Delving into the Latest Updates on Ustekinumab biosimilar (CSPC) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Ustekinumab Biosimilar (CSPC Megalith Biopharmaceutial Co., Ltd.), 乌司奴单抗生物类似药（石药集团巨石生物制药有限公司）, SYSA-1902

+ [2]

Target

IL-12p40

Action

inhibitors

Mechanism

IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Plaque psoriasis

Inactive Indication-

Originator Organization

CSPC Megalith Biopharmaceutial Co., Ltd.

Active Organization

CSPC Megalith Biopharmaceutial Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (19 May 2026),

Plaque psoriasis

Regulation-

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Structure/Sequence

Sequence Code 143665H

The sequence is quoted from: *****

Sequence Code 143874L

The sequence is quoted from: *****

主要目的：评价乌司奴单抗注射液与喜达诺®治疗中重度斑块状银屑病疗效的一致性。次要目的：基于次要疗效终点，评价乌司奴单抗注射液与喜达诺®治疗中度至重度斑块状银屑病的疗效。评价乌司奴单抗注射液与喜达诺®治疗中重度斑块状银屑病患者的安全性、耐受性。评价乌司奴单抗注射液与喜达诺®在中重度斑块状银屑病患者中的免疫原性。评价乌司奴单抗注射液与喜达诺®在中重度斑块状银屑病患者中的PK特征。

[Translation]

Primary objective: To evaluate the consistency of efficacy between ustekinumab injection and Xidalun® in the treatment of moderate to severe plaque psoriasis. Secondary objective: To evaluate the efficacy of ustekinumab injection and Xidalun® in the treatment of moderate to severe plaque psoriasis based on secondary efficacy endpoints. To evaluate the safety and tolerability of ustekinumab injection and Xidalun® in the treatment of patients with moderate to severe plaque psoriasis. To evaluate the immunogenicity of ustekinumab injection and Xidalun® in patients with moderate to severe plaque psoriasis. To evaluate the PK characteristics of ustekinumab injection and Xidalun® in patients with moderate to severe plaque psoriasis.

Start Date29 Mar 2023

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

ChiCTR2300069534

/ Not yet recruitingPhase 3IIT

A multicenter, randomized, double-blind, parallel-controlled phase III clinical trial evaluating the efficacy and safety of ustekinumab injection versus Stelara in the treatment of moderate to severe plaque psoriasis

Start Date20 Mar 2023

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

[+1]

CTR20221461

/ CompletedPhase 1

比较健康男性受试者单次皮下注射乌司奴单抗注射液SYSA1902注射液和喜达诺®后的随机、双盲、平行对照的药代动力学、安全性和免疫原性的I期研究

[Translation] A randomized, double-blind, parallel-controlled phase I study comparing the pharmacokinetics, safety, and immunogenicity of ustekinumab injection SYSA1902 injection and sildenafil® after a single subcutaneous injection in healthy male subjects

主要目的：考察生物类似药乌司奴单抗注射液（SYSA1902）的药代动力学特征，并以乌司奴单抗注射液（喜达诺®/Stelara®）为参照药，比较健康男性受试者皮下注射两制剂后的主要药代动力学参数，评价两制剂的药代动力学相似性。次要目的：比较生物类似药乌司奴单抗注射液（SYSA1902）和乌司奴单抗注射液（喜达诺®/Stelara®）在健康男性受试者中单次皮下注射45mg/0.5mL后的安全性和免疫原性。

[Translation]

Primary objective: To investigate the pharmacokinetic characteristics of the biosimilar ustekinumab injection (SYSA1902), and to compare the main pharmacokinetic parameters of the two preparations after subcutaneous injection in healthy male subjects with ustekinumab injection (Xidanuo®/Stelara®) as the reference drug, and to evaluate the pharmacokinetic similarity of the two preparations. Secondary objective: To compare the safety and immunogenicity of the biosimilar ustekinumab injection (SYSA1902) and ustekinumab injection (Xidanuo®/Stelara®) after a single subcutaneous injection of 45 mg/0.5 mL in healthy male subjects.

