Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer

CHENGDU, China, June 10, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the 'Company') today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) (佳泰莱®) in combination with the PD-L1 monoclonal antibody tagitanlimab (科泰莱®) was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting the research, development and marketing of innovative treatment options that address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study.
This marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA. Sac-TMT has previously received this designation for:
Locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-TKI therapy in January 2023;
Locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023；
First-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024.
Results from a Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with tagitanlimab in first-line advanced or metastatic non-squamous NSCLC patients were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting[1].
Dr. Michael Ge, CEO of Kelun-Biotech said, 'This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible.'
[1] Abstract #8529: Lung Cancer – Non-Small Cell Metastatic, ASCO Annual Meeting, 2025
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, 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, Macao, 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, two new indication applications 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 and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab2 or other agents for several types of cancer. These studies are sponsored and led by MSD.
About Tagitanlimab (科泰莱®)Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.
About Kelun-BiotechKelun-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 and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
Media: klbio_pr@kelun.com

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Malaysian Reserve

18 hours ago

• Malaysian Reserve

Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medici

The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine. In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand.1 In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.2,3 Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%). While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for the treatment of obesity. 'The ACHIEVE-1 trial demonstrated that orforglipron, a novel oral small-molecule GLP-1, achieved clinically meaningful reductions in A1C and body weight over 40 weeks in adults with type 2 diabetes,' said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator. 'The early onset of glycemic improvement, observed as soon as four weeks, reinforces the therapeutic potential of orforglipron as an effective, oral GLP-1 therapy for early type 2 diabetes treatment. These findings support further investigation in broader populations and longer-duration studies.' Full Results Orforglipron 3 mg Orforglipron 12 mg Orforglipron 36 mg Placebo Primary Endpoint A1C reduction from baseline of 8.0 %i Efficacy estimand 1.3 % 1.6 % 1.5 % 0.1 % Treatment-regimen estimand4 1.2 % 1.5 % 1.5 % 0.4 % Key Secondary Endpointsii Percent weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.7 % 6.1 % 7.9 % 1.6 % Treatment-regimen estimand 4.5 % 5.8 % 7.6 % 1.7 % Weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.4 kg (9.7 lbs) 5.5 kg (12.2 lbs) 7.3 kg (16.0 lbs) 1.3 kg (2.9 lbs) Treatment-regimen estimand 4.2 kg (9.3 lbs) 5.2 kg (11.5 lbs) 7.2 kg (15.8 lbs) 1.5 kg (3.4 lbs) Percent of participants achieving A1C <7 %i Efficacy estimand 72.9 % 76.2 % 74.9 % 28.0 % Treatment-regimen estimand 68.1 % 72.9 % 72.7 % 33.0 % Percent of participants achieving A1C ≤6.5 %i,ii Efficacy estimand 61.5 % 62.3 % 66.0 % 13.5 % Treatment-regimen estimand 56.9 % 58.1 % 61.9 % 14.9 % Percent of participants achieving A1C <5.7 %iii Efficacy estimand 17.7 % 25.8 % 23.9 % 3.8 % Treatment-regimen estimand 16.8 % 23.9 % 21.5 % 3.8 % Fasting serum glucose reduction from baseline of 147.5 mg/dLi Efficacy estimand 30.6 mg/dL 37.4 mg/dL 37.8 mg/dL 1.1 mg/dL Treatment-regimen estimand 30.7 mg/dL 36.5 mg/dL 34.7 mg/dL 10.8 mg/dL iSuperiority test was adjusted for from the full list of key secondary endpoints are available in the of participants achieving A1C <5.7% across all orforglipron doses and body weight for orforglipron 3 mg were not controlled for Type 1 error. 