Transaction will create a global powerhouse for mining finance and reduce complexity and costs for Canadian market participantsAcquisition will strengthen TMX's ability to serve clients across the capital markets ecosystem, expands global presence, accelerates growth strategyAnalyst webcast and conference call on Wednesday, April 22, 2026 at 8:00am EDT to discussToronto, Ontario--(ACN Newswire via SeaPRwire.com - April 22, 2026) - TMX Group Limited (TSX: X) (TMX Group) announced today an agreement to acquire Middlebury Holdings Pty. Limited (Cboe Australia) and Cboe Canada Holdings, ULC (Cboe Canada) from Cboe Global Markets, Inc. for US$300 million ($409 million*) in total consideration, a transaction that will bolster TMX's ability to serve clients across the capital markets ecosystem, expand the company's global presence, and accelerate the company's growth strategy, while reducing cost and complexity for Canadian market participants."We are tremendously excited to announce the acquisition of Cboe Australia and Cboe Canada, a deal that represents a unique opportunity to strengthen our domestic marketplace for clients and the entire stakeholder ecosystem, while expanding the reach and impact of our presence in a region of the world we know well," said John McKenzie, Chief Executive Officer, TMX Group. "We look forward to working with our industry partners to ensure a smooth transition, and to exploring innovative ways to serve the needs of issuers and investors across the Australian market, while continuing to seek out opportunities to accelerate our enterprise growth strategy."Cboe Australia and Cboe Canada offer equities trading venues, listing venues and market data solutions. Cboe Australia is an innovative securities exchange offering companies strategic tailored support for public market listings, including ETFs, as well as structured products and warrants, and providing a trading venue for brokers and investors with efficient and cost-effective access to local and global investment opportunities. Cboe Australia was also recently granted a license for corporate listings. Cboe Canada includes MATCHNow, NEO-L, NEO-N, and NEO-D, as well as ETF, CDR and corporate listings."The teams at Cboe Australia and Cboe Canada have delivered consistent performance and built resilient, high-quality markets," said Craig Donohue, Chief Executive Officer, Cboe Global Markets. "These businesses are well positioned for their next chapter, and we will work closely with TMX, our local regulators, and our clients to ensure a seamless transition."Transaction HighlightsTMX's acquisition of Cboe Australia will bring together the world's leading mining and energy transition financing ecosystems, unlocking potential to innovate for a growing global client base.TMX's acquisition of Cboe Canada enhances the quality of client experience across domestic equities marketplaces:Increasing efficiency of access to capital and liquidity for Canadian issuers, andReducing direct and indirect costs for participants, while improving execution quality and resiliency.Transaction expected to be accretive to adjusted earnings per share within the first 12 months of closing, excluding synergies.Revenue growth expected to be in-line with TMX's long-term financial objectivesCombined Cboe Canada and Cboe Australia businesses delivered revenue of approximately $87 million in 2025, and adjusted EBITDA of approximately $25 million**.Further Transaction DetailsThe purchase of each business is subject to regulatory approvals and customary closing conditions in Australia and Canada. The two components of this acquisition, Cboe Australia and Cboe Canada, are expected to close separately, each after required approvals have been obtained.Canaccord Genuity and Macquarie Capital are acting as financial advisors to TMX Group. FGS Longview is acting as strategic communications advisor to TMX Group.*Based on USD/CAD exchange rate of 1.3644 at April 21, 2026. Actual amounts in Canadian dollars are subject to change.