[Translation] Phase II clinical study on the efficacy and safety of HRS7535 tablets in the treatment of type 2 diabetic nephropathy subjects (multicenter, randomized, double-blind, placebo-controlled, parallel design)

评价治疗16周后，HRS-7535片治疗2型糖尿病肾病受试者的有效性

[Translation]

To evaluate the effectiveness of HRS-7535 tablets in the treatment of subjects with type 2 diabetic nephropathy after 16 weeks of treatment

Start Date17 Jun 2024

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

NCT06415214 / Not yet recruitingPhase 2

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetic Kidney Disease

The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetic kidney disease.

Start Date01 Jun 2024

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

NCT06393348 / Not yet recruitingPhase 2

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.

Start Date01 Jun 2024

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

100 Clinical Results associated with HRS-7535

100 Translational Medicine associated with HRS-7535

100 Patents (Medical) associated with HRS-7535

Literatures (Medical) associated with HRS-7535

01 Mar 2024·Diabetes, obesity & metabolism

Safety, pharmacokinetics and pharmacodynamics of HRS‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial

Article

Author: Zhou, Renpeng ; Shu, Chang ; Wang, Quanren ; Fan, Yang ; Ye, Zi ; Zhang, Qian ; Du, Yijun ; Qin, Huiling ; Shen, Yu ; Feng, Sheng ; Hu, Wei ; Zhang, Qin ; Wu, Jingying ; Xu, Yimei

Abstract:

Aim:

To assess the safety, tolerability, pharmacokinetics (PKs) and pharmacodynamics of HRS‐7535, a novel glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), in healthy participants.

Materials and Methods:

This phase 1 trial consisted of single‐ascending dose (SAD), food effect (FE) and multiple‐ascending dose (MAD) parts. In the SAD part, participants were randomized (6:2) to receive HRS‐7535 (at doses of 15, 60 and 120 mg; administered orally once daily) or placebo. In the FE part, participants were randomized (8:2) to receive a single dose of 90‐mg HRS‐7535 or placebo, in both fed and fasted states. In the MAD part, participants were randomized (18:6) to receive daily HRS‐7535 (120 mg [30/60/90/120‐mg titration scheme]) or placebo for 28 days. The primary endpoints were safety and tolerability.

Results:

Nausea and vomiting were the most frequently reported AEs across all three parts. In the SAD part, the median Tmax was 5.98‐5.99 hours and the geometric mean t1/2 was 5.28‐9.08 hours across the HRS‐7535 dosing range. In the MAD part, the median Tmax was 5.98‐10.98 hours and the geometric mean t1/2 was 6.48‐8.42 hours on day 28 in participants on HRS‐7535. PKs were approximately dose‐proportional. On day 29 in the MAD part, the mean (percentage) reduction in body weight from baseline was 4.38 kg (6.63%) for participants who received HRS‐7535, compared with 0.8 kg (1.18%) for those participants who received a placebo.

Conclusions:

HRS‐7535 exhibited a safety and tolerability profile consistent with other GLP‐1RAs and showed PKs suitable for once‐daily dosing. These findings support further clinical development of HRS‐7535 for type 2 diabetes.

News (Medical) associated with HRS-7535

20 May 2024

·www.echemi.com

Hefty $6 Billion Deal: Hengrui Licenses GLP-1 Portfolio to Hercules

Hengrui Medicine, a leading innovative global pharmaceutical company, has announced a landmark deal. The company has granted the exclusive rights to develop, manufacture, and commercialize its proprietary GLP-1 class of innovative drugs - HRS-7535, HRS9531, and HRS-4729 - to Hercules, a new biopharmaceutical company based in the United States. Hercules, founded in May 2024, is backed by a consortium of prominent investment firms, including Bain Capital Life Sciences Fund, Atlas Ventures, RTW Capital, and Lyra Capital, who have collectively invested $400 million to establish the company. Bain Capital Life Sciences Fund, established in 2016, has a global investment focus on the pharmaceutical, biotechnology, medical device, diagnostics, and life sciences tool sectors, with a particular emphasis on driving medical innovation and addressing unmet healthcare needs. Under the terms of the agreement, Hercules will pay Hengrui an upfront payment and near-term milestone payments totaling $110 million, as well as up to $200 million in clinical development and regulatory milestones, and up to $5.725 billion in sales milestones, along with tiered royalties on net sales ranging from low single-digit to low double-digit percentages. In exchange, Hengrui will acquire a 19.9% equity stake in Hercules. Hengrui's innovative GLP-1 portfolio holds significant promise for the treatment of type 2 diabetes (T2DM) and obesity. HRS-7535, an oral small-molecule GLP-1 receptor agonist, can enhance insulin secretion, suppress glucagon release, and increase satiety, making it a potential game-changer in the management of T2DM and weight loss. HRS9531, a dual agonist targeting the glucose-dependent insulinotropic polypeptide receptor (GIPR) and the GLP-1 receptor, aims to synergistically promote insulin secretion, suppress energy intake, and improve insulin sensitivity, while mitigating the gastrointestinal side effects associated with GLP-1 agonists. The licensing deal underscores Hengrui's commitment to advancing its innovative pipeline and making its research and development achievements accessible to patients globally. With over a decade of R&D investments totaling nearly $40 billion, Hengrui has already launched 16 innovative drugs and 4 second-class new drugs in China, with more than 90 self-developed innovative products in various stages of development. This landmark partnership with Hercules is set to further strengthen Hengrui's position as a leading global biopharmaceutical player, as it continues to drive medical innovation and address unmet healthcare needs worldwide.