'This convenient once-daily pill with no restrictions on food and water intake could be an option for millions of people with type 2 diabetes who prefer oral medications over injectables,' said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. 'The positive ACHIEVE-1 results position orforglipron as a potential treatment option with meaningful A1C and weight reduction, and a safety profile similar to injectable GLP-1 therapies. We look forward to the four remaining global readouts from the ACHIEVE program, as well as results of the ATTAIN program in obesity, and working with regulators to bring this once-daily oral GLP-1 to people around the world.' The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. The most common adverse events for participants treated with orforglipron (3 mg, 12 mg and 36 mg, respectively) were diarrhea (19%, 21% and 26%) vs. 9% with placebo, nausea (13%, 18% and 16%) vs. 2% with placebo, dyspepsia (11%, 20% and 15%) vs. 7% with placebo, constipation (8%, 17% and 14%) vs. 4% with placebo, and vomiting (5%, 7% and 14%) vs. 1% with placebo. These gastrointestinal-related adverse events were generally mild-to-moderate in severity and occurred primarily during dose escalation. Overall treatment discontinuation rates due to adverse events were 6% (3 mg), 4% (12 mg) and 8% (36 mg) for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Later this year, Lilly expects to share topline results from ACHIEVE-2, evaluating orforglipron compared with dapagliflozin, and ACHIEVE-3, evaluating orforglipron compared to oral semaglutide, both in adults with type 2 diabetes inadequately controlled with metformin. ATTAIN-1 and ATTAIN-2, evaluating orforglipron for weight management, will also be shared in the third quarter of this year. Lilly remains on track to submit orforglipron for weight management to global regulatory agencies by the end of this year and for the treatment of type 2 diabetes in 2026. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.6 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity. About ACHIEVE-1 and the ACHIEVE clinical trial program ACHIEVE-1 (NCT05971940) is a Phase 3, 40-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 3 mg, 12 mg and 36 mg as monotherapy to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The trial randomized 559 participants across the U.S., China, India, Japan and Mexico in 1:1:1:1 ratio to receive either 3 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (3 mg, 12 mg, 36 mg) is superior in A1C reduction from baseline after 40 weeks, compared to placebo, in people with type 2 diabetes who have not taken any anti-diabetic medications for at least 90 days prior to visit 1, and are naïve to insulin therapy. Study participants had a HbA1c between ≥7.0% and ≤9.5% and a BMI of ≥23 kg/m2. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 3 mg (via a 1 mg step), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Flexible dosing was not permitted. The ACHIEVE Phase 3 global clinical development program for orforglipron has enrolled more than 6,000 people with type 2 diabetes across five global registration trials. The program began in 2023 with results anticipated later this year and into 2026. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY The efficacy estimand represents the treatment effect had on all participants who adhered to the study drug (with possible dose interruptions) for 40 weeks without initiating additional antihyperglycemic medications (>14 days of use). American Diabetes Association. Standards of Care in Diabetes—2020 Abridged for Primary Care Providers. Clinical Diabetes 2020; 38(1):10–38. Percent of participants achieving A1C <5.7% across all doses was not controlled for Type 1 error. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or initiation of additional antihyperglycemic medications. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with type 2 diabetes, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for type 2 diabetes, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Brooke Frost; 317-432-9145 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors)

