In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which has detrimental effects on health by lessening improvements in glucose and insulin levels, contributing to weight regain by reducing basal metabolic rate, and increasing the risk of falls, and fractures. Data in animals and humans suggest that bimagrumab, an investigational new drug for obesity that inhibits the activin type II receptor (ActRII) inhibitor, may build muscle and bone while resulting in a loss of fat mass. Semaglutide, which is FDA-approved for the treatment of obesity, results in loss of fat mass, but its effects on muscle and bone are less clear. The investigators hypothesize that in a randomized, placebo-controlled trial of 65 adults with obesity randomized to IV bimagrumab, identical IV placebo plus semaglutide, or identical IV placebo alone, bimagrumab will result in improvements in muscle, fat, and bone compared to semaglutide or placebo when given in addition to a lifestyle intervention for weight loss over 52 weeks.

开始日期2025-01-01

申办/合作机构

The Schwartz Center for Compassionate Healthcare

NCT06643728 / Recruiting临床2期

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight Without Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 54 weeks.

开始日期2024-10-21

申办/合作机构

Eli Lilly & Co.

NCT05616013 / Active, not recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

开始日期2022-11-16

申办/合作机构

Eli Lilly & Co.

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100 项与比马格鲁单抗相关的专利（医药）

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项与比马格鲁单抗相关的文献（医药）

2024-12-01·METABOLISM-CLINICAL AND EXPERIMENTAL

The impact of weight loss on fat-free mass, muscle, bone and hematopoiesis health: Implications for emerging pharmacotherapies aiming at fat reduction and lean mass preservation

Review

作者: Kokkorakis, Michail ; Mantzoros, Christos S. ; Mantzoros, Christos S ; Stefanakis, Konstantinos

Similar to bariatric surgery, incretin receptor agonists have revolutionized the treatment of obesity, achieving up to 15-25 % weight loss in many patients, i.e., at a rate approaching that achieved with bariatric surgery. However, over 25 % of total weight lost from both surgery and pharmacotherapy typically comes from fat-free mass, including skeletal muscle mass, which is often overlooked and can impair metabolic health and increase the risk of subsequent sarcopenic obesity. Loss of muscle and bone as well as anemia can compromise physical function, metabolic rate, and overall health, especially in older adults. The myostatin-activin-follistatin-inhibin system, originally implicated in reproductive function and subsequently muscle regulation, appears to be crucial for muscle and bone maintenance during weight loss. Activins and myostatin promote muscle degradation, while follistatins inhibit their activity in states of negative energy balance, thereby preserving lean mass. Novel compounds in the pipeline, such as Bimagrumab, Trevogrumab, and Garetosmab-which inhibit activin and myostatin signaling-have demonstrated promise in preventing muscle loss while promoting fat loss. Either alone or combined with incretin receptor agonists, these medications may enhance fat loss while preserving or even increasing muscle and bone mass, offering a potential solution for improving body composition and metabolic health during significant weight loss. Since this dual therapeutic approach could help address the challenges of muscle and bone loss during weight loss, well-designed studies are needed to optimize these strategies and assess long-term benefits. For the time being, considerations like advanced age and prefrailty may affect the choice of suitable candidates in clinical practice for current and emerging anti-obesity medications due to the associated risk of sarcopenia.

2024-02-01·Molecular metabolism

Antibody blockade of activin type II receptors preserves skeletal muscle mass and enhances fat loss during GLP-1 receptor agonism

Article

作者: Baur, Joseph A ; Holman, Corey D ; Seale, Patrick ; Titchenell, Paul M ; Calhoun, Ryan ; Nunn, Elizabeth ; Gavin, Matthew ; Lee, Michelle ; Drareni, Karima ; Uehara, Kahealani ; Jaiswal, Natasha ; Stefkovich, Megan

OBJECTIVE:

Glucagon-like peptide 1 (GLP-1) receptor agonists reduce food intake, producing remarkable weight loss in overweight and obese individuals. While much of this weight loss is fat mass, there is also a loss of lean mass, similar to other approaches that induce calorie deficit. Targeting signaling pathways that regulate skeletal muscle hypertrophy is a promising avenue to preserve lean mass and modulate body composition. Myostatin and Activin A are TGFβ-like ligands that signal via the activin type II receptors (ActRII) to antagonize muscle growth. Pre-clinical and clinical studies demonstrate that ActRII blockade induces skeletal muscle hypertrophy and reduces fat mass. In this manuscript, we test the hypothesis that combined ActRII blockade and GLP-1 receptor agonism will preserve muscle mass, leading to improvements in skeletomuscular and metabolic function and enhanced fat loss.

