Zirconium (89Zr) girentuximabum senvedoxamum

一，三百万大军中国创新药诺曼底登陆尽管目前的Ai热潮席卷全球，但是若论哪一个行业最先会让中国在全球的产业中披荆斩棘，统治整个世界，我不会选中国的AI，也不会选中国的风能，光能，储能以及电动汽车等等。不是中国的这些产业不够好，不够强。诸如这些能在全球占据优势的产业，中国还有很多，比如汽车配件产业，钢铁产业等等。但是若以本身具有的含金量，体量，以及未来拥有的不可撼动的竞争优势以及商业模式和永续发展的角度看。中国的创新药当成为中国在全世界最耀眼的产业。如果你不相信，那请看看中国的创新药公司已经在全球的渗透的宽度和体量。以下是我简单列举的中国的创新药公司在FDA申报的临床的管线。为什么选30家公司？因为这30家公司就代表着30只大军。代表着300万的创新药大军早就在诺曼底登陆了。代表着一直庞大的不可逆的力量发起了气势磅礴的进攻第一军：百济神州。有多款经FDA批准临床实验的产品，较为典型的有5款，分别为百悦泽®、百泽安®、索托克拉、BGB-16673、Ociperlimab。百济神州每年大概都能将20个左右的临床前分子推进到临床，不用去关心百济在FDA有多少款临床的管线，临床对百济就像每天喝水一样简单，百济神州追求的全球的重磅炸弹。第二军，恒瑞医药。有近20个创新药项目获得美国FDA批准开展临床实验。其中，有4款自主研发的ADC创新药获得美国FDA快速通道资格认定，3款创新药获得美国FDA孤儿药资格认定。恒瑞实行的是群狼战术，总有一些产品能跑出来，在仿制转创新的路上，恒瑞医药连一秒钟都没有犹豫，你大爷毕竟还是你大爷。第三军，迈威生物。有8款进入FDA临床实验的产品，分别是7MW4911、9MW2821、7MW3711和9MW3811，3011,7141,1911,3211。实际上，迈威生物已经准备了12款FDA的临床申报产品，全都是全球首发。对于一个不到200亿人民币的创新药企来说，迈威生物无异于拼命三郎。如果选一个未来的最确定的10倍创新药企业，我首先迈威生物。第四军，百利天恒。有6款FDA批准的临床实验产品，分别为BL-B01D1、BL-M07D1、SI-B001、BL-M05D1、BL-M11D1和BL-M17D1，实际上，百利天恒已经在2024年报里公布了9款FDA申报临床的产品。百利天恒就是一个灰姑娘的逆袭的故事。掌门人朱义已经明确不想多BD了，要少买，要自己在全球卖药。百利天恒的1000多亿市值是很有道理的。第五军，中国生物制药。有6款FDA获批临床实验的产品，分别为LM-350、TQB2102、LM-302、LM-305、TQB2101和TQB6411。第六军，映恩生物。有7款获得FDA批准临床实验的产品，分别为DB-1303、DB-1310、DB-1311、DB-1305、DB-1419、DB-2304和DB-1317。资本市场总是有很多的聪明的资金的，映恩生物拥有多款对国际企业BD的产品，充分证明在线管线的技术含量。我也很意外映恩生物还拥有如此之多的FDA临床的产品，这个公司野心不小。第七军，信达生物。在FDA临床的药品有8款。以12亿美元的首付款BD后，信达生物摘去了头上的研发能力不强的帽子。信达生物的管线很丰富，很厚，这家公司奉行低调发育，时不时的搞一大笔钱。走的稳，自然也就走的远，按照信达生物现在的市值，我认为属于明显的低估了。第八军，康方生物。有3款FDA批准临床相关的产品，分别是派安普利单抗、依沃西单抗和AK146D1,5，诺诚健华有3款FDA批准临床实验的产品，分别为奥布替尼、ICP-248、ICP-332。康方生物的依沃西单抗BD给SUMMIT后，在击败K药的战斗中，不十分利索，但是康方生物拥有15个左右的全球最佳分子的潜力，给一点点时间，康方生物一定会调整姿势，席卷FDA。第九军，亚盛医药。有3款FDA批准临床实验的产品，分别为奥雷巴替尼、利沙托克拉（APG-2575）、APG-244。孤儿药之王，亚盛医药拥有超过16个孤儿药之王的认证。对于研发的实力，毋庸置疑，多年受困资金的束缚的亚盛医药，总有一天，会在解决掉资金的压力后，展现孤儿药之王应有的风采。第十军，远大医药。有3款经FDA批准临床实验并获批相关适应症的产品，分别为TLX250-CDx、SIR-Spheres®钇（90Y）微球注射液和TLX591-CDx。远大在中国创新药的投资者中，名声不够显赫，但是远大医药却拥有两个FDA的突破性疗法的认证。甚至FDA让远大医药一天展开更多的适应症。由于罗列的军队太多，每一支军队都有自己的独特的优势，一以下的20只军队，就不再一一的解读了。也有一些数据不太准确，大差不差。第十一军，先声药业。有5款FDA批准的临床实验产品，分别为SIM0500、SIM0508、SIM0609、SIM0686和先必新®舌下片第十二军，君实生物。有7款创新药物获准在美国开展临床试验，分别为JS001、JS004、JS016、JS006、JS009、JS110、JS207第十三军，和誉B。有3款FDA批准的临床实验产品，分别为匹米替尼（ABSK021）、依帕戈替尼（ABSK011）和ABSK131第十四军，和铂医药。有5款FDA批准的临床实验产品，分别为HBM1020、HBM1022,，HBM1007、HBM9027和HBM9033第十五军，百奥赛图。有4款FDA批准临床实验的产品，分别是YH001、YH003、YH008和YH002第十六军，加科思。有3款FDA批准临床实验的产品，分别是JAB-23E73、JAB-30355和戈来雷塞（JAB-21822）,第十七军，乐普生物。有3款FDA批准临床实验的产品，分别是MRG003、MRG004A和Cretostimogene（CG0070第十八军，宜明昂科。