中国生物制药TQC3721吸入混悬液III期注册临床完成全部受试者入组

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no responsibility for the contents of this announcement, make no representation as to its accuracy or
completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in
reliance upon the whole or any part of the contents of this announcement.
(Incorporated in the Cayman Islands with limited liability)
Website: www.sbpgroup.com
(Stock code: 1177)
VOLUNTARY ANNOUNCEMENT
COMPLETION OF ALL SUBJECTS ENROLLMENT IN THE PHASE III
REGISTRATIONAL CLINICAL TRIAL OF TQC3721 INHALATION SUSPENSION
“PDE3/4 INHIBITOR”
The board of directors (the “Board”) of Sino Biopharmaceutical Limited (the “Company”, together with
its subsidiaries, the “Group”) announces that a Phase III pivotal registrational clinical trial (PACER-
III) of TQC3721 inhalation suspension “PDE3/4 inhibitor”, a national Category 1 innovative drug
independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), a subsidiary
of the Group, for the maintenance treatment of chronic obstructive pulmonary disease (COPD), has
recently completed the enrollment of all subjects.
TQC3721 inhalation suspension is a dual-target PDE3/4 inhibitor. Phosphodiesterases (PDEs) are an
enzyme superfamily that regulates various pathological and physiological processes by catalysing
the hydrolysis and inactivation of cyclic adenosine monophosphate (cAMP) and cyclic guanosine
monophosphate (cGMP). Among these, PDE3 is highly expressed in airway smooth muscle, while PDE4
is widely expressed in various types of inflammatory cells. TQC3721 exerts its effects through a dual
mechanism: on the one hand, it promotes airway smooth muscle relaxation to improve ventilation; on
the other hand, it inhibits the inflammatory response, thereby effectively controlling the progression of
the disease.

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COPD is a lung disease characterised by chronic respiratory symptoms (dyspnoea, cough and sputum
production), with chronic airway inflammation and persistent airflow obstruction as its core pathological
mechanisms. COPD is the third leading cause of death worldwide, with more than 391 million patients.
Current treatment for COPD primarily relies on long-acting muscarinic antagonists (LAMAs) and
long-acting β2-adrenergic agonists (LABAs), which can improve lung function but have limited
efficacy against airway inflammation. Inhaled corticosteroids (ICS), as a primary treatment for chronic
inflammatory airway diseases, can reduce acute exacerbations when used in combination with LABAs or
LAMAs. However, they offer limited benefit to patients with low blood eosinophil counts and increase
the risk of pneumonia. Consequently, there is an urgent need to develop novel drugs that combine anti-
inflammatory effects with the ability to improve airflow obstruction.
As an innovative inhalation formulation, TQC3721 has been developed in two formulations – a nebulised
inhalation suspension and a dry powder inhalation – catering to different patient populations, disease
severity levels and commercial application scenarios. In the context of COPD, TQC3721 nebulised
inhalation suspension has demonstrated best-in-class potential in Phase II studies[1, 2]. This formulation
has now completed Phase III clinical enrollment, while the dry powder inhalation formulation is
concurrently advancing to Phase II clinical trials, it is expected to become the first domestically
developed inhaled PDE3/4 dual inhibitor approved in China.
Sources:
[1] Luo Z, et al. TQC3721 in COPD: A Phase 2, Multicentre, Randomised, Double-Blind Trial [Poster]. ERS 2025,
Amsterdam, Sept 2025.
[2] He LX, Yang L, Xiao ZK, et al. Effects of a Novel Dual Phosphodiesterase 3 and 4 Inhibitor TQC3721 in Patients With
COPD in China (PACER-II): A Phase 2, Multicenter, Randomized, Double-Anonymized, Placebo-Controlled Trial.
Chest. 2026;169(6):1536-1550. doi:10.1016/j.chest.2025.12.055
By order of the Board
Sino Biopharmaceutical Limited
Tse, Theresa Y Y
Chairwoman
Hong Kong, 8 October 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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整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等內容
而引致的任何損失承擔任何責任。
（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
TQC3721吸入混懸液「PDE3/4抑制劑」III期註冊臨床完成全部受試者入組
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」）自主研發的國家1類創新藥TQC3721吸入混懸液
「PDE3/4抑制劑」用於慢性阻塞性肺疾病(COPD)維持治療的關鍵註冊III期臨床試驗(PACER-III)，已
於近期完成全部受試者入組。
TQC3721吸入混懸液是一款PDE3/4雙靶點抑制劑。磷酸二酯酶(PDEs)是一個酶超家族，通過催化環
磷酸腺甘(cAMP)和環磷酸鳥甘(cGMP)水解失活，從而調控多種病理、生理過程。其中，PDE3在氣
道平滑肌中高表達，PDE4則廣泛表達於各類炎症細胞。TQC3721通過雙重機制發揮作用：一方面促
進氣道平滑肌鬆弛以改善通氣，另一方面抑制炎症反應，從而有效控制疾病進展。

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COPD是一種以慢性呼吸道症狀（呼吸困難、咳嗽、咳痰）為特徵的肺部疾病，核心病理機制為慢性氣
道炎症和持續性氣流阻塞。COPD是全球第三大死亡原因，患病人數超過3.91億。當前COPD治療以
長效毒蕈鹼拮抗劑(LAMA)和長效β2受體激動劑(LABA)為主，可改善肺功能，但對氣道炎症療效有
限。吸入性糖皮質激素(ICS)作為慢性炎症性氣道疾病的主要治療手段，與LABA或LAMA聯用可減
少急性加重，但對血嗜酸性粒細胞計數低的患者獲益有限，且增加肺炎風險。因此，亟需開發兼具
抗炎與改善氣流阻塞作用的新型藥物。
作為一款創新吸入制劑，TQC3721佈局霧化吸入混懸液與乾粉吸入粉霧劑兩種劑型，可適配不同患
者群體、疾病嚴重程度及商業化應用場景。針對COPD，TQC3721霧化吸入混懸液在II期研究中已展
現出同類最佳潛力[1,2]，該劑型目前已完成III期臨床入組，乾粉吸入粉霧劑亦同步推進至II期臨床，
有望成為中國首款獲批上市的國產吸入式PDE3/4雙重抑制劑。
資料來源：
[1] Luo Z, et al. TQC3721 in COPD: A Phase 2, Multicentre, Randomised, Double-Blind Trial [Poster]. ERS 2025,
Amsterdam, Sept 2025.
[2] He LX, Yang L, Xiao ZK, et al. Effects of a Novel Dual Phosphodiesterase 3 and 4 Inhibitor TQC3721 in Patients With
COPD in China (PACER-II): A Phase 2, Multicenter, Randomized, Double-Anonymized, Placebo-Controlled Trial.
Chest. 2026;169(6):1536-1550. doi:10.1016/j.chest.2025.12.055
承董事會命
中國生物製藥有限公司
主席
謝其潤
香港，二零二六年十月八日
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。