METHODS:

In this study, we explore the therapeutic potential of bimagrumab, a monoclonal antibody against ActRII, to modify body composition alone and during weight loss induced by GLP-1 receptor agonist semaglutide in diet-induced obese mice. Mechanistically, we define the specific role of the anabolic kinase Akt in mediating the hypertrophic muscle effects of ActRII inhibition in vivo.

RESULTS:

Treatment of obese mice with bimagrumab induced a ∼10 % increase in lean mass while simultaneously decreasing fat mass. Daily treatment of obese mice with semaglutide potently decreased body weight; this included a significant decrease in both muscle and fat mass. Combination treatment with bimagrumab and semaglutide led to superior fat mass loss while simultaneously preserving lean mass despite reduced food intake. Treatment with both drugs was associated with improved metabolic outcomes, and increased lean mass was associated with improved exercise performance. Deletion of both Akt isoforms in skeletal muscle modestly reduced, but did not prevent, muscle hypertrophy driven by ActRII inhibition.

CONCLUSIONS:

Collectively, these data demonstrate that blockade of ActRII signaling improves body composition and metabolic parameters during calorie deficit driven by GLP-1 receptor agonism and demonstrate the existence of Akt-independent pathways supporting muscle hypertrophy in the absence of ActRII signaling.

2023-03-01·Peptides

An update on peptide-based therapies for type 2 diabetes and obesity

Review

作者: Flatt, Peter R ; Conlon, J Michael ; Bailey, Clifford J

Long-acting analogues of the naturally occurring incretin, glucagon-like peptide-1 (GLP-1) and those modified to interact also with receptors for glucose-dependent insulinotropic polypeptide (GIP) have shown high glucose-lowering and weight-lowering efficacy when administered by once-weekly subcutaneous injection. These analogues herald an exciting new era in peptide-based therapy for type 2 diabetes (T2D) and obesity. Of note is the GLP-1R agonist semaglutide, available in oral and injectable formulations and in clinical trials combined with the long-acting amylin analogue, cagrilintide. Particularly high efficacy in both glucose- and weight lowering capacities has also been observed with the GLP-1R/GIP-R unimolecular dual agonist, tirzepatide. In addition, a number of long-acting unimolecular GLP-1R/GCGR dual agonist peptides and GLP-1R/GCGR/GIPR triagonist peptides have entered clinical trials. Other pharmacological approaches to chronic weight management include the human monoclonal antibody, bimagrumab which blocks activin type II receptors and is associated with growth of skeletal muscle, an antibody blocking activation of GIPR to which are conjugated GLP-1R peptide agonists (AMG-133), and the melanocortin-4 receptor agonist, setmelanotide for use in certain inherited obesity conditions. The high global demand for the GLP-1R agonists liraglutide and semaglutide as anti-obesity agents has led to shortage so that their use in T2D therapy is currently being prioritized.

