🇭🇰 港交所SBP GROUPQwen · 实盘不做把握 8/10不做原因:消息已过时
北京时间·🕒 发布 09-07 18:35:00时区推断·⟳ 抓取 09-07 18:36:59·⚡ 决策 09-12 21:47:37 +5d03h·44.8 天前
中国生物制药（01177.HK）自愿公告：正大天晴自研 PDE3/4 抑制剂 TQC3721 吸入粉雾剂两项 I 期数据在 ERS 2026 以壁报形式披露，COPD 患者 FEV1 呈剂量依赖改善、联用格隆溴铵效果与 IND/GLY 相当
事件是 2026-09-07 港股盘后（18:35 HK）的一手自愿公告，至 now（2026-09-12 21:41 HK，周六闭市）已经过 09-08、09-09、09-10、09-11 共 4 个交易日完整消化：首反应日 +6.86%（收 5.84、盘中最高 5.87）随后 -4.02%/-2.32%/-4.20%，收 5.25，已跌回公告前收盘 5.47 之下，5 日 -5.15%，量比 0.74（无承接放量）。这是典型的高开冲高后逐日派发，催化窗口已关闭。同时事件性质为 I 期壁报（n=72 剂量递增 + 投稿时 n=23 的亚组），不含金额、监管里程碑或指引变化，而 TQC3721 的核心经济价值已于 2026-07-08 通过对阿斯利康授权落地，相对约 981 亿港元市值的增量不足（超大市值软催化）。方向虽正面，但既无做多 edge，也不满足做空红线（无造假/指引下修/监管处罚等强空催化，近 20 日仍 +11.58%），故 RESEARCHED_AVOID。
📄 原文SBP GROUP↗ 原文
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
不做 中国生物制药（01177.HK）
催化窗口已关闭且属超大市值软催化：①时点——公告为 2026-09-07 港股盘后一手披露，至 now（2026-09-12 21:41 HK，周六闭市）已过 09-08/09-09/09-10/09-11 四个交易日，首反应日 +6.86%（收 5.84、高 5.87）后三日 -4.02%/-2.32%/-4.20% 收 5.25，已低于公告前收盘 5.47，量比 0.74，典型冲高派发/见光死，周一 09-14 开盘入场等于在催化被完全消化后追高。②materialit…
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
事实：港交所披露易一手自愿公告，正大天晴 TQC3721 DPI 两项 I 期 COPD 数据在 ERS 2026 以壁报披露，FEV1 呈剂量依赖改善（1000 μg 组 +497 mL）、联用格隆溴铵与 IND/GLY 相当、安全性可控。影响链：科学层面支持 DPI+LAMA 固定复方继续开发 → 但阶段仍停留在 I 期，无注册性读出、无申报/获批、无新增现金流；同资产海外权益已于 2026-07-08 授权阿斯利康（2 亿美元首付 + 最高 19 亿美元里程碑），本次属确认性信息而非里程碑。价格/证据：市值约 981 亿港元、PE 37.8；公告后首反应日 09-08 +6.86%，随后三日 -4.02%/-2.32%/-4.20%，收 5.25 已低于公告前 5.47，量比 0.74，20 日仍 +11.58%、13 周轨迹 100→124→117 处高位回落段；同会议同市场同相位的可比先例（02493.HK 2026-09-04 盘后 ERS 2026 壁报公告）+1/+3/+5 日为 -0.5%/-0.8%/-2.2%、胜率 0%。结论：催化已被完全消化且呈派发形态，早期壁报对巨型市值缺乏增量，做多无 edge、做空不达红线 → 不做；下一港股交易时段为 2026-09-14 09:30 HK。
🔎 新鲜度:最早出现 2026-09-07 · 扩散 low · price-in 风险 high ↗
关键理由
- 不做多：本次新增事实只是 I 期壁报数据（n=72 剂量递增 + 投稿时 n=23 亚组），不推进监管阶段、不带金额、不改指引，而 TQC3721 海外权益已在 2026-07-08 授权阿斯利康兑现，对约 981 亿港元市值的短线增量不足
- 不做多的核心是时点：公告已过 4 个交易日，09-08 冲高 +6.86% 后三日累计 -10.4%、现价 5.25 低于公告前 5.47，量比 0.74，市场已完成重定价并派发，周一（09-14）入场等于在催化窗口关闭后追一个已证伪的短线反应
- 不做空：股价回落源于 sell-the-news/板块消化而非新的公司级净负面事实，近 20 日仍 +11.58%，且 7 月 AZ 授权与 GSK 合作为实质利好，不满足做空红线①（无强空催化）
主要风险
- 09-09 至 09-11 连续三日回落（尤其 09-11 单日 -4.2%）可能存在本轮内部 KB 未命中、且无 Web 检索工具核实的公司级或行业级利空，若周一开盘前出现相关一手公告需重新研判
