Olaratumab

MELBOURNE, Australia and INDIANAPOLIS, April 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 March 2025 (Q1 2025). All figures are in $US unless stated otherwise. Strong Q1 2025 revenue growth Q1 2025 unaudited revenue of approximately $186 million represents an increase of 62% over the prior year corresponding quarter (Q1 2024: $115M) and a quarter-over-quarter increase of 31% (Q4 2024: $142 million) and includes: $151 million from global sales of Illuccix®, up 35% over the prior year corresponding quarter (Q1 2024: $112 million) and a quarter-over-quarter increase of 9% (Q4 2024: $139 million).$33 million from RLS Radiopharmacies (RLS) since the acquisition completed on 27 January 20251. FY 2025 guidance reaffirmed Telix confirms FY 2025 revenue guidance of $770 million to $800 million2.Guidance reflects revenue from Illuccix® sales in jurisdictions with a marketing authorization, and 11 months of revenue from RLS1,3.Revenue guidance is expected to be updated at the appropriate time, following and subject to reimbursement for Gozellix® in the United States (U.S.) and Illuccix® in ex-U.S. markets.Telix confirms research and development (R&D) expenditure guidance, expecting a year-over-year increased investment range for FY 2025 of 20% to 25% compared to FY 2024. Q1 2025 commentary and recent highlights Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, stated, “Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape. Telix is the only company with two FDA4-approved PSMA-PET5 imaging agents – Illuccix and Gozellix – enabling us to broaden patient reach and maximize choice for our customers. The expansion of our commercial portfolio and launches of Illuccix into new international markets provides a foundation to diversify and grow revenue globally, while we continue to deliver on multiple catalysts in our pipeline. This quarter also includes the first two months of revenue from RLS since completion of our acquisition, highlighting its potential as a platform to drive further growth. This strategic acquisition has significantly expanded our manufacturing footprint in the U.S., which we believe is an increasingly important consideration amid changing global trade dynamics.” Therapeutics business ProstACT™ Global, the Phase 3 trial of TLX591 (177Lu-rosopatamab tetraxetan), Telix’s prostate cancer therapy candidate, continues to recruit and remains on track to deliver a Part 1 readout (safety and dosimetry) in H1 2025.IPAX-Linz, a Phase 2 investigator-initiated trial of TLX101 (131I-iodofalan, or 131I-IPA), Telix’s brain cancer therapy candidate, reported positive preliminary results. Early efficacy from IPAX-1 was substantiated and TLX101 was found to be well tolerated in combination with external beam radiation therapy. No serious adverse events were reported in patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma, often after multiple resections6.Following consultations with the FDA, the Company remains on track to submit Investigational New Drug (IND) applications to enable pivotal trials for TLX101 and Telix’s kidney cancer therapy candidate (TLX250, 177Lu-DOTA-girentuximab) to commence this year, subject to regulatory approval.The first patient was dosed in the Phase 1 ZOLAR7 trial of TLX300-CDx (89Zr-olaratumab), which aims to validate the use of olaratumab, an antibody exclusively licensed from Eli Lilly and Company (Lilly), as a potential treatment for advanced, metastatic soft tissue sarcoma.Telix completed the acquisition of a suite of clinically validated FAP8-targeting therapeutic and precision medicine (diagnostic) radiopharmaceutical candidates. Telix has added the lead FAP-targeting therapeutic compound to its pipeline under the designation TLX400.Telix acquired the therapeutics assets of antibody engineering company ImaginAb, Inc. The transaction included a pipeline of next-generation therapeutic candidates, a proprietary novel biologics technology platform, and a protein engineering and discovery research facility in Los Angeles, California9, staffed by a talented team of discovery, protein engineering and radiopharmaceutical development experts who joined the Company on the ImaginAb acquisition closing.Telix announced that it has developed and validated a breakthrough generator technology for the production of lead-212 (212Pb) and successfully completed first production of this promising alpha-emitting therapeutic radioisotope10. The new generator technology, developed internally by Telix’s IsoTherapeutics team, significantly increases the amount of radioactivity, yield and shelf life compared to currently available 212Pb generators and provides an additional isotope supply for Telix’s next-generation targeted alpha therapy program. Precision Medicine business On 21 March 2025, the FDA approved the New Drug Application (NDA) for Gozellix®11, Telix’s next-generation PSMA-PET imaging agent for prostate cancer that provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products.Commercial launch of Gozellix® in the U.S. is expected to commence during Q2 2025 where Telix has appointed