117

项与比马格鲁单抗相关的新闻（医药）

2024-11-06

·EndPoints

‘We’re good’ on weight loss: Biopharmas turn to muscle with new obesity drugs

SAN ANTONIO — It took decades to get to the GLP-1 breakthrough in obesity treatment. Now, the biopharma industry is clamoring over the field’s next frontier: staving off the losses in muscle or lean mass that have been seen with existing drugs. Muscle preservation has become an increasing focus as leaders gathered in Texas this week for ObesityWeek, one of the main medical research conferences centered around the chronic disease. “If you look at the field of incretins — whether it’s single agonists, dual agonists, triple agonists — in my mind, I don’t think we need more weight loss,” Scholar Rock CSO Mo Qatanani told Endpoints News on the sidelines of the confab. “As far as weight loss, I think we’re good; there’s a lot of advancement there,” he added. “I think the next step to look at is this healthier weight loss that you can maintain, that’s durable.” Muscle preservation is key for a variety of health reasons, including implications on metabolism and the overall endocrine system, said Volkan Granit, a Biohaven medical director and neurologist. Retaining muscle mass is particularly relevant for elderly patients, he said, noting the risk of sarcopenia. Biohaven and Scholar Rock are developing myostatin-focused drugs for both spinal muscular atrophy and obesity. If muscle is retained, it could also help extend the durability of obesity drugs and lead to more fat loss, leaders in the field said. Patients on GLP-1s are losing more muscle in a year than they normally would in 10 years, Veru CEO Mitchell Steiner said. The Miami-based biotech is testing an oral selective androgen receptor modulator called enobosarm in a Phase 2b trial in combination with Wegovy. The company will have 16-week data in January 2025, and it plans to run two Phase 3 studies in obesity, for which a partner “would be wonderful,” Steiner said. The GLP-1s aren’t alone in affecting muscle loss. Many types of weight loss approaches, like gastric bypass surgery and caloric restriction, also impair lean mass, according to leaders in the field. “The rule of thumb is you want to keep it 70/30: 70% loss of fat, 30% loss of lean body mass,” said Nikhil Dhurandhar, chair of the nutritional sciences department at Texas Tech University and editor-in-chief of the International Journal of Obesity . Studies have shown about 25% to 55% of lean body mass loss for the GLP-1 class, Dhurandhar said, describing it as a “big deal.” At this point, though, he said he’s a proponent of adding walking exercises and “adequate protein diet” interventions on top of GLP-1 treatment rather than additional obesity medicines. Eli Lilly and Novo Nordisk, the GLP-1 behemoths, are among those also developing medicines thought to have less of an impact on muscle loss. “We’re all waiting for the big gorilla in the room to materialize, which is the ongoing, now Lilly-sponsored trial with bimagrumab plus semaglutide,” SixPeaks Bio CEO Philip Just Larsen said. AstraZeneca has the option to buy his preclinical biotech, which is developing activin-focused drugs for what it calls “healthy weight loss.” Bimagrumab aims to block both activin and myostatin signaling. The drug was originally at Novartis, then swooped up by Versanis Bio, which Lilly bought for up to $1.9 billion last year. Versanis was testing bimagrumab in combination with semaglutide, but Lilly has yet to report those results. Last month, the Indianapolis-based pharma started a new trial testing the injectable in combination with tirzepatide. Nadia Ahmad, an associate VP who leads Lilly’s Phase 3 obesity trials, said it has to be thought of in a broader body composition lens. “With potential investigational medications like bimagrumab, it’s about the fat mass as much as it is about muscle preservation,” Ahmad said on the sidelines of ObesityWeek, “and being able to really hone in on efficacy from a fat mass reduction standpoint, because that’s the crux of what we’re trying to treat here.” Drug developers are also looking at the pancreatic hormone amylin as a potential way of honing in on selective fat loss. Zealand Pharma thinks its petrelintide asset, weeks away from entering Phase 2, could be a “ foundational ,” first-line approach that could rid the need for GLP-1 for some patients. Novo also has an amylin program, combined with semaglutide, that will have key Phase 3 data by year’s end. AstraZeneca also highlighted the potential for amylin earlier this week, as did Structure Therapeutics.