- 若后续 TQC3721 雾化混悬液中国 III 期 topline 阳性、或 DPI 剂型进入 II/III 期或申报，事件性质将从 I 期软催化升级为里程碑，届时须按新催化重新评估而非沿用本次结论
反向证据
- 做多前查反向 · 来源 kb_search · 日期 2026-07-08 · 影响 weakens
命中 5 条券商纪要/研报，一致显示该资产的重大价值节点（AZ 授权 + GSK 合作 + 雾化混悬液 III 期 + CDE 突破性治疗资格）均在本次公告之前已公开；本次仅新增 I 期 DPI 壁报，阶段未推进，无未定价增量
检索:中国生物制药 TQC3721 PDE3/4 抑制剂 COPD 临床进展 管线价值 原文 ↗ - 做多前查反向 · 来源 kb_search · 日期 2026-09-09 · 影响 weakens
未检索到 9 月针对 01177.HK 的新增公司级利空（命中项多为 CDE 受理/沟通交流公示等与他司相关记录）；但真实日线显示 09-08 冲高后连续三日回落、5 日 -5.15%、量比 0.74，且未找到任何支持周一继续做多的新一手催化
检索:中国生物制药 1177 9月 股价下跌 中期业绩 配售 利空 创新药 BD 原文 ↗ - 做空前查反向 · 来源 kb_search · 日期 2026-09-11 · 影响 invalidates
未发现造假、监管处罚/调查、业绩或指引大幅下修、核心客户流失等强空催化；近 20 日仍 +11.58%、13 周轨迹 100→124→117，回落属 sell-the-news 与板块消化，做空红线①（明确强空催化）不满足，故不开空，也不输出 risk_signals
检索:中国生物制药 01177.HK 做空 利空 监管 指引下修 业绩暴雷 高位回落 原文 ↗
先例如何影响了这次决策
对本次决策的影响:先例与自身反应共同确认本次 I 期壁报属『已消化 + 见光死』类型，直接否掉 LONG；同时先例中没有出现基本面恶化型下跌，也不支持把 sell-the-news 当作做空催化，最终落在 AVOID 且不输出 risk_signals
方向:唯一可核验的同市场、同会议、同相位（盘后自愿公告披露学术会议壁报）先例，公告后 +1/+3/+5 日为 -0.48%/-0.77%/-2.22%，胜率 0%（超额 +1 日仅 +0.51%，因当日恒指基准更弱）；叠加本标的自身首反应日 +6.86% 后三日累计 -10.4% 的真实 OHLC，方向读数为『中性偏负、不具持续性』，不支持在催化 4 日后追多
涨幅量级:无相似度≥8 且锚完全干净（decision_grade n=0、provenance clean_n=0，样本质量 very_thin）的对齐样本，故不用先例数字定 tp/sl；即便勉强校准，量级也指向零至负，任何做多止盈参数都无依据
形态:反复出现『公告后冲高→逐日回落』的派发形态：本标的 09-08 开 5.42→高 5.87→收 5.84，随后 09-09 开 5.77 收 5.61、09-11 开 5.48（=前收）全天走低收 5.25，均为高开低走；可比先例 02493.HK 亦为公告后小幅阴跌无反弹
历史先例(按相似度)
- 相似度 7/10 02493.HK 2026-09-04 邁威生物（02493.HK）2026-09-04 港股盘后自愿公告，将在 ERS 2026 以壁报形式报告 9MW1911 最新临床数据；无金额、无监管里程碑，公告前 1 日仅 -0.38%（无抢跑） 原文 ↗
事件后 +1日 -0.5% · +2日 +0.4% · +3日 -0.8% · +4日 -0.9% · +5日 -2.2%
相似度依据:同为港股上市中国创新药企、同一次 ERS 2026 年会、同为盘后自愿公告披露早期临床壁报数据、同样无金额与监管里程碑；差异是标的与资产不同、市值与流动性显著更小
经验:港股创新药企把学术会议壁报包装成盘后自愿公告，若不含金额/注册性读出/申报进展，事后基本不产生正向重定价，公告后多为小幅阴跌——会议季壁报流不是可交易催化
工具执行结果 · 成功 11 · 降级 0 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 22 ms
{"result": "search_processed_events:agent query=`sino biopharmaceutical tqc3721 dpi phase i ers 2026 | tqc3721 copd 临床数据 公告 | 中国生物制药 1177 tqc3721 | 正大天晴 pde3/4 抑制剂 copd 吸入粉雾剂 i期数据`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 2.8/72 小时、41 条本臂决策(完整)，返回 0 条候选。未命中只表示这些 agent query 表达式没有召回候选，不能据此证明消息首发或不是重复；按当前事件继续正常研判。"} - fetch_decision_experience 成功 stock_tools HTTP · 11 ms