The Star

a day ago

• The Star

Laos, China forge partnership to facilitate cross-border transport, trade

Viengkhone Sitthixay explains about the Thanaleng Dry Port and Vientiane Logistics Park to Prof. Dr Kikeo Khaykhamphithoune (left) duing his visit to the exhibited booth. KUNMING, (China): Laos's Thanaleng Dry Port (TDP) has established partnerships with key Chinese firms to advance cross-border cargo transport and regional trade connectivity. At the recent 9th China-South Asia Exposition held in Kunming, southwestern China's Yunnan province, the Thanaleng Dry Port Sole Co., Ltd. signed the Strategic Cross-Border Partnership with Anning Dry Port International Holding Co., Ltd. The partnership aims to enhance logistics efficiency between Laos and China by streamlining customs processes, sharing warehouse resources, and standardising documentation. The deal will leverage TDP's role as a key logistics hub linking China with Southeast Asia, while also tapping into the strategic convergence of major regional railways at Anning Dry Port — including links to Vietnam and Myanmar. 'The unique characteristics of the harbor position it as a key hub for China's national transport network, enabling the Thanaleng Dry Port to diversify and enhance its service,' TDP said in a statement. Thanaleng Dry Port – the single-window customs clearance point for freight transport on the Laos-China railway - also signed an additional cooperation deal with Lao Financial Holding Sole., Ltd., China Intelligent Electric Vehicles Co., Ltd., and Yunnan Maimiao Automobile Service Co., Ltd. The Cross-Border Automotive Industry and Financial Services Full-chain Platform and Bonded Warehouse Cooperation agreement aims to support and promote win-win cooperation by utilising the bonded warehouses of the Thanaleng Dry Port as a primary service to jointly establish a platform for cross-border trade and integrated investment services. These include the pre-tax import of goods + bonded warehouse services + pre-tax payment sales + sales with installment payment options + after-sales services in order to help elevate the Lao automotive industry and develop cross-border trade in the region. The partnerships are part of the Lao dry port's broader strategy to engage with regional and global players to advance cross-border transport and position itself as a key logistics connector linking Southeast Asia to China and even extending to Europe. During the 9th China-South Asia Exposition, the Thanaleng Dry Port - the converging point between the Laos-China and Laos-Thailand railways - set up a booth at the six-day event to showcase its logistics service products that have been introduced since it began operation in December 2021. Vice President of Thanaleng Dry Port Sole Co., Ltd., Viengkhone Sitthixay, and his team welcomed Lao Deputy Prime Minister Prof. Dr Kikeo Khaykhamphithoune and foreign guests to the company's booth where the DPM was briefed about the Lao landmark project. The dry port's Managing Director, Sakhone Philangam, told the guests that the dry port and its associated Vientiane Logistics Park are priority projects of the Lao government and form an integral part of the broader strategy to transform landlocked Laos into a land-link country. The progress made in this direction was showcased at the Kunming expo, where businesses set up more than 2,000 booths in total. The event provides an excellent opportunity for Lao businesses to explore avenues and establish trade partnerships with international companies, particularly those in China and Southeast Asia. - Vientiane Times/ANN