临床2期临床3期

2024-11-02

·药智网

礼来“卷”自己

礼来减肥药又有新动作。近日，礼来注册了GLP-1R/GIPR/GCGR三靶点激动剂Retatrutide的第6项用于减重的三期临床试验，与替尔泊肽头对头比较在肥胖成人中的疗效和安全性。去年11月，替尔泊肽的减重适应症刚刚获批上市，且势头正猛。尽管最新三季报显示，替尔泊肽增速不及市场预期，公司股价也应声大跌，但其前三季度总额依然高达110亿美元，再次缩小与诺和诺德司美格鲁肽的差距。而在礼来最新的预期中，Retatrutide的疗效将超越替尔泊肽。为此，礼来火力全开，连开5项减重三期临床，拟入组人数超5000人。那么，这一次，Retatrutide是否能延续礼来在GLP-1减重领域的辉煌？ 01 礼来押注Retatrutide 替尔泊肽是目前已经问世的GLP-1药物中减重效果最好的。在针对不伴2型糖尿病肥胖受试者的III期SURMOUNT-1研究中，经过72周替尔泊肽治疗后，15mg剂量组的参与者平均体重减轻高达22.5%（24公斤）；在针对伴2型糖尿病肥胖受试者的III期SURMOUNT-2研究中，经过72周替尔泊肽治疗后，15mg剂量组的参与者平均体重减轻15.7%。礼来当时表示，这是首个在3期临床试验中平均减重效果超过20%的研究性药物。由于减重效果突出，替尔泊肽上市即大卖。尽管最新三季报增速不及市场预期，但替尔泊肽总销售额依然达到43.7亿美元，前三季度总额高达110亿美元，再次缩小与诺和诺德司美格鲁肽的差距。而在礼来最新的预期中，Retatrutide的疗效将超越替尔泊肽。在保证安全性和耐受性的前提下，48周给药最高剂量可减重22%-24%，同时对糖尿病患者可以36周降低2%糖化血红蛋白（HbA1c）。礼来去年公布了一项Retatrutide减重的II期研究。结果显示，12mg Retatrutide组受试者在接受24周的治疗后体重降低了17.5%，时间拉长至48周时，降幅达到24.2%。并且从减重曲线来看，并未到达平台期。另一项纳入2型糖尿病患者的Ⅱ期试验则显示，24周时12mg剂量组使HbA1降低了2.02%（安慰剂组0.01%）。如果能够维持这一效果，礼来对Retatrutide的期待并不为过，头对头PK掉替尔泊肽也只是时间问题。而Retatrutide之所以能够展现出强于替尔泊肽的潜力，核心在于其机制。Retatrutide是目前临床进度最快的同时靶向GLP-1R/GIPR/GCGR的降糖减重药。其在过去降糖减重药所用单一靶点GLP-1和双靶点GLP-1/GIP的基础上再添一个GCG。三者都是与血糖水平紧密相关的激素。GLP-1和GIP是肠促胰素，促进胰岛素的分泌，同时引起饱腹感，降低食欲，GCG则能够诱导能量消耗，增加脂质的代谢。过往的研究发现将GLP-1信号与GIP、GCG或两者相结合可增强胰岛素反应，超过单独使用GLP-1产生的胰岛素反应。替尔泊肽已经表现出GLP-1R/GIPR双靶点的极强竞争力，而Retatrutide在其基础上，通过激活GCGR从而增加能量消耗，进而实现超出双靶点的血糖控制和体重减少的效果。基于对机制的信心及过往临床的数据验证，礼来正在加速推进Retatrutide的临床。在此之前，礼来围绕Retatrutide已经连开8项三期临床，包括5项减重和3项二型糖尿病。其中，仅减重适应症拟临床入组人数就超过5000人。尽管替尔泊肽的减重适应症，去年11月刚刚获批，势头正猛。但是，对礼来来说，这更像是一场不得不进行的头对头试验。从GLP-1单靶点到双靶点减肥药、GLP-1联用疗法，入局者无数，谁都不愿意错过这一潜力无限的市场。与其被别人颠覆，不如自我迭代。 02 代谢巨头的自我迭代礼来在降糖减重领域深耕多年，深谙GLP-1药物发展之势。从2005年第一个GLP-1药物艾塞那肽被批准用于2型糖尿病，近20年来GLP-1领域内药物更新迭代都有礼来的深入参与。某种程度上，礼来的GLP-1药物管线布局的变化可以被看作GLP-1领域的缩影。尤其是在和老对头诺和诺德的竞争中，从双方产品的迭代可以窥见GLP-1药物的发展方向：从单靶点到多靶点，从日制剂到周制剂，从注射到口服。最初礼来成功研发GLP-1的艾塞那肽，作为FIC为糖尿病患者提供了新的选择，但半衰期短，一周需要两次注射给药，给患者依从性带来不小挑战；接着诺和诺德的利拉鲁肽和礼来的度拉糖肽接连上市，分别把给药频率降低到了一天一次和一周一次；直到2017年，诺和诺德推出了鼎鼎大名的司美格鲁肽，一周一次注射给药，同时另辟蹊径推出了口服版本，双方的竞争在不断迭代中，持续升温。 2022年，替尔泊肽上市，是全球首个同时作用于GLP-1R/GIPR两个靶点的新一代药物。虽然与司美格鲁肽头对头的SURMOUNT-5研究还在进行中，但在名为SURPASS-2的大规模研究中，5mg、10mg、15mg剂量的替尔泊肽，在改善成人2型糖尿病患者的血糖水平和体重方面均优于1mg司美格鲁肽。正如前文所说，替尔泊肽上市即爆卖，但面对前赴后继的竞争者，礼来已经在加速推进三靶点Retatrutide的研发，自我迭代。说到底，它们都是围绕市场需求——更高效、更安全、更便捷，来引领GLP-1药物的迭代，从单靶点到多靶点以及长效、口服。除了这两个代谢巨头，国内外还有其余药企也在顺应这一趋势布局减重降糖药。比如VIKING的VK2735，这是一款GLP-1R/GIPR受体激动剂，今年上半年先后公布注射剂型Ⅱ期试验和口服片剂Ⅰ期试验的积极结果；安进将GIPR抗体融合GLP-1，制备的AMG133有成为月制剂潜力。而国内至少有9款有GLP-1R/GIPR双靶点药物进入临床阶段，众生药业的RAY1225半衰期为替尔泊肽的两倍，有望实现两周给药一次；信达生物的玛仕度肽则将另一靶点设定为GCGR，已经进入上市申请阶段。三靶点方面，联邦制药和康源药业研发的UBT251肥胖适应症正在开展1期临床，韩美制药的efocipegtrutide已进入II期，不过适应症为MASH。面对诸多竞争，礼来的布局也不只是更领先的三靶点药物，还包括口服小分子Orforglipron，以及收购新的减重增肌药Bimagrumab，单独使用或联合替尔泊肽，以求在保证肌肉质量的前提下安全减重。从首个推出GLP-1药物，到创新开发双靶点、三靶点，在已登顶降糖减重药后，一边推动GLP-1作用更大化一边迎击GLP-1现存痛点。礼来的布局策略，对其他GLP-1靶点竞争药企乃至整个创新药行业都能带来重要启示。正是由于不安于现状、思进取，礼来才能一直走在降糖减重的最前方。来源 | 氨基观察（药智网获取授权转载）撰稿 | 李灿责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

