Innovent Announces First Participant Dosed of IBI128 (Tigulixostat, XOI) in Phase 3 Clinical Study Accessibility StatementSkip Navigation SAN FRANCISCO and SUZHOU, China, March 22, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the xanthine oxidase ...

Core Insights - Swedish Orphan Biovitrum (Sobi) has agreed to acquire US-based Arthrosi Therapeutics for Skr9.1bn ($950m) in cash, with potential additional payments of up to Skr5.3bn ($550m) based on milestones [1][5] Group 1: Acquisition Details - The acquisition aims to enhance Sobi's presence in the gout treatment market [1] - Sobi will finance the upfront payment primarily through debt, utilizing existing credit facilities and a new credit facility from Handelsbanken and Danske Bank [4] - The transaction is expected to close in the first half of 2026, subject to customary closing conditions [3] Group 2: Product and Market Impact - Arthrosi is developing pozdeutinurad, a next-generation urate transporter 1 (URAT1) inhibitor, currently in two Phase III trials for managing progressive and tophaceous gout, with results expected in 2026 [2][3] - The therapy aims to lower serum urate levels, reduce gout flares, and address tophi in patients with progressive forms of the disease [3] - The acquisition is anticipated to positively impact Sobi's mid to long-term growth and margin profile [5]

Core Insights - Innovent Biologics has successfully dosed the first participant in a Phase 1 clinical trial of IBI3011, an anti-IL-1RAP monoclonal antibody aimed at treating gout flares [1][7] Clinical Development - The Phase 1 trial is a single ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics of IBI3011, with plans to enroll 40 healthy volunteers and 24 patients with gout flares [2] - IBI3011 is the first anti-IL1RAP monoclonal antibody in China, showing significant potential in preclinical models for suppressing gout flares [6][9] Market Need - The number of gout patients in China has exceeded 3 million as of 2019, with rising living standards contributing to this increase [3] - Current treatments for gout flares are limited, with only one IL-1 targeted agent approved in China, indicating a substantial unmet clinical need [4] Mechanism of Action - IL-1RAP acts as a co-receptor that mediates inflammatory signaling pathways, and targeting it can block multiple IL-1 family pathways, potentially leading to rapid control of inflammation and alleviation of gout symptoms [5][9] Future Prospects - Innovent plans to initiate a Phase 3 trial of IBI128 (tigulixostat) for gout patients with hyperuricemia, which has shown strong efficacy in reducing serum uric acid levels in Phase 2 trials [6][7] - The combination of IBI3011 and IBI128 is expected to provide a comprehensive treatment approach for patients with gout and hyperuricemia, enhancing personalized treatment options [6][7] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, having launched 17 products and currently having multiple assets in clinical trials [10] - The company collaborates with over 30 global healthcare companies, enhancing its research and development capabilities [10]

Financial Data and Key Metrics Changes - For the first nine months of 2025, total revenues were $43.6 million, a 24% increase compared to the same period last year [4] - Total revenues for the third quarter were $17.9 million, reflecting a decrease of 1% compared to the same period in 2024 [4] - The net loss for the nine-month period ended September 30, 2025, was $1.1 million, or $0.01 per share, compared to a net loss of $3.6 million, or $0.05 per share for the same period in 2024 [17] - For the three months ended September 30, 2025, net income was approximately $2.4 million, or $0.03 per share, compared to net income of $3.2 million, or $0.04 per share for the same period in 2024 [18] Business Line Data and Key Metrics Changes - Total revenues from selling goods for the nine months ended September 30, 2025, were $43.1 million, an increase of $8.3 million, or 24%, compared to $34.8 million for the same period in 2024 [10] - Revenues consisted of $18.6 million in sales of Elefabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer, and $9.1 million in sales of Elelyso to Fiocruz in Brazil [10] - For the three months ended September 30, 2025, total revenues from selling goods were $17.7 million, a decrease of $0.1 million, or 1%, compared to $17.8 million for the same period in 2024 [10] Market Data and Key Metrics Changes - The company recognizes revenues from sales to partners, and individual purchases vary from quarter to quarter as each partner controls its own inventories [11] - The company anticipates a significant increase in the overall gout market in the next five to six years, particularly for uncontrolled gout patients requiring uricases [22] Company Strategy and Development Direction - The operating strategy focuses on three pillars: driving commercial success with Elefabrio, advancing PRX-115 and other early-stage pipeline programs, and maintaining financial discipline [7] - The company is preparing for the phase two clinical trial of PRX-115, which is viewed as a strategic investment in the pipeline and long-term growth [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Elefabrio's long-term potential and is working closely with Chiesi to support the re-examination of the once-in-four-weeks dosing regimen [6] - The company believes that the achievements in 2025 position it for long-term growth and value creation [19] Other Important Information - Research and development expenses for the nine months ended September 30, 2025, totaled $13.9 million, an increase of 58% compared to the prior year period [13] - Selling general and administrative expenses for the nine months ended September 30, 2025, were $8.2 million, down 11% from the same period last year [14] - The company had $29.4 million in cash and cash equivalents at September 30, 2025, sufficient to satisfy capital needs for at least 12 months [18] Q&A Session Summary Question: Timeline for the re-examination of the CHMP opinion on Elefabrio - The company expects to have an answer in Q1 of 2026 regarding the re-examination request [22] Question: Comments on the competitive landscape in treatment refractory gout - The company foresees a significant increase in the overall gout market and believes that if the phase two trial is successful, it could capture a substantial market share [22] Question: Predictability of royalty-based revenue recognition related to Elefabrio sales - The company continues to recognize what it sells to Chiesi's inventory and is optimistic about future revenue [23][24] Question: Cash runway guidance - The cash runway guidance is based on both operating expenditures and continued receipt of royalty-based revenue on Elefabrio [25][26] Question: Anticipated R&D growth during the phase two of PRX-115 - The company is taking into account the expenses associated with the phase two trial and has sufficient cash for more than 12 months to fund this trial [45]

