study with Hemlibra, Roche's existing prophylactic treatment for haemophilia A [3][4] Product Details - NXT007 is engineered to optimize factor VIII-mimetic activity and enhance potency, efficacy, and administration convenience, aiming for sustained elevated bleed protection [6][5] - The clinical trials for NXT007 involve participants aged 12 to 65, with no treated bleeds observed in the highest dose cohorts [4][7] Market Context - Haemophilia A affects approximately 900,000 people globally, leading to significant health concerns due to uncontrolled bleeding [8][7] - The development of inhibitors to factor VIII replacement therapies presents a serious complication, highlighting the need for innovative treatments like NXT007 [8]