🇭🇰 港交所TENNOR THERAP-BQwen · 实盘可交易 · 做多市场:港股把握 5/10
北京时间·🕒 发布 08:03:00时区推断·⟳ 抓取 08:03:54·⚡ 决策 09-07 08:12:07 +8m13s·50.2 天前
丹諾醫藥-B（06872.HK）盘前公告：利福喹酮(TNP-2092)关节腔注射治疗人工关节感染(PJI)的IIa期概念验证试验取得积极顶线结果（早期/急性5例6及12个月治疗成功率100%、慢性2例中1例成功、无药物相关TEAE/SAE），并获NMPA批准且已启动多中心IIb期试验
港交所披露易一手自愿公告（issuer=primary），港股周一盘前08:03发布、市场尚未交易，跨源已处理消息库0命中，属新鲜未定价催化；事件把TNP-2092从“IIa概念验证待读出”推进到“POC阳性+NMPA许可并启动多中心IIb”，是全球首个PJI专用抗菌药的关键去风险节点，对一家两款核心产品支撑估值的未盈利18A具实质materiality；标的近5日/20日下跌10.7%/11.8%、量比0.82，无抢跑或泄露迹象。因此给方向明确的LONG，但用限价封顶+8%、small仓、5日时间止损承接“n=10小样本中期分析、股价处下行趋势、日成交额仅约900万–1,250万港元”的执行与估值风险。
📄 原文TENNOR THERAP-B↗ 原文
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
无法定价入场 09-07 当日开盘 @168.40 → 等下一常规开盘离场
日 K 取自复盘打分切片 · 蓝点/蓝虚线 = 纸面入场价 · 灰虚线 = 纸面离场 · 持有期红底 = 赚(价格在入场线上方)、绿底 = 亏
💡 交易逻辑做多：TNP-2092治PJI的IIa概念验证阳性+NMPA批准并启动IIb，盘前一手披露未定价
怎么买 限价买入 不高于昨收 +8%、2 个交易日内有效
怎么卖 止盈 +10%(半仓)/+20%(清仓) · 止损 -8% · 时间止损 5日
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
分时走势
做多 06872.HK 丹諾醫藥-B
建仓日早于近 30 天,只有日线图
成交明细 · 纸面
做多 06872.HK 丹諾醫藥-B
| 收益状态 | 无法定价 basis_unreconciled |
|---|---|
| 进场成交 | 2026-09-07 · 当日开盘 · @168.403 · 成交 17% |
| 离场成交 | — |
| 建仓日 | 2026-09-07 · 进场不早于新闻时刻 + 2 分钟 |
收益口径 event_time_plus_2min_10min_walk_open_topup_to_next_open_exchange_calendar_fill_model_local_notional_v9 · method_id m8db1cbc8f2d · 截至 2026-10-27 13:51
研究档案
结论摘要
事实：公司盘前公告TNP-2092关节腔注射治疗PJI的IIa期POC中期分析阳性（早期/急性5例6个月与12个月成功率均100%，慢性2例中1例成功，9例安全性分析无药物相关TEAE/SAE），并获NMPA许可启动多中心IIb期。影响链：PJI全球尚无创新抗菌药获批、现有DAIR失败率>30%、慢性二期翻修失败率>10%、美国单例治疗成本>39万美元，非手术方案若成立即为first-in-class；公司两大核心产品之一（内部SOTP曾给利福喹酮约20–25亿港元、占总估值约三分之一），IIa→IIb的状态迁移显著降低该资产的技术与监管折价，但商业化收入最早仍在2028年以后（内部资料推演2030年销售约5亿元人民币、2035年峰值约12亿元）。价格/证据：行情快照显示2026-09-04收盘168.0港元、20日-11.81%、5日-10.73%、距52周高-41.46%、日成交额约900万–1,250万港元、量比0.82，近10日逐日无放量抢跑，故本次催化尚未被定价；反向检索未发现公司级新增利空（解禁/配售/业绩下修/数据质疑）。结论：ENTER LONG，限价不超过前收+8%（约181.4港元），small仓，tp 10%/20%两档，sl -8%（约2倍20日日波动率3.82%），5个交易日时间止损；跳空超8%则放弃不追。历史先例本轮无法联网溯源核验，幅度参数改以波动率与
🔎 新鲜度:最早出现 2026-09-07 · 扩散 low · price-in 风险 low ↗
关键理由
- 一手issuer公告且港股盘前发布：IIa期POC阳性（早期/急性PJI 6与12个月成功率100%、无药物相关TEAE/SAE）叠加NMPA许可并启动多中心IIb，是first-in-class PJI资产的关键去风险状态迁移
- 该资产是公司两大核心产品之一、全球唯一处于临床开发阶段的PJI小分子，内部SOTP曾给它约20–25亿港元（约占65–75亿港元总估值三分之一），POC阳性+IIb启动足以支撑该分部估值上修
- 股价处下行通道（20日-11.81%、距52周高-41.46%）且量比0.82、无事件前放量抢跑，说明本条催化未被提前定价，盘前存在明确的预期差窗口
主要风险
- 疗效证据基础极薄：仅10例入组、7例疗效集、单臂无对照的中期分析，慢性PJI成功率仅50%，IIb期或完整数据可能不及标题，公司自身已提示可能无法成功开发上市
- 执行与估值风险：日成交额仅约900万–1,250万港元、18A-B自由流通盘小，开盘可能大幅跳空（限价+8%封顶会踏空）；股价已高于内部资料65–75亿港元SOTP（按换手率反推约88亿港元市值），处13周下行轨迹（指数化100→73），存在见光死/借利好出货可能
反向证据
- 做多前查反向 · 来源 kb_search · 日期 2026-06-08 · 影响 weakens
未检索到公司级新增利空（无配售/减持/业绩下修/数据质疑/监管问询）；但检索到公司2025年无任何收入、税后亏损约1.5亿元人民币、研发开支约7,187万元、现金约5.58亿港元，且2026年5月才以18A上市（招股价75.7港元），属未盈利高烧钱主体，长期存在融资摊薄风险
检索:丹诺医药 6872 股价 解禁 配股 减持 现金 研发开支 风险 利福特尼唑 NDA 审批进展 原文 ↗ - 做多前查反向 · 来源 kb_search · 影响 none
2026-07-01以后KB无该公司中报、解禁或下跌原因的针对性披露，8月18日(-8.39%)、8月19日(-5.37%)、9月3日(-6.81%)的回撤在可得资料中无对应公司利空解释，倾向为上市后估值消化/板块beta，但不排除存在未被内部库覆盖的负面消息
检索:丹诺医药-B 2026年中期业绩 亏损 现金 储备 基石 禁售 股价下跌 原因 - 做多前查反向 · 来源 filing · 日期 2026-09-04 · 影响 weakens
无抢跑证据（近5日逐日0.0/-1.1/+0.2/-6.8/-3.3，量比0.82，9月3日与4日成交额约916万/917万港元无异常放大）；但13周轨迹指数化100→73、距52周高-41.46%，做多处逆风，且按换手率反推市值约88亿港元已高于内部资料65–75亿港元SOTP，见光死/高开低走风险不可忽略
检索:06872.HK 近20日走势/量能/是否事件前抢跑（price_snapshot + current_kline） 原文 ↗
先例如何影响了这次决策
对本次决策的影响:先例缺失直接压低confidence至5、把仓位定为small、把买点设成限价而非开盘市价，并缩短时间止损到5个交易日
方向:未取得可核验先例，方向判断完全依赖本次一手公告的事实与状态迁移（IIa POC阳性→IIb获准启动）及生物医药doctrine的阶段分层
涨幅量级:无高相似、锚干净的先例可用于校准幅度；tp/sl改以标的20日已实现波动率3.82%/日为基准（sl -8%≈2倍日波动、tp 10%/20%），并以限价封顶+8%与small仓替代先例定幅
形态:无法量化18A早期临床阳性读出的见光死/高开低走概率；仅能从标的自身轨迹（13周100→73、20日-11.81%、量比0.82）判断无抢跑、但处下行趋势，故不追跳空
工具执行结果 · 成功 10 · 降级 1 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 148 ms
{"result": "search_processed_events:agent query=`6872.hk 人工關節感染 iia期 | tennor therapeutics rifaquizinone prosthetic joint infection | 丹諾醫藥 tnp-2092 利福喹酮 | 丹诺医药 pji iib期临床试验启动`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 52.2/72 小时、2496 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 · 14 ms
{ - stock_quote 降级 stock_tools HTTP · 179 ms
取价失败: 订阅额度不足，订阅失败，已用订阅额度：4000/4000 - search_case_library 成功 stock_tools HTTP · 18 ms
{"result": "search_case_library「06872.HK」无历史决策命中(我们过去没在这些标的上决策过,或历史尚未回填)。\n◆ 06872.HK：相关历史决策 0 条 · 其中该标的 ENTER 0 条(0.0%) · 我们从没在这只票上 ENTER 过"} - kb_search 成功 stock_tools HTTP · 2,003 ms
{ - price_snapshot 成功 stock_tools HTTP · 20 ms
{ - kb_fetch_document 成功 stock_tools HTTP · 163 ms
{ - kb_search 成功 stock_tools HTTP · 5,567 ms
{ - current_kline 成功 stock_tools HTTP · 109 ms
{ - kb_search 成功 stock_tools HTTP · 4,585 ms
{ - validate_order 成功 stock_tools HTTP · 15 ms
{
原文全文
展开原文 · 12,118 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.
МԚ哦
TenNor Therapeutics (Suzhou) Limited
丹諾醫藥（蘇州）股份有限公司
(A joint stock company incorporated in the People ’s Republic of China with limited liability)
(Stock code: 6872)
VOLUNTARY ANNOUNCEMENT
POSITIVE RESULTS FROM A PHASE IIA PROOF-OF-CONCEPT
CLINICAL TRIAL OF RIFAQUIZINONE (TNP-2092) FOR THE
TREATMENT OF PROSTHETIC JOINT INFECTION AND INITIATION OF
A MULTI-CENTER PHASE IIB CLINICAL TRIAL
This announcement is made by TenNor Therapeutics (Suzhou) Limited (the “Company”) and its
subsidiaries (the “Group”) on a voluntary basis to keep the shareholders and potential investors of
the Company informed of the latest business developments of the Group.
The board of directors (the “Board”) of the Company is pleased to announce that positive top-line
results were obtained from the Phase IIa proof-of-concept clinical trial of the Company’s new drug
candidate, rifaquizinone (TNP-2092), administered via intra-articular injection for the treatment
of prosthetic joint infection ( “PJI”). Rifaquizinone (TNP-2092) is the world ’s first new drug
candidate developed specifically to target infections associated with implantable medical devices
through a triple-targeting mechanism of action. Based on those proof-of-concept data, the Company
has received approval for a multi-center Phase IIb clinical trial from the National Medical Products
Administration of the PRC (the “NMPA”) and the trial has recently been initiated.
Positive Results from a Phase IIa Proof-of-Concept Clinical Trial
The Phase IIa proof-of-concept clinical trial conducted in China evaluated the efficacy and safety
of intra-articular injection of rifaquizinone (TNP-2092) without surgical debridement in patients
with early postoperative, acute hematogenous, or chronic PJI.
According to the interim analysis as of 1 July 2026 (the “Data Cutoff Date”), the trial enrolled a
total of 10 patients, of whom 7 were patients with confirmed Gram-positive bacterial infections by
bacterial culture or next-generation gene sequencing and were included in the efficacy analysis set;
2 patients were excluded from the efficacy analysis due to negative culture results, and 1 newly
enrolled patient at the Data Cutoff Date had no efficacy data