**Based on average AUD/CAD of 0.90 for 2025. Cboe Australia and Canada revenue and EBITDA are compilations of financial information provided to us for the Cboe entities as of December 31, 2025. The Cboe financial information is unaudited and prepared in accordance with IFRS (Cboe Canada) or Australian Accounting Standards (Cboe Australia) for public companies.Teleconference / Audio WebcastTMX Group will host a teleconference / audio webcast to discuss the transaction.Time: 8:00 a.m. - 9:00 a.m. ET on Wednesday, April 22, 2026Participants may access the conference call via the webcast link: https://www.gowebcasting.com/14669.The audio webcast of the conference call and investor presentation will also be available on TMX Group's website at www.tmx.com, under Investor Relations.Alternatively, participants may join the live call by dialing 1-833-752-4317 or 1-647-846-2266.An audio replay of the conference call will be available at 1-855-669-9658 or 1-412-317-0088, [access code 6830744].Caution Regarding Forward-Looking InformationThis press release of TMX Group Limited ("TMX Group", "us", "we", "our") contains "forward-looking information" (as defined in applicable Canadian securities legislation) that is based on expectations, assumptions, estimates, projections and other factors that management believes to be relevant as of the date of this press release. Often, but not always, such forward-looking information can be identified by the use of forward-looking words such as "plans", "expects", "projects", "is expected", "projected", "budget", "scheduled", "targeted", "estimates", "forecasts", "intends", "anticipates", "believes", or variations or the negatives of such words and phrases or statements that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved or not be taken, occur or be achieved. Forward-looking information, by its nature, requires TMX Group to make assumptions and is subject to significant risks and uncertainties which may give rise to the possibility that our expectations or conclusions will not prove to be accurate and that our assumptions may not be correct. Examples of forward-looking information in this press release include, but are not limited to, the anticipated benefits of the transactions to TMX Group, Cboe Canada and Cboe Australia; the expected impact on TMX Group's earnings and Adjusted earnings per share; expectations regarding the revenue growth of Cboe Canada and Cboe Australia; the ability to integrate Cboe Canada and Cboe Australia into TMX Group and the potential synergies; the expected impact on TMX's long-term growth strategy and transformational objectives; the potential for geographic expansion; the ability for TMX Group to accelerate Cboe Canada and Cboe Australia's growth; the timing and receipt of regulatory approval; and closing of the transaction, each of which is subject to a number of significant risks and uncertainties. These risks include, but are not limited to: competition from other exchanges or marketplaces, including alternative trading systems and new technologies, on a national and international basis; dependence on the economies of Canada, the United States and Australia; adverse effects on our results caused by global economic conditions (including geopolitical events, interest rate movements or threats of recession) or uncertainties including changes in business cycles that impact our sector; failure to retain and attract qualified personnel; geopolitical and other factors which could cause business interruption; dependence on information technology; vulnerability of our networks and third party service providers to security risks, including cyber attacks; failure to properly identify or implement our strategies; regulatory constraints; constraints imposed by our level of indebtedness, risks of litigation or other proceedings; dependence on adequate numbers of customers; failure to develop, market or gain acceptance of new products; failure to close and effectively integrate acquisitions, including the Cboe Canada and Cboe Australia acquisition, to achieve planned economics or divest underperforming businesses; currency risk; adverse effect of new business activities; adverse effects from business divestitures; not being able to meet cash requirements because of our holding company structure and restrictions on paying inter-corporate dividends; dependence on third party suppliers and service providers; dependence of trading operations on a small number of clients; risks associated with our clearing operations; challenges related