Delving into the Latest Updates on Semaglutide biosimilar (Chongqing Chenan Biopharmaceutical &Shanghai Bovax Biotechnology) with Synapse

Overview

Basic Info

Drug Type

Recombinant polypeptide, Biosimilar

Synonyms

Semaglutide Biosimilar (Chongqing Chenan Biopharmaceutical Co., Ltd./Shanghai BOWEI BIOMEDICAL CO., LTD), 司美格鲁肽生物类似药（重庆宸安生物制药有限公司/上海博唯生物科技有限公司）, CA-505

+ [2]

Target

GLP-1R

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

ObesityDiabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Chongqing Chenan Biopharmaceutical Co., Ltd.

Shanghai BOWEI BIOMEDICAL CO., LTD

Active Organization

Chongqing Chenan Biopharmaceutical Co., Ltd.

Shanghai BOWEI BIOMEDICAL CO., LTD

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 50953

The sequence is quoted from: *****

主要目的：以原研药物司美格鲁肽注射液（诺和泰®）为对照，评价重庆宸安生物制药有限公司研制的司美格鲁肽注射液（CA505）治疗成人2型糖尿病的疗效。次要目的：1）以原研药物司美格鲁肽注射液（诺和泰®）为对照，评价重庆宸安生物制药有限公司研制的司美格鲁肽注射液（CA505）治疗成人2型糖尿病的安全性。2）比较司美格鲁肽注射液（CA505）和诺和泰®在2型糖尿病患者中多次给药后关键药代动力学（PK）参数（AUC0-τ、Css,min）的相似性。

[Translation]

Primary objective: To evaluate the efficacy of semaglutide injection (CA505) developed by Chongqing Chen'an Biopharmaceutical Co., Ltd. in the treatment of type 2 diabetes in adults, using the original drug semaglutide injection (Novota®) as a control. Secondary objectives: 1) To evaluate the safety of semaglutide injection (CA505) developed by Chongqing Chen'an Biopharmaceutical Co., Ltd. in the treatment of type 2 diabetes in adults, using the original drug semaglutide injection (Novota®) as a control. 2) To compare the similarity of key pharmacokinetic (PK) parameters (AUC0-τ, Css,min) between semaglutide injection (CA505) and Novota® in patients with type 2 diabetes after multiple doses.

Start Date04 Jul 2023

Sponsor / Collaborator

Shanghai BOWEI BIOMEDICAL CO., LTD

[+1]

CTR20222768

/ CompletedPhase 1

司美格鲁肽注射液在健康受试者中的随机、开放、单次给药、两制剂、平行设计的药代动力学比对试验

[Translation] A randomized, open-label, single-dose, two-formulation, parallel-design pharmacokinetic comparison study of semaglutide injection in healthy subjects

评价受试制剂司美格鲁肽注射液（CA505注射液）与参比制剂司美格鲁肽注射液（诺和泰®）单次给药在健康成年受试者体内PK特征的相似性和安全性

[Translation]

To evaluate the similarity and safety of the PK characteristics of the test preparation semaglutide injection (CA505 injection) and the reference preparation semaglutide injection (Novotai®) in healthy adult subjects after a single dose

Start Date12 Nov 2022

Sponsor / Collaborator

Shanghai BOWEI BIOMEDICAL CO., LTD

[+1]

CTR20250241

/ Not yet recruitingPhase 3

多中心、随机、开放、平行对照比较司美格鲁肽注射液（CA507）和Wegovy®在成年肥胖受试者中的有效性和安全性

[Translation] A multicenter, randomized, open, parallel controlled comparison of the efficacy and safety of semaglutide injection (CA507) and Wegovy® in adult obese subjects

以原研药物司美格鲁肽注射液（Wegovy®）为对照，评价重庆宸安生物制药有限公司研制的司美格鲁肽注射液（CA507）在成年肥胖受试者中的有效性和安全性。主要疗效终点为治疗44周后体重较基线变化百分比，等效性的界值为±4.16%。

[Translation]

The efficacy and safety of semaglutide injection (CA507) developed by Chongqing Chenan Biopharmaceutical Co., Ltd. in adult obese subjects were evaluated using the original drug semaglutide injection (Wegovy®) as a control. The primary efficacy endpoint was the percentage change in body weight compared with baseline after 44 weeks of treatment, and the margin of equivalence was ±4.16%.

Start Date-

Sponsor / Collaborator

Chongqing Chenan Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Semaglutide biosimilar (Chongqing Chenan Biopharmaceutical &Shanghai Bovax Biotechnology)

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100 Translational Medicine associated with Semaglutide biosimilar (Chongqing Chenan Biopharmaceutical &Shanghai Bovax Biotechnology)

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100 Patents (Medical) associated with Semaglutide biosimilar (Chongqing Chenan Biopharmaceutical &Shanghai Bovax Biotechnology)

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100 Deals associated with Semaglutide biosimilar (Chongqing Chenan Biopharmaceutical &Shanghai Bovax Biotechnology)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	CN	Chongqing Chenan Biopharmaceutical Co., Ltd.	21 Jan 2025
Diabetes Mellitus, Type 2	Phase 3	CN	Chongqing Chenan Biopharmaceutical Co., Ltd.	04 Jul 2023
Diabetes Mellitus, Type 2	Phase 3	CN	Shanghai BOWEI BIOMEDICAL CO., LTD	04 Jul 2023