Malaysian Reserve

2 days ago

• Malaysian Reserve

Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The L

Both subcutaneous and oral formulations will advance straight to phase 3 development based on completed clinical studies and feedback received from regulatory authorities1,2 PLAINSBORO, N.J., June 20, 2025 /PRNewswire/ — Today, results from two early-phase clinical trials evaluating Novo Nordisk's amycretin, an innovative investigational obesity treatment designed to target appetite regulation, were published in The Lancet.1 In a phase 1b/2a clinical trial of 125 adults with overweight or obesity, once-weekly subcutaneous amycretin appeared to be safe and tolerable in trial participants, who also achieved significantly greater weight loss across the full range of doses investigated versus placebo.1 A related phase 1 trial of once-daily oral amycretin in adults with obesity or overweight also showed that treatment was safe and tolerable with an observed reduction in body weight compared to placebo.2 No weight loss plateau was observed in either trial at the end of the respective treatment durations.1,2 Data on subcutaneous amycretin is scheduled to be presented on Sunday, June 22nd, during a late-breaking poster session at the American Diabetes Association's® (ADA) 85th Scientific Sessions.1 'We are pleased with the promising results of amycretin and the feedback from regulatory authorities and are excited to advance both subcutaneous and oral versions of this molecule into phase 3 development for weight management. At Novo Nordisk, we understand that addressing obesity is a complex challenge that many patients face. These results reflect our robust pipeline in obesity, our focus on progressing scientific innovation and expanding the range of options available to patients and healthcare professionals,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'We remain steadfast in our mission to discover and develop therapies that can have a meaningful impact in the lives of those affected by obesity.' Results from the phase 1b/2a trial of subcutaneous amycretin showed treatment-emergent adverse events (TEAEs) were mild or moderate in severity and increased in frequency in a dose-dependent manner. The most frequent reported TEAEs were gastrointestinal in nature. Compared to placebo, participants receiving amycretin observed greater weight loss across the full range of doses investigated.1 Subcutaneous amycretin at multiple doses demonstrated greater weight reduction than placebo at the end of the trial. Participants who received the highest doses (up to 60 mg) reported body weight reductions of up to 24.3% versus 1.1% with placebo after 36 weeks of treatment. Results from this first-in-human phase 1b/2a study support further investigation of potential weight-loss efficacy of amycretin. Results from the published phase 1 trial of oral amycretin showed that the most common TEAEs were related to gastrointestinal symptoms (mainly nausea and vomiting) and decreased appetite; these were most frequent for the higher doses. Trial participants receiving the study treatment demonstrated significantly greater weight loss across the full range of doses investigated versus the placebo group.2 Exploratory results showed participants taking 100 mg per day of oral amycretin achieved a mean weight loss of 13.1% versus 1.2% with placebo after 12 weeks.2 Based on these phase 1 results, longer evaluation with more participants is warranted to substantiate the full efficacy findings of oral amycretin on body weight reductions and changes in metabolic parameters. Novo Nordisk will advance both subcutaneous and oral amycretin formulations straight to phase 3 development for weight management based on these and other completed clinical studies, as well as feedback received from regulatory authorities. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide a treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is under investigation for oral and subcutaneous administration, and is not approved in the US for weight loss. About the phase 1b/2a subcutaneous amycretin trialThe phase 1b/2a trial was a randomized, placebo-controlled, single-center, double-blinded study of 125 participants assessing the safety, tolerability, pharmacokinetics, and effects on body weight after subcutaneous administration of amycretin in people with overweight or obesity.1 Adults with a body mass index of 27-39.9kg/m2 and glycated hemoglobin (HbA1c) <6.5% were eligible for the trial.1 The trial was conducted in 5 parts: a single ascending dose (Part A) for determination of pharmacokinetics and starting dose for the first multiple dose cohort in which the safety and tolerability were explored using dose escalation until 36 weeks of total treatment duration (Part B).1 Lastly, in the multiple ascending dose – dose response parts, body weight loss was explored for up to 36 weeks of dosing by escalating to dose levels of 1.25 mg, 5 mg, and 20 mg, respectively, dosed for 12 weeks (Part E, D and C).1 About the phase 1 oral amycretin trial The phase 1 single-center, randomized, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (Part A) and multiple ascending doses (Part B, 10 days of treatment; Part C/D, 12 weeks of treatment) of 144 adult participants with overweight or obesity.2 The primary endpoint was the number of treatment-emergent adverse events (TEAEs) observed in the trial. The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.2 About obesityObesity is a serious chronic, progressive, and complex disease that requires long-term management.3-5 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.3,5 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.6,7 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.8,9 In the US, about 40% of adults live with obesity.10 About Novo NordiskNovo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit Facebook, Instagram, and X. Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at Contacts for further information Media: Liz Skrbkova (US)+1 609 917 0632USMediaRelations@ Ambre James-Brown (Global)+45 3079 9289Globalmedia@ Investors: Frederik Taylor Pitter (US)+1 609 613 0568fptr@ Jacob Martin Wiborg Rode (Global)+45 3075 5956jrde@ Sina Meyer (Global)+45 3079 6656 azey@ Ida Schaap Melvold (Global)+45 3077 5649 idmg@ Max Ung (Global)+45 3077 6414mxun@ References Dahl K, Toubro S, Dey S, et al. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: Results of a randomised, controlled, phase 1b/2a study. The Lancet. Published online: June 20, 2025. Gasiorek A, Heydorn A, Gabery S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, randomised, placebo-controlled study. The Lancet. Published online: June 20, 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed June 2025. Available at: © 2025 Novo Nordisk All rights reserved. US25SEMO01477 June 2025