to international expansion; restrictions on ownership of TMX Group common shares; inability to protect our intellectual property; adverse effect of a systemic market event on certain of our businesses; risks associated with the credit of customers; cost structures being largely fixed; the failure to realize cost reductions in the amount or the time frame anticipated; dependence on market activity that cannot be controlled; the regulatory constraints that apply to the business of TMX Group and its regulated subsidiaries, costs of on exchange clearing and depository services, trading volumes (which could be higher or lower than estimated) and the resulting impact on revenues; future levels of revenues being lower than expected or costs being higher than expected.Forward-looking information is based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions with respect to the impact of the cost of acquisition financing on adjusted earnings per share; assumptions in connection with the ability of TMX Group to successfully compete against global and regional marketplaces and other venues; business and economic conditions generally; exchange rates (including estimates of exchange rates from Canadian dollars to the U.S. dollar, British pound sterling, or Australian dollar), commodities prices, the level of trading and activity on markets, and particularly the level of trading in TMX Group's key products; business development and marketing and sales activity; the continued availability of financing on appropriate terms for future projects; changes to interest rates and the timing thereof; productivity at TMX Group, as well as that of TMX Group's competitors; market competition; research and development activities; the successful introduction and client acceptance of new products and services; successful introduction of various technology assets and capabilities; the impact on TMX Group and its customers of various regulations; TMX Group's ongoing relations with its employees; and the extent of any labour, equipment or other disruptions at any of its operations of any significance other than any planned maintenance or similar shutdowns.In addition to the assumptions outlined above, forward looking information related to long term revenue CAGR objectives, and long term adjusted earnings per share CAGR objectives are based on assumptions that include, but not limited to:TMX Group's success in achieving growth initiatives and business objectives;continued investment in growth businesses and in transformation initiatives including next generation technology and systems;no significant changes to our effective tax rate, and number of shares outstanding;organic and inorganic growth in recurring revenuemoderate levels of market volatility over the long term;level of listings, trading, and clearing consistent with historical activity;economic growth consistent with historical activity;no significant changes in regulations;continued disciplined expense management across our business;continued re-prioritization of investment towards enterprise solutions and new capabilities;free cash flow generation consistent with historical run rate; anda limited impact from inflation, rising interest rates and supply chain constraints on our plans to grow our business over the long term including on the ability of our listed issuers to raise capital.While we anticipate that subsequent events and developments may cause TMX Group's views to change, TMX Group has no intention to update this forward-looking information, except as required by applicable securities law. This forward-looking information should not be relied upon as representing TMX Group's views as of any date subsequent to the date of this press release. TMX Group has attempted to identify important factors that could cause actual actions, events or results to differ materially from those current expectations described in forward-looking information. However, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended and that could cause actual actions, events or results to differ materially from current expectations. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. These factors are not intended to represent a complete list of the factors that could affect TMX Group. Important additional information identifying risks and uncertainties and other factors is contained in TMX Group's 2025 Annual Report under the headings entitled "Caution Regarding Forward-Looking Information" and "Enterprise Risk Management" which may be accessed at tmx.com in the Investor Relations section under Regulatory Filings.Non-GAAP Financial MeasuresThis press release includes references to financial measures that are not defined by GAAP. Although such non-GAAP measures are calculated according to accepted industry practice, such measures disclosed in this press release may be different from non-GAAP measures used by other companies. This data is intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with GAAP. While TMX Group believes these measures provide investors with greater transparency and supplemental data relating to the transaction, readers are cautioned that these non-GAAP measures are not alternatives to measures determined in accordance with GAAP and should not, on their own, be construed as indicators of TMX Group's or Cboe Canada and Cboe Australia's future performance or profitability. Readers should not rely on any single financial measure when evaluating TMX Group's business or that of Cboe Canada and Cboe Australia. We use non-GAAP measures and non-GAAP ratios that do not have standardized meanings prescribed by GAAP and are, therefore, unlikely to be comparable to similar measures presented by other companies. Management uses these measures, and excludes certain items, because it believes doing so provides investors a more effective analysis of underlying operating and financial performance, including, in some cases, our ability to generate cash and our ability to repay debt. Management also uses these measures to more effectively measure performance over time, and excluding these items increases comparability across periods. The exclusion of certain items does not imply that they are non-recurring or not useful to investors.Adjusted earnings per share provided above is a non-GAAP ratio and does not have a standardized meaning prescribed by GAAP and is therefore unlikely to be comparable to similar measures presented by other companies. TMX Group presents Adjusted EPS and excludes, among other things, acquisition, integration, and related items; amortization of intangibles related to acquisitions; strategic re-alignment expenses; dispute, litigation and related items; and other items as disclosed in TMX Group's 2025 Annual Report. For more information on Adjusted EPS, including definitions and explanations of how these measures provide useful information, refer to Non-GAAP Measures in TMX Group's 2025 Annual Report.Adjusted EBITDA is calculated as net income excluding interest expense, income tax expense, depreciation and amortization, acquisition, integration, and related costs, one-time income (loss), and other significant items that are not reflective of the underlying business operations of Cboe Canada and Cboe Australia. Cboe Canada and Cboe Australia Adjusted EBITDA is a compilation of financial information provided to us for Cboe Canada and Cboe Australia entities as of December 31, 2025. The Cboe Canada and Cboe Australia financial information is unaudited and prepared in accordance with IFRS (Cboe Canada) or Australian Accounting Standards (Cboe Australia) for public companies. Adjusted EBITDA for Cboe Canada and Cboe Australia excludes certain items such as discontinued operations, transfer pricing, unrealized gains / losses, and one-time employee costs.About TMX Group (TSX: X) TMX Group operates global markets, and builds digital communities and analytic solutions that facilitate the funding, growth and success of businesses, traders and investors. TMX Group's key operations include Toronto Stock Exchange, TSX Venture Exchange, TSX Alpha Exchange, The Canadian Depository for Securities, Montréal Exchange, Canadian Derivatives Clearing Corporation, TSX Trust, TMX Trayport, TMX Datalinx, TMX VettaFi and TMX Newsfile, which provide listing markets, trading markets, clearing facilities, depository services, technology solutions, data products and other services to the global financial community. TMX Group is headquartered in Toronto and operates offices across North America (Montréal, Calgary, Vancouver and New York), as well as in key international markets including London, Singapore, and Vienna. For more information about TMX Group, visit www.tmx.com. Follow TMX Group on X: @TMXGroup.For more information please contact:Catherine KeeHead of Media RelationsTMX Group416-671-1704catherine.kee@tmx.comAmanda TangHead of Investor RelationsTMX Group416-895-5848amanda.tang@tmx.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/293729 Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

HONG KONG, Apr 22, 2026 - (ACN Newswire via SeaPRwire.com) - Hengrui Pharma reported steady growth in the first quarter of 2026. In Q1 2026, the Company recorded revenue of RMB 8.14 billion, up 12.98% year-over-year, while net profit attributable to shareholders increased by 21.78% to RMB 2.28 billion. Innovative drugs remained the key growth driver, generating RMB 4.53 billion in revenue, up 25.75% year-over-year and accounting for 61.69% of total pharmaceutical sales.The Company continued to advance its innovation-driven strategy with sustained R&D investment and solid pipeline progress. R&D investments in Q1 2026 totaled RMB 2.22 billion, representing for approximately 27.32% of revenue.During the period, three innovative products and new indications were approved in China, which included an anti-PD-L1/TGF-βRII bi-functional fusion protein and an indication expansion for HER2-targeting ADC.In terms of pipeline advancement, the Company obtained 26 clinical trial approvals and had 8 new drug applications accepted in China across key therapeutic areas including oncology, metabolic, cardiovascular, and immunological diseases.Business development has become a recurring and increasingly important growth driver, with RMB 787 million in out-licensing revenue recognized during the quarter, primarily from the collaboration with GSK. Since 2023, Hengrui Pharma has completed 12 overseas business development transactions, including out-licensing, NewCo structures, and strategic alliance models.A key milestone during the period was the successful Nasdaq listing of Kailera Therapeutics (NASDAQ: KLRA), a NewCo company built around Hengrui Pharma’s GLP-1-based assets. This milestone reflects continued progress in executing the Company’s NewCo strategy, with Hengrui and Kailera working together to advance the global development of the GLP-1 portfolio.Looking ahead, Hengrui Pharma will remain committed to innovation and globalization, strengthening its pipeline and advancing the development and commercialization of innovative therapies to benefit patients worldwide. Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

香港, 2026年4月22日 - (亞太商訊 via SeaPRwire.com) - 4月22日晚，恒瑞醫藥發佈 2026年第一季度經營業績。2026年第一季度，公司實現營業收入81.41億元，同比增長12.98%；歸屬於於上市公司股東的淨利潤22.82億元，同比增長21.78%；歸屬於上市公司股東的扣除非經常性損益的淨利潤21.72億元，同比增長16.59%。2026年第一季度，公司創新藥銷售收入45.26億元，同比增長25.75%，佔藥品銷售收入的比重達61.69%。創新藥銷售收入中，抗腫瘤產品收入33.13億元，同比增長11.63%，佔整體創新藥銷售收入的73.20%。非腫瘤產品收入12.13億元，同比增長92.13%，佔整體創新藥銷售收入的26.80%。多款創新藥及新適應症獲批, 臨床研究高效推進公司持續加大創新力度，維持較高的研發投入，報告期內公司累計研發投入22.24億元，佔營業收入的27.32%，其中費用化研發投入16.51億元。在持續高強度研發投入的驅動下，恒瑞醫藥優質創新成果持續獲批，在研管線快速推進，創新研發成果加速轉化。在新藥和新適應症獲批方面，2026年以來，有3項創新成果獲批。首先，公司自主研發的1類創新藥、全球首款獲批上市的抗PD-L1/TGF-βRII雙特異性抗體融合蛋白瑞拉芙普α注射液（艾澤利(R)）獲批上市，聯合氟尿嘧啶類和鉑類藥物用於經充分驗證的檢測評估PD-L1陽性（CPS≥1）的局部晚期不可切除、復發或轉移性胃及胃食管結合部腺癌的一線治療。此外，公司自主研發的HER2 ADC、1類創新藥注射用瑞康曲妥珠單抗（艾維達(R)）新增適應症：本品適用於治療既往接受過一種或一種以上抗HER2藥物治療的局部晚期或轉移性HER2陽性成人乳腺癌患者。這是瑞康曲妥珠單抗（艾維達(R)）獲批上市的第2項適應症，也是在乳腺癌領域獲批的首個適應症，並在適應症獲批後一個月內，即被納入 2026中國臨床腫瘤學會乳腺癌診療指南，臨床價值獲得快速認可。同時，公司自主研發的1類創新藥海曲泊帕乙醇胺片（恒曲(R)）新增第三個適應症，用於重型再生障礙性貧血一線治療。在上市申報方面成果顯著，公司8項新藥上市申請獲受理（按品種適應症計），涵蓋腫瘤、代謝、心血管、免疫等疾病領域，包括去年首次獲批上市的創新藥磷羅拉匹坦帕洛諾司瓊（瑞坦寧(R)）用於預防中度致吐性抗腫瘤藥物引起的急性和遲發性噁心和嘔吐、瑞康曲妥珠單抗（艾維達(R)）用於HER2陽性結直腸癌。在臨床研發方面，公司一季度累計取得臨床試驗批准通知書26個（按品種適應症計）；2026年以來獲得CDE突破性治療品種認定6項，包括腫瘤創新產品HRS-4642注射液（KRAS G12D）和已上市的HER2 ADC瑞康曲妥珠單抗（艾維達(R)），以及非腫瘤創新產品HRS-5346片（Lp(a)）等。其中瑞康曲妥珠單抗已11次被納入突破性治療品種名單。NewCo模式成功落地，國際化再迎里程碑近年來，恒瑞醫藥持續構建開放合作的國際化生態，BD已成為常態化業務和新的增長引擎。一季度，創新藥對外許可業務確認收入7.87億元，主要系GSK確認的收入。自2023年起，恒瑞已完成12筆海外業務拓展交易，包括對外許可、NewCo和戰略聯盟等不同模式，合作物件包括GSK、默沙東等大型跨國藥企。近期，恒瑞醫藥國際化發展迎來新的里程碑。4月17日，公司合作夥伴Kailera Therapeutics公司（股票代碼：KLRA）成功在美國納斯達克交易所掛牌上市。這是恒瑞醫藥「NewCo」出海模式的成功實踐 - 驗證了全球化創新合作的高效路徑，標誌著恒瑞醫藥國際化發展再上新台階。2024年5月，恒瑞醫藥以「NewCo」模式將自主研發的GLP-1產品組合在除大中華區以外的全球範圍內開發、生產和商業化的獨家權利許可給Kailera，首付款加潛在里程碑付款累計可高達60億美元，公司還取得Kailera的部分股權。此後雙方共同努力，穩步推進GLP-1產品組合在海內外的開發落地。目前GLP-1/GIP雙受體激動劑瑞普泊肽（研發代號：HRS9531 ，大中華區外稱KAI-9531）在中國擬開發用於超重/肥胖及相關合併症、2型糖尿病等適應症，其中注射劑型用於成人長期體重管理的上市申請（NDA）已在中國獲受理。值得一提的是，在報告期內，口服瑞普泊肽已公佈中國Ⅱ期減重研究結果[1]，治療第26周時，參與者較基線平均體重下降最高達12.1%，且未觀察到平台期，同時嘔吐發生率不超過11.4%。口服瑞普泊肽計畫在中國推進肥胖症Ⅲ期臨床。口服小分子GLP-1受體激動劑HRS-7535擬開發用於超重/肥胖、2型糖尿病等適應症，其中2型糖尿病與超重或肥胖適應症均已在中國推進至Ⅲ期；GLP-1/GIP/GCG三重受體激動劑HRS-4729正在中國開展針對超重或肥胖的Ⅰ期臨床試驗，目前全球範圍內尚無同類產品上市。Kailera方面，目前正在開展瑞普泊肽注射液治療肥胖症的全球Ⅲ期臨床研究。HRS-7535（大中華區外稱KAI-7535）今年將啟動全球Ⅱ期臨床試驗，HRS-4729（大中華區外稱KAI-4729）將啟動全球Ⅰ期臨床試驗；口服瑞普泊肽則可能最早於2027年上半年啟動全球Ⅲ期臨床試驗。恒瑞醫藥表示，未來公司將繼續堅持自主研發與開放合作並重，持續探索多元化的創新國際合作模式，加速融入全球藥物創新生態、將更多優質創新藥品惠及全球患者。國際學術舞台頻頻亮相，多項臨床資料引關注 2026年以來，公司多項重磅臨床資料亮相國際知名學術會議，包括歐洲肺癌大會（ELCC）、美國癌症研究協會年會（AACR）、美國心臟病學會科學年會(ACC)、美國皮膚病學會年會（AAD）等。腫瘤領域，AACR大會重磅發表了公司肺癌領域研究成果。一項瑞康曲妥珠單抗單藥或聯合阿得貝利單抗一線治療HER2突變晚期非小細胞肺癌Ⅱ期研究結果顯示[2]，無論是單藥或聯合方案均展現出具有臨床意義的抗腫瘤活性，且無進展生存期呈持續獲益趨勢，整體安全性良好且可控。另一項阿得貝利單抗聯合化療圍術期治療可切除II-IIIB期非小細胞肺癌的III期臨床研究期中分析資料顯示[3]，該療法在主要終點病理緩解率和無事件生存期上均取得了統計學顯著且具有臨床意義的改善，安全性良好。基於該研究，阿得貝利單抗已於2025年遞交用於非小細胞肺癌相關治療的新適應症上市申請。非腫瘤領域，公司於ACC大會披露了新一代心肌肌球蛋白（Myosin）小分子抑制劑HRS-1893治療梗阻性肥厚型心肌病II期研究積極結果[4]，結果顯示HRS-1893可快速顯著降低左心室流出道壓差，在療效、安全性及給藥便利性方面具備潛在同類最佳臨床特徵。此外，公司自主研發的全球首創IL-23p19/IL-36R雙靶點抗體SHR-1139用於中重度斑塊狀銀屑病患者I期研究資料於AAD大會重磅發佈[5]，結果顯示SHR-1139在該患者群體中展現出具有臨床意義的獲益以及超長效作用特徵，同時安全性和耐受性良好。同時，公司有多項研究成果登上《臨床腫瘤學雜誌》、《英國醫學雜誌》、《美國醫學會心臟病學雜誌》等國際權威學術期刊。腫瘤領域，《臨床腫瘤學雜誌》重磅發表了CARES-005（CHANCE 2005） 研究。結果顯示[6]，與單純TACE治療相比，接受TACE聯合靶免（「雙艾」組合）治療的不可切除肝細胞癌（HCC）患者無進展生存期取得了具有臨床意義和統計學顯著性的改善，特別是納入的患者90%為高負荷、超40%為CNLC Ⅲa期（尤其合併Vp3-4門靜脈癌栓），補充了該治療策略的關鍵證據。基於進一步佈局的註冊Ⅲ期研究，「雙艾」組合聯合TACE治療不可切除HCC的上市許可申請已於2026年年初獲國家藥監局受理。同期，該刊還發表了瑞康曲妥珠單抗治療HER2表達的晚期胃/胃食管結合部腺癌和結直腸癌I期結果[7]，初步顯示出良好的抗腫瘤活性和安全性。非腫瘤領域，公司自主研發的ANGPTL3全人源單克隆抗體SHR-1918用於成人純合子家族性高膽固醇血症（HoFH）患者的Ⅱ期臨床研究發表於《美國醫學會心臟病學雜誌》。結果顯示[8]，每4週一次皮下注射 600mg SHR-1918可為HoFH受試者帶來顯著且持續的低密度脂蛋白膽固醇（LDL-C）降低（平均近60%降幅），並具有良好的安全性及耐受性。SHR-1918治療成人和12歲及以上的未成年人純合子家族性高膽固醇血症（HoFH）患者的上市申請已獲國家藥監局受理且被納入優先審評。憑藉高品質發展成效與持續創新，公司行業影響力持續提升。國際知名諮詢機構Citeline發佈的《Pharma R&D Annual Review 2026》顯示，恒瑞醫藥蟬聯自研管線數量全球第二；榮獲2026「中國傑出僱主」認證，這是公司連續5年獲此稱號，充分體現了公司在人才發展與組織建設方面的卓越表現。在持續高強度研發投入的驅動下，恒瑞醫藥將繼續堅持創新與國際化雙輪驅動戰略，深耕腫瘤、心血管與代謝、免疫與呼吸、神經科學四大核心治療領域，以創新助力「健康中國」，造福全球患者。參考文獻：[1] 根據研究資料整理.[2] Shun Lu,et al. 2026 AACR, Abs CT301[3] Yi-Long Wu, et al. Perioperative adebrelimab (A) plus chemotherapy (chemo) in resectable stage II-III NSCLC: Phase 3 EFS interim analysis (IA) and molecular residual disease (MRD) analysis. 2026AACR, CT014.[4] Efficacy And Safety Of BHB/HRS-1893 In Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results From A 12-week Phase 2 Study. ACC.26. Late-Breaking Clinical Trials, Session 321, Featured Clinical Research V.[5] Xu JH, et al. A Randomized, Double-blind, Dose-Escalation, Placebo-Controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1139 for Patients with Moderate-to-Severe Plaque Psoriasis. Poster 75013, AAD 2026.[6] Zhu HD, Fan WJ, Zhao C, et al. Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial. J Clin Oncol. Published online February 24, 2026.[7] Liu T, Luo S, Yuan X, et al. Trastuzumab Rezetecan in Human Epidermal Growth Factor Receptor 2-Expressing Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: A Multicenter, Open-Label, Phase I Trial. J Clin Oncol. Published online March 4, 2026.[8] Peng D, Wang L, Pi L, et al. Anti-ANGPTL3 Antibody SHR-1918 for Homozygous Familial Hypercholesterolemia: A Nonrandomized Clinical Trial. JAMA Cardiol. 2026 Jan 7.  Copyright 2026 亞太商訊 via SeaPRwire.com. All rights reserved. www.acnnewswire.com

HONG KONG, Apr 22, 2026 - (ACN Newswire via SeaPRwire.com) - Apr 20, Everest Medicines announced that the first-in-human (FIH) clinical trial data of EVM16, a proprietary personalized mRNA cancer vaccine, were presented at the 2026 American Association for Cancer Research  Annual Meeting (AACR 2026). The data include results from EVM16 as  a monotherapy and in combination with the PD-1 inhibitor tislelizumab in patients with advanced solid tumors. The results demonstrated that EVM16 has a favorable safety and tolerability profile, robust immunogenicity, and promising preliminary efficacy in patients with advanced solid tumors, supporting its further clinical development.The clinical trial (EVM16CX01, NCT06541639) was conducted jointly by Peking University Cancer Hospital and Fudan University Shanghai Cancer Center, with the first patient dosed in March 2025. EVM16CX01 is a first-in-human (FIH), dose-escalation, and expansion study evaluating the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with tislelizumab in patients with advanced solid tumors. The study follows a 3+3 dose-escalation design across three dose levels (0.1 mg, 0.3 mg, and 1.0 mg). Eligible patients are those with advanced or recurrent solid tumors who have failed standard of care and have at least one measurable target lesion. Patients receive 2 doses of EVM16 monotherapy once every two weeks, followed by combination therapy of EVM16 and tislelizumab. As of December 7, 2025, a total of 9 patients had been enrolled.No dose-limiting toxicities (DLTs) were observed. All patients experienced at least one investigational product (IP) related adverse event (AE), all of which were Grade ≤ 2 and resolved spontaneously. EVM16 elicited strong neoantigen-specific T cell responses in 8 of 9 patients, which showed a dose-dependent trend. A gastroesophageal junction cancer patient who failed 3 prior lines of systemic therapy achieved a confirmed partial response and a PFS of 126 days. Another 2 patients achieved stable disease. A non-small cell lung cancer patient who failed 3 prior lines of systemic therapy achieved a PFS of 88 days, and an esophageal squamous cell carcinoma patient who failed 3 prior lines of systemic therapy has been followed up for 112 days to date and has not experienced disease progression.“As a novel personalized mRNA cancer vaccine, EVM16 has demonstrated encouraging clinical development potential in its first-in-human clinical trial,” said Professor Shen Lin, Director of the Gastrointestinal Oncology Department at Beijing Cancer Hospital and Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology. “The data show a favorable safety and tolerability profile in patients with advanced solid tumors, with no dose-limiting toxicities (DLTs) observed. Importantly, EVM16 stimulated neoantigen-specific T cell responses with a dose-dependent trend, highlighting its consistent immune activation capability. Preliminary anti-tumor activity signals, including partial response (PR) and stable disease (SD), were observed in patients who had failed multiple lines of standard-of-care therapies, suggesting potential clinical activity. These findings provide early clinical validation of EVM16 and reinforce its differentiated mechanism as a personalized mRNA cancer vaccine. While immunotherapies, including checkpoint inhibitors, have transformed the treatment landscape in selected tumor types, most patients, particularly those with heavily pretreated advanced solid tumors, still represent a significant unmet medical need. Personalized mRNA cancer vaccines represented by EVM16 may help expand the population benefiting from immunotherapy and provide additional treatment options.” “The favorable safety, tolerability, immunogenicity, and preliminary efficacy results for EVM16 provide initial evidence of its therapeutic potential and support the clinical value of our in-house mRNA platform,” said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Patients with advanced solid tumors, particularly those who have failed multiple lines of therapy, continue to suffer from limited treatment options. As our first in-house developed personalized mRNA cancer vaccine, EVM16 demonstrates the ability to induce immune activation and generate neoantigen-specific T cell responses, which may help reduce the risk of tumor metastasis or recurrence. This further underscores its potential as a novel approach in cancer immunotherapy. This project is powered by EVER-NEO-1, Everest’s proprietary AI-based neoantigen prediction algorithm. It analyzes patient-specific tumor mutations to identify highly immunogenic neoantigens and support the design of personalized mRNA vaccine candidates. The algorithm incorporates iterative learning capabilities designed to continuously improve neoantigen prediction accuracy and selection efficiency. Leveraging our leading mRNA platform, we will continue to advance the clinical development of EVM16 and bring this innovative therapy to more patients.”Everest Medicines has localized its clinically validated proprietary AI+mRNA platform, establishing an end-to-end integrated platform spanning antigen design, mRNA sequence