Colecalciferol

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the reference products With the FDA approval of STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) Celltrion's biosimilar portfolio continues to grow, expanding treatment options to reach more patients JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products.[1], [2] "The approval of STOBOCLO and OSENVELT is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives. We are committed to continuous innovation to meet these goals leveraging our experience and successful track record with biosimilar and novel biologics." The FDA approval is based on robust clinical evidence, including results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles. "Denosumab is used to improve or protect bone health in patients with osteoporosis or those undergoing various cancer treatments and as a therapy for a lifetime for postmenopausal osteoporosis (PMO) patients," said Prof. Jean-Yves Reginster, Professor of Medicine, Protein Research Chair, Biochemistry Dept, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia and Director WHO Collaborating Centre for Epidemiology of Musculoskeletal Health and Aging, Liège, Belgium. "Biosimilars have expanded into new therapeutic areas such as immunology, oncology and ophthalmology as they continue to offer significant cost-saving potential while expanding patient access. Having a denosumab product with a clinically proven track record in quality and safety is a valuable addition for my patients." In accordance with a settlement agreement with Amgen Inc., STOBOCLO and OSENVELT are expected to be available in the U.S. in June 2025. About STOBOCLO® (denosumab-bmwo) STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA ® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. STOBOCLO was also approved by the European Medicines Agency (EMA) in February 2025. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving a adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity : If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information. About OSENVELT® (denosumab-bmwo) OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA ® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. OSENVELT was also approved by the European Medicines Agency (EMA) in February 2025. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. For more information, see Full Prescribing Information . About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website . and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has seven biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (Ustekinumab-stba), and AVTOZMA® (tocilizumab-anoh) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit , and stay updated with our latest news and events on our social media - LinkedIn FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STOBOCLO® and OSENVELT® are registered trademarks of Celltrion Inc. PROLIA® and XGEVA® are registered trademarks of Amgen Inc. References US-CT-P41-24-00010 For further information please contact:  Andria Arena [email protected] +1 516-578-0057 SOURCE Celltrion WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

点击“蓝字”关注我们 非酒精性脂肪性肝病（NAFLD）现在也被称为代谢功能障碍相关脂肪肝 (MASLD)，是全球性常见的肝脏疾病。随着生活方式的改变，尤其是饮食不均衡、肥胖、2型糖尿病（T2DM）的流行，NAFLD的患病率不断上升。NAFLD的管理继续给医师带来挑战，因为目前尚无批准的有效药物治疗这一疾病。生活方式干预，包括饮食改善和增加运动，仍然是治疗NAFLD的首选策略。近年来，维生素作为一种重要的辅助治疗手段在NAFLD的管理中逐渐受到关注。 NAFLD与代谢综合征和T2DM互为因果 NAFLD已成为全球最常见的慢性肝病之一，全球和亚洲的患病率均接近30%[1]。NAFLD是遗传易感个体由于营养过剩和胰岛素抵抗 (IR) 引起的慢性进展性肝病， 疾病谱包括非酒精性脂肪肝（NAFL）、 代谢性（非酒精性）脂肪性肝炎（MASH）及其相关纤维化和肝硬化。随着肥胖和T2DM的流行，全球NAFLD患病率和发病率不断增高。 肝脏是机体调节能量和糖脂代谢的中枢器官，能量密集型饮食和久坐少动生活方式及其催生的肥胖、代谢综合征、T2DM是NAFLD的主要危险因素，脂肪组织和肝脏对营养素过剩的抵抗能力决定了NAFLD的发生和进展。NAFLD与代谢综合征和T2DM互为因果，共同促进动脉硬化性心血管病（CVD）、慢性肾脏病（CKD）、肝脏失代偿，以及肝细胞癌（HCC）等恶性肿瘤的发生。 维生素，无论是脂溶性（A、D、E、K）还是水溶性（B 族和C族），都是维持健康所必需的微量营养素，维生素缺乏与NAFLD的发生和严重程度相关。维生素紊乱与NAFLD中的脂毒性肝脏环境、免疫系统改变、氧化性生物分子损伤、氧化还原过程失调、不必要的炎症、基因突变、表观遗传修饰和肠道微生物组变化相关。由于维生素A、B、C、D和E会影响肝脏的多种病理生理过程，因此它们是NAFLD治疗的有希望的潜在选择[2]。中国成人患者微营养素临床应用指南（2024版）也提到[3]：肝病患者容易缺乏维生素 A、D等脂溶性维生素，维生素 B1、C 等水溶性维生素，锌、硒等微量元素；营养治疗的同时应补充多种维生素与微量元素。 维生素E可使MASH人群的肝脏组织学得到明显改善 MASH患者通常表现为肝细胞脂肪变性、肝脏慢性炎症甚至纤维化，严重者可能最终发展为肝硬化或肝癌。氧化应激是MASH过程中的主要因素，维生素E是一种天然抗氧化剂，是治疗MASH最有前景的药物之一。维生素E通过减轻氧化应激、降低肝脏炎症和抗脂肪氧化，帮助减缓NAFLD的进程。近期一项发表在Cell Reports Medicine杂志的研究探讨中等剂量维生素E（300 mg/天）在非糖尿病MASH患者中的疗效和安全性[4]。该研究纳入了中国15家医疗中心的124例经肝活检证实的非糖尿病MASH患者，分别接受每日300 mg维生素E或安慰剂治疗96周。结果表明，维生素E组有29.3%的患者达到了肝脏组织学综合改善的标准，而安慰剂组仅为14.1%。服用维生素E受试者的肝脏变化主要包括脂肪变性减轻、肝小叶炎症和纤维化改善。生化指标结果也表明，接受维生素E治疗的患者在肝酶（如ALT、AST）水平、肝脏硬度和炎症性细胞因子水平上均有显著下降。 较高的膳食维生素B3摄入量，可降低NAFLD的死亡风险 维生素B群，尤其是维生素B12、B6、叶酸，能够通过改善脂肪代谢、减轻肝脏炎症对NAFLD产生积极影响。烟酸又称维生素B3，是水溶性B族维生素的一种。烟酸性质相对稳定，一般烹调加工损失较少，但会随水流失。烟酸可直接从食物中摄取，动物肝、肾、鱼禽肉类、全谷、坚果中含量丰富。烟酸作为吡啶辅酶烟酰胺腺嘌呤二核苷酸(NAD)和烟酰胺腺嘌呤二核苷酸磷酸(NADP)合成的前体，在广泛的细胞代谢反应、能量代谢和氧化还原反应中发挥重要作用。一项研究探讨NAFLD患者膳食烟酸摄入量与全因死亡率和CVD死亡率的关系[5]。研究者根据维生素B3摄入量，将受试者分为3组：低摄入组（≤18.4mg/天）、中等摄入组（18.5~26.6mg/天）和高摄入组（≥26.7mg/天），结果发现，与摄入量最低的受试者相比，摄入量最高的受试者，全因死亡风险降低30%（HR=0.70，P=0.03），但膳食烟酸摄入量与CVD死亡风险无明显负相关。烟酸是NAD合成的前体之一，目前已成为预防和治疗肝脏疾病的重要靶点。 维生素D与NAFLD之间的关系已经受到广泛研究。维生素D不仅仅与骨骼健康相关，它也在脂肪代谢、免疫调节和抗炎反应中扮演着重要角色。维生素D缺乏与NAFLD的发生及其进展相关。在肝病患者中，维生素D具有抗增殖、免疫调节和抗纤维化的作用，缺乏时可能导致脂肪变性，加速纤维化进展，增加肝细胞癌发生的风险，还会影响丙型病毒性肝炎患者持续病毒学应答率[3]。维生素D能够通过调节肝脏脂肪的合成、代谢以及胰岛素抵抗来影响NAFLD。研究表明[6]，，改善脂质代谢异常，增强胰岛素敏感性。从机制上讲，维生素D3通过增强机体抗氧化能力、减少局部铁聚集和调节铁死亡相关蛋白的表达，来抑制NAFLD进展过程中的铁死亡。 结语 维生素在非酒精性脂肪肝的治疗中具有重要的潜力，尤其是维生素D、E、C和B群等。这些维生素通过调节脂肪代谢、减少氧化应激、减轻炎症反应等途径，帮助减缓NAFLD的进展。然而，维生素补充的效果因个体差异而异，且可能与其他药物治疗结合使用时效果更佳。因此，未来的研究应重点探索维生素与其他药物治疗联合应用的效果，并进一步验证其对NAFLD长期管理的作用。 参考文献： 1.中华医学会肝病学分会. 代谢相关（非酒精性）脂肪性肝病防治指南（2024年版）[J]. 中华肝脏病杂志, 2024, 32(5):418-434. DOI: 10.3760/cma.j.cn501113-20240327-00163. 2.Abe R M, Masroor A, Khorochkov A, et al. (August 03, 2021) The Role of Vitamins in Non-Alcoholic Fatty Liver Disease: A Systematic Review.Cureus 13(8): e16855. DOI 10.7759/cureus.1685. 3.中国成人患者微营养素临床应用指南（2024版）。中华医学杂志?2024?年3?月19日第104卷第11期. 4.Song, Y., Wenjing, N., Minghua, Z., et al. (2025). Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study. Cell Reports Medicine, 6(101939). 5..JAMA Network Open. 2024;7(2):e2354277. doi:10.1001/jamanetworkopen.2023.54277 6.Eur J Nutr. 2024 Dec 21;64(1):50. doi: 10.1007/s00394-024-03554-0. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。 最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！ （来源：《国际糖尿病》编辑部） 版权声明 版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。