临床结果临床3期临床2期

2024-10-31

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第42期/总第163期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）全球（不含中国）共有5个新药获批上市。其中，NDA批准1个，新适应症批准4个。与上个统计周期相比，本次减少1个批准新药。 10月22日，TEVA宣布FDA已批准SELARSDI（Adalimumab-ryvk）130mg/26mL单剂量小瓶用于静脉输注，治疗患有克罗恩病和溃疡性结肠炎的成人患者。FDA已于2024年4月批准了SELARSDI 45mg/0.5mL和90mg/mL单剂量预装注射器用于皮下注射。SIMLANDI是一种人源单克隆抗体，选择性靶向p40蛋白，p40蛋白是白细胞介素（IL）-12和IL-23细胞因子共有的成分，在治疗免疫介导的疾病中起着至关重要的作用。 10月23日，Janssen宣布，EC批准了DARZALEX®（Daratumumab）皮下制剂与硼替佐米、来那度胺和地塞米松（Daratumumab-VRd）联合用于符合自体干细胞移植条件的新诊断多发性骨髓瘤患者。这一批准得到了III期PERSEUS研究数据的支持：中位随访47.5个月后，PFS的主要终点显著改善，疾病进展或死亡风险降低了58%，阴性率评估为75.2%，完全反应为87.9%，≥12个月的持续MRD阴性为64.8%。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）全球（不含中国）共有6个新药申报上市。其中，NDA申报3个，BLA申报3个。与上次统计周期相比，本次减少4个NDA/BLA申报。 10月21日，百济神州宣布CHMP发布了积极意见，建议延长TEVIMBRA（替雷利珠单抗）在胃癌或胃食管交界处（G/GEJ）腺癌和食管鳞状细胞癌（ESCC）中的授权。RATIONALE-305和306试验表明，替雷利珠单抗联合化疗提高了生存率，突出了其为符合条件的患者提供更好治疗结果的潜力。 NDA/BLA申报（部分）根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）全球（不含中国）无药物获监管机构特殊资格认定。与上次统计周期相比，本次减少4个获监管机构特殊资格认定的药物。 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）全球（不含中国）新药临床研发状态更新共计63条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及免疫系统疾病等共计14个领域。其中，肿瘤领域临床进展更新居各领域之首，为21条：涉及化学药15条，生物药6条。 10月24日，再鼎医药在2024年ENA大会上，公布了正在进行的ZL-1310全球Ia期临床研究数据。ZL-1310正在此前接受过至少一种含铂化疗方案治疗的广泛期小细胞肺癌（ES-SCLC）患者中进行临床研究。主要的有效性结果包括：至少接受过一次治疗后评估的患者ORR为74%，DLL3 H-Score评分大于5的患者均表现出肿瘤缓解，ZL-1310在所有剂量水平上均表现出抗肿瘤活性并具有良好的耐受性。 10月25日，盟科药业宣布自主研发的拟用于治疗非结核分枝杆菌感染的新型苯并硼唑类抗菌药MRX-5在澳大利亚的I期临床试验已顺利完成，并达到预期目标。研究结果表明，MRX-5在健康成人群体中显现出良好的安全性和耐受性，在50mg~1200mg剂量范围内，健康受试者单次口服MRX-5后，其活性代谢物MRX-6038的药代动力学呈线性且可预测。此外，食物影响研究初步数据显示MRX-6038无食物效应。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.10.19-10.25）全球（含中国）医药交易时间共计33起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）国内共有4个新药获NMPA批准上市。其中，BLA批准1个，新适应症批准3个。与上次统计周期相比，本次减少4个NMPA批准新药。 10月16日，NMPA官网公示，罗欣药业申报的替戈拉生片新适应症上市申请已获得批准。替戈拉生片是一款钾离子竞争性酸阻滞剂类药物（P-CAB），本次获批的适应症为：与适当的抗菌疗法联用根除幽门螺杆菌。研究结果显示，全分析集（FAS）中替戈拉生组和对照组的幽门螺杆菌根除率分别为93.5%和86.4%，证明了含替戈拉生铋剂四联疗法根除幽门螺杆菌的非劣效性。此外，两组之间的安全性相似。 10月21日，百济神州宣布其PD-1抑制剂替雷利珠单抗新适应症上市申请获得NMPA批准，联合含铂化疗新辅助治疗，并在手术后继续本品单药辅助治疗，用于可切除的II期或IIIA期非小细胞肺癌患者的治疗。替雷利珠单抗联合化疗组有71.2%的患者对药物治疗产生应答，84.1%的患者接受了根治性手术，微创手术率更高，微创转开胸率更低，且淋巴结清除数量相似而全肺切除的比例更低。国内新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）国内共有24个新药获临床默示许可，涉及27个受理号。其中，化学药6个，治疗用生物制品12个，预防用生物制品6个。