logo
Novotech憑藉與Tune Therapeutics的策略合作榮膺Citeline CRO年度合作夥伴關係獎

Novotech憑藉與Tune Therapeutics的策略合作榮膺Citeline CRO年度合作夥伴關係獎

Business Wire13-05-2025
澳洲雪梨--(BUSINESS WIRE)--(美國商業資訊)-- 作為一家可提供全方位服務的國際性受託研究機構 (CRO) 和科學諮詢公司,Novotech有幸榮膺Citeline CRO年度合作夥伴關係獎。這項殊榮表彰了Novotech與表觀基因編輯龍頭企業Tune Therapeutics之間的策略合作,嘉許了雙方團隊之間的卓越合作夥伴關係,並為CRO與生物技術公司之間的合作夥伴關係樹立了業界新標杆。
Novotech 與 Tune Therapeutics 的合作重點是一項有潛力徹底改變慢性乙型肝炎治療格局的表觀遺傳療法的突破性臨床試驗計劃。
Share
CRO年度合作夥伴關係獎旨在表彰CRO與製藥或生物技術公司之間的出色合作。為實現共同目標,雙方勠力同心,致力於推動臨床研究計畫的發展。
治療策略總監Sarah Anderson和業務開發副總監Steve Roan在2025年5月8日於波士頓舉行的Citeline頒獎典禮上代表Novotech受獎。Tune Therapeutics財務副總裁Katie Tarashuck作為合作夥伴代表出席了頒獎典禮。
Novotech和Tune Therapeutics之間的策略合作聚焦於一項開創性臨床試驗計畫,該計畫旨在推動表觀基因療法取得突破性進展,有望徹底改變慢性B型肝炎 (CHB) 的治療格局。雙方的合作夥伴關係將使Novotech的監管、營運和臨床方面的專業知識與Tune的創新科學研發平台和靈活開發策略深度融合。
Novotech執行長John Moller博士表示:「Citeline對我們的認可不僅體現了我們與Tune Therapeutics之間堅實的合作夥伴關係,同時也彰顯了我們的國際團隊致力於幫助患者更快地獲得新型療法的承諾。能與Tune等具有遠見卓識的生物技術公司合作,我們倍感榮幸。同時,我們也期待繼續在療法開發領域提供卓越的臨床服務。」
Tune Therapeutics開發長Heidi Zhang博士表示:「Tune很高興能與Novotech共同受獎。我們攜手進行了創新,將表觀基因組編輯療法融入臨床研究,為全球逾2.5億CHB患者帶來了新曙光。」
這項殊榮認可了Novotech與生物技術合作夥伴之間的通力合作能力,對於該公司運用其監管和臨床專業知識,在多樣化全球環境下有效展開臨床試驗給予肯定。
Zhang博士還表示:「合作的優勢在於我們共同承諾提高透明度、願意直迎挑戰,並能夠組建團隊以迅速有效地採取對策的能力。」
关于 Novotech
Novotech是一家可提供全方位服務的國際性受託研究機構 (CRO) 和科學諮詢公司,在藥物研發的各個階段提供指導,深受生物技術及中小型製藥公司的信賴。
Novotech業務涉及全球多個國家和地區,在亞太地區、北美和歐洲設有30多個辦事處,並與5000多個試驗中心建立了合作關係,透過提供關鍵臨床試驗資源網絡、廣泛接觸不同的受試者群體,幫助客戶加速將前沿的治療方法推向市場。
Novotech透過以客戶為中心的服務模式,將人員、流程和技術無縫整合,提供定制化解決方案,推動變革性的治療方法進入市場。Novotech採用真正的合作夥伴關係模式,堅定地致力於幫助客戶取得成功、推動創新並促進全球醫療保健的發展。Novotech憑藉卓越的臨床試驗執行和創新能力獲得了眾多業界榮譽,包括連續19年蟬聯Frost & Sullivan CRO年度公司獎 (Frost & Sullivan CRO Company of the Year)。Novotech在臨床以及法規方面深厚的專業知識,以及對本地市場的深刻洞察,使其能夠為臨床試驗的順利進行、資料分析的強化以及加速受試者招募策略方面提供支援。
Novotech與客戶攜手,將科學進步轉化為能夠改善全球健康狀況的治療方法,實踐推動創新、創造卓越成果的使命。
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Ethics officials say Georgia PAC tied to Ponzi scheme illegally sought to influence elections
Ethics officials say Georgia PAC tied to Ponzi scheme illegally sought to influence elections

Hamilton Spectator

time2 days ago

  • Hamilton Spectator

Ethics officials say Georgia PAC tied to Ponzi scheme illegally sought to influence elections

ATLANTA (AP) — Georgia's Ethics Commission says a political action committee linked to what federal investigators have called a Ponzi scheme illegally sought to influence elections. The complaint, filed Wednesday, says the spending came from the now-dissolved Georgia Republican Assembly PAC between 2021 and 2024. The committee was headed by Edwin Brant Frost V, the son of a man named in a U.S. Securities and Exchange Commission lawsuit as heading a scheme that took at least $140 million from hundreds of investors. A company named First Liberty Building & Loan promised investors big returns from making high-interest loans to businesses with short-term cash needs, but the SEC complaint says Edwin Brant Frost IV skimmed $17 million for himself, his relatives and their affiliated companies. More than $1 million of that went to political spending that entrenched the Frost family's influence in Republican politics in Georgia, Alabama, Maine and other states, investigators said. But while much is disclosed in campaign contributions, Wednesday's filing raises questions about whether the Frosts were spending on politics in undisclosed ways. The complaint says the PAC could legally give to candidates, but it never registered as an independent committee to directly advocate for and against candidates while spending more than $220,000 to do so. 'The ethics complaint filed today represent our initial charges against the Georgia Republican Assembly-PAC,' Ethics Commission Executive Director David Emadi said in a statement. 'Our investigation remains ongoing and additional charges may be coming at a future date, but we intend to aggressively pursue all violations of Georgia law committed by the GRA which illegally influenced elections in 2022 and 2024.' State Rep. Dale Washburn said undisclosed spending is pernicious. The Macon Republican was attacked in a 2022 mailing cited in the complaint, 'The whole dark money thing, where you can attack a candidate with a name that really doesn't represent who is behind the attack, I think that is a problem and it should be addressed,' Washburn said. No criminal charges have been announced in the alleged financial fraud. Brant Frost V wasn't named in the civil lawsuit filed by the SEC. However, the SEC in a subpoena filed last week sought information about activities of Brant Frost V as a First Liberty employee. The younger Frost made appearances on conservative talk shows promoting First Liberty, and some investors said they dealt with Brant Frost V when putting money into First Liberty. The younger Frost also garnered attention when he incorporated a new lending firm — Heartland Capital LLC. Brant Frost V filed the incorporation papers on June 26, the day before First Liberty announced it had gone bust. Brant Frost V didn't immediately respond to an email and a text message Wednesday. A lawyer for Brant Frost IV didn't respond to an email. Conflict with another political group The PAC shared a name with the Georgia Republican Assembly, a group that seeks to push the Republican Party further to the right . The assembly often endorsed and the PAC often contributed to insurgent Republicans who opposed established GOP leaders. But assembly President Nathaniel Darnell said that while the GRA authorized and promoted the PAC, it was a 'totally separate entity.' 'The entire time the PAC was in operation, the Frosts controlled it with zero oversight from the GRA organization,' said Darnell, who said he personally lost an unspecified amount of money invested in First Liberty. The Frosts had a falling-out with the GRA following this year's state Republican convention . They and other supporters of Georgia GOP Chairman Josh McKoon publicly resigned after the GRA expelled Katie Frost, the sister of Brant Frost V. Katie Frost led a nominating committee that recommended delegates vote against a number of GRA-endorsed party officer candidates. Campaign disclosures show the Frosts and associated companies donated a majority of the PAC's money. One focus was supporting Republican challengers who opposed late state House Speaker David Ralston , whom the GRA viewed as a corrupt moderate. But the complaint shows the PAC also didn't disclose spending in school board races in Coweta County, where the Frosts live, and in a county commissioner race in neighboring Meriwether County. Washburn said he believed he was targeted over his support for Ralston and for a bill that would have allowed some immigrants to pay in-state tuition at Georgia universities and colleges. 'I was kind of taken aback by those mailers when they happened and was honestly angered by them because I thought they were very deceitful and misrepresented some things,' he said. Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .

Frost & Sullivan Released Report: 'Nuoyuan Medical: Class I New Drug Pemefolacianine Completes Phase I Clinical Trial, Advancing Intraoperative Precision Diagnosis'
Frost & Sullivan Released Report: 'Nuoyuan Medical: Class I New Drug Pemefolacianine Completes Phase I Clinical Trial, Advancing Intraoperative Precision Diagnosis'

Associated Press

time2 days ago

  • Associated Press

Frost & Sullivan Released Report: 'Nuoyuan Medical: Class I New Drug Pemefolacianine Completes Phase I Clinical Trial, Advancing Intraoperative Precision Diagnosis'

Frost & Sullivan released a report titled 'Nuoyuan Medical: Class I New Drug Pemefolacianine Completes Phase I Clinical Trial, Advancing Intraoperative Precision Diagnosis.' The report highlights how Nanjing Nuoyuan Medical Devices Co., Ltd. (Nuoyuan Medical) independently developed Class I new drug, Pemefolacianine, recently completed Phase I clinical trials in China with promising results. As an innovative fluorescent imaging agent targeting folate receptor alpha (FRα), Pemefolacianine demonstrated excellent safety and favorable pharmacokinetics. Adopting a dual-track development model of 'drug-device integration', Nuoyuan Medical focuses on technology convergence and clinical translation, driving the joint development of Pemefolacianine and a series of molecular imaging contrast agents along with supporting imaging systems. Pemefolacianine is expected to systematically address the limitations of current contrast agents in intraoperative precision diagnosis of tumors. When combined with a fluorescence imaging system, it offers a superior, real-time diagnostic tool for surgery. Nuoyuan Medical is currently conducting a Phase II clinical trial of Pemefolacianine in China, while clinical trial preparations are underway in the United States. The company has completed patent filings in many countries, demonstrating its strong global competitiveness and forward-looking strategy in the field of molecular imaging. I. The Contemporary Needs of the Precision Tumor Diagnosis and the Advancement of Molecular Imaging Contrast Agents Limitations of Traditional Fluorescent Contrast Agents Indocyanine Green (ICG) is a widely used near-infrared fluorescent agent that has been applied in clinical diagnostics and intraoperative image-guided procedures since its approval in 1956. As a representative passively-targeted agent, ICG has limited specificity for tumor tissues, often leading to a high rate of false-positive findings. Additionally, its relatively low fluorescence quantum yield restricts imaging performance. These limitations have become major bottlenecks to further advances in precision diagnosis during oncologic surgery. The Emergence and Significance of Targeted Fluorescent Contrast Agents To address urgent clinical needs, targeted fluorescent contrast agents have been developed. These contrast agents typically consist of three key components: a targeting ligand, a linker, and a fluorochrome. The fluorochrome emits fluorescence at a defined wavelength, while the targeting ligand binds specifically to biomolecules or cell receptors that are overexpressed on the surface of tumor cells. These novel contrast agents enable precise localization of tumors, improve the accuracy of intraoperative tumor margin identification, allow detection of small lesions, and reduce the risk of residual tumor tissue, ultimately helping to lower postoperative recurrence rates. II. Clinical Value of Pemefolacianine - Folate Receptor Alpha (FRα) is the Key Tumor Biomarker Folate receptors (FRs) are glycoproteins located on the cell membrane and include several subtypes. Among them, alpha subtype (FRα) and beta subtype (FRβ) have drawn particular attention due to their distinct biological features in tumor development and progression. Studies have shown that FRα is overexpressed in various malignancies such as lung cancer and ovarian cancer, while its expression in normal tissues is minimal. This stark contrast makes FRα an ideal molecular marker for tumor diagnosis and therapy. In comparison, FRβ is upregulated in acute myeloid leukemia (AML) and tumor-associated macrophages (TAMs), and also exhibits a certain degree of expression in normal tissues. These marked differences in expression patterns between FR subtypes provide a solid theoretical basis for developing contrast agents that specifically target FRα. - Design Concept and Mechanism of Action of Pemefolacianine Pemefolacianine is a next-generation near-infrared fluorescent (NIRF) agent developed by Nuoyuan Medical using its Artificial Intelligence for Drug Discovery (AIDD) platform. Its core design aims to achieve highly specific targeting of FRα. Preclinical studies have shown that Pemefolacianine has strong selectivity for FRα, with an affinity approximately eight times higher than for FRβ. It can precisely identify and bind to FRα, which is overexpressed on tumor cell surfaces, enabling accurate localization and real-time imaging of tumor tissue. This specific molecular recognition mechanism significantly improves the spatial resolution and specificity of tumor imaging, while effectively reducing the false-positive rate. Pemefolacianine holds a first-mover advantage in the field of fluorescent contrast agents and is currently the only FRα-targeted contrast agent undergoing clinical development worldwide. It is well positioned to provide a new technological foundation for precision tumor diagnosis and treatment. - The Analysis of OTL-38 (Cytalux) Clinical Application OTL-38 is the first near-infrared fluorescent (NIRF) contrast agent targeting folate receptors (FR) to be approved by the U.S. Food and Drug Administration (FDA). In clinical use, it enables precise detection of small lesions, including those potentially missed by conventional methods, thereby significantly enhancing lesion detection efficiency. OTL-38 was approved by the FDA in 2021 and 2022 for intraoperative identification of malignant lesions in ovarian cancer and lung cancer, respectively. Despite its favorable contrast imaging effect, OTL-38 has certain limitations. Firstly, it lacks selectivity between FRα and FRβ, which has led to a relatively high false-positive rate in clinical trials. Secondly, in terms of pharmaceutical stability, OTL-38 must be stored and transported at temperatures below -20°C. - Advantages of Pemefolacianine With a strong foundation in AIDD, Nuoyuan Medical has developed Pemefolacianine, a structurally novel contrast agent designed to offer a more effective real-time diagnostic for precision tumor surgery. - Enhanced Targeting: Pemefolacianine selectively binds to FRα, which may help reduce the clinical false-positive rate. - Improved Stability: Pemefolacianine remains stable at 2-8°C or 25°C, greatly easing