Satralizumab

Core revenue, core operating profit, and core net income at ¥552.9 billion (-4.6%), ¥262.8 billion (+13.3%), and ¥189.5 billion (+10.6%), respectively (all changes year-on-year) Excluding Ronapreve’s temporary impact, which its supply to the government has completed last year, both revenue and profit increased. Solid growth in the core business, including good progress in export to Roche Steady progress in R&D activities for both early and late-stage development of in-house products PiaSky has been launched in Japan for the first time in the world Alecensa has been approved in Europe and China for adjuvant treatment of ALK-positive non-small cell lung cancer Initiation of new clinical studies for early-stage development projects, GYM329 and DONQ52 TOKYO, July 25, 2024 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its financial results for the second quarter (interim results) of fiscal year 2024. “In the interim period of 2024, revenue decreased year-on-year while profit grew. Although the temporary impact of the COVID-19 treatment Ronapreve®, for which its supply to the government had been completed last year, remained significant, profit increased steadily due to solid business momentum. In Japan, sales of new products Phesgo® and Vabysmo® and a mainstay product Actemra® grew, however, impacted by Ronapreve, NHI drug price revision, and the market penetration of biosimilars, domestic sales decreased by 30.7%. Overseas sales increased by 28.2%, with the substantial increase in exports of Hemlibra® outweighing the decrease in Actemra exports. In research and development, PiaSky® was launched in Japan ahead of other countries, followed by approval in the United States, and recommendation for approval in Europe. In addition, Alecensa® received approval for an additional indication in Europe and China following the approval in the United States as a post-operative adjuvant therapy for ALK-positive non-small cell lung cancer, and has started to contribute to the treatment of patients. Early development also advanced, including the initiation of new clinical trials such as GYM329 for obesity and DONQ52 for celiac disease. Also, under the alliance with Roche, we have started new clinical trials, making progress in research and development in order to provide value to patients. Regarding our growth strategy “TOP I 2030,” the initially planned initiatives have generally been progressing smoothly over the past three years. On the other hand, we recognize the need for further efforts in light of overall progress and changes in the business environment. We reconfirmed the path to achieve our challenging goals of “Double R&D output” and “Launch global in-house products every year” in 2030, and refined the details of the reforms. We will continue our efforts to realize the reforms and ensure achievement of our goals, aiming to become a top innovator,” said Dr. Osamu Okuda, Chugai’s President and CEO. Chugai reported decreased revenue and increased operating profit year-on-year for the second quarter (interim period, Core-basis). Regarding revenue, domestic sales decreased by 30.7% year-on-year. In the oncology field, although mature products such as Avastin® were impacted by the NHI drug price revision and biosimilars, the overall decrease was 6.1% contributed by growth of new product Phesgo. In the specialty field, sales decreased by 47.4%, mainly due to continued impact of the completion of Ronapreve supply to the government, which recorded ¥81.2 billion last year, while our new product Vabysmo, mainstay products including Actemra, Evrysdi®, Enspryng® performed well. Overseas sales increased by 28.2% year-on-year, greatly exceeding the same period last year, which was contributed by the increase in Hemlibra export which grew by 54.6% year-on-year. Other revenue increased by 18.9%, driven by the increase in Hemlibra related income and one-time income. Cost to sales ratio improved by 13.3 percentage points year-on-year to 33.0%, mainly due to a change in the product mix. Research and development expenses increased mainly due to investments into drug discovery and early development, and increases associated with the progress of development projects. Selling, general and administration expenses increased by 3.6% due mainly to foreign exchange rate fluctuations and an increase in the enterprise tax (pro forma standard taxation). Other operating income (expense) was ¥0.8 billion in income. As a result, Core operating profit totaled ¥262.8 billion (+13.3%). In addition, we refined our growth strategy TOP I 2030 launched in 2021. The initiatives we initially envisioned are steadily progressing. Given that this is a 10-year long-term strategy, we have reviewed progress over the past three years, current environmental changes and other factors, and reconfirmed the path toward our 2030 goals for the purpose of achieving our challenging goals with greater certainty. Specifically, we have updated the five reforms (Drug Discovery, Development, Pharmaceutical Technology, Value Delivery, and Foundation for Growth) and the mid-term milestones. To achieve the challenging goals of “Double R&D output” and “Launch global in-house products every year” set forth in TOP I 2030, each employee will strive to take the transformations as their own issue and to steadily make changes, in order to contribute to patients. Chugai also made good progress in research and development, both in the early and late stages of developments, particularly in maximizing the value of in-house developed products and mainstay products. For in-house products, PiaSky, an anti-complement (C5) Recycling antibody, has been launched in Japan for a rare disease paroxysmal nocturnal hemoglobinuria (PNH), for the first time in the world. This marks the second launch in Japan of an antibody drug applying Chugai's proprietary Recycling Antibody® technology. PiaSky has been approved in the U.S., and received a recommendation for approval from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in EU. Also, the drug is undergoing review by other regulatory authorities including Taiwan. In addition, the anti-IL-31RA, a humanized monoclonal antibody Mitchga®(generic name: nemolizumab), has been launched in a new formulation in Japan by Maruho, the domestic out-licensing partner of nemolizumab, for the new indication of pruritus associated with atopic dermatitis in children and prurigo nodularis in adults and children. Furthermore, Alecensa has been granted additional indication in Europe and China following the U.S. for adjuvant treatment of ALK-positive non-small cell lung cancer. Additionally, rolling submission to the U.S. Food and Drug Administration (FDA) was initiated for the combination therapy of avutometinib, a RAF/MEK clamp being developed by Verastem Oncology, and defactinib, a selective FAK inhibitor, for the treatment of recurrent KRAS mutant low-grade serous ovarian cancer. In early development, a phase I clinical trial for the latent myostatin-sweeping antibody GYM329 has been initiated the treatment of obesity. A Phase Ic clinical trial has been initiated for the multi-specific antibody DONQ52 to evaluate its suppressive effect on the immune response induced by wheat intake in patients with celiac disease. For projects in-licensed from Roche, a new Phase III clinical trial has been initiated for RG6299 in IgA nephropathy, and a new Phase I/II clinical trial has been initiated for zilebesiran in hypertension. [2024 second quarter (interim) results] [Sales breakdown] [Oncology field (Domestic) Top5-selling medicines] [Specialty field (Domestic) Top5-selling medicines plus Ronapreve] *Ronapreve has not been listed in the National Health Insurance (NHI) price list. [Progress in R&D activities from Apr 25th, 2024 to Jul 25th, 2024] About Core results Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders. Trademarks used or mentioned in this release are protected by law. [PDF 647KB] Back

In neuromyelitis optica spectrum disorder, Ultomiris’ current competitors include Roche’s Enspryng and Amgen’s Uplizna. (AstraZeneca) Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well. The FDA has cleared Ultomiris for patients with anti-AQP4 antibody-positive NMOSD, which by AZ’s estimates constitutes about 75% of all NMOSD cases. Compared with Soliris, Ultomiris reduces the dosing frequency from biweekly infusions to once every eight weeks during the maintenance phase. AZ has been hoping that Ultomiris’ long-acting nature could help it reach more patients with various autoimmune diseases. The NMOSD nod came later than expected. The FDA first rejected Ultomiris in the indication in September, requesting AZ to modify the design of a mandated safety monitoring program known as a Risk Evaluation and Mitigation Strategy. In NMOSD, Ultomiris’ current competitors include Roche’s Enspryng, a once-monthly injection that can be self-administered; and Amgen’s Uplizna, which is an infusion that can be given every six months. NMOSD is a rare chronic autoimmune disorder of the central nervous system affecting about 200,000 people worldwide. It’s more common in women beginning in their 30s and 40s. Ultomiris proved its worth in NMOSD in the phase 3 CHAMPION-NMOSD trial. In the study, no patients experienced an adjudicated relapse by the time the last enrolled participant completed their 50-week visit, or after a median treatment duration of 73 weeks. Compared to external control, Ultomiris led to a 98.6% reduction in the risk of relapse. By comparison, 89% of anti-AQP4 antibody-positive patients who took Amgen’s Uplizna in the N-MOmentum trial remained relapse-free during a six-month period. For Roche’s Enspryng, the relapse-free rate at 96 weeks was 76.5% in the SAKuraStar monotherapy study and 91.1% in the SAkuraSky study, in which patients also received baseline immunosuppressant therapy. With Ultomiris, AZ now offers a treatment option that has the potential to eliminate relapses with a dosing schedule every eight weeks, Marc Dunoyer, CEO of AZ’s Alexion rare disease unit, said in a statement Monday. First approved by the FDA in late 2018, Ultomiris is also allowed in multiple other autoimmune diseases, including generalized myasthenia gravis (gMG) thanks to a 2022 approval. Roche last week just reported a positive phase 3 trial for Enspryng in gMG but said the size of clinical benefit didn’t meet the company’s expectations. With just the NMOSD label, Enspryng brought Roche 256 Swiss francs ($285 million) in sales in 2023. And Uplizna, a key asset that Amgen brought as part of its $27.8 billion acquisition of Horizon Therapeutics, generated $65 million in sales last year after an FDA NMOSD nod in mid-2020. A phase 3 readout for Uplizna in myasthenia gravis is expected in the second half of this year. Thanks to its multiple indications, Ultomiris reeled in nearly $3 billion in sales last year, up 51% year over year, although some of the growth came at the cost of Soliris. AZ is not done expanding Ultomiris. Two phase 3 trials are testing the long-acting C5 inhibitor in hematopoietic stem cell transplant-associated thrombotic microangiopathy and cardiac surgery-associated acute kidney injury. AZ believes both diseases hold blockbuster opportunities. Besides those studies, midphase trials are underway in lupus nephritis and immunoglobulin A nephropathy. The British pharma suffered a setback recently as it canned a phase 2 trial for Ultomiris in dermatomyositis due to disappointing efficacy.