与上次统计周期相比，本次增加73个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.10.19-10.25）国内共有2个新药申报上市，涉及3个受理号。其中，化药1个，治疗用生物制品1个。与上个统计周期相比，本次减少26个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.10.12-10.25）国内共有40个新药申报临床，涉及50个受理号。其中，化学药19个，治疗用生物制品18个，预防用生物制品3个。与上次统计周期相比，本次减少50个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.10.12-10.25）国内共有5个药物获NMPA特殊资格认定。其中，化学药1个，生物药4个。与上次统计周期相比，本次增加1个获监管机构特殊资格认定的药物。 10月24日，CDE官网公示，宜联生物注射用YL201拟纳入突破性治疗品种，拟定适应症为经初始含铂治疗失败的复发性小细胞肺癌。临床研究数据显示，有效性方面，在276例存在至少一次基线后肿瘤评估的患者中，ORR为44.6%，DCR为83.7%。其中，ES-SCLC队列共计72例可评估疗效的患者，既往全部接受过含铂化疗，95%接受过抗PD-1/L1治疗。YL201在ES-SCLC患者中的ORR为68.1%，mPFS为6.2个月。YL201在脑转移患者中的疗效与整体人群可比，ORR为52.2%，mPFS为5.3个月。 10月25日，CDE官网公示诗健生物研发的重组人源化抗Trop2单抗-SN38偶联物拟纳入突破性治疗品种，拟定适应症为既往未经系统治疗的不可手术的局部晚期、复发或转移性PD-L1阴性三阴性乳腺癌。在Ib期临床研究中，ESG401一线治疗转移性三阴性乳腺癌队列取得了积极结果，ORR达到86%，DCR为100%。ESG401作为mTNBC患者的一线治疗，具有显著的抗肿瘤活性、持久的肿瘤缓解和良好的安全性。国内监管机构特殊资格认定药物 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.10.12-10.25）国内新药临床研发状态更新共计6条，涉及肿瘤、呼吸系统、遗传和代谢疾病以及眼部疾病共计6个领域。其中，化学药3条，生物药3条。与上次统计周期相比，本次增加2条国内新药临床研发状态更新。 10月21日，信达生物2024年AAO年会上公布了其研发的重组人血管内皮生长因子受体（VEGFR）-抗体-人补体受体1（CR1）融合蛋白Efdamrofusp alfa注射液（IBI302）在新生血管性年龄相关性黄斑变性（nAMD）的临床II期数据。研究结果显示：第40周时，IBI302 6.4mg组、IBI302 8.0mg组、阿柏西普 2.0mg组BCVA较基线变化均值分别为+10.5、+11.0、+9.8个ETDRS字母数；IBI302 6.4mg组与8.0mg组维持Q12W给药间隔的受试者比例分别为81%、88%；IBI302安全性特征与既往研究一致，整体安全性良好。 10月25日，中国原创脑卒中新药研究TASTE-2在WSC以口头报告形式发表：急性缺血型卒中患者在血管内取栓治疗前，联合依达拉奉右莰醇（先必新®）进行脑细胞保护，显著改善了患者90天时恢复神经功能独立的患者比例，降低了患者致残比例。在EVT前使用脑细胞保护剂依达拉奉右莰醇治疗，对比安慰剂，患者90天后功能评分2以下的比例为55.0% vs. 49.6%，且安全性良好。国内新药研发进展（部分） 05 国内新药研发领域政策法规动态国家药监局药审中心关于发布《已上市境外生产药品转移至境内生产的药品上市注册申请申报资料要求（预防用生物制品）》的通告（2024年第43号）按照国家药品监督管理局的部署，药审中心组织制定了《已上市境外生产药品转移至境内生产的药品上市注册申请申报资料要求（预防用生物制品）》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。特此通告。 06 国内新药研发领域热点新闻下一代减肥药新星，BD预期打满 GLP-1减肥药市场已步入更为紧张刺激的下半场：一边是礼来与诺和诺德两大巨头，在临床试验、产能扩张及商业化上展开了全方位的激烈比拼；另一边，中国药企也在纷纷加速研发步伐，通过提高药物疗效和差异化设计突围。与此同时，新型减肥药正悄然崛起成为新的蓝海。其中，ActRII靶向药物凭借既减重又增肌的独特疗效脱颖而出。近日更是喜报频传：礼来启动了Bimagrumab联合替尔泊肽增肌减脂的Ⅱ期临床试验；来凯医药的LAE102临床试验也取得重大进展，且公司股价因此暴涨近40%。更多资讯，请阅读原文重回“凡间”的片仔癀依旧“能打” 片仔癀终于回到了“凡间”。今年6月以来，片仔癀二手市场回收价格出现了明显下跌，从三年前的1500元/粒跌至600元/粒左右。曾经被赋予了奢侈品属性、礼品属性甚至金融属性的“仙丹”片仔癀，重新回归到药品属性。但即使如此，“百年老字号”片仔癀依旧是A股市值最高的中药股，在消费降级的背景下，前三季度依旧实现了营收84.5亿元，同比增长11.19%，净利润26.87亿元，同比增长11.73%的超预期业绩。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“1031创新药周报”，即可下载。