License out/in

20 May 2024

·www.echemi.com

Mapping Hengrun's GLP-1 Global Expansion: A $6 Billion Journey

In a landmark move, China's pharmaceutical giant Hengrun has licensed out the global development, manufacturing and commercialization rights (excluding Greater China) of its three innovative GLP-1 drugs to the newly-founded US biotech company Hercules. This $6 billion deal marks a significant step in Hengrun's international expansion strategy. The licensed GLP-1 assets include HRS-7535, HRS-9531, and HRS-4729. Hercules, a $400 million startup backed by leading investors like Bain Capital Life Sciences, Atlas Ventures, RTW Capital and Lyra Capital, will pay Hengrun an upfront payment and near-term milestones totaling $110 million. Additional clinical, regulatory and sales milestones could reach up to $220 million and $5.725 billion respectively, along with tiered royalties on net sales. Notably, Hengrun will also acquire a 19.9% equity stake in Hercules as part of the deal, a departure from typical license-out transactions. The two companies will establish a joint steering committee to coordinate the global development and commercialization of the licensed products. This deal represents Hengrun's accelerated pursuit of global expansion amidst the dual pressures of limited payment terms and internal R&D challenges faced by domestic Chinese pharma firms in recent years. After establishing a US subsidiary in 2022, Hengrun has now embraced the mainstream "license-out" strategy adopted by domestic biotech companies to partner with international players and expand overseas. In 2023 alone, Hengrun announced five out-licensing agreements worth over $4 billion. The latest GLP-1 transaction builds on these efforts, allowing Hengrun to not only secure upfront and milestone payments, but also gain a strategic stake in the platform created by Hercules to further drive its global market access. The surging interest in GLP-1 therapies for weight management and diabetes, driven by recent market successes, has fueled a frenzy of deal-making in this space. Hengrun's $6 billion licensing agreement underscores the immense commercial potential of its GLP-1 portfolio as it seeks to expand its footprint in the lucrative global markets.

License out/in

16 May 2024

·endpts.com

Bain, Atlas, RTW back new biotech developing obesity drugs with $400M

A new obesity biotech has entered the field — and it has $400 million from well-known life sciences investors to test investigational GLP-1 and GIP candidates licensed from Jiangsu Hengrui Pharmaceuticals. Bain Capital Life Sciences, Atlas Venture, RTW and Lyra Capital have invested in a new biotech named Hercules CM NewCo, per an announcement this week from China-based Hengrui. Hercules’ pipeline now includes the global, ex-China rights to HRS-7535, HRS9531 and HRS-4729, according to the release. The deal includes $110 million in upfront payments to Hengrui, according to a source familiar with the deal. Hercules, a placeholder name for the biotech, will be based in the US, the source said. The new company is a partnership between Bain, Atlas and RTW, the source added.

100 Deals associated with HRS-7535

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Type 2 diabetes mellitus with established diabetic nephropathy	Phase 2	CN	Shandong Suncadia Medicine Co., Ltd.Startup	17 Jun 2024
Diabetic Nephropathies	Phase 2	-	Shandong Suncadia Medicine Co., Ltd.Startup	01 Jun 2024
Obesity	Phase 2	-	Shandong Suncadia Medicine Co., Ltd.Startup	01 Feb 2024
Diabetes Mellitus, Type 2	Phase 2	-	Shandong Suncadia Medicine Co., Ltd.Startup	28 Feb 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05347758 (EASD2023)	Phase 1	-	24	HRS-7535 15 mg	sqdtxswotj(vjoaeojlpo) = Most common treatment-emergent adverse events in both SAD and MAD were nausea bijkdaielc (gairsmlyro ) View more	Positive	03 Oct 2023
				HRS-7535 60 mg
NCT05347758 (ADA2023) Manual	Phase 1	-	48	HRS-7535 (SAD)	huaclogyjs(zjuapgpbpa) = Most common treatment-emergent adverse events in both SAD and MAD were nausea and vomiting; all TEAEs were mild in severity. sbicgmoqdq (dobkfmhsrp ) View more	Positive	20 Jun 2023
				HRS-7535 (MAD)

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