KIRIN HLDGS CO LTD S/ADR - KNBWY STOCK NEWS

Kyowa Kirin has appointed Steve Schaefer as the new President of North America, effective April 11, 2023. Schaefer joins from Takeda where he held senior roles, including Senior Vice President of the Neuroscience Business Unit. With over 25 years of experience in the pharmaceutical sector, he has been integral in managing multi-billion dollar commercial portfolios and is known for his expertise in advanced analytics and sales operations.

Schaefer succeeds Gary Zieziula, who is retiring after leading the company through significant growth since April 2020. Under Zieziula's leadership, Kyowa Kirin North America has become the fastest-growing region for the company, contributing over a quarter of global revenues. The transition aims to further enhance Kyowa Kirin's innovative therapies across North America.

Kirin Holdings Company, Limited has announced that Norges Bank has lifted its observation of the company as of March 22, 2023, following the completion of the Myanmar business transfer. Initially placed under observation in March 2021 due to ethical concerns, Kirin's exit from the Myanmar market began in February 2022, culminating in the share transfer completion on January 23, 2023. The company has committed to measures for the fair treatment of local employees, including salary protections and severance. Kirin remains focused on its global business expansion across Food & Beverages, Pharmaceuticals, and Health Sciences.

Kyowa Kirin Co., Ltd. announces the presentation of Phase 2b study data for rocatinlimab (KHK4083/AMG 451) at the American Academy of Dermatology 2023 Annual Meeting from March 17-22 in New Orleans. The trial involved 274 patients with moderate-to-severe atopic dermatitis, demonstrating significant reductions in serum IgE concentrations and improvements in patient-reported outcomes. Rocatinlimab's IgE reductions were maintained to Week 56. The study's adverse events were similar across groups, with no serious complications reported. Collaborative efforts with Amgen are also highlighted to further develop this potential treatment.

Kyowa Kirin Co., Ltd. announced the presentation of data from its Phase 2b study of rocatinlimab at the American Academy of Dermatology 2023 Annual Meeting on March 17-21 in New Orleans. Rocatinlimab, an investigational anti-OX40 monoclonal antibody, aims to treat moderate-to-severe atopic dermatitis, which affects approximately 15-20% of children and 10% of adults globally. Two posters will be presented, focusing on its efficacy and the reduction of IgE concentrations. Kyowa Kirin has partnered with Amgen for the development and commercialization of rocatinlimab globally, except in Japan, where it retains rights.

MEI Pharma and Kyowa Kirin announced the discontinuation of global development for zandelisib, targeting B-cell malignancies, outside Japan after receiving recent FDA guidance. MEI Pharma cited the inability to complete clinical development within a feasible timeframe for further investment as the reason. Although disappointed, Kyowa Kirin will continue clinical trials in Japan and consider regulatory submissions based on the Phase 2 MIRAGE and TIDAL studies. The decision does not relate to clinical data generated to date but reflects regulatory challenges.

MEI Pharma and Kyowa Kirin have announced the presentation of three abstracts related to zandelisib, a PI3Kδ inhibitor for B-cell malignancies, at the American Society of Hematology Annual Meeting on December 10-13, 2022. The presentations will cover the efficacy and safety of zandelisib, both as a standalone treatment and in combination with zanubrutinib, along with immune-related toxicities. These findings may support ongoing clinical trials and potential marketing approvals globally.

MEI Pharma (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. have published Phase 1b clinical study results for zandelisib, a PI3Kδ inhibitor, in The Lancet Oncology. The study showed that an intermittent dosing schedule of zandelisib resulted in a lower risk of significant adverse events than a continuous regimen, without sacrificing efficacy. Out of 97 patients evaluated, the intermittent group exhibited a 20% incidence of Grade 3 or worse adverse events compared to 45% in the continuous group. These results support further Phase 2 and Phase 3 studies for zandelisib in patients with B-cell malignancies.

MEI Pharma announced promising data from the zandelisib clinical development program presented at the 2022 European Hematology Association Hybrid Congress. The Phase 2 TIDAL study reported a 70.3% objective response rate and a 35.2% complete response rate in patients with relapsed or refractory follicular lymphoma. Notably, 87.5% of responses occurred within the first two therapy cycles. Adverse events led to a 9.9% discontinuation rate, primarily consisting of Grade 3 AEs. The study aims to continue assessing zandelisib's safety and efficacy as enrollment progresses in additional cohorts.