上市批准临床3期临床结果申请上市

100 项与比马格鲁单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10620	比马格鲁单抗	-	DB12584

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
包涵体肌炎	临床3期	美国	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	日本	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	比利时	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	丹麦	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	法国	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	意大利	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	荷兰	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	瑞士	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	英国	Novartis Pharmaceuticals Corp.	2015-11-02

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SO 52 (EASD2023)	临床1/2期	体重下降 \| 肌肉萎缩	-	Bimagrumab 3 mg/kg	觸窪憲餘憲鬱鑰壓顧鏇(窪鏇繭築鏇願夢繭鏇襯) = 製鹽鹽衊憲簾廠繭顧獵憲醖積襯壓艱選網築餘 (選艱憲鹽鑰遞蓋願鏇醖 )	积极	2023-10-04
				Bimagrumab 10 mg/kg	鏇鹹衊憲選廠構簾範鑰(繭網夢觸夢獵製壓積鑰) = 窪遞淵鬱艱窪襯壓鏇衊憲積餘艱夢鹽蓋醖壓鏇 (壓艱獵齋築艱鏇簾膚網 )
NCT05616013 (ADA2023)	临床2期	体重下降	75	Bimagrumab 10 mg/kg IV	選積製醖齋廠艱構糧獵(糧膚築製餘觸艱築淵齋) = 襯蓋積夢簾遞鹽鏇製鹽願衊鬱淵鏇網簾膚獵齋 (鬱蓋簾膚廠範齋衊獵願 ) 更多	-	2023-06-20
				Placebo	選積製醖齋廠艱構糧獵(糧膚築製餘觸艱築淵齋) = 壓餘窪積餘獵繭繭襯壓願衊鬱淵鏇網簾膚獵齋 (鬱蓋簾膚廠範齋衊獵願 ) 更多
PRNewswire 人工标引	临床2期	糖尿病	569	Bimagrumab	範鬱鑰膚築餘淵膚鏇淵(夢艱鬱醖壓壓築淵築襯) = 齋鬱艱憲簾衊夢齋襯廠製鹽獵鬱願衊獵衊顧製 (糧夢餘獵淵醖糧簾顧鬱 )	积极	2022-06-11
				Placebo	範鬱鑰膚築餘淵膚鏇淵(夢艱鬱醖壓壓築淵築襯) = 製壓繭衊簾衊觸鑰願蓋製鹽獵鬱願衊獵衊顧製 (糧夢餘獵淵醖糧簾顧鬱 )
NCT03005288 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	2型糖尿病 \| 肥胖	75	Bimagrumab	淵鬱選選鬱築襯顧鬱繭(衊淵鬱鏇願蓋壓壓簾觸) = 窪糧願窪醖鹹觸遞鏇廠簾鏇簾餘鏇鹽築選膚醖 (積網艱鏇餘齋窪淵鬱醖, -8.3 ~ -6.6) 更多	积极	2021-01-04
				Placebo	淵鬱選選鬱築襯顧鬱繭(衊淵鬱鏇願蓋壓壓簾觸) = 夢範願鹹遞鑰醖鹽鹽積簾鏇簾餘鏇鹽築選膚醖 (積網艱鏇餘齋窪淵鬱醖, -0.99 ~ 0.63) 更多
NCT02250443 (Pubmed \| Ann Neurol) 人工标引	临床2/3期	包涵体肌炎	10	Bimagrumab	壓窪選顧淵鬱窪餘糧廠(鬱憲糧糧築糧觸製膚遞) = muscle spasms and falls (both 9 of 10, 90%),diarrhea (6 of 10, 60%) and acne and skin eruption (both 5 of 10, 50%) 顧淵網夢遞餘廠糧遞窪 (鬱艱淵選簾淵廠鹹鹽醖 )	不佳	2020-10-06
NCT02333331 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	肌肉减少症	180	SOC+Bimagrumab	簾窪製構蓋廠獵構製範(範顧夢鏇鏇鹽艱憲壓鑰) = 餘窪遞積壓蓋鹹蓋製鏇顧鏇夢鹽鏇簾襯糧鬱衊 (網構遞夢鏇積鑰鏇鑰鹹, 0.90 ~ 1.77) 更多	积极	2020-10-01
				SOC+Placebo	簾窪製構蓋廠獵構製範(範顧夢鏇鏇鹽艱憲壓鑰) = 餘衊壓齋願齋觸範簾製顧鏇夢鹽鏇簾襯糧鬱衊 (網構遞夢鏇積鑰鏇鑰鹹, 0.53 ~ 1.52) 更多
NCT03005288 (CTgov)	临床2期	2型糖尿病 \| 肥胖	78	BYM338 10 mg/kg (BYM338 10 mg/kg)	窪獵積衊繭壓構窪鹽願(齋網顧艱鏇鏇築鑰鬱製) = 齋顧鹹淵憲鑰鹽獵糧鑰窪壓壓淵鬱選鏇壓醖選 (鏇簾糧窪網醖簾顧鹹繭, 觸選醖網膚獵鹽選醖顧 ~ 憲膚鏇製廠構製蓋醖壓) 更多	-	2020-06-04
				Placebo (Placebo)	窪獵積衊繭壓構窪鹽願(齋網顧艱鏇鏇築鑰鬱製) = 簾廠壓範壓遞餘顧壓夢窪壓壓淵鬱選鏇壓醖選 (鏇簾糧窪網醖簾顧鹹繭, 鹽壓繭餘廠餘獵簾選鹽 ~ 壓遞鹽簾簾艱鹹窪壓餘) 更多
NCT01925209 (RESILIENT, Pubmed) 人工标引	临床2期	包涵体肌炎	251	bimagrumab	膚獵構醖願願廠蓋鑰網(製願齋蓋觸醖壓窪齋築) = 鏇襯鏇構遞鹹糧憲醖襯構網製淵顧範衊選襯網 (顧醖範網醖構選範積襯 )	不佳	2019-09-01
				Placebo	壓醖窪觸鬱鹹夢獵餘顧(簾壓衊齋積顧構醖選膚) = 鹹襯淵網築膚齋選鏇襯製膚鹽襯鑰簾網積鏇窪 (餘構齋鑰醖鑰選鑰夢齋 ) 更多
NCT02333331 (CTgov)	临床2期	肌肉减少症	217	bimagrumab (BYM338 70 mg)	顧醖膚鏇齋餘壓獵觸範(網構艱夢鏇壓遞鏇糧鑰) = 願願淵築繭餘艱鏇衊醖齋淵鬱廠範艱顧餘壓選 (鬱觸範廠鹹蓋願範網製, 醖蓋鏇鏇壓築簾簾製製 ~ 獵鹽築製壓積襯觸簾簾) 更多	-	2019-08-06
				bimagrumab (BYM338 210 mg)	顧醖膚鏇齋餘壓獵觸範(網構艱夢鏇壓遞鏇糧鑰) = 夢衊蓋糧選齋憲淵糧壓齋淵鬱廠範艱顧餘壓選 (鬱觸範廠鹹蓋願範網製, 淵築襯糧醖觸糧鏇繭鏇 ~ 齋蓋蓋鑰遞襯蓋窪鹹鬱) 更多
NCT02250443 (BYM338, CTgov)	临床2/3期	包涵体肌炎	10	BYM338 (Bimagrumab)	淵築襯繭觸觸顧繭遞願(淵願願網繭襯範簾積積) = 齋憲鑰網願願淵餘簾選觸觸衊窪構簾鹹鬱壓壓 (鑰觸鏇鏇夢構齋繭糧糧, 網糧觸選夢淵製鏇範鑰 ~ 蓋窪醖製淵窪窪窪網繭) 更多	-	2018-04-10