{ - stock_quote 成功 stock_tools HTTP · 408 ms
{ - search_case_library 成功 stock_tools HTTP · 18 ms
{"result": "search_case_library「01177.HK」—— 与这些标的相关、事件类型=产品发布/技术突破的自家决策案例(本页 4 条,该标的全历史相关记录共 30 条；ENTER 只按该标的自己的腿统计):\n◆ 01177.HK：相关历史决策 30 条 · 其中该标的 ENTER 1 条(3.3%) · 已结算 1 笔 · 胜率 100% · 中位 +0.83% · 均值 +0.83% ⚠️只有 1 笔,样本太薄,只能当线索不能当规律\n↑ 胜率/收益口径:ENTER 当日之后 T+1 开盘入场、次日开盘出场,做空腿已按方向取反(所以正数=这个方向做对了)。统计的 - kb_search 成功 stock_tools HTTP · 3,374 ms
{ - kb_search 成功 stock_tools HTTP · 6,255 ms
{ - kb_search 成功 stock_tools HTTP · 3,545 ms
{ - price_snapshot 成功 stock_tools HTTP · 681 ms
{ - normalize_ticker 成功 stock_tools HTTP · 10 ms
未归一到唯一代码;请用 stock_quote 的 candidates 消歧,或直接给代码。 - direct_instrument_candidates 成功 stock_tools HTTP · 13 ms
{ - event_study 成功 stock_tools HTTP · 18 ms
{
原文全文
展开原文 · 9,049 字
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take
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
PHASE I CLINICAL TRIAL DATA FOR TQC3721 DRY POWDER INHALER,
A “PDE3/4 INHIBITOR”, PRESENTED AT ERS 2026
The board of directors (the “Board”) of Sino Biopharmaceutical Limited (the “Company”, together with
its subsidiaries, the “Group”) announces that data from two Phase I clinical studies of TQC3721 dry
powder inhaler (DPI), a “PDE3/4 inhibitor” independently developed by the Group’s subsidiary, Chia
Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), was presented at the European Respiratory
Society 2026 Annual Meeting (ERS 2026).
Abstract Title: Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A
Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients
Abstract number: 376
Presentation format: Poster session
This is a randomised, controlled, dose-escalation Phase I trial conducted in patients with chronic
obstructive pulmonary disease (COPD), designed to evaluate its safety and efficacy. A total of 72
patients were enrolled in the study and randomised into six cohorts to receive escalating doses of
TQC3721 DPI or placebo, with the dose-ranging interval spanning from 125 μg to 1.5 mg.
On Day 9 of treatment, the mean change from baseline in peak forced expiratory volume in one second
(FEV1) following administration of TQC3721 DPI across the various dose groups showed a clear dosedependent pattern: 300.0 mL in the 125 μg group, 288.9 mL in the 250 μg group, 263.0 mL in the 500 μg
group, 344.0 mL in the 750 μg group, 497.0 mL in the 1000 μg group, and 410.0 mL in the 1500 μg
group. The study found that TQC3721 DPI significantly improved lung function in patients with COPD
and demonstrated good safety, with similar rates of adverse events across all groups, supporting its
further clinical development.
1
Abstract Title: Late Breaking Abstract – A Randomised, Open-Label, Active-Controlled Phase I Study
of the Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide
in Patients with COPD
Abstract Number: 4853
Presentation format: Poster session
The second part of this Phase I study is a randomised, open-label, active-controlled proof-of-concept
study designed to evaluate the safety and preliminary efficacy of the combination of TQC3721
DPI and glycopyrronium bromide. The study planned to enrol 40 patients with COPD, who were to
receive TQC3721 DPI combined with glycopyrronium bromide at different doses and frequencies, or
indacaterol/glycopyrronium bromide (IND/GLY) inhaled powder as positive control.
At the time of submission, among the 23 patients who had completed two weeks of treatment, the group
receiving 1 mg of TQC3721 (twice daily) combined with 50 μg of glycopyrronium bromide (once daily)
demonstrated clinically significant improvements in lung function compared with the IND/GLY group: a
203-mL improvement in trough FEV1 and a 110-mL improvement in peak FEV1 from baseline.
Enrolment and follow-up of all 40 subjects have now been completed. The study results are broadly
consistent with the published data; the combination regimen of TQC3721 DPI and glycopyrronium
bromide demonstrated bronchodilator effects comparable to those of the dual bronchodilator IND/GLY,
with good tolerability and treatment-emergent adverse events (TEAEs) that were generally mild and
manageable throughout the treatment period. These results provide strong support for the development
of a fixed-dose combination formulation of TQC3721 DPI and LAMA. This fixed-dose combination is
referred to as a triple-action dual bronchodilator.
TQC3721 is a novel PDE3/4 inhibitor independently developed by CTTQ, which aims to alleviate
symptoms and suppress inflammation through the dual mechanism of bronchodilation and antiinflammatory activity. For COPD, the TQC3721 nebulised suspension has demonstrated best-in-class
potential in a Phase IIb study; this formulation is currently undergoing a Phase III clinical trial in China
and has been included in the list of breakthrough therapies by the Centre for Drug Evaluation (CDE)
of the China’s National Medical Products Administration (NMPA); positive top-line data has also been
obtained from the Phase II clinical trial of the dry powder inhaler formulation.
2
Sources:
[1]
Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomised, Double-Blind, PlaceboControlled, Dose-Ranging Study in COPD Patients. L. Yang, L. He, et al. ERS 2026 (#376).
[2]
Late Breaking Abstract – A Randomised, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4
Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients with COPD. Z. Luo, L. He, et al.
ERS 2026 (#4853).
[3]
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, Multicentre, Randomised, Double-Anonymised, Placebo-Controlled Trial.
Chest. 2026;169(6):1536–1550. doi:10.1016/j.chest.2025.12.055
[4]
Lancet. 28 April 2018:391(10131):1706–1717.
[5]
Ensifentrine Plus a Long-Acting Muscarinic Antagonist in COPD: A Trifunctional Dual Bronchodilation Perspective.
Drugs. September 2025;85(9):1099–1107.
By order of the Board
Sino Biopharmaceutical Limited
Tse, Theresa Y Y
Chairwoman
Hong Kong, 7 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.
3
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完
整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份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吸入粉霧劑「PDE3/4抑制劑」於ERS 2026公佈I期臨床研究數據
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TQC3721吸入粉霧劑(DPI)「PDE3/4
抑制劑」已於歐洲呼吸學會2026年會(ERS 2026)上公佈2項1期臨床研究數據。
摘要標題：Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients
摘要編號：376
報告形式：Poster session
這是一項在慢性阻塞性肺疾病(COPD)患者中開展的隨機、對照、劑量遞增試驗，旨在評價TQC3721
DPI在中重度COPD患者中的安全性、耐受性和初步的量效關係，是其I期臨床試驗的第一部分。該
研究共納入72例患者，在6個隊列中分別接受遞增劑量的TQC3721 DPI或安慰劑，劑量探索的範圍為
125 μg至1.5mg。
治療第9天，TQC3721 DPI各劑量組給藥後第一秒用力呼氣容積(FEV1)峰值較基線的平均變化呈現明
確的劑量依賴性：125 μg組300.0 mL，250 μg組288.9 mL，500 μg組263.0 mL，750 μg組344.0 mL，
1000 μg組497.0 mL，1500 μg組410.0 mL。研究發現，TQC3721 DPI能明顯改善COPD患者肺功能，
且安全性良好，各組不良事件發生率相似，支持其進一步臨床開發。
1
摘要標題：Late Breaking Abstract - A Randomized, Open-Label, Active-Controlled Phase I Study
of Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in
Patients with COPD
摘要編號：4853
報告形式：Poster session
該I期研究第二部分，是一項隨機、開放、陽性藥對照的概念驗證研究，研究目的為評價TQC3721
DPI與格隆溴銨聯合用藥的安全性和初步療效。該研究計劃納入40例COPD患者，分別接受不同劑量
和頻次的TQC3721 DPI聯合格隆溴銨，或接受茚達特羅╱格隆溴銨(IND/GLY)吸入粉霧劑作為陽性
對照。
在截止投稿時，完成2周治療的23例患者中，與IND/GLY相比，1mg TQC3721（每日兩次）聯合50 μg
格隆溴銨（每日一次）組展示了具有臨床意義的肺功能改善：FEV1谷值較基線改善203 mL、FEV1峰
值較基線改善110 mL。
目前該研究已經完成全部40例受試者入組和觀察，研究結果與公佈數據基本一致，TQC3721 DPI與
格隆溴銨的聯合用藥方案展現了與雙重支氣管擴張劑IND/GLY相當的支氣管擴張效應，且耐受性良
好，治療期間出現的不良事件(TEAEs)整體安全可控。這些結果為TQC3721 DPI和LAMA的固定劑量
複方製劑開發提供了有力支持。該固定複方製劑被稱為三功能雙支擴劑。
TQC3721是正大天晴自主研發的一款全新機制PDE3/4抑制劑，通過擴張支氣管和抗炎的雙重機制，
達到減輕症狀並抑制炎症的目的。針對COPD，TQC3721霧化吸入混懸液在IIb期研究中已展現出同
類最佳潛力，目前該劑型正於中國開展III期臨床試驗，並已被中國國家藥品監督管理局藥品審評中
心(CDE)納入突破性治療藥物名單；乾粉吸入粉霧劑的2期臨床試驗亦獲得了積極的頂線數據。
2
資料來源：
[1]
Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomized, Double-Blind, PlaceboControlled, Dose-Ranging Study in COPD Patients. L. Yang, L. He, et al. ERS 2026 (#376).
[2]
Late Breaking Abstract – A Randomized, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4
Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients with COPD. Z. Luo, L. He, et al.
ERS 2026 (#4853).
[3]
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
[4]
Lancet. 2018 Apr 28:391(10131):1706-1717.
[5]
Ensifentrine Plus a Long-Acting Muscarinic Antagonist in COPD: A Trifunctional Dual Bronchodilation Perspective.
Drugs. 2025 Sep;85(9):1099-1107.
承董事會命
中國生物製藥有限公司
主席
謝其潤
香港，二零二六年九月七日
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。
3
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
PHASE I CLINICAL TRIAL DATA FOR TQC3721 DRY POWDER INHALER,
A “PDE3/4 INHIBITOR”, PRESENTED AT ERS 2026
The board of directors (the “Board”) of Sino Biopharmaceutical Limited (the “Company”, together with
its subsidiaries, the “Group”) announces that data from two Phase I clinical studies of TQC3721 dry
powder inhaler (DPI), a “PDE3/4 inhibitor” independently developed by the Group’s subsidiary, Chia
Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), was presented at the European Respiratory
Society 2026 Annual Meeting (ERS 2026).