有7款FDA批准临床实验的产品，分别为IMM01、IMM0306、IMM2510、IMM2520、IMM2902、IMM47和IMM40H第十九军，荣昌生物。有3款FDA批准临床实验的产品，分别是泰它西普、维迪西妥单抗和RC88第二十军，科伦博泰。有2款FDA批准临床实验的产品，分别是芦康沙妥珠单抗（sac-TMT）和第二代选择性RET抑制剂A400（EP0031）第二十一军，三生制药。有3款FDA批准临床实验的产品，分别是SSGJ-706、SSGJ-707和抗IL-4Rα单抗第二十二军，迪哲医药。有1款产品获FDA批准上市，另有1款产品获FDA“快速通道认定”，总共有不低于5款药品申请了FDA的临床实验。第二十三军，益方生物。有3款产品获得了FDA批准开展临床实验，分别是D-0120、D-0502和D-2570十四军，海创药业。公司有5个获得FDA临床批准的产品，分别为HC-1119、HP501、HP515、HP537和HP5682第二十五军，石药集团。有6款FDA批准临床试验的产品。第二十六军，复宏汉霖。有4款FDA批准临床实验的产品，分别是HLX43、HLX22、HLX13和HLX42第二十七军，翰森制药。有5个产品获得FDA临床批准，分别是HS-20110、HS-20089、HS-20093、HS-10535和HS-20094第二十八军，维立志博。有6款产品获得了FDA的临床许可，具体如下：LBL-024：LBL-034：LBL-033：。LBL-047：LBL-015：LBL-007：第二十九军，德琪医药。有3款FDA批准临床的产品，分别是ATG-031、ATG-017和ATG-022第三十军,诺诚健华。有3款FDA批准临床实验的产品，分别为奥布替尼、ICP-248、ICP-332二，BD不过沿途下了个蛋中国创新药产业正经历着从"追赶者"到"规则制定者"的历史性转变。根据最新统计数据，全球创新药管线中，中国贡献占比从2020年的8%跃升至2025年的32%，正式超越日本成为"第二梯队"领头羊。正如我在第一部分的罗列，如出一辙。这一转变在FDA临床试验批准方面表现得尤为突出。中国创新药在美国的临床研发起步相对较晚，但增长势头强劲。2007-2023年期间，共有177家中国本土药企的350款原研创新药在美国开展了针对499个适应症的691项临床试验，包括I期临床试验399项（49%）、II期临床试验269项（39%）和III期临床试验83项（12%）162。2024年成为中国创新药FDA临床试验的重要转折点。根据Insight数据库统计，2024年启动的临床试验中，申办者是中国企业、试验地点包含海外的新药临床试验共122项，其中III期（包括II/III）共有14项164。从药物类型看，包括2款PROTAC、4款ADC、1款双抗和1款三抗，其余均为化药，显示出中国创新药研发的多元化趋势。如果投资创新药的投资者稍微用一点心，你可以发现，在我罗列的30只大军中，几乎每一支大军都有对全球药企进行BD，但是，但是，你们发现了没有，每一支大军又留了许多的后手，一是全部保留了中国市场的权益，另外，在BD的管线之外，全部留有自己的王牌的在研管线。你以为的中国创新药业BD是卖身？是丧失了更多的利益？不，相对于创新药本身要求的长时间，大量的资金以及风险的偏好。整个中国对于创新药的资本支持，太少了。少到了中国的创新药企业不得不在全球猥琐发育，顺便就BD几个项目，下几个金蛋，然后拿着BD回来的钱，继续下一阶段的发育。在BD的研发管线之外，即使你不去看更多的资料，仅仅按照我在第一部分的30路大军里去寻找，我们可以清晰的看到，在BD的管线之外，我们的创新药企，仍然有太多的重磅炸弹。我们任然具备许多重磅的全球权益的产品。三，平行的世界，平行的估值2023年8月，恒瑞医药将哮喘药SHR-1905的海外权益以2500万美元首付、潜在里程碑款总计10.25亿美元授权给美国药企AiolosBio。仅半年后，跨国药企GSK即以10亿美元首付款和4亿美元里程碑款的价格整体收购AiolosBio，而从恒瑞医药买来的SHR-1905管线是AiolosBio的唯一资产。这一买一卖之间，AiolosBio凭空赚到了10亿美元首付款，恒瑞医药的这款管线被高价转手，不少从业者认为恒瑞医药吃了大亏。无独有偶。2023年11月，普米斯生物与德国药企BNT达成首笔授权协议，以5500万美元首付款，授予BNT除大中华区外的全球权益，潜在里程碑款总计超10亿美元，将其PD-L1/VEGF双抗PM8002（后被BNT命名为BNT327）授权给BNT。2024年11月13日，BNT又以8亿美元现金和1.5亿里程碑款全资收购了普米斯生物，将其变为自己的中国研发中心。2025年6月2日，BNT与美国药企BMS宣布达成战略合作，双方将共同开发双抗药物BNT327。BMS将向BNT支付15亿美元的首付款，并在2028年前支付总计20亿美元的非或有性周年付款，此外，BNT还有资格获得高达76亿美元的额外开发、监管和商业里程碑付款，潜在交易总额达到111亿美元。这两笔BD交易，极大的震撼了中国的创新药企业和投资者。我们在之前，从来没有想过中国的在线管线可以值这么钱，我们从来没有想过可以这么给一个在研的管线估值。中国创新药企业可以吃一次亏，可以吃两次亏，但是不可能永远吃亏。此后，2025年5月，三生制药首付款12.5亿美金BD了在研管线，2025年10月，信达生物的BD照样是收到了首付款12亿美金。很明显，这些巨额的首付款的背后，是对中国的创新药的在研管线的估值重构。而这些在研管线的拥有者，中国的创新药企业却依然在按照白菜价的估值水平。默沙东收购只有唯一药品Ohtuvayre（ensifentrine，恩西芬群）的维罗纳公司，花了100亿美金。