URAT1

SAN FRANCISCO, April 1, 2025 /PRNewswire/ -- Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians' choice of standard of care for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). FDA's approval of the pivotal Phase 3 protocol follows a successful Type B End-of-Phase 2 meeting, during which Yingli Pharma discussed the overall development program and regulatory path. The Phase 3 study is planned to commence during the second quarter of 2025. Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3Kδ) developed by Yingli Pharma. "This is a major milestone for linperlisib.", said Michael Hui, Chairman and Chief Executive Officer of Yingli Pharma, "We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL." In this Phase 3 study, linperlisib will be evaluated versus physicians' choice of standard of care in R/R PTCL patients who have received one or more prior systemic therapies. The Phase 3 study will open enrollment in the U.S. and other countries. About linperlisib Linperlisib is a next-generation highly selective PI3Kδ inhibitor with a well-tolerated and differentiated safety profile as indicated from clinical trials in follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies. In November 2022, linperlisib was approved in China for the treatment of adult patients with R/R FL. Also in 2022, linperlisib received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma and T-Cell Lymphoma. To date, over 6000 patients have been treated with linperlisib in clinical studies and post market approval with consistent and well-tolerated safety profile. Linperlisib has been studied in three clinical trials in R/R PTCL in China, U.S. and Europe, with greater than 165 R/R PTCL patients treated. Collectively, these studies have demonstrated a high objective response rate, high complete response rate, promising progression free survival, overall survival, and a very manageable safety profile through the ongoing evaluations. Overall, Chinese, U.S. and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial. About Yingli Pharma Yingli Pharma is a clinical stage biopharmaceutical company founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark. The company is dedicated to serving unmet medical needs of patients and focuses on discovery and development of therapy for cancer, metabolic and immune diseases. Yingli Pharma is advancing a portfolio of drugs through clinical development, including panRAS, TGFβR1 oral small molecule inhibitors in oncology, and URAT1 and HIPK2 inhibitors in metabolic and immune diseases. Linperlisib, the company's first drug candidate was awarded NMPA Breakthrough Therapy status in China, making Yingli Pharma the second pharmaceutical company in China and the first in Shanghai to receive this recognition. For more information, please see: CONTACT: Wendy Xiong, MD , Email : [email protected], Phone : 669-842-3439 SOURCE Shanghai Yingli Pharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

— REDUCE 2 enrollment completed well ahead of schedule— — Plan to initiate replicate Phase 3 trial, REDUCE 1, in 1Q25 — SAN DIEGO, March 5, 2025 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the completion of enrollment for its pivotal global Phase 3 REDUCE 2 trial. "We would like to thank the gout community for its support, trust and participation as we complete this important step in the advancement of the AR882 program," said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer of Arthrosi Therapeutics. "Previous Phase 2 studies have shown a rapid and clinically meaningful decrease in sUA and tophi size, giving us confidence in our ability to bring this potentially transformative, novel treatment to patients living with gout and significantly improve their quality of life." REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study has reached its target enrollment of 750 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients are randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flares and tophi over time. The trial is expected to be completed in the first half of 2026. For more information about REDUCE 2, please visit (identifier NCT06439602). About Arthrosi: Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. AR882 has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase 2b study. Arthrosi is currently advancing AR882 in a pivotal Phase 3 program. About Gout: In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies. Media Contact: Shunqi Yan, PhD Founder & Chief Operating Officer [email protected] Investor Contact: Precision AQ Alex Lobo 212-698-8802 [email protected] SOURCE Arthrosi Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

(San Diego, December 18, 2024) – Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout, today announced that it has enrolled more than 50% of patients in its pivotal Phase 3 REDUCE 2 trial evaluating AR882 for the reduction of sUA in gout patients. “We are excited by the momentum we have seen in the REDUCE 2 study since enrolling the first patient in July 2024. This is a reflection of the commitment of our team and clinical collaborators as we seek to redefine the standard of care for patients with gout,” said Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. “With our REDUCE 2 study well ahead of its projected schedule, we expect to complete enrollment in the first half of 2025, and in parallel, plan to initiate our REDUCE 1 study, a replicate Phase 3 study in the first quarter of 2025.” Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer at Arthrosi Therapeutics added, “There remains a large unmet need for a safe and convenient gout treatment, which can provide clinical benefit with reduction of tophi and flares. We remain highly encouraged by the potential of AR882, and believe that our pivotal phase 3 program will support a comprehensive New Drug Application to the U.S. Food and Drug Administration as we seek to improve the lives of all gout patients.”