Abstract Title: Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A
Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients
Abstract number: 376
Presentation format: Poster session
This is a randomised, controlled, dose-escalation Phase I trial conducted in patients with chronic
obstructive pulmonary disease (COPD), designed to evaluate its safety and efficacy. A total of 72
patients were enrolled in the study and randomised into six cohorts to receive escalating doses of
TQC3721 DPI or placebo, with the dose-ranging interval spanning from 125 μg to 1.5 mg.
On Day 9 of treatment, the mean change from baseline in peak forced expiratory volume in one second
(FEV1) following administration of TQC3721 DPI across the various dose groups showed a clear dosedependent pattern: 300.0 mL in the 125 μg group, 288.9 mL in the 250 μg group, 263.0 mL in the 500 μg
group, 344.0 mL in the 750 μg group, 497.0 mL in the 1000 μg group, and 410.0 mL in the 1500 μg
group. The study found that TQC3721 DPI significantly improved lung function in patients with COPD
and demonstrated good safety, with similar rates of adverse events across all groups, supporting its
further clinical development.
1
Abstract Title: Late Breaking Abstract – A Randomised, Open-Label, Active-Controlled Phase I Study
of the Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide
in Patients with COPD
Abstract Number: 4853
Presentation format: Poster session
The second part of this Phase I study is a randomised, open-label, active-controlled proof-of-concept
study designed to evaluate the safety and preliminary efficacy of the combination of TQC3721
DPI and glycopyrronium bromide. The study planned to enrol 40 patients with COPD, who were to
receive TQC3721 DPI combined with glycopyrronium bromide at different doses and frequencies, or
indacaterol/glycopyrronium bromide (IND/GLY) inhaled powder as positive control.
At the time of submission, among the 23 patients who had completed two weeks of treatment, the group
receiving 1 mg of TQC3721 (twice daily) combined with 50 μg of glycopyrronium bromide (once daily)
demonstrated clinically significant improvements in lung function compared with the IND/GLY group: a
203-mL improvement in trough FEV1 and a 110-mL improvement in peak FEV1 from baseline.
Enrolment and follow-up of all 40 subjects have now been completed. The study results are broadly
consistent with the published data; the combination regimen of TQC3721 DPI and glycopyrronium
bromide demonstrated bronchodilator effects comparable to those of the dual bronchodilator IND/GLY,
with good tolerability and treatment-emergent adverse events (TEAEs) that were generally mild and
manageable throughout the treatment period. These results provide strong support for the development
of a fixed-dose combination formulation of TQC3721 DPI and LAMA. This fixed-dose combination is
referred to as a triple-action dual bronchodilator.
TQC3721 is a novel PDE3/4 inhibitor independently developed by CTTQ, which aims to alleviate
symptoms and suppress inflammation through the dual mechanism of bronchodilation and antiinflammatory activity. For COPD, the TQC3721 nebulised suspension has demonstrated best-in-class
potential in a Phase IIb study; this formulation is currently undergoing a Phase III clinical trial in China
and has been included in the list of breakthrough therapies by the Centre for Drug Evaluation (CDE)
of the China’s National Medical Products Administration (NMPA); positive top-line data has also been
obtained from the Phase II clinical trial of the dry powder inhaler formulation.
2
Sources:
[1]
Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomised, Double-Blind, PlaceboControlled, Dose-Ranging Study in COPD Patients. L. Yang, L. He, et al. ERS 2026 (#376).
[2]
Late Breaking Abstract – A Randomised, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4
Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients with COPD. Z. Luo, L. He, et al.
ERS 2026 (#4853).
[3]
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, Multicentre, Randomised, Double-Anonymised, Placebo-Controlled Trial.
Chest. 2026;169(6):1536–1550. doi:10.1016/j.chest.2025.12.055
[4]
Lancet. 28 April 2018:391(10131):1706–1717.
[5]
Ensifentrine Plus a Long-Acting Muscarinic Antagonist in COPD: A Trifunctional Dual Bronchodilation Perspective.
Drugs. September 2025;85(9):1099–1107.
By order of the Board
Sino Biopharmaceutical Limited
Tse, Theresa Y Y
Chairwoman
Hong Kong, 7 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.