Start Date01 Jul 2022

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with Ustekinumab biosimilar (CSPC)

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100 Translational Medicine associated with Ustekinumab biosimilar (CSPC)

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100 Patents (Medical) associated with Ustekinumab biosimilar (CSPC)

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1

Literatures (Medical) associated with Ustekinumab biosimilar (CSPC)

01 Jul 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study

Article

Author: Li, Shanshan ; Duan, Xinsuo ; Ji, Chao ; Li, Ziyan ; Ma, Liping ; Li, Xiaodong ; Gao, Xinghua ; Liang, Yunsheng ; Li, Yumei ; Wang, Jinyan ; Lu, Fengyan ; Fan, Juanli ; Wu, Liming ; Li, Yanling ; Lei, Tiechi ; Cui, Yong ; Feng, Yanyan ; Xia, Lixin ; Zhang, Furen ; Wang, Lihua ; Guo, Shuping ; Miao, Guoying ; Zhao, Jiawen ; Yang, Xiumin ; Chen, Rixin ; Li, Linfeng

BACKGROUND:

SYSA1902 is a biosimilar of ustekinumab.

OBJECTIVE:

Evaluate the efficacy and safety of SYSA1902 compared with reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

METHODS:

Eligible patients were randomized to receive SYSA1902 or ustekinumab (Stelara, Janssen) 45 mg subcutaneously at week 0, 4, 16, 28, and 40. The primary end point was the percentage improvement from baseline in psoriasis area and severity index (PASI) at week 12. Equivalence was verified if the 95% CI of difference was within ± 15%.

RESULTS:

A Total of 446 patients were assigned to SYSA1902 (n = 224) and ustekinumab groups (n = 222). At week 12, the mean percentage change from baseline in PASI was 86.4% in the SYSA1902 group and 84.7% in the ustekinumab group, with a difference of 1.68% (95% CI, -1.45 to 4.81), which fell within the equivalence margins. PASI 75 at week 12 was achieved by 185 (83.3%) of patients receiving SYSA1902 versus 172 (79.3%) receiving ustekinumab. Overall treatment-emergent adverse events rate was 89.3% and 85.6% in the SYSA1902 and ustekinumab groups. Most treatment-emergent adverse events were mild to moderate, with upper respiratory tract infection being the most common.

LIMITATIONS:

Data limited to Chinese patients.

CONCLUSION:

SYSA1902 is equivalent to ustekinumab for the treatment of moderate-to-severe plaque psoriasis.

100 Deals associated with Ustekinumab biosimilar (CSPC)

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External Link

KEGG	Wiki	ATC	Drug Bank
D09214	Ustekinumab biosimilar (CSPC)	L04AC05	DB05679

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Plaque psoriasis	China	CSPC Megalith Biopharmaceutial Co., Ltd.	19 May 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2300069534 (Pubmed) Manual	Phase 3	Plaque psoriasis	446	SYSA1902	gwcyfvmtgw(opnmrnhawa) = kuybsvdhuz srthkdckqm (aichpstvge ) Met View more	Similar	01 Apr 2025
				Ustekinumab	gwcyfvmtgw(opnmrnhawa) = dcqvfmekup srthkdckqm (aichpstvge ) Met View more
ChiCTR2300069534 (AAD2025)	Phase 3	Plaque psoriasis	446	SYSA1902 45 mg	hisfwbigqe(smnxqdrjny) = vhyfhaljoe ogkktiuspu (zomgqsetvm ) View more	Positive	07 Mar 2025
				Ustekinumab (StelaraTM, Janssen) 45 mg	hisfwbigqe(smnxqdrjny) = szpqprjroz ogkktiuspu (zomgqsetvm ) View more

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Ustekinumab biosimilar (CSPC)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation