[Translation] A multicenter, randomized, open, parallel controlled comparison of the efficacy and safety of semaglutide injection (CA505) and Novotel® in the treatment of type 2 diabetes

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]

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

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

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

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

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
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
Myocardial Infarction	Phase 1	CN	Chongqing Chenan Biopharmaceutical Co., Ltd.	12 Nov 2022
Myocardial Infarction	Phase 1	CN	Shanghai BOWEI BIOMEDICAL CO., LTD	12 Nov 2022
Stroke	Phase 1	CN	Shanghai BOWEI BIOMEDICAL CO., LTD	12 Nov 2022
Stroke	Phase 1	CN	Chongqing Chenan Biopharmaceutical Co., Ltd.	12 Nov 2022
Obesity	IND Approval	CN	Chongqing Chenan Biopharmaceutical Co., Ltd.	08 Jul 2024

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