Clinical research results for Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) published in Nature Medicine, a top international medical journal
CHENGDU, China, April 12, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the 'Company') today announced that results from a Phase 3 registrational clinical study evaluating the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) for the treatment of adult patients with advanced triple-negative breast cancer (TNBC) and results from an early Phase I/II clinical study of sac-TMT for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) were published in the top international medical journal Nature Medicine (Impact Factor (IF)= 58.7).
Results
TNBC: Based on the results of the multicenter, randomized, controlled Phase III OptiTROP-Breast01 (NCT05347134) clinical study, the current publication reports on the efficacy and safety of sac-TMT versus investigator's choice chemotherapy for the treatment of patients with locally advanced, recurrent or metastatic TNBC. The results of the study showed that sac-TMT demonstrated statistically and clinically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to investigator's choice chemotherapy. Based on this study, sac-TMT was approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). The data from this study were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
NSCLC: Based on the results of two early clinical studies of sac-TMT, the article reports on the efficacy and safety of sac-TMT in previously treated advanced NSCLC with or without epidermal growth factor receptor (EGFR) mutations. The article also explored in vitro experiments on the potential mechanisms of sac-TMT treatment for NSCLC, suggesting that EGFR mutations can increase the endocytosis and anti-tumor activity of TROP2 ADCs.
Dr. Michael Ge, CEO of Kelun-Biotech said, 'These successful publications in Nature Medicine mark the international academic community's recognition of the clinical efficacy and application value of sac-TMT in the treatment of advanced TNBC and NSCLC. The Company's novel product, sac-TMT, has been marketed in China for two indications. Meanwhile, the Company is also actively promoting the registrational clinical studies of sac-TMT in multiple indications, including breast cancer and lung cancer. Kelun-Biotech has always been committed to promoting innovation and leadership, and we look forward to continuing our research in the field of ADCs in partnership with MSD.'
About sac-TMT (佳泰莱®)
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).
To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
View original content to download multimedia: https://www.prnewswire.com/news-releases/clinical-research-results-for-kelun-biotechs-trop2-adc-sacituzumab-tirumotecan-sac-tmt-published-in-nature-medicine-a-top-international-medical-journal-302426984.html
SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
7 hours ago
- Yahoo
Cyberway Product Innovation Platform: Empowering Enterprise Innovation Processes and Building Exceptional Product Strength
GUANGZHOU , June 22, 2025 /PRNewswire/ -- In the fiercely competitive FMCG market, only efficient innovation can create a true competitive edge. As consumer preferences change rapidly and the market environment remains uncertain, how can companies precisely identify needs, execute efficiently, and continuously optimize their strategies? The Cyberway Product Innovation Platform empowers FMCG enterprises to achieve sustainable growth by providing powerful capabilities in pre-planning insight, in-process control, and post-launch analytics—ultimately enabling the development of exceptional product strength. Before: AI-Powered Foresight for Accurate Market Opportunity Detection AI Opportunity Discovery: Real-time industry data, user behavior, and competitor insights are captured to automatically identify blue ocean markets and unmet needs—fueling inspiration for new product planning. Accelerate Opportunity Capture: Shorten market research cycles and improve speed and accuracy of opportunity identification. AI-Driven Product Definition: Using opportunity and competitor analysis, combined with internal product knowledge bases, the system intelligently generates product concepts, optimizes configurations, and refines packaging and formulas. Agile Response: Ensure product design closely aligns with market needs and competition, allowing rapid focus on core value and improving product-market fit. End-to-End User Demand Management: A comprehensive demand management framework tracks records, statuses, and feedback, aggregating omnichannel voice of customer with AI to identify high-value & Accurate: By realizing and verifying demand in closed-loop cycles, continuously refine product performance, minimize resource waste, and pave the way for the next breakout product. During: Efficient Execution to Deliver Outstanding Products Scientific Project Management System: Integrates visual dashboards, all-in-one workbenches, and real-time notifications via Feishu, WeCom, and DingTalk for full project transparency and synchronized decision-making across teams. Core Value: Reduce communication overhead, improve collaboration efficiency, and prevent project delays. Standardized Project Workflow: Based on industry templates and task libraries, enabling tiered and structured project management tailored to channel requirements. Flexible Control: Guarantees high-quality delivery while allowing adaptive workflows, ensuring key tasks succeed the first time. Cross-Functional Online Collaboration: Integrates marketing, go-to-market, and product workflows to shorten timelines. Interlocked nodes require mutual confirmation to ensure stability and avoid cost waste. Key Feature: Enables synergistic cooperation across departments for performance greater than the sum of its parts. AI Marketing: Tracks competitor strategies and social trends in real time, dynamically generating targeted content and pricing strategies using internal knowledge. Efficient & Agile: Accelerates creative production and drives an integrated "strategy-content-pricing" engine for rapid market response. Online Knowledge Repository: A dedicated enterprise R&D knowledge base aggregating key data such as risk warnings, solutions, and technical documentation. Significant Boost: Empowers faster troubleshooting and prevents redundant errors in R&D. Comprehensive Quality Control System: Embeds IPD checkpoints and technical reviews to govern key milestones; incorporates risk management for prevention, monitoring, and post-analysis. Ultimate Goal: Ensure high-quality project delivery while minimizing potential risks. After: Data-Driven Innovation Strategy Optimization Project Review: Compare project baselines with actual execution to deeply analyze quality, timeline, and cost performance. Deeper Insights: Identify key factors that influence project success. Go-to-Market Tracking: Monitor GMV trends across