Eli Lilly & Co.

– RECIST-based ORR of 38.5% (confirmed) and 46.2% (unconfirmed) – mRECIST-based ORR of 61.5% with a complete response (CR) rate of 23% – No Grade 3 or higher adverse events related to RZ-001 observed – Highlights clinical potential of RNA trans-splicing ribozyme platform technology April 20, 2026 --- Rznomics announced today that it presented interim clinical data from its ongoing study of RZ-001, an RNA editing-based investigational anticancer therapy, in patients with hepatocellular carcinoma (HCC) during an oral presentation at the AACR 2026 (American Association for Cancer Research Annual Meeting), held on April 19, 2026, in San Diego, California. The presentation was delivered by Professor Yoon-Jun Kim of the Department of Gastroenterology at Seoul National University Hospital. The study includes patients with HCC who are refractory to or ineligible for transarterial chemoembolization (TACE) and have not received prior systemic therapy. According to the data presented, combination treatment of RZ-001 with atezolizumab and bevacizumab demonstrated an objective response rate (ORR) of 38.5% (confirmed) and 46.2% (unconfirmed) based on RECIST v1.1 criteria. Under mRECIST criteria, the ORR reached 61.5%, with a complete response (CR) rate of 23%, suggesting deep tumor responses. Given that mRECIST reflects tumor necrosis, these findings may indicate meaningful therapeutic impact in HCC. At interim analysis, responses are typically categorized as "confirmed" or "unconfirmed." Confirmed responses are those validated through subsequent assessments, while unconfirmed responses represent initial observations. In this study, patients classified as having "unconfirmed PR" under RECIST criteria had achieved an initial tumor size reduction of at least 30%. In terms of safety, a total of five Grade 3 or higher adverse events were reported as related to combination agents, including hypertension (2 cases), proteinuria, hyperglycemia, and gastrointestinal bleeding. Notably, no Grade 3 or higher adverse events were attributed to RZ-001. The company believes these results demonstrate a favorable safety profile for RZ-001, with no treatment-related safety concerns identified to date, along with encouraging signals of antitumor activity in terms of both response depth and overall response rate in combination with standard immunotherapy. "This oral presentation at AACR represents an important milestone for our lead program RZ-001," said Seong-Wook Lee, Chief Executive Officer of Rznomics. "We are encouraged by the early efficacy and safety signals observed, and we believe these data support the potential of RZ-001 as a novel therapeutic approach for HCC." He added, "Beyond the RZ-001 program, these findings could further support the clinical applicability of our RNA trans-splicing ribozyme platform technology." Hepatocellular Carcinoma (HCC) is the most common type of primary liver cancer, accounting for the vast majority of liver cancer cases worldwide. It originates in the hepatocytes, the main cells of the liver, and is often associated with chronic liver diseases such as cirrhosis or viral hepatitis (B or C). HCC is known for its aggressive nature and high recurrence rates, presenting a significant global health challenge. Because it is often diagnosed at advanced stages, there is a critical unmet medical need for innovative therapies that can provide deeper and more durable responses than current systemic treatments. Transarterial Chemoembolization (TACE) is a minimally invasive, localized procedure frequently used to treat patients with intermediate-stage liver cancer. The procedure involves delivering a concentrated dose of chemotherapy directly to the tumor through the hepatic artery, while simultaneously blocking (embolizing) the blood vessels that supply the tumor with oxygen and nutrients. While TACE can be effective for localized control, patients are considered "TACE refractory" when the tumor continues to progress or recurs despite multiple sessions, at which point systemic therapy is typically required. RECIST v1.1 is the standardized international guideline used to evaluate how solid tumors respond to treatment based on anatomical changes in tumor size. It primarily focuses on the sum of the longest diameters of target lesions, where a significant reduction in physical dimensions is categorized as a "response." While it remains the gold standard for most oncology trials, it mainly tracks physical shrinkage and may not fully capture the immediate biological impact of therapies that induce cell death without an immediate change in the overall tumor mass. mRECIST is a specialized assessment tool developed specifically for Hepatocellular Carcinoma (HCC) to provide a more accurate evaluation of therapeutic efficacy. Unlike traditional criteria that measure the total size of a tumor, mRECIST focuses on the "viable" or living portion by measuring arterial enhancement—the area with active blood flow as seen on imaging. This is particularly critical in HCC because effective targeted or local treatments often cause internal tumor necrosis (cell death). In such cases, the tumor's overall size may remain the same even though the cancer cells are dead, a successful response that mRECIST is uniquely designed to capture. Rznomics is a clinical-stage biopharmaceutical company based in South Korea focused on developing RNA-based gene therapies. The company's proprietary trans-splicing ribozyme platform enables precise RNA editing and has broad applicability across multiple indications. The company signed a research collaboration and license agreement with global pharmaceutical company Eli Lilly in May 2025 for the development of a novel RNA editing therapeutic and listed on the KOSDAQ market in December 2025. (KOSDAQ 476830) The content above comes from the network. if any infringement, please contact us to modify.