诺华收购AvidityBiosciences花了120亿美金，后者没有商业化的产品，只拥有RNA疗法的技术平台和几款临床前的产品。强生收购Intra-Cellular花了146亿美金，以获得其重磅抗精神病药物Caplyta。、看看这些并购，通常都是为了一款药品，或者一个技术平台，代价都是上百亿美金。不出意外，也不会有意外，不需要两三年时间，就会有MNC向中国的创新药公司发起上百亿美金的并购案例。那时我们终将明白，既然都是在FDA做临床试验，既然都是在欧洲做临床试验，既然都是在中国做临床试验。无论在临床的管线是美国公司，还是中国公司的，抑或是欧洲公司的，这些管线面对的监管是一样的，要求的技术水平是一样的，面对的病人群体是一样的，开出的药品价格是一样的。当然，同样的市场，收益也应该是一样的。就不应该永远存在美国公司高高在上的估值，而中国的创新药公司白菜价的局面。平行的世界，就应该是平行的估值。而要走到这个平行的世界，中国的创新药公司，很多很多，都还具备很多倍的潜力。

MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use of Telix’s investigational PET1 agent, TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab), for molecular imaging of renal masses. Published on the SNMMI website3 and in The Journal of Nuclear Medicine4, the guideline panel5, comprising internationally renowned and multidisciplinary expert key opinion leaders, concludes that “the emerging use of molecular imaging for risk stratification of indeterminate renal masses offers the opportunity to more effectively characterize such lesions and optimize patient management decisions”. The panel asserts that antibody-based radiotracers exhibit lower renal clearance, thereby improving visualization of renal masses. It emphasizes that TLX250-CDx PET “appears to be a well-tolerated and accurate method for non-invasive identification of ccRCC6” and notes by contrast, the high renal excretion with 18F-FDG PET, which obscures accurate lesion detection. The panel references data from Telix’s pivotal Phase 3 ZIRCON trial7, which met all primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions8. TLX250-CDx works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on >95% of ccRCC cells9, to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency. Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology and guideline author, commented, “The recognition of 89Zr-girentuximab PET in the SNMMI/EANM/ACNM clinical guidelines reflects a shift toward precision medicine in renal cancer, providing clinicians with a more accurate tool for diagnosis to guide optimal, individualized treatment planning for patients.” Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, added, “The inclusion of TLX250-CDx PET imaging for the first time in SNMMI/EANM/ACNM guidelines is an important development for Telix and will help raise awareness of this breakthrough precision diagnostic. Subject to regulatory approval, endorsement by this expert global multidisciplinary panel will help to drive adoption and implementation into clinical