Cardinal Health, Inc. (Cardinal Health)12 and RLS Radiopharmacies as distribution partners.Telix received a positive decision on the decentralized Marketing Authorization Application (MAA) for Illuccix® in the European Economic Area (EEA)13. Illuccix® also received MAA approval in the United Kingdom (UK) and Brazil. Country level approvals are now being implemented in the EEA, with approvals to date granted in Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway, and Sweden14.Illuccix® is now commercially available in Brazil, under the joint venture with R2PHARMA (Telix Innovations Brazil, Ltda.), and commercial launches will commence in the UK and in European markets where Illuccix® has received approval during Q2 2025.The FDA accepted the Biologics License Application (BLA) for Telix’s kidney cancer imaging candidate TLX250-CDx (Zircaix®15, 89Zr-DFO-girentuximab), granted a Priority Review, and provided a PDUFA16 goal date of 27 August 2025.The NDA for TLX101-CDx (Pixclara®15, 18F-floretyrosine or 18F-FET), Telix’s brain cancer imaging candidate, continues to progress with a PDUFA goal date of 26 April 2025. Telix Manufacturing Solutions (TMS) In April, the TMS Brussels South facility (Seneffe) received notice of its GMP accreditation, enabling first commercial radiopharmaceutical dose production.Telix reaffirms that it does not expect any material impact on its business or supply chain as a result of the international trade tariffs announced by the U.S. government on 2 April 2025 (subject to a three-month delay) or the subsequent inclusion of pharmaceuticals. Telix has an extensive U.S.-based manufacturing and distribution infrastructure, including third-party manufacturing sites and radiopharmacy partner networks, for the production and delivery of its FDA-approved products Illuccix® and Gozellix®17.Telix also notes that it does not rely on rare earth elements of the kind utilized in semi-conductor supply chains and is therefore not impacted by the recent export controls imposed by the Chinese government this month. Board renewal Telix announced new Director appointments as part of a Board succession planning and renewal process18: H Kevin McCann AO will retire as a Non-Executive Director (NED) and Board Chairman on 21 May 2025, immediately following Telix’s Annual General Meeting.Tiffany Olson will be appointed Board Chair following Mr. McCann’s retirement.Marie McDonald joined the Board as a NED, effective 3 March 2025 and, on appointment, immediately succeeded Mr. McCann as Chair of the People Committee.Anne Whitaker joined the Board as a NED, effective 7 April 2025, and was appointed as a member of the Audit and Risk Committee and the People Committee. Guidance disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation, regulation, or policy that affects product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix’s ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Telix’s prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA19, the Australian Therapeutic Goods Administration (TGA)20, Health Canada21, the UK Medicines and Healthcare Products Regulatory Agency (MHRA)22, by the Brazilian Health Regulatory Agency (ANVISA)23, and in multiple countries within the European Economic Area (EEA)24. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM25. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the FDA26. Telix’s osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix’s miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Telix Investor Relations (U.S.) Annie KasparianTelix Pharmaceuticals LimitedDirector Investor Relations and Corporate CommunicationsEmail: annie.kasparian@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. ______________________________________________1 Excludes revenue contribution from Illuccix® sales.2 Refer to ASX disclosures 20 February 2025. 3 See Guidance Disclaimer for further information.4 U.S. Food and Drug Administration.5 Imaging of prostate-specific membrane antigen with positron emission tomography.6 Telix ASX disclosure 16 April 2025.7 Telix media release 1 April 2025. ClinicalTrials.gov ID: NCT06537596.8 Fibroblast activation protein.9 Telix ASX disclosure 13 January 2025.10 Telix media release 13 March 2025.11 Telix ASX disclosure 21 March 2025.12 Telix media release 8 April 2025.13 Telix ASX disclosure 17 March 2025.14 Illuccix® received marketing authorization in the UK, Brazil, Denmark, Luxembourg, Malta, the Netherlands and Norway during Q1 2025. Illuccix® received marketing authorization in Ireland and Sweden on 4 and 11 April 2025, respectively. 15 Brand name subject to final regulatory approval. 16 Prescription Drug User Fee Act.   17 Telix ASX disclosure 7 April 2025.18 Telix ASX disclosure 26 February 2025.19 Telix ASX disclosure 20 December 2021.20 Telix ASX disclosure 2 November 2021.21 Telix ASX disclosure 14 October 2022.22 Telix ASX disclosure 13 February 2025.23 Telix ASX disclosure 18 March 2025.24 Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release.25 Telix ASX disclosure 17 January 2025.26 Telix ASX disclosure 21 March 2025.

