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42 minutes ago
- Health
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New Data Presented at AAIC Demonstrates Investigational LEQEMBI® (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
Lecanemab subcutaneous autoinjector has the potential to become a new expanded treatment option for patients with early Alzheimer's disease, their care partners and healthcare professionals, with results showing a comparable efficacy and safety profile to the intravenous formulation TOKYO and CAMBRIDGE, Mass., July 30, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that results on investigational maintenance therapy with subcutaneous autoinjector (SC-AI) of lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, and virtually. Only lecanemab fights AD in two ways— targeting both protofibrils and plaque, which can impact tau accumulation downstream. Importance of Ongoing Treatment and SC Development Program Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped1, Eisai is investigating a new lecanemab SC maintenance treatment option following 18 months of IV therapy so patients can continue to fight this progressive, relentless disease. Clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD, to evaluate a range of doses administered by SC vial or autoinjector. Eisai has developed a SC-AI for maintenance therapy at a dose of 360 mg weekly and a 500 mg SC-AI is being developed for initiation dosing. Similar Impact on Clinical Outcomes and Biomarkers with IV and SC Dosing The pharmacology (PK/PD), clinical (efficacy endpoints such as CDR-SB) and biomarker (amyloid PET and blood biomarkers) relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option. Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing. Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months. Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10 mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E. Safety MattersThe safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with <1% systemic injection/infusion reactions. Across all SC doses, the rate of systemic injection/infusion reactions is 1% compared to 26% with IV. The 360 mg SC maintenance dose was initiated after 18 months of IV treatment, beyond the high-risk period for ARIA. There were 0 cases of ARIA-E observed out of 49 treated with 360 mg SC weekly maintenance for a mean of 6 months. Study Participants Successfully Administered SC-AI and Found it Easy to UseTo optimize the safe and effective use of SC autoinjector (SC-AI), additional studies were conducted, including a human factors (HF) study and a tolerability assessment of the device. The HF Study involved 110 participants (63 early AD patients, 32 care partners, and 15 healthcare professionals: HCPs) to assess the appropriate administration of lecanemab SC-AI. Overall, 95% (104/110) of participants successfully administered the maintenance dose. The Autoinjector Device Acceptability Study involved 126 participants (25 early AD patients, 50 care partners, and 51 HCPs), to evaluate the device's ease of use, convenience and feasibility of administration. As an interim outcome, over 95% of participants reported that the SC-AI is easy to administer. They were highly satisfied with it and had no concerns about administration, even at home. Furthermore, all patients responded that they welcomed the introduction of SC-AI. These studies and evaluations of lecanemab SC-AI have demonstrated that the investigational SC-AI offers efficacy and safety comparable to IV administration with the potential to reduce the incidence of infusion site adverse events. From the perspective of patients and care partners, benefits included the ability to use the device at home, shortening treatment time, and to continue treatment without having to worry about visiting an infusion center. From the perspective of HCPs, they reported that the device has the potential to provide a new option for patients who are benefiting from lecanemab to continue the treatment. The SC formulation has the potential to reduce medical preparation and administration time related to IV therapy. These factors suggest that the SC AI may play an important role in continuing treatment for early AD. This release is based on the content of the presentations given at AAIC, "Featured Research Session #4-13-FRS-C: Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease," held at 9:00 AM on Wednesday, July 30, and also includes some content from the Developing Topics session held at 8:00 AM on Sunday, July 27, entitled "Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery in Early Alzheimer's Disease Patients." Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. * Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD. 2 MEDIA CONTACTSEisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department +44 (0) 797 487 9419 Emea-comms@ Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 Libby_Holman@ Biogen Inc. Madeleine Shin +1-781-464-3260 INVESTOR CONTACTSEisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 Biogen Inc. Tim Power + 1-781-464-2442 IR@ Notes to Editors 1. About lecanemab (generic name, brand name: LEQEMBI®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells.2 It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction. Lecanemab has been approved in 46 countries and is under regulatory review in 11 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S. After an 18 months initiation phase with once every two weeks of dosing, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks or continuing 10 mg/kg once every two weeks may be considered. Additionally, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. About the Collaboration between Eisai and Biogen for ADEisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. About the Collaboration between Eisai and BioArctic for ADSince 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. 4. About Eisai Co., Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit and Eisai EMEA LinkedIn. 5. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at Follow Biogen on social media – Facebook, LinkedIn, X, YouTube. Biogen Safe HarborThis news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. View original content to download multimedia: SOURCE Eisai Inc.
Indianapolis Star
2 hours ago
- Business
- Indianapolis Star
Does JCPenney stores sale affect Indiana locations? How many stores are left in 2025? What we know
JCPenney and the Copper Property CTL Pass Through Trust finally have a buyer for 119 JCPenney stores after filing for bankruptcy in 2020 during the COVID-19 pandemic An affiliate of Onyx Partners, Ltd. will pay $947 million to own the department store locations. Here's what we know: Copper Property — a trust formed by JCPenney's lenders as part of the retailer's reorganization after its 2020 bankruptcy filing — has been seeking buyers through the property management company Newmark and Hilco Real Estate. An affiliate of Onyx Partners, Ltd. — a Boston private equity firm — will pay $947 million for 119 JCPenney stores. Copper Property announced the all-cash sale on July 25. A Sept. 8 closing of the deal is expected for the net-lease stores, which pay rent and operating expenses. "The Buyer has now completed its due diligence, and its deposit under the Agreement is non-refundable," Copper Property Trust said in a news release on July 25. Copper Property took control of about 160 JCPenney locations and six distribution centers after the bankruptcy filing. Simon Property Group and Brookfield Asset Management Inc. took over JCPenney operations and the remaining locations. JCPenney recently announced seven store closures in February 2025 that officially shuttered in May 2025. The chain originally closed more than 200 U.S. locations when the retailer filed for bankruptcy amid the COVID-19 pandemic. As for the 119 stores sold to Onyx Partners, all locations are currently operational. The company did not respond to a request for comment on possible store closures from USA TODAY. JCPenney currently has about 650 stores. The department store chain was one of the largest retailers to file for Chapter 11 bankruptcy protection. One Indiana JCPenney location was sold in the Onyx Partners deal:
3 hours ago
- Politics
Japan Minister Voices Concern over Illegal Residents from Turkey
News from Japan Politics Jul 30, 2025 22:09 (JST) Tokyo, July 30 (Jiji Press)--Japanese Justice Minister Keisuke Suzuki on Wednesday expressed "extremely serious concern" about illegal Turkish residents in Japan. Suzuki conveyed this concern at a meeting with Turkish Ambassador to Japan Oguzhan Ertugrul. The ambassador responded that Turkey is urging its citizens to follow Japanese laws and customs while in Japan. According to Suzuki, there were 1,372 illegal residents of Turkish nationality as of Jan. 1. In some municipalities, friction and trouble between locals and Kurdish residents of Turkish nationality have been reported. "In light of the growing anxiety among the (Japanese) people, we are also moving toward dealing strictly with illegal stays," Suzuki said, requesting cooperation from the Turkish government. END [Copyright The Jiji Press, Ltd.] Jiji Press
4 hours ago
- Business
Japan's Paternal Leave Rate Hits Record 40.5 Pct
News from Japan Jul 30, 2025 17:15 (JST) Tokyo, July 30 (Jiji Press)--The proportion of male employees in Japan who took parental leave in fiscal 2024 rose 10.4 percentage points from the previous year to a record high of 40.5 pct, a labor ministry survey showed Wednesday. The increase in the year that ended last March came as the country started requiring companies to check whether employees wish to take parental leave and introduced a new parental leave initiative in 2022. The new initiative enables fathers to take up to four weeks of leave within eight weeks after the birth of a child, in addition to conventional parental leave. The leave can be taken in two installments. About 60 pct of fathers who took parental leave used the initiative. The government aims to raise the parental leave rate for men to 50 pct in calendar 2025. The survey was conducted last October and received valid responses from 3,383 businesses with five or more employees. [Copyright The Jiji Press, Ltd.] Jiji Press
Associated Press
6 hours ago
- Business
- 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:
