[Translation] ACCLAIM-Lp(a): A phase 3, randomized, double-blind, parallel, placebo-controlled study evaluating the effect of lepodisiran on major adverse cardiovascular events in adults with established atherosclerotic cardiovascular disease or at increased risk for a first cardiovascular event and elevated lipoprotein(a) levels

在脂蛋白(a)水平升高的成人中评价lepodisiran 对主要不良心血管事件影响

[Translation]

To evaluate the effect of lepodisiran on major adverse cardiovascular events in adults with elevated lipoprotein(a) levels

Start Date02 Jul 2024

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

CTR20240035 / RecruitingPhase 1

一项 LOXO-435（LY3866288）治疗携带FGFR3变异的晚期恶性实体肿瘤的开放标签、多中心研究

[Translation] An open-label, multicenter study of LOXO-435 (LY3866288) in patients with advanced solid tumors harboring FGFR3 mutations

主要目的：本研究的主要目的是更多地了解 LOXO-435 的安全性、副作用和有效性。

[Translation]

Primary Objective: The primary objective of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435.

Start Date12 Jun 2024

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

CTR20241024 / RecruitingPhase 3

一项在中至重度特应性皮炎受试者中评价Lebrikizumab联合/不联合外用皮质类固醇治疗时的有效性和安全性的多中心、随机、双盲、安慰剂对照、3期试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of lebrikizumab with or without topical corticosteroids in subjects with moderate to severe atopic dermatitis

主要目的： Combo队列检验以下假设：与TCS联合治疗时，第16周时Lebrikizumab 250 mg Q2W在减轻中至重度AD受试者的AD体征和症状方面优于安慰剂 Mono队列作为单药治疗时，第16周时Lebrikizumab 250 mg Q2W与安慰剂在减轻中至重度AD受试者的AD体征和症状方面进行比较关键次要目的： Combo队列在16周诱导期（第0周至第16周）联合TCS治疗时，比较Lebrikizumab 250 mg Q2W与安慰剂在中至重度AD受试者中的有效性和健康结局指标

[Translation]

Primary Objective: Combo cohort tests the hypothesis that Lebrikizumab 250 mg Q2W is superior to placebo in reducing signs and symptoms of AD in subjects with moderate to severe AD at week 16 when combined with TCS Mono cohort compares Lebrikizumab 250 mg Q2W with placebo in reducing signs and symptoms of AD in subjects with moderate to severe AD at week 16 as monotherapy Key Secondary Objectives: Combo cohort compares the efficacy and health outcome measures of Lebrikizumab 250 mg Q2W with placebo in subjects with moderate to severe AD when combined with TCS during the 16-week induction period (weeks 0 to 16)

Start Date24 Apr 2024

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

100 Clinical Results associated with Eli Lilly Suzhou Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Eli Lilly Suzhou Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Eli Lilly Suzhou Pharmaceutical Co. Ltd.

01 May 2024·Diabetes Therapy

Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups

Article

Author: Du, Liying ; Lu, Song ; Ji, Linong ; Tang, Jiani ; Bi, Yan

INTRODUCTIONTirzepatide is a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist. In the SURPASS-AP-Combo trial, once-weekly tirzepatide was associated with improved glycemic control and weight loss versus insulin glargine and was generally well tolerated in an Asia-Pacific, predominately Chinese, population with type 2 diabetes (T2D). This post hoc subgroup analysis of SURPASS-AP-Combo assessed the potential influence of patient baseline characteristics on the efficacy and safety of tirzepatide.METHODSChanges from baseline to week 40 in HbA1c, body weight, fasting serum glucose (FSG), and daily glucose average from self-measured blood glucose profiles were analyzed by potential influential factors including age (< 65, ≥ 65 years), sex, baseline HbA1c (≤ 8.5, > 8.5%), body mass index (BMI) (< 25, ≥ 25 kg/m²), body weight (< 75, ≥ 75 kg), duration of diabetes (< 10, ≥ 10 years), and concomitant oral antihyperglycemic medications (metformin, metformin plus sulphonylurea). Gastrointestinal adverse events and hypoglycemia were also evaluated.RESULTSAt week 40, all tirzepatide doses were associated with reduced HbA1c, body weight, FSG, and daily glucose average from baseline in all subgroups. Greater HbA1c reductions were achieved in patients with higher baseline HbA1c across all tirzepatide doses, higher body weight with 10 mg and younger age with 15 mg tirzepatide. Greater reductions in body weight were observed in patients with higher body weight across all tirzepatide doses, lower baseline HbA1c with 5 mg and higher BMI with 5 mg tirzepatide.CONCLUSIONSIn this post hoc analysis, tirzepatide was associated with reduced blood glucose and body weight in a predominantly Chinese population with T2D across different subgroups, consistent with previous reports for tirzepatide.CLINICAL TRIAL REGISTRATIONNCT04093752.

01 Apr 2024·Diabetes, Obesity and Metabolism

Efficacy and safety of tirzepatide in people with type 2 diabetes by baseline body mass index: An exploratory subgroup analysis of SURPASS‐AP‐Combo

Article

Author: Du, Liying ; Ma, Jianhua ; Ji, Linong ; Wang, Rui ; Liu, Ming

AbstractAimsTo assess the efficacy and safety of tirzepatide versus insulin glargine in people with type 2 diabetes (T2D) by baseline body mass index (BMI).Materials and MethodsParticipants with T2D from the Phase 3 SURPASS‐AP‐Combo trial (NCT04093752) were categorized into three BMI subgroups (normal weight [<25 kg/m2], overweight [≥25 and <30 kg/m2], and obese [≥30 kg/m2]) according to World Health Organization criteria. Exploratory outcomes including glycaemic control, body weight, cardiometabolic risk, and safety were compared among three tirzepatide doses (5, 10 or 15 mg) and insulin glargine.ResultsOf 907 participants, 235 (25.9%) had a BMI <25 kg/m2, 458 (50.5%) a BMI ≥25 to <30 kg/m2, and 214 (23.6%) a BMI ≥30 kg/m2 at baseline. At Week 40, all tirzepatide doses led to a greater reduction in mean glycated haemoglobin (HbA1c; −2.0% to −2.8% vs. −0.8% to −1.0%, respectively) and percent change in body weight (−5.5% to −10.8% vs. 1.0% to 2.5%, respectively) versus insulin glargine, across the BMI subgroups. Compared with insulin glargine, a higher proportion of tirzepatide‐treated participants achieved treatment goals for HbA1c and body weight reduction. Improvements in other cardiometabolic indicators were also observed with tirzepatide across all the BMI subgroups. The safety profile of tirzepatide was similar across all subgroups by BMI. The most frequent adverse events with tirzepatide were gastrointestinal‐related events and decreased appetite, with relatively few events leading to treatment discontinuation.ConclusionsIn participants with T2D, regardless of baseline BMI, treatment with tirzepatide resulted in statistically significant and clinically meaningful glycaemic reductions and body weight reductions compared with insulin glargine, with a safety profile consistent with previous reports.

01 Jan 2024·Diabetes, Obesity and Metabolism

Ultra‐rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double‐blind phase 3 study

Article

Author: Yuan, Yuan ; Pérez Manghi, Federico ; Yan, Xiang ; García-Hernández, Pedro ; Ma, Jianhua ; Zhou, Zhiguang ; Xu, Jianwei ; Feng, Qiong ; Wang, Guixia ; Liu, Wei

AbstractAimsTo investigate the efficacy and safety of ultra‐rapid lispro (URLi) versus insulin lispro in predominantly Chinese patients with type 1 diabetes (T1D) in a prospective, randomized, double‐blind, treat‐to‐target, phase 3 study.Materials and MethodsFollowing a lead‐in period, during which insulin glargine U‐100 or insulin degludec U‐100 was optimized, patients were randomly assigned (1:1) to URLi (n = 176) or insulin lispro (n = 178). The primary objective was to test the noninferiority of URLi to insulin lispro in glycaemic control (noninferiority margin = 0.4% for glycated haemoglobin [HbA1c] change from baseline to week 26), with testing for the superiority of URLi to insulin lispro with regard to 1‐ and 2‐hour postprandial glucose (PPG) excursions during a mixed‐meal tolerance test and HbA1c change at week 26 as the multiplicity‐adjusted objectives.ResultsFrom baseline to week 26, HbA1c decreased by 0.21% and 0.28% with URLi and insulin lispro, respectively, with a least squares mean treatment difference of 0.07% (95% confidence interval −0.11 to 0.24; P = 0.467). URLi demonstrated smaller 1‐ and 2‐hour PPG excursions at week 26 with least squares mean treatment differences of −1.0 mmol/L (−17.8 mg/dL) and −1.4 mmol/L (−25.5 mg/dL), respectively (p < 0.005 for both) versus insulin lispro. The safety profiles of URLi and insulin lispro were similar.ConclusionsIn this study, URLi administered in a basal‐bolus regimen demonstrated superiority to insulin lispro in controlling PPG excursions, with noninferiority of HbA1c control in predominantly Chinese patients with T1D.

100 Deals associated with Eli Lilly Suzhou Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Eli Lilly Suzhou Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Insulin human(Eli Lilly & Co.) ( INSR )	Diabetes Mellitus More	Approved
Tirzepatide ( GIPR x GLP-1R )	Diabetes Mellitus, Type 2 More	Approved
Baricitinib ( JAK1 x JAK2 )	Alopecia Areata More	Approved
Pirtobrutinib ( BTK C481S )	Mantle cell lymphoma recurrent More	Approved
Ramucirumab ( VEGFR2 )	Hepatocellular Carcinoma More	Approved

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