Core Viewpoint - Innovent Biologics announced positive results from the Phase 2 clinical study of tigulixostat, a xanthine oxidase inhibitor, showing superior urate-lowering efficacy compared to febuxostat in Chinese gout patients, leading to plans for a Phase 3 study in late 2025 [1][7][12]. Group 1: Clinical Study Results - The Phase 2 study involved 84 participants with a mean age of 37 years and a mean baseline serum uric acid level of 575 μmol/L (9.6 mg/dL) [3]. - At week 16, the proportion of participants achieving serum uric acid (sUA) levels below 360 μmol/L (6 mg/dL) was significantly higher in the tigulixostat groups: 55.0% for 50 mg, 81.0% for 100 mg, and 85.7% for 200 mg, compared to 18.2% for febuxostat [6]. - The percent change in sUA from baseline was -38.66% for the 50 mg group, -48.61% for the 100 mg group, and -57.11% for the 200 mg group, while febuxostat showed a change of -24.11% [6]. Group 2: Safety Profile - Tigulixostat exhibited a favorable safety profile with no increased risk of renal impairment and similar incidence of adverse events across groups, all of which were mild to moderate [6][12]. - No serious adverse events were reported, and the incidence of gout flare was comparable between tigulixostat and febuxostat groups [6]. Group 3: Market Context and Need - Gout and hyperuricemia are increasingly recognized as major chronic diseases, with a prevalence of hyperuricemia in China at 13.3%, affecting approximately 15.5 million gout patients [5]. - Current treatments like allopurinol and febuxostat have significant safety concerns, highlighting the urgent need for safer and more effective options [10][12]. Group 4: Future Development Plans - Based on the positive Phase 2 results, Innovent plans to accelerate the Phase 3 clinical development of tigulixostat to provide new treatment options for gout patients in China [7][12]. - The company is committed to advancing its pipeline in cardiovascular and metabolic diseases, addressing a broad population affected by related conditions [7].

Core Insights - XORTX Therapeutics Inc. has initiated the preparation for an Investigational New Drug (IND) application for its lead program, XRx-026, aimed at treating gout, with support from Allucent, a global contract research organization [1][3] - The IND preparation will involve a thorough review of non-clinical, pharmacologic, toxicological, and regulatory progress, and is expected to be submitted in the second half of 2025 [2][3] - The FDA has outlined four critical requirements for the New Drug Application (NDA) submission for XORLO™, the proprietary formulation of oxypurinol [3][6] Company Developments - XORTX has confirmed the issuance of 73,871 common shares at US$1.54 per share, resulting in gross proceeds of approximately USD $113,547.11 during the quarter ended March 31, 2025, under its at-the-market offering [4] - The company is focused on developing innovative therapies for gout and progressive kidney disease, with three clinically advanced products in development [9] Market Context - Approximately 44 million individuals in the U.S. have elevated uric acid levels, with 9.2 million living with gout, indicating a significant market need for effective treatments [5] - The global prevalence of gout is expected to double over the next 25 years, highlighting the growing demand for new therapeutic options [5] Product Insights - The XRx-026 program is developing XORLO™, which aims to provide an alternative for patients who cannot tolerate existing xanthine oxidase inhibitors, addressing a notable gap in current treatment options [6][7] - Current standard treatments for gout have limitations, with 3-5% of patients unable to tolerate allopurinol, and febuxostat carrying cardiovascular risk warnings [6][7]

Core Insights - XORTX Therapeutics Inc. is advancing its lead gout program, XRx-026, with a focus on filing a New Drug Application (NDA) within approximately 12 months, targeting a market opportunity of USD $700 million annually [3][6][8] Group 1: Strategic Focus and Achievements - The company has prioritized the XRx-026 gout program, leveraging advancements in the proprietary XORLO™ formulation, which demonstrates increased oral bioavailability [2][4] - Significant achievements in 2025 include the validation of the XORLO™ formulation and progress in both the XRx-026 and XRx-008 programs [5][6] - Engagement with the FDA through a Type B meeting has clarified the regulatory path for NDA submission via the 505(b)(2) pathway [6] Group 2: Goals and Future Plans - Key objectives for 2025/2026 include advancing the XRx-026 program and preparing for NDA filing, alongside conducting clinical trials to support regulatory submissions [6][12] - The company plans to pursue both non-dilutive and dilutive funding, and is actively seeking partnerships with major pharmaceutical and biotech companies to accelerate commercialization [7][8] - Preparations for commercialization will include market studies and engagement with healthcare professionals to analyze pricing and branding strategies [12]

Core Viewpoint - XORTX Therapeutics Inc. is conducting a non-brokered private placement to raise up to USD $3,000,000 to advance its gout treatment programs and for general corporate purposes [1][3]. Group 1: Offering Details - The private placement will involve the issuance of up to 3,409,090 common share units at a price of USD $0.88 per unit, each unit consisting of one common share and one common share purchase warrant [1]. - Each warrant will allow the holder to purchase an additional common share at a price of USD $1.20, valid for 60 months from the closing date, with an acceleration clause if the common shares exceed USD $2.00 for 10 consecutive trading days [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to advancing XORTX's programs for gout, as well as for working capital and general corporate purposes [3]. Group 3: Company Overview - XORTX is focused on developing innovative therapies for progressive kidney disease and gout, with three clinically advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury related to respiratory virus infections [4]. - The company is also developing XRx-225, a pre-clinical program for Type 2 diabetic nephropathy, targeting purine metabolism and xanthine oxidase to reduce uric acid production [4].