Telix Spins Off Rhine Pharma to Expand Global Access to Radiopharmaceuticals
Telix Spins Off Rhine Pharma to Expand Global Access to Radiopharmaceuticals
MELBOURNE, Australia, Oct. 22, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the spin-off of Rhine Pharma[1], which has the mission of expanding global access to innovative radiopharmaceuticals for cancer imaging and treatment using two generator-produced isotopes, technetium-99m (99mTc) and rhenium-188 (188Re).
墨爾本,澳洲,2024年10月22日 / PRNewswire / - Telix Pharmaceuticals有限公司(ASX:TLX,Telix,本公司)今天宣佈旋轉Rhine Pharma[1],其使命是利用兩種由發電機產生的同位素technetium-9900萬(99mTc)和rhenium-188(188Re),擴大全球創新放射性藥物,用於癌症影像和治療。
Rhine Pharma was formed following a collaboration between Telix and Heidelberg University Hospital (UKHD), which aimed to develop a PSMA[2]-targeting small molecule that could be labelled with either 99mTc for SPECT[3] imaging, or 188Re for radioligand therapy. The collaboration successfully created a potential next-generation theranostic compound, RHN001[4], which Rhine Pharma is now advancing into a novel Phase I/IIa theranostic clinical study (the 'RHINO Trial'), exploring the safety profile and efficacy of both 99mTc-RHN001 and 188Re-RHN001 in patients with advanced prostate cancer.
Rhine Pharma是Telix和海德堡大學醫院(UKHD)合作後成立的,旨在開發可用99mTc進行SPECT[3]成像或用188Re進行放射配體治療的PSMA[2]-靶向化合物。該合作成功創建了一種潛在的下一代治療探針RHN001[4],Rhine Pharma現在將其推進到一項新型I/IIa期治療性臨床研究('RHINO試驗')中,研究99mTc-RHN001和188Re-RHN001在晚期前列腺癌患者中的安全性和療效。
Because 99mTc and 188Re can each be produced using on-site generators, they enable a highly-differentiated solution for regions with limited radiopharmaceutical manufacturing infrastructure or dispersed populations. 99mTc enables imaging of patients with widely available SPECT scanners, while 188Re has demonstrated potential as a therapeutic isotope, thanks to its high-energy beta emission that maximises damage to tumour cells. Its short half-life (16.9 hours) also has the potential to simplify patient workflows in busy treatment centres with high patient demand or limited nuclear waste management capabilities.
由於99mTc和188Re可以分別使用現場發電機產生,它們爲具有有限放射性藥物製造基礎設施或分散人口的地區提供了高度差異化的解決方案。 99mTc能夠利用SPECt掃描儀進行廣泛可用的患者成像,而188Re已經展現出作爲治療同位素的潛力,得益於其最大限度地損傷腫瘤細胞的高能β發射。其較短的半衰期(16.9小時)也有可能簡化繁忙治療中心中繁忙患者需求或有限核廢物管理能力的病人工作流程。
Radiopharmaceuticals based on more common therapeutic radioisotopes (on market or in development) such as lutetium-177 (177Lu) and actinium-225 (225Ac), are typically centrally manufactured in facilities that require significant investment and infrastructure to operate, such as reactors or cyclotrons. By contrast, a generator is a convenient system for on-site production of some commonly-used radionuclides.
基於更常見的治療性放射同位素(在市場上或開發中)如lutetium-177(177Lu)和actinium-225(225Ac)的放射性藥物通常在需要大量投資和基礎設施運營的中央製造設施中製造,例如反應堆或迴旋加速器。相比之下,發電機是一種便利的系統,用於常用放射核素的現場生產。
Richard Valeix, Chief Executive Officer, Therapeutics, Telix, said, "Rhine Pharma is an example of identifying an access-to-medicine challenge and then working to fix it. While radiopharmaceuticals can be a powerful way to image and treat cancer, manufacturing doses and getting them to patients can be complex and costly, particularly in emerging markets or geographically dispersed populations. Using generators for production could reduce costs and simplify the supply chain. This means the combination of 188Re and 99mTc has potential for addressing unmet needs in cancer treatment for more people, in more countries."
