中国生物制药TQH5528口服STAT6降解剂在ERS 2026公布临床前数据

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(Incorporated in the Cayman Islands with limited liability)
Website: www.sbpgroup.com
(Stock code: 1177)

VOLUNTARY ANNOUNCEMENT
TQH5528 “ORAL STAT6 DEGRADER” PRECLINICAL STUDY DATA
PRESENTED AT ERS 2026
The Board of Directors (the “Board”) of Sino Biopharmaceutical Limited (the “Company”, together
with its subsidiaries, the “Group”) announces that preclinical study data of TQH5528, an “oral STAT6
degrader” independently developed by the Group’s subsidiary, Chia Tai Tianqing Pharmaceutical Group
Co., Ltd. (“CTTQ”), were presented as an oral presentation at the European Respiratory Society 2026
Annual Congress (ERS 2026), alongside an e-poster presentation.
TQH5528 is an oral STAT6 degrader developed by CTTQ based on its proprietary Orally Available
Protein Degrader (OAPD ®) platform. TQH5528 targets the IL-4/IL-13/STAT6 signalling axis and
exerts its therapeutic effect through a protein degradation mechanism, with potential to become a newgeneration therapeutic agent that offers a more convenient administration route as an alternative to
injectable biologics.
Abstract title: Preclinical evaluation of TQH5528, an oral STAT6 degrader for Th2-driven allergic
diseases
Abstract number: 5554
Presentation format: Oral presentation
Preclinical study data:
TQH5528 possesses a novel CRBN ligand structure and exhibits several key molecular characteristics:
1) No IMiD-related activity, thereby avoiding associated off-target risks; 2) potent STAT6 degradation
activity at the picomolar level; 3) superior inhibitory efficacy against the IL-4/IL-13 pathway compared
to KT-621; and 4) favourable oral exposure and bioavailability across multiple species, supporting
development for oral administration.
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Data from in vitro cellular assays indicate that, across multiple human Th2-related cell assessment
systems, TQH5528 exhibits greater activity than KT-621 and dupilumab in terms of STAT6 protein
degradation, pSTAT6 inhibition and suppression of downstream cytokine release, demonstrating distinct
in vitro pharmacological advantages.
In vivo pharmacological and pharmacodynamic studies in non-human primates (NHPs) demonstrated
that TQH5528 achieves rapid, profound and long-lasting degradation of the STAT6 protein. A single
dose results in significant downregulation of STAT6; with multiple daily dosing, complete degradation
of STAT6 in the blood is achieved within just 4 hours of administration; at low doses, >95%
degradation of STAT6 is achieved in various tissues and cells, including the spleen, lungs and peripheral
blood mononuclear cells (PBMCs), with the pharmacological effect exhibiting clear time- and dosedependency.
In an HDM-induced asthma mouse model humanized for IL-4/IL-4R, TQH5528 demonstrated excellent
in vivo therapeutic efficacy: it significantly improved methacholine-induced airway hyperresponsiveness,
whilst simultaneously reducing inflammatory cells in peripheral blood and alleviating eosinophil
infiltration, exhibiting outstanding in vivo efficacy.
As an oral STAT6 degrader, TQH5528 potently inhibits the IL-4/IL-13 pathway, achieving sustained
STAT6 protein depletion without rebound in non-human primates; it demonstrates robust therapeutic
efficacy in humanised asthma mouse model, and in vivo safety studies are currently underway.
Sources:
[1]

Preclinical evaluation of TQH5528, an oral STAT6 degrader for Th2-driven allergic diseases. Dan Mei, Baomin Liu, et
al. ERS 2026 (#5554).

[2]

Potent and Selective Oral STAT6 Degrader, KT-621, Inhibits IL-4 and IL-13 Functions in Human Cells and Blocks Th2
Inflammation in House Dust Mite Models of Asthma Prophylactically and Therapeutically. ATS Annual Meeting 2025 •
May 16-21, 2025 • San Francisco, CA. Kymera Therapeutics.

[3]

Highly selective and reversible STAT6 inhibition demonstrates potential for differentiated efficacy and safety profile in
type 2 allergic inflammation. Recludix Pharma Presented at the ATS 2025 International Conference, May 18 –21, 2025
in San Francisco, CA, USA.