Recorded Q1'26 revenue of KRW 1,257 billion and operating profit of KRW 581 billion Performance driven by full utilization across Plants 1 through 4 and robust operational execution Strengthened the foundations for future growth through U.S. expansion and strategic partnerships INCHEON, South Korea, April 22, 2026 /PRNewswire/ -- Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), reported financial results for the first quarter of fiscal year 2026. "In the first quarter, Samsung Biologics delivered stable growth, supported by consistent execution across our manufacturing network and continued demand from clients," said John Rim, President and CEO of Samsung Biologics. "With full operations in plants at our Bio Campus I and Plant 5 ramp-up underway, we are further strengthening manufacturing readiness and service capacity to support evolving client needs. As our global footprint continues to expand, we remain focused on quality excellence, operational consistency, and strategic investment to support sustainable long-term growth." Financial Highlights In the first quarter of 2026, Samsung Biologics reported revenue of KRW 1,257 billion and operating profit of KRW 581 billion. Performance was mainly driven by full utilization across Plants 1 through 4 and continued project execution. Samsung Biologics maintained solid momentum, with cumulative contract value exceeding USD 21.4 billion, reflecting continued demand from global clients. The company successfully completed the first commercial-scale engineering run at its dedicated antibody-drug conjugate facility, demonstrating operational readiness and execution capabilities across diverse modalities. Business Updates and 2026 Outlook Samsung Biologics remains on track to meet its 2026 guidance, supported by continued operations across Plants 1 through 4 and the progressive ramp-up of Plant 5. In March, Samsung Biologics completed the acquisition of its Rockville manufacturing facility in Maryland, U.S. for USD 353 million, establishing its first U.S. manufacturing presence and further strengthening client proximity and supply chain resilience in a key market. Samsung Biologics also continues to evaluate strategic investments to further diversify its manufacturing network and support clients seeking regional supply alignment amid an evolving global operating environment. Samsung Biologics entered a strategic partnership with Coalition for Epidemic Preparedness Innovations (CEPI) to support global health emergency preparedness through agile manufacturing capacity and rapid response capabilities. In addition, the company announced a collaboration with Eli Lilly and Company to foster open innovation and biotechnology ecosystem development. These initiatives reflect the company's broader commitment to long-term industry collaboration and sustainable growth. The company continued to strengthen its integrated service offering through expanded CDO capabilities, including master cell bank production and vector construction services, supporting broader development solutions for clients. Cumulative regulatory approvals surpassed 440, reflecting Samsung Biologics' continued focus on quality, compliance, and reliable execution across global markets. On the sustainability front, Samsung Biologics achieved the EcoVadis' Platinum rating, the highest level of recognition for corporate sustainability performance. The company also completed third-party validation of its Product Carbon Footprint system and published its ESG engagement report to strengthen transparency and stakeholder collaboration. At this year's CDMO Leadership Awards, Samsung Biologics was awarded the Sustainability Leadership Award, a jury-selected distinction recognizing efforts to advance sustainable practices across its operations and value chain. For more details on performance and financials, please refer to the Earnings Release. About Samsung Biologics Samsung Biologics (KRX: 207940.KS) is a leading contract development and manufacturing organization (CDMO), offering end-to-end integrated services that range from late discovery to commercial manufacturing. With a combined biomanufacturing capacity of 785,000 liters across Bio Campus I and II in Korea, and 60,000 from its manufacturing facility in Rockville, Maryland, U.S., Samsung Biologics holds a total global manufacturing capacity of 845,000 liters. The company has also secured land for Bio Campus III, laying the groundwork for future capacity expansion to support next-generation therapies and emerging modalities. Samsung Biologics' global manufacturing and commercial network spans Korea, the U.S., and Japan. Samsung Biologics America supports clients based in the U.S. and Europe, while its Tokyo and Songdo based sales offices serve the APAC region. Samsung Biologics leverages cutting-edge technologies and expertise to advance diverse modalities, including multispecific antibodies, fusion proteins, antibody-drug conjugates, and mRNA therapeutics. By implementing its ExellenS™ framework across its manufacturing network with standardized designs, unified processes, and advanced digitalization, Samsung Biologics ensures plant equivalency and speed for manufacturing continuity. Samsung Biologics continues to invest in new capabilities to maximize operational and quality excellence, ensuring flexibility and agility for clients. The company is committed to the on-time, in-full delivery of safe, high-quality biomedicines, as well as to making sustainable business decisions for the betterment of society and global health. For more information, visit . Media contacts Claire Kim, Senior Director [email protected] Becky Lee, Director [email protected] SOURCE Samsung Biologics 21% more press release views with Request a Demo

The future of a Medicare pilot to cover obesity drugs is up in the air after too few major insurance companies agreed to participate, according to reports from The Wall Street Journal and Bloomberg.The Centers for Medicare & Medicaid Services (CMS) announced the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) model at the end of 2025 as a way for Medicare and state Medicaid plans to bypass a prohibition on covering weight-loss treatments. The pilot also allowed for the agency to negotiate with GLP-1 drugmakers for lower net prices. Novo Nordisk and Eli Lilly had agreed in November to sell their respective injectable products Wegovy/Ozempic (semaglutide) and Zepbound/Mounjaro (tirzepatide) to Medicare for $245 per month, with beneficiary co-pays sitting at just $50 per month.CMS had projected a January 2027 launch for the Medicare Part D portion of BALANCE. To help seniors get discounted obesity drugs sooner, the agency said it would offer a short-term bridging programme, starting in July 2026, under which it would pay for the GLP-1 treatments until BALANCE took effect. However, the structure of the BALANCE model requires insurers to opt in, with the programme only cleared to launch if plans enrolling about 80% of Medicare beneficiaries agreed to participate. Applications for insurers to join BALANCE were due Monday.Now, it looks like BALANCE has not met the insurer threshold. A spokesperson for CVS Health, the parent of Medicare insurer Aetna, told Bloomberg that the company declined to participate in the programme. And Bobby Hunter, UnitedHealth’s chief of government programmes, called out  "some notable challenges and outstanding questions with the currently planned structure" on a call with analysts Tuesday. With the launch of BALANCE seemingly on pause, a CMS spokesperson told WSJ that the agency has extended the government-bankrolled short-term programme "after listening to stakeholder feedback."An update posted Tuesday to CMS's webpage for its "Medicare GLP-1 Bridge" initiative notes that it will now provide eligible Medicare Part D beneficiaries access to certain weight-loss drugs through Dec. 31, 2027. The decision "allow[s] CMS to collect additional data on GLP-1 utilisation to share with Part D plan sponsors ahead of potential implementation of BALANCE in Part D."