optimization, lipid nanoparticles (LNP) targeted delivery and scalable manufacturing, with the potential to address significant unmet medical needs globally.EVM16 is a novel personalized therapeutic mRNA cancer vaccine in-house developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest’s proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. The vaccine uses a lipid nanoparticle (LNP) delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth.From an investment and market perspective, personalized cancer vaccines are in an early stage of breakthrough. According to Grand View Research, the global personalized cancer vaccine market is projected to reach $1.45 billion by 2030, with a staggering compound annual growth rate (CAGR) of 44.86% from 2025 to 2030. Myguide Securities points out that mRNA cancer vaccines have the potential to achieve pan-cancer coverage while offering the advantages of high accessibility, “off-the-shelf” availability, and personalization. As a highly promising new form of immunotherapy, it can enter clinical use as adjuvant therapies through extensive combinations, gradually unlocking a market space worth tens of billions of dollars.Against this backdrop, Everest Medicines is accelerating its strategic positioning in this field, progressively building a research and development pipeline with global competitiveness. Leveraging its proprietary AI+mRNA platform and its leading clinical position in China, Everest Medicines is currently at a critical juncture for industrialization and valuation growth. The upcoming readout of first-in-human (FIH) clinical trial data for EVM16 is expected to further release clinical and commercial potential, continuing to attract focus from the market and investors, and helping the company achieve a significant leap in value within the immunotherapy sector. Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com

香港, 2026年4月22日 - (亞太商訊 via SeaPRwire.com) - 4月20日，雲頂新耀宣佈在2026年美國癌症研究協會（AACR）年會上公佈其自主研發的mRNA個性化腫瘤治療性疫苗EVM16單藥治療及聯合PD-1抑制劑（替雷利珠單抗）治療晚期實體瘤的首次人體臨床試驗（FIH）數據。結果顯示出良好的安全性和耐受性、顯著的免疫原性及積極的初步療效信號，支持進一步臨床開發的推進。據悉，該臨床試驗由北京大學腫瘤醫院與復旦大學附屬腫瘤醫院聯合發起（EVM16CX01，NCT06541639），並於2025年3月完成首例患者給藥。EVM16CX01是一項評估EVM16注射液單藥及聯合PD-1抑制劑治療對晚期或復發實體瘤患者的安全性、耐受性、免疫原性和初步療效的劑量遞增及擴展研究，該試驗採用3+3 劑量遞增設計，包括三個劑量組：0.1 mg、0.3 mg和1.0 mg。入選患者為經標準治療失敗的晚期或復發性實體瘤患者，且至少有一個可測量靶病灶。患者將接受2次EVM16單藥治療（每兩週一次），隨後接受EVM16聯合替雷利珠單抗治療。截至2025年12月7日，共入組9例患者。安全性和耐受性方面，EVM16未觀察到劑量限制性毒性（DLT）。所有患者均報告至少一次與研究藥物相關的不良事件，均為2級及以下，且均可自行緩解。 EVM16在9例患者中有8例誘導出強烈的新抗原特異性T細胞免疫反應，並顯示出劑量依賴性趨勢。初步臨床療效方面，一例既往接受過三線系統治療失敗的胃食管結合部癌患者達到確認的部分緩解（PR），無進展生存期（PFS）為126天。另有2例患者達到疾病穩定(SD)，其中一例既往接受過三線系統治療失敗的非小細胞肺癌患者PFS為88天，另一例既往接受過三線系統治療失敗的食管鱗癌患者截至數據截止日已隨訪112天，尚未觀察到疾病進展。北京大學腫瘤醫院消化腫瘤內科主任、中國臨床腫瘤學會胃癌專家委員會主任委員沈琳教授表示：「EVM16作為一款新型mRNA個性化腫瘤治療性疫苗，在首次人體臨床試驗中展現出良好的臨床開發潛力。數據顯示，該疫苗在晚期實體瘤患者中整體安全性與耐受性良好，未觀察到劑量限制性毒性。在免疫學層面，EVM16能夠誘導新抗原特異性T細胞應答，並呈現一定劑量依賴趨勢，提示其具有較強的免疫啟動能力。在療效探索方面，臨床試驗在既往接受多線標準治療失敗的患者中觀察到初步抗腫瘤活性信號，包括部分緩解（PR）及疾病穩定（SD），顯示其免疫學作用機制具有改善臨床獲益的潛力。總體而言，該臨床試驗初步驗證了EVM16通過新抗原驅動T細胞應答實現腫瘤免疫啟動的臨床價值，為其後續臨床開發提供了重要依據。當前，儘管免疫檢查點抑制劑已顯著改善部分腫瘤的治療格局，但總體獲益人群仍有限，尤其是在多線治療失敗的晚期實體瘤患者中仍存在顯著未滿足需求。EVM16所代表的mRNA個性化腫瘤治療性疫苗治療路徑，有望在現有免疫治療基礎上進一步拓展受益人群，並帶來更多治療選擇。」雲頂新耀首席執行官羅永慶表示：「非常高興看到EVM16的首次人體臨床試驗數據在AACR大會上公佈。此次公佈的在晚期實體瘤患者中展現出良好的安全性與耐受性、療效及作用機制等方面的積極結果，初步驗證了EVM16的治療潛力和雲頂新耀自研mRNA平台的臨床價值。對於晚期實體瘤患者而言，尤其是多線治療失敗人群，仍然缺乏有效且具有針對性的治療選擇。EVM16作為公司自主研發的mRNA個性化腫瘤治療性疫苗，具備誘導免疫啟動並產生新抗原特異性T細胞應答的潛力，有望預防腫瘤轉移或復發，代表了腫瘤免疫治療的重要探索方向。該項目基於公司自主研發的EVER-NEO-1『妙算』腫瘤新抗原人工智慧演算法系統。該系統可基於患者腫瘤特異性突變進行分析，識別具有較高免疫原性的腫瘤新抗原，並生成相應的mRNA疫苗設計方案，且具備自我迭代優化能力，以持續提升新抗原預測與篩選效率。依託國際領先的mRNA平台，我們將加速推進EVM16後續臨床開發工作，推動該創新療法惠及更多患者。」雲頂新耀已成功將經過臨床驗證的自研AI+mRNA平台本地化，構建了一個涵蓋從抗原設計、mRNA序列優化、脂質納米顆粒（LNP）靶向遞送技術到產業化生產的端到端全產業鏈平台，具備了在全球範圍內解決巨大未滿足醫療需求的潛力。EVM16是公司自主研發的mRNA個性化腫瘤治療性疫苗，根據每位患者特有的腫瘤細胞突變，通過EVER-NEO-1「妙算」系統識別具有較高免疫原性的腫瘤新抗原，並設計編碼數十種腫瘤新抗原的mRNA治療性疫苗。EVM16通過LNP靶向遞送系統在體內進行高效的抗原呈遞，啟動患者自身的新抗原特異性T細胞免疫，進而達到殺傷腫瘤細胞和治療癌症的目的。從投資與市場維度來看，個體化腫瘤疫苗尚處早期突破期。根據Grand View Research的預測，全球個性化癌症疫苗市場規模2030年將達14.5億美元，2025-2030年複合增長率高達44.86%。麥高證券指出，mRNA腫瘤疫苗有望實現泛癌種覆蓋，同時兼具高可及性、現貨化與個性化優勢。作為極具潛力的新型腫瘤免疫療法，其可通過廣泛聯用，以輔助療法切入臨床，逐步打開數百億美元的市場空間。在此背景下，雲頂新耀在該領域的佈局正加速落地，逐步構建具備全球競爭力的研發管線。依託自主AI+mRNA平台與國內率先佈局的臨床身位，雲頂新耀正處於產業化與估值成長的關鍵節點。本次EVM16首次人體臨床試驗（FIH）數據的讀出，有望進一步釋放臨床與商業化潛力，進一步吸引市場及投資者持續聚焦，助力公司在腫瘤免疫賽道實現長足的價值跨越。 Copyright 2026 亞太商訊 via SeaPRwire.com. All rights reserved. www.acnnewswire.com