Therapeutics的首席執行官Richard Valeix表示:「Rhine Pharma是識別藥物獲取挑戰並努力解決的一個例子。雖然放射性藥物可以成爲影像和治療癌症的有力方式,但製造劑量並將其送達患者可能會複雜而昂貴,尤其是在新興市場或地理上分散的人口中。使用發電機生產可以降低成本並簡化供應鏈。這意味着結合188Re和99mTc有潛力滿足更多人、更多國家的癌症治療需求。」
Christian Behrenbruch, Managing Director and Group Chief Executive Officer, Telix, said, "This is an exciting story of collaborative innovation aligned with our values, particularly our commitment to increasing access to medicine. It also demonstrates Telix's ability to drive in-house innovation that can move seamlessly from the laboratory to the clinic and evolve commercially. Spinning off Rhine Pharma makes room in our pipeline for future opportunities and gives Rhine Pharma the focus it needs to succeed."
Telix的董事總經理兼集團首席執行官Christian Behrenbruch表示:「這是一個充滿合作創新的激動人心故事,與我們的價值觀完全一致,特別是我們增加獲得藥物的承諾。它還展示了Telix推動內部創新,能夠無縫從實驗室轉移到診所並商業化發展。Rhine Pharma的分拆爲我們的管道留出了未來機會,並給予Rhine Pharma成功所需的關注。」
Rhine Pharma is strongly supported by its renowned Founding Scientific Advisors - Professor Frederik Giesel[5], Professor Ken Herrmann[6], Professor Clemens Kratochwil[7] and Dr Jens Cardinale[8] - and is working closely with the Nuclear Medicine Research Infrastructure (NuMeRI), a groundbreaking facility at the University of Pretoria, South Africa. Opened in May 2024, the facility is committed to advancing nuclear medicine research in the region. The RHINO Trial has received both ethics and regulatory approval in South Africa and is being run by NuMeRI's CEO and President, Professor Mike Sathekge, and his team.
Rhine Pharma得到其著名的創始科學顧問-Professor Frederik Giesel,Professor Ken Herrmann,Professor Clemens Kratochwil和Dr Jens Cardinale的大力支持,並與南非比勒陀利亞大學的開創性核醫學研究基礎設施(NuMeRI)密切合作。這一設施於2024年5月啓用,致力於推動該地區的核醫學研究。RHINO試驗已在南非獲得倫理和監管批准,並由NuMeRI的首席執行官兼總統Mike Sathekge教授及其團隊負責運行。”
Professor Sathekge said, "NuMeRI is working to bring the benefits of precision medicine and radiopharmaceutical therapy to more people, regardless of their location or income. It's only through innovation and collaboration that we can marshal the resources needed to achieve this goal, and partnering with Rhine Pharma on this clinical trial is an exciting opportunity to advance research in this area. We look forward to seeing how RHN001 performs in the clinic."
Sathekge教授表示:「NuMeRI致力於將精準醫學和放射性藥物治療的益處帶給更多人,無論他們所在地或收入如何。只有通過創新和合作,我們才能認真籌集實現這一目標所需的資源,與Rhine Pharma合作進行這項臨床試驗是推動該領域研究的令人興奮的機會。我們期待看到RHN001在診所表現如何。」
About Rhine Pharma
關於萊因製藥
Rhine Pharma is a wholly-owned subsidiary of Telix and once key milestones are achieved, Telix plans to structure it as an independent company. Its mission is to expand global access to innovative cancer imaging and therapy by leveraging the unique benefits of technetium-99m (99mTc) and rhenium-188 (188Re). Visit for further information.
萊因製藥是澳大利亞Telix的全資子公司,一旦實現關鍵里程碑,Telix計劃將其構建成一個獨立公司。其使命是通過利用鍀-9900萬(99mTc)和錸-188(188Re)的獨特優勢,擴大全球創新癌症影像和治療的訪問。 了解更多信息,請訪問
About Telix Pharmaceuticals Limited
關於Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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).
Telix是一家專注於治療和診斷放射藥物及相關醫療設備的生物製藥公司。Telix總部位於澳大利亞墨爾本,國際業務遍及美國、歐洲(比利時和瑞士)以及日本。Telix正在開發一系列臨床和商業化階段的產品,旨在解決腫瘤學和罕見病領域的重大醫療需求。Telix在澳大利亞證券交易所上市(ASX:TLX)。
Telix's lead 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 U.S. Food and Drug Administration (FDA)[9], by the Australian Therapeutic Goods Administration (TGA) [10], and by Health Canada[11]. No other Telix product has received a marketing authorisation in any jurisdiction.
Telix的主要成像產品鎵-68(68Ga)戈澤肽注射液(又名68Ga PSMA-11,市場上銷售的品牌名爲Illuccix),已獲得美國食品和藥物管理局(FDA)[9]、澳大利亞治療品管理局(TGA)[10]和加拿大衛生部[11]的批准。 Telix的其他產品在任何司法管轄區均未獲得營銷授權。
Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.