关注并星标CPHI制药在线从2025年起至2029年，多款生物制剂将陆续面临专利保护终止的节点，涵盖肿瘤、自身免疫、代谢紊乱及罕见病等多个高价值治疗领域（图1）。这些面临专利悬崖的重要药物不仅在全球药品销售榜上长期占据前列，也在各大跨国药企的收入结构中扮演核心角色。随着专利期的结束，生物类似药的进入将加速重塑市场竞争格局，为仿制药企打开数十亿美元级别的商业机会，同时也迫使原研药企加快布局生命周期管理、差异化竞争与市场准入策略的调整。专利悬崖不仅意味着法律地位的转变，更预示着一个新的竞争周期的开启。　　图1. 2025-2029年部分生物制剂专利到期时间轴。2025年：HER2靶向格局或生变，自免仿制潜力渐显2025年将成为HER2阳性乳腺癌治疗领域的一个转折点。基因泰克的Perjeta（Pertuzumab，帕妥珠单抗，中国商品名：帕捷特）专利即将到期，这款与Herceptin联用的疗法是乳腺癌靶向治疗的重要基石。尽管生物类似药的开发在结构与疗效比对上仍有一定技术门槛，但已有多家公司布局相关管线，预示着HER2靶向治疗未来将走向价格优化与市场细分并行的格局。同样在2025年面临专利悬崖的GSK的Benlysta（belimumab，贝利尤单抗，中国商品名：倍力腾）是系统性红斑狼疮领域的首个生物制剂。其结构相对传统，开发难度较低，因此生物类似药的进入预计将更加迅速，有望打破目前该领域的高价垄断，扩大治疗的可及性。Blincyto（Blinatumomab，贝林妥欧单抗，中文商品名：贝利妥）为Amgen开发的双特异性抗体，用于治疗急性淋巴细胞白血病，其构建机制复杂、剂型特殊，对生物类似药开发提出更高挑战，仿制企业需具备扎实的双抗工艺平台。Elelyso（taliglucerase alfa）则针对戈谢病这一罕见病种，尽管市场规模有限，但在专利到期后，价格的适度下降可能带来治疗的边际人群扩大。2026年：自身免疫与软组织肿瘤治疗面临洗牌2026年，基因泰克的另一款 HER2阳性乳腺癌药物Kadcyla（ado-trastuzumab emtansin）专利即将到期。虽Kadcyla专利保护期将尽，但其作为 ADC模态的药物具有复杂的生产工艺和药代动力学特性，使得仿制门槛依然很高。其潜在生物类似药需在连接子稳定性、毒素释放效率等多个维度实现一致性，预计市场进入将较为谨慎。礼来的Lartruvo（Olaratumab，奥拉鲁单抗）尽管曾获FDA加速批准用于软组织肉瘤，但由于后期研究未达预期已退出市场，其专利到期更多具象征意义。而礼来另一款单抗药物Taltz（Ixekizumab，依奇珠单抗，中文商品名：拓咨）则是礼来在银屑病和银屑病关节炎领域的重要布局产品之一，其结构较为常规。随着IL-17通路药物竞争日趋激烈，Taltz的专利到期可能刺激同类产品价格联动式下调，也为生物类似药打开切入口。2027年：代谢病与罕见病治疗双线释放机会2027年，代谢性疾病治疗将成为焦点。礼来的Trulicity（Dulaglutide，度拉糖肽，中文商品名：度易达）为GLP-1受体激动剂类生物药，其在全球2型糖尿病管理中占据重要地位。尽管目前GLP-1药物以多肽新药（如semaglutide和tirzepatide）为主导，但生物类似药仍可能凭借医保放量和价格优势切入市场，特别是在发展中国家。需要指出的是，虽然度拉糖肽的名称似乎显示其分子模态为多肽，但根据FDA的标准，该药物属于蛋白质（氨基酸残基数量远大于40）。