By order of the Board
Sino Biopharmaceutical Limited
Tse, Theresa Y Y
Chairwoman
Hong Kong, 8 September 2026

As at the date of this announcement, the Board of the Company comprises five executive directors,
namely Ms. Tse, Theresa Y Y, Mr. Tse Ping, Ms. Cheng Cheung Ling, Mr. Tse, Eric S Y and Mr. Tse
Hsin and six independent non-executive directors, namely Mr. Lu Zhengfei, Ms. Lu Hong, Mr. Zhang
Lu Fu, Dr. Li Kwok Tung Donald, Dr. Chen Lieping and Dr. Lu Bai.
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（於開曼群島註冊成立之有限公司）
網站：www.sbpgroup.com
（股份編號：1177）

自願公告
TQH5528「口服STAT6降解劑」於ERS 2026公布臨床前研究數據
中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團附
屬公司正大天晴藥業集團股份有限公司（「正大天晴」）自主研發的TQH5528「口服STAT6降解劑」已於
歐洲呼吸學會2026年會(ERS 2026)上，以口頭報告(Oral)形式公布臨床前研究數據，並同步展示電子
壁報（e-poster）。
TQH5528是正大天晴基於全球自主知識產權的口服蛋白降解劑技術平台(OAPD ® )開發的一款口服
STAT6降解劑。TQH5528靶向IL-4/IL-13/STAT6信號軸，依靠蛋白降解機制發揮藥效，有潛力成為
替代注射生物制劑、給藥更便捷的新一代治療藥物。
摘要標題：Preclinical evaluation of TQH5528, an oral STAT6 degrader for Th2-driven allergic diseases
摘要編號：5554
報告形式：Oral presentation
臨床前研究數據：
TQH5528擁有全新CRBN配體結構，具備多項關鍵分子特徵：1）無IMiD相關活性，避免相關脫靶風
險；2）皮摩爾級別強效STAT6降解活性；3）對IL-4/IL-13通路抑制效力優於對照分子KT-621；及4）在
多個物種中展現良好口服暴露與生物利用度，支持口服給藥開發。

1

體外細胞試驗數據顯示，在多項人源Th2相關細胞評價體系中，對比KT-621以及度普利尤單抗，
TQH5528對STAT6蛋白降解、pSTAT6抑制、下游炎症因子釋放抑制均表現出更強活性，體現出差異
化的體外藥效優勢。
非人靈長類動物(NHP)體內藥理藥效研究顯示，TQH5528可以實現快速、深度、長效的STAT6蛋白
降解。單次給藥後即可實現STAT6顯著下調；每日多次給藥，給藥僅4小時即可實現血液中STAT6完
全降解；低劑量下，脾臟、肺、外周血單個核細胞(PBMC)等多種組織、細胞可實現＞95% STAT6降
解，藥效具備明確的時間－劑量依賴性。
在HDM誘導、IL-4/IL-4R人源化哮喘小鼠模型中，TQH5528展現出優異體內治療效果：可顯著改善
乙酰甲膽鹼激發後的氣道高反應性，同時下調外周血炎症細胞、改善嗜酸性粒細胞浸潤，體內藥效
表現優異。
作為口服STAT6降解劑，TQH5528可強效抑制IL-4/IL-13通路，在非人靈長類動物體內實現持續、
無反彈的STAT6蛋白耗竭；在人源化哮喘小鼠模型中展現強勁治療效果，體內安全性研究正在推進
中。
資料來源：
[1]

Preclinical evaluation of TQH5528, an oral STAT6 degrader for Th2-driven allergic diseases. Dan Mei, Baomin Liu, et
al. ERS 2026 (#5554).

[2]

Potent and Selective Oral STAT6 Degrader, KT-621, Inhibits IL-4 and IL-13 Functions in Human Cells and Blocks Th2
Inflammation in House Dust Mite Models of Asthma Prophylactically and Therapeutically. ATS Annual Meeting 2025
• May 16-21, 2025 • San Francisco, CA. Kymera Therapeutics.

[3]

Highly selective and reversible STAT6 inhibition demonstrates potential for differentiated efficacy and safety profile in
type 2 allergic inflammation. Recludix Pharma Presented at the ATS 2025 International Conference, May 18 –21, 2025
in San Francisco, CA, USA.

承董事會命
中國生物製藥有限公司
主席
謝其潤
香港，二零二六年九月八日

於本公告日期，本公司董事會包括五位執行董事，即謝其潤女士、謝炳先生、鄭翔玲女士、謝承潤
先生及謝炘先生，以及六位獨立非執行董事，即陸正飛先生、魯紅女士、張魯夫先生、李國棟醫
生、陳列平博士及魯白博士。

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