太阳制药获得DCGI批准，推出类似Wegovy的减肥药，将在诺和诺德专利到期后上市Sun Pharma gets DCGI nod for Wegovy-like weight loss drug, launch after Novo Nordisk's patent expiry

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01/23

Sun Pharmaceutical Industries Ltd太阳制药工业有限公司. on Friday said it has received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of周五表示，已获得印度药品管制总局 (...

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Noveltreat will be available in five dose strengths-- 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, and 2.4 mg/0.75 mL-- with a maintenance dose of 2.4 mg once weekly, administered via a prefilled pen for accurate and convenient dosing..印度药品监管总局 (DCGI) 的批准是基于在印度进行的 III 期临床试验的审查结果。Noveltreat 将提供五种剂量规格：0.25 毫克/0.5 毫升、0.5 毫克/0.5 毫升、1 毫克/0.5 毫升、1.7 毫克/0.75 毫升和 2.4 毫克/0.75 毫升，维持剂量为每周一次 2.4 毫克，通过预填充注射笔给药，确保剂量准确且使用方便。India's ‌top ‌drugmaker ‌by revenue,印度按收入计算的顶级制药商，Sun Pharma太阳制药’s DCGI approval to make and market a获得DCGI批准进行生产和销售generic semaglutide通用司美格鲁肽injection comes amid a patent dispute with注射剂的到来正值与Novo Nordisk诺和诺德in the Delhi High Court involving semaglutide, the active ingredient in blockbuster drugs like Ozempic and Wegovy. Under Indian law, Novo Nordisk holds a secondary patent in India covering semaglutide’s formulation and delivery that runs until March 2026.在德里高等法院涉及司美格鲁肽的案件中，司美格鲁肽是像Ozempic和Wegovy这样的重磅药物的活性成分。根据印度法律，诺和诺德在印度拥有覆盖司美格鲁肽配方和递送的次级专利，该专利有效期至2026年3月。In December 2025, the High Court allowed Sun Pharma to manufacture and export its semaglutide formulation, marking a significant interim win for the Indian drugmaker in the ongoing dispute. But the court barred Sun Pharma from selling the generic in the Indian domestic market until Novo Nordisk’s patent expires in March 2026.2025年12月，高等法院允许太阳制药生产并出口其司美鲁肽制剂，这标志着这家印度制药商在持续的争议中取得了重要的阶段性胜利。然而，法院禁止太阳制药在印度国内市场销售该仿制药，直至诺和诺德的专利在2026年3月到期。The bench also directed the company to file an affidavit and provide export account details as part of its undertaking..法庭还指示该公司提交一份宣誓书，并提供出口账目详情作为其承诺的一部分。Live Events现场活动“Obesity and diabetes have emerged as two of the most pressing health challenges confronting India, and GLP-1 based therapies can play a meaningful role in addressing this growing burden. Noveltreat meets global quality standards and is supported by robust Indian clinical evidence on efficacy and safety for weight management.“肥胖和糖尿病已成为印度面临的最紧迫的两大健康挑战，而基于GLP-1的疗法可以在应对这一日益增长的负担中发挥重要作用。Noveltreat符合全球质量标准，并有印度强有力的临床证据支持其在体重管理方面的有效性和安全性。”As India’s largest pharmaceutical company with leadership in cardiometabolic therapies, we are committed to improving access to generic semaglutide across the country after the patent expiry,” said Kirti Ganorkar, Managing Director, Sun Pharma..印度最大制药公司、在心脑代谢治疗领域处于领先地位的太阳制药总经理基尔蒂·加诺卡表示：“我们承诺在专利到期后，提高全国范围内对通用名药物司美格鲁肽的可及性。”In December 2025, Sun Pharma also received DCGI approval to manufacture and market semaglutide injection for type 2 diabetes under the brand name Sematrinity, which will be launched after patent expiry.2025年12月，太阳制药公司还获得了印度药品监管总局（DCGI）的批准，可以生产和销售用于治疗2型糖尿病的司美鲁肽注射液，并将以品牌名Sematrinity上市，该产品将在专利到期后推出。GLP-1 receptor agonists are considered highly effective for treating obesity and type 2 diabetes while reducing cardiovascular and renal complications.GLP-1受体激动剂被认为是治疗肥胖症和2型糖尿病同时减少心血管和肾脏并发症的高效药物。According to NFHS-5, nearly one in four Indians aged 15–49 is overweight or obese, and about 101 million people in India live with diabetes, as per the ICMR INDIAB 17 study. Around 64% of diabetic patients in India do not reach their target HbA1c levels, highlighting the urgent need for effective therapies and lifestyle interventions..根据NFHS-5的数据，将近四分之一的15-49岁印度人超重或肥胖，而根据ICMR INDIAB 17研究，大约有1.01亿印度人患有糖尿病。印度约64%的糖尿病患者未能达到其目标HbA1c水平，凸显了对有效治疗和生活方式干预的迫切需求。Add添加as a Reliable and Trusted News Source作为一个可靠和值得信赖的新闻来源Add Now!立即添加！(You can now subscribe to our（你现在可以订阅我们的Economic Times WhatsApp channel经济时报WhatsApp频道))(You can now subscribe to our（你现在可以订阅我们的Economic Times WhatsApp channel经济时报WhatsApp频道))","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}