3
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完
整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份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吸入粉霧劑「PDE3/4抑制劑」於ERS 2026公佈I期臨床研究數據
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TQC3721吸入粉霧劑(DPI)「PDE3/4
抑制劑」已於歐洲呼吸學會2026年會(ERS 2026)上公佈2項1期臨床研究數據。
摘要標題：Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients
摘要編號：376
報告形式：Poster session
這是一項在慢性阻塞性肺疾病(COPD)患者中開展的隨機、對照、劑量遞增試驗，旨在評價TQC3721
DPI在中重度COPD患者中的安全性、耐受性和初步的量效關係，是其I期臨床試驗的第一部分。該
研究共納入72例患者，在6個隊列中分別接受遞增劑量的TQC3721 DPI或安慰劑，劑量探索的範圍為
125 μg至1.5mg。
治療第9天，TQC3721 DPI各劑量組給藥後第一秒用力呼氣容積(FEV1)峰值較基線的平均變化呈現明
確的劑量依賴性：125 μg組300.0 mL，250 μg組288.9 mL，500 μg組263.0 mL，750 μg組344.0 mL，
1000 μg組497.0 mL，1500 μg組410.0 mL。研究發現，TQC3721 DPI能明顯改善COPD患者肺功能，
且安全性良好，各組不良事件發生率相似，支持其進一步臨床開發。
1
摘要標題：Late Breaking Abstract - A Randomized, Open-Label, Active-Controlled Phase I Study
of Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in
Patients with COPD
摘要編號：4853
報告形式：Poster session
該I期研究第二部分，是一項隨機、開放、陽性藥對照的概念驗證研究，研究目的為評價TQC3721
DPI與格隆溴銨聯合用藥的安全性和初步療效。該研究計劃納入40例COPD患者，分別接受不同劑量
和頻次的TQC3721 DPI聯合格隆溴銨，或接受茚達特羅╱格隆溴銨(IND/GLY)吸入粉霧劑作為陽性
對照。
在截止投稿時，完成2周治療的23例患者中，與IND/GLY相比，1mg TQC3721（每日兩次）聯合50 μg
格隆溴銨（每日一次）組展示了具有臨床意義的肺功能改善：FEV1谷值較基線改善203 mL、FEV1峰
值較基線改善110 mL。
目前該研究已經完成全部40例受試者入組和觀察，研究結果與公佈數據基本一致，TQC3721 DPI與
格隆溴銨的聯合用藥方案展現了與雙重支氣管擴張劑IND/GLY相當的支氣管擴張效應，且耐受性良
好，治療期間出現的不良事件(TEAEs)整體安全可控。這些結果為TQC3721 DPI和LAMA的固定劑量
複方製劑開發提供了有力支持。該固定複方製劑被稱為三功能雙支擴劑。
TQC3721是正大天晴自主研發的一款全新機制PDE3/4抑制劑，通過擴張支氣管和抗炎的雙重機制，
達到減輕症狀並抑制炎症的目的。針對COPD，TQC3721霧化吸入混懸液在IIb期研究中已展現出同
類最佳潛力，目前該劑型正於中國開展III期臨床試驗，並已被中國國家藥品監督管理局藥品審評中
心(CDE)納入突破性治療藥物名單；乾粉吸入粉霧劑的2期臨床試驗亦獲得了積極的頂線數據。
2
資料來源：
[1]
Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomized, Double-Blind, PlaceboControlled, Dose-Ranging Study in COPD Patients. L. Yang, L. He, et al. ERS 2026 (#376).
[2]
Late Breaking Abstract – A Randomized, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4
Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients with COPD. Z. Luo, L. He, et al.
ERS 2026 (#4853).
[3]
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
[4]
Lancet. 2018 Apr 28:391(10131):1706-1717.
[5]
Ensifentrine Plus a Long-Acting Muscarinic Antagonist in COPD: A Trifunctional Dual Bronchodilation Perspective.
Drugs. 2025 Sep;85(9):1099-1107.
承董事會命
中國生物製藥有限公司
主席
謝其潤
香港，二零二六年九月七日
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。
3
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