e-commerce platforms, VOC on social media, and promotional campaign outcomes to pinpoint growth opportunities and risks, driving agile strategy iteration. Advanced Capabilities: Fuel product iteration and innovation, providing a core foundation for the next-generation breakout product. Data Asset Management: Leverages delivery data and gate review points to auto-update master product data, creating a unified view with field supplementation and relationship validation. Long-Term Value: Enables full-lifecycle product data management, enhancing both data quality and business utility. The Cyberway Product Innovation Collaboration Platform is a powerful enabler for FMCG enterprises to enhance product innovation with AI, reduce waste, shorten R&D cycles, and create market bestsellers. From ideation to launch and ongoing optimization, the platform empowers excellence at every stage—allowing businesses to stand out in an intensely competitive landscape. We look forward to partnering with more brands to explore new ways of innovation and co-create the next market blockbuster! Website: Email：Marketing@ View original content: SOURCE Cyberway Information Technology Co., Ltd. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
8 hours ago
- Yahoo
We Think Annovis Bio (NYSE:ANVS) Needs To Drive Business Growth Carefully
Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the right price. For example, biotech and mining exploration companies often lose money for years before finding success with a new treatment or mineral discovery. But the harsh reality is that very many loss making companies burn through all their cash and go bankrupt. So, the natural question for Annovis Bio (NYSE:ANVS) shareholders is whether they should be concerned by its rate of cash burn. In this report, we will consider the company's annual negative free cash flow, henceforth referring to it as the 'cash burn'. We'll start by comparing its cash burn with its cash reserves in order to calculate its cash runway. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. A cash runway is defined as the length of time it would take a company to run out of money if it kept spending at its current rate of cash burn. As at March 2025, Annovis Bio had cash of US$22m and no debt. Importantly, its cash burn was US$23m over the trailing twelve months. That means it had a cash runway of around 12 months as of March 2025. Notably, analysts forecast that Annovis Bio will break even (at a free cash flow level) in about 5 years. That means unless the company reduces its cash burn quickly, it may well look to raise more cash. You can see how its cash balance has changed over time in the image below. See our latest analysis for Annovis Bio Because Annovis Bio isn't currently generating revenue, we consider it an early-stage business. Nonetheless, we can still examine its cash burn trajectory as part of our assessment of its cash burn situation. As it happens, the company's cash burn reduced by 35% over the last year, which suggests that management are mindful of the possibility of running out of cash. Clearly, however, the crucial factor is whether the company will grow its business going forward. So you might want to take a peek at how much the company is expected to grow in the next few years. Even though it has reduced its cash burn recently, shareholders should still consider how easy it would be for Annovis Bio to raise more cash in the future. Generally speaking, a listed business can raise new cash through issuing shares or taking on debt. Many companies end up issuing new shares to fund future growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn. Since it has a market capitalisation of US$51m, Annovis Bio's US$23m in cash burn equates to about 45% of its market value. From this perspective, it seems that the company spent a huge amount relative to its market value, and we'd be very wary of a painful capital raising. Even though its cash burn relative to its market cap makes us a little nervous, we are compelled to mention that we thought Annovis Bio's cash burn reduction was relatively promising. Shareholders can take heart from the fact that analysts are forecasting it will reach breakeven. Looking at the factors mentioned in this short report, we do think that its cash burn is a bit risky, and it does make us slightly nervous about the stock. Taking a deeper dive, we've spotted 7 warning signs for Annovis Bio you should be aware of, and 4 of them make us uncomfortable. If you would prefer to check out another company with better fundamentals, then do not miss this free list of interesting companies, that have HIGH return on equity and low debt or this list of stocks which are all forecast to grow. — Investing narratives with Fair Values Vita Life Sciences Set for a 12.72% Revenue Growth While Tackling Operational Challenges By Robbo – Community Contributor Fair Value Estimated: A$2.42 · 0.1% Overvalued Vossloh rides a €500 billion wave to boost growth and earnings in the next decade By Chris1 – Community Contributor Fair Value Estimated: €78.41 · 0.1% Overvalued Intuitive Surgical Will Transform Healthcare with 12% Revenue Growth By Unike – Community Contributor Fair Value Estimated: $325.55 · 0.6% Undervalued View more featured narratives — Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20 hours ago
- Yahoo
Vertex (VRTX) Stock PT Lowered to $420 on slower Alyftrek Uptake
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) is one of the 10 biotech stocks screaming a buy. On June 17, RBC Capital reiterated a Sector Perform rating on the stock but cut the price target to $420 from $423. The adjustment is in response to the company confirming gradual patient conversion from Trikafta to the company's next-generation cystic fibrosis treatment, Alyftrek. A research team in lab coats testing a new ImmunoPhage platform in a modern biotechnology lab. RBC Capital remains concerned about the gradual conversion compared to consensus expectations. Consequently, it has warned it could affect the company's operating margins by up to 2%. Nevertheless, the research firm insists that the company's cystic fibrosis franchise remains well-insulated from sector headwinds. However, RBC Capital has reiterated that Vertex could require stronger execution to adopt Alyftrek to justify the current valuation in the market. Consequently, its reduced price target reflects lower year Alyftrek conversion rates. Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) is a global biotechnology company that develops and commercializes therapies for serious diseases. They are known for their work in cystic fibrosis (CF) and are expanding into other areas like cell and genetic therapies. While we acknowledge the potential of VRTX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 13 Best Software Stocks to Buy Now and 11 Must-Buy AI Stocks Analysts Are Betting On. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