Telix投資者關係
Telix Investor Relations
Ms. Kyahn Williamson
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]
Kyahn Williamson女士
Telix製藥有限公司
高級副總裁投資者關係和企業傳訊
電子郵件:[email protected]
Legal Notices
法律聲明
You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website.
您應該閱讀此公告,並與我們在最近提交給澳大利亞證券交易所(ASX)或我們網站上披露的風險因素一起閱讀。
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.
本公告中包含的信息不打算在包括美國在內的任何管轄區作爲Telix Pharmaceuticals Limited (Telix)證券的認購提供、邀請或推薦。本公告中包含的信息和意見可能隨時改變,無需事先通知。根據法律最大允許範圍,Telix不承擔對本公告中包含的任何信息或意見的更新或修訂的任何義務或承諾,包括任何前瞻性陳述(如下所述),不論是因爲新信息、未來發展、期望或假設的改變還是其他原因。就本公告中包含的信息或表達的意見的準確性或完整性,不作任何明示或暗示的陳述或保證。
This announcement may contain forward-looking statements 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 commercialisation 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; 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.
此公告可能包含與預期未來事件、財務表現、計劃、策略或業務發展相關的前瞻性聲明。前瞻性聲明通常可以通過使用"可能"、"預期"、"打算"、"計劃"、"估計"、"預見"、"相信"、"展望"、"預測"和"指導"等詞語來識別,或者通過這些詞語的否定形式或其他類似的術語或表達來識別。前瞻性聲明涉及已知和未知的風險、不確定性和可能導致我們的實際結果、活動水平、表現或成就與這些前瞻性聲明所表達或暗示的任何未來結果、活動水平、表現或成就有實質性差異的其他因素。前瞻性聲明基於Telix的良好信念假設,這些假設涉及在Telix業務和未來運營中存在並影響Telix的財務、市場、監管和其他風險和考慮,但不能保證任何假設都將被證明是正確的。在Telix業務的背景下,前瞻性聲明可能包括但不限於有關以下方面的聲明:Telix的臨床前和臨床試驗的啓動、時間安排、進展和結果以及Telix的研發項目;Telix能否將產品候選進展到、招募和成功完成臨床研究,包括跨國臨床試驗;以及Telix產品候選提交監管申請和獲得批准的時間或可能性、製造活動和產品營銷活動;Telix的銷售、營銷、分銷和製造能力和策略;Telix的產品候選獲批後的商業化時間;以及Telix是否能夠以合理成本獲得其產品和產品候選的充足原材料;Telix的費用、未來收入和資本需求的估計;Telix的財務表現;有關Telix競爭對手和行業的發展;以及在其產品候選獲得批准後,Telix產品候選的定價和報銷。Telix的實際結果、表現或成就可能與此類聲明可能表述或暗示的結果實質性不同,這種差異可能是不利的。因此,您不應完全依賴這些前瞻性聲明。
2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
2024年Telix Pharmaceuticals有限公司。Telix Pharmaceuticals和Illuccix的名稱和標誌是Telix Pharmaceuticals有限公司及其關聯公司的商標-保留所有權利。
[1] Wholly owned Telix subsidiary. |
[2] Prostate-specific membrane antigen. |
[3] Single photon emission computed tomography. |
[4] Cardinale J. et al. J Nucl Med. 2023. |
[5] Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich Heine University Duesseldorf, Duesseldorf, Germany. |
[6] Department of Nuclear Medicine at the Universitätsklinikum Essen, Essen, Germany. |
[7] Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany. |
[8] Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf. |
[9] Telix ASX disclosure 20 December 2021. |
[10] Telix ASX disclosure 2 November 2021. |
[11] Telix ASX disclosure 14 October 2022. |
[1] Telix全資子公司。 |
[2] 前列腺特異性膜抗原。 |
[3] 單光子發射計算機斷層掃描。 |
[4] Cardinale J.等人 J Nucl Med. 2023。 |
[5]德國杜塞爾多夫海因裏希·海因大學醫學院和大學醫院核醫學部。 |
[6]Essen大學醫學部核醫學科,Essen,德國。 |
[7]德國海德堡大學醫院核醫學部,海德堡。 |
[8]德國杜塞爾多夫醫學院和大學醫院核醫學部。 |
[9] Telix ASX 披露 2021年12月20日。 |
[10] Telix ASX 披露 2021年11月2日。 |
[11] Telix ASX 披露 2022年10月14日。 |
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