workflows, supporting clinical utility and enhancing decision-making to improve patient outcomes.” SNMMI, EANM and ACNM periodically define new procedure standards/guidelines to help advance the science of nuclear medicine and to improve the quality of service to patients. Each standard/guideline, representing a policy statement by these groups undergoes a thorough consensus process in which it has been subjected to extensive review. About TLX250-CDx TLX250-CDx is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. For more on TLX250-CDx and Telix’s theranostic kidney cancer program, click here. TLX250-CDx has not received a marketing authorization in any jurisdiction. 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, United Kingdom, 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. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA10. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (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 (Global) Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Telix Investor Relations (U.S.)  Annie Kasparian  Telix Pharmaceuticals Limited  Director Investor Relations and Corporate Communications  Email: annie.kasparian@telixpharma.com Media Contact Eliza SchleifsteinEliza@schleifsteinpr.com Legal Notices Cautionary Statement Regarding Forward-Looking Statements. 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. 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All rights reserved. 1 Positron emission tomography.2 Brand name subject to final regulatory approval.3 https://snmmi.org/common/Uploaded%20files/Web/Clinical%20Practice/Procedure%20Standards/2025/SNMMI_EANM_ACNM_Renal_Masses-Final%20JNM%20sumbission.pdf4 SNMMI/EANM/ACNM Procedure Standard/Procedure Guideline on the Use of Molecular Imaging for Renal Mass Characterization (October 2025), available at: https://jnm.snmjournals.org/content/early/2025/10/09/jnumed.125.271332.abstract5 Steven P. Rowe, Brian M. Shuch, Mark W. Ball, Axel Bex, Mehrbod S. Javadi, Alan Klitzke, Karolien Goffin, Peter Mulders, Neeta Pandit-Taskar, Ashwin Singh Parihar, Benjamin L. Viglianti, Michael A. Gorin, and Ken Herrmann.6 Clear cell renal cell carcinoma, the most common and one of the most aggressive subtypes of kidney cancer. 7 ClinicalTrials.gov ID: NCT03849118.8 Telix ASX disclosures 7 November 2022. Shuch et al. Lancet Oncology. 2024.9 Stillebroer et al. Eur Urol. 2010.10 Telix ASX disclosure 21 March 2025.