storage and transportation requirements. - Better Compatibility: Pemefolacianine is compatible with 0.9% sodium chloride injection or 5% glucose injection, offering better suitability for diabetic patients. - Higher Safety Profile: In the Phase I clinical trial of Pemefolacianine, no drug-related adverse events were observed. III. The Results of Pemefolacianine Phase I Clinical Trial in China The Phase I clinical trial of Pemefolacianine in China has been successfully completed with positive results. The study was initiated following approval from the ethics committee (YW2025-010(F1)) and was registered on the Chinese Clinical Trial Register (CTR20250567). A total of 32 healthy participants were enrolled and randomized at a 6:2 ratio to receive either Pemefolacianine for injection or a placebo. No drug-related adverse events were reported during the trial, indicating that Pemefolacianine has a favorable safety and tolerability profile. The area under the AUC (area under the curve) and the maximum plasma concentration (Cmax) of Pemefolacianine increased linearly with dose. The elimination half-life ranged from 1.59 to 7.86 hours. Additionally, both fluorescence intensity and central point spectral values exhibited a dose-dependent correlation. Table: Key Results of Pemefolacianine Phase I Clinical Trial in China IV. Global Clinical Development and Market Strategy Nuoyuan Medical recognizes the strategic importance of globalizing innovative drug development and has implemented a dual-track clinical development and market strategy for Pemefolacianine across both Chinese and international markets. To support this goal, the company has adopted a 'China U.S. dual filing and approval' approach. In addition, Pemefolacianine has secured patent authorizations in China, the U.S., Europe, and Japan, establishing a strong foundation for global commercialization and intellectual property protection. - Domestic Development Plan: Initiation of Phase II Clinical Trial in China Following the successful completion of the Phase I trial and confirmation of its safety profile, Nuoyuan Medical has launched a Phase II clinical trial of Pemefolacianine in China. This trial aims to systematically evaluate the efficacy of Pemefolacianine in intraoperative tumor imaging, along with further assessment of its safety. - International Strategy: FDA IND Approval and Global Expansion After the U.S. FDA approved Cytalux (OTL-38), the first folate receptor-targeted contrast agent, Pemefolacianine became the first FRα-targeted fluorescent contrast agent from China to receive Investigational New Drug (IND) approval from the FDA. Nuoyuan Medical is actively preparing for clinical trials in the United States to accelerate its global registration, with the goal of positioning Pemefolacianine as a leading targeted fluorescent contrast agent worldwide. V. Robust Product Pipeline and Forward-Looking Strategy In addition to Pemefolacianine, Nuoyuan Medical has established a diverse molecular imaging product pipeline, reflecting its strong capabilities in innovative drug development and forward-looking strategic planning. With a comprehensive portfolio spanning both fluorescent and radionuclide imaging, and encompassing both broad-spectrum and targeted contrast agents, the company is well-positioned for resilience and long-term growth in the molecular imaging market. Currently, the next-generation broad-spectrum fluorescent contrast agent Glydocyanine Green and the next-generation SPECT-CT radionuclide contrast agent NY-99mTc-FAPI-068 have both entered the IND submission stage in China and the United States. Indocyanine Green (ICG) for Injection: As a broad-spectrum fluorescent imaging agent, ICG has received marketing approval from China's National Medical Products Administration (NMPA) and passed dual consistency evaluations, meeting international quality standards. Glydocyanine Green: A next-generation broad-spectrum fluorescent imaging agent, Glydocyanine Green addresses the limitations of conventional ICG in targeting and imaging performance. It offers enhanced tumor-targeting ability, higher fluorescence efficiency, and favorable in vivo pharmacokinetics. Its imaging window exceeds 72 hours, making it suitable for visualizing solid tumors and the upper urinary tract. NY-99mTc-FAPI-068: A next-generation fibroblast activation protein (FAP) targeted radionuclide imaging agent. Data from investigator-initiated trials (IITs) show that it delivers high tumor uptake, low uptake in normal organs such as the liver, an extended imaging window, and a strong safety profile. It is intended for use in the diagnosis, staging, and follow-up of multiple tumor types, including pancreatic cancer, lung cancer, and neuroendocrine tumors. VI. Integration of Drug and Device Innovation to Elevate Precision Oncology to New Heights Nanjing Nuoyuan Medical Devices Co., Ltd. is a technologically advanced enterprise based in Jiangsu Province, China, dedicated to the R&D, manufacturing, and commercialization of high-end medical devices and novel targeted contrast agents. The company has adopted an innovation-driven model that promotes coordinated development of drugs and devices, with a drug-led approach, aiming to deliver comprehensive solutions for precision oncology. Its core technology platforms include molecular fluorescence, Raman spectroscopy, CMOS imaging, medical artificial intelligence, and AIDD. Nuoyuan Medical has established a robust product pipeline, consisting of multiple series of oncology diagnostic and therapeutic systems and molecular imaging contrast agents. The company holds fully independent intellectual property rights, with over 160 granted patents in China and abroad, reflecting its strong global competitiveness. As a pioneer in China's molecular imaging field, Nuoyuan Medical has developed a portfolio of internationally advanced molecular imaging systems, including surgical fluorescence imaging systems, 4K endoscopic fluorescence imaging systems, 4K 3D endoscopic fluorescence systems, and AI-assisted Raman spectroscopy-based multimodal fluorescence navigation systems. The company has also independently developed innovative fluorescent probes and radionuclide imaging contrast agents, such as Pemefolacianine, Glydocyanine Green, and NY-99mTc-FAPI-068, achieving true synergy between imaging technologies and diagnostic contrast agents. With continued implementation of its dual-engine 'drug-device integration' strategy, Nuoyuan Medical is establishing a full-chain solution for clinical diagnosis and treatment integration, and is enabling the transition to a new era of submillimeter-precision oncologic surgery. Media Contact Company Name: Frost & Sullivan Contact Person: Qian Li Email: Send Email Country: China Website:

Novotech Awarded Veeva Hero Award at 2025 Veeva R&D and Quality Summit
Novotech Awarded Veeva Hero Award at 2025 Veeva R&D and Quality Summit

Business Wire

time3 days ago

  • Business Wire

Novotech Awarded Veeva Hero Award at 2025 Veeva R&D and Quality Summit

SYDNEY--(BUSINESS WIRE)--Novotech, a globally recognized full-service clinical research organization (CRO), is proud to announce that we have received the highly regarded Veeva Hero award presented at the 2025 Veeva R&D and Quality Summit in Seoul, South Korea. Novotech, a globally recognized full-service clinical research organization (CRO), is proud to announce that we have received the highly regarded Veeva Hero award presented at the 2025 Veeva R&D and Quality Summit in Seoul, South Korea. Share Each year, Veeva recognizes industry-leading companies and organizations driving transformational change and growth as "Veeva Heroes." This year, Novotech was recognized for its early and proactive adoption of Veeva platforms to streamline global clinical trials through strong collaboration across sponsors, CRO, and trial sites accelerating drug development and reinforcing its evolution from a regional leader to a global player. 'This recognition was made possible thanks to the dedication and hard work of our cross-functional internal Veeva team, whose efforts were instrumental in achieving this milestone,' stated Dr. Yooni Kim, Managing Director, Asia-Pacific. 'Their commitment and collaborative spirit exemplify the core values that drive our success.' The strategic collaboration between has significantly contributed to mutual growth in the Korean market, enabling biotech and pharma sponsors to accelerate product development and expedite the delivery of innovative therapies to patients. Novotech remains committed to advancing this partnership fostering innovation and driving excellence in clinical research. For further information, please visit About Novotech Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase. With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations. Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide. Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies. Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store