Repatha（Evolocumab，依洛尤单抗，中文商品名：瑞百安）则是降脂治疗领域的明星产品，靶向PCSK9，技术结构相对清晰，安进的原研市场或将迎来仿制挑战者。另一方面，罕见病药物如Myalept（metreleptin，中文商品名：美曲普汀）与Sylvant（siltuximab，司妥昔单抗，中文商品名：萨温珂）分别用于脂肪营养不良与Castleman病，尽管患者基数较小，但在定价上长期维持高位，仿制药若成功推出，将显著影响药企盈利结构。2028年：免疫肿瘤黄金时代走向价格重估2028年将是免疫肿瘤药物市场重新洗牌的关键时刻。默沙东的Keytruda（Pembrolizumab，帕博利珠单抗，中文商品名：可瑞达）与BMS的Opdivo（Nivolumab，纳武利尤单抗，中文商品名：欧狄沃）这两大令人高山仰止的肿瘤学产品均将步入专利到期周期，这两款超巨重磅炸弹PD-1免疫检查点抑制剂几乎主导了全球多个癌种的一线免疫治疗格局。尽管其结构相对标准，技术仿制障碍较低，但监管机构对生物类似药在免疫肿瘤领域的临床一致性要求极高，加之其适应症广泛，将使得生物类似药的开发必须精细划分适应症并分阶段获批，逐步蚕食市场份额。专利到期将加速PD-1药物在中低收入市场的普及，也可能促使原研药大幅调整定价策略，以留存市场份额。2029年：自身免疫与血液瘤市场再迎竞逐到2029年，更多大体量产品将面对专利悬崖 。强生的Darzalex（Daratumumab，达雷妥尤单抗，中文商品名 ：兆珂）作为CD38靶点的多发性骨髓瘤生物制剂，在全球范围内维持了稳定的市场扩张，是多发性骨髓瘤治疗的主力产品，随着其全球销售额突破百亿美元，专利到期后的市场争夺战料将激烈。其复杂糖基化模式以及Fc改造机制为仿制企业带来技术挑战，但在高价格驱动下，已有多家企业提前展开布局。Ocrevus（ocrelizumab，奥瑞珠单抗）则是罗氏在多发性硬化治疗中的核心资产，兼具高效与安全性，其结构仿制可行，但治疗窗要求精细，后续药物可能更注重使用便捷性与长期随访数据。诺华的Cosentyx（Secukinumab，司库奇尤单抗，中文名称：可善挺）与安进的Enbrel（Etanercept，依那西普）则均为成熟的自身免疫治疗药物，市场格局已经相对开放，生物类似药的渗透速度预计将更快，并可能引导IL通路及TNF通路药物价格进一步下探。而Enbrel在美国延长专利的多年争议也提醒市场，专利并非铁板一块，法律诉讼、授权模式与市场准入政策同样决定产品生命周期的真正终点。结语：从专利到市场，生物制剂的新周期已然开启随着2025–2029年间一系列重磅生物制剂的专利相继到期，原研药企需要重新审视生命周期管理策略，从新适应症拓展、给药方式创新，到自有生物类似药的内部布局，争取在失去专利保护后依然保有市场份额。而对于仿制药企业而言，技术平台成熟度、质量一致性、监管路径优化以及成本控制将是能否在新一轮“生物仿制潮”中脱颖而出的关键。更值得注意的是，随着医保体系对高值药物价格的持续挤压，以及新兴市场国家生物药仿制能力的提升，这一轮专利悬崖或许将不仅仅是一个商业接力的过程，更可能成为全球药物可及性提升与创新转化效率再平衡的重要契机。附表 2025-2029年面临专利悬崖的部分生物制剂END2025金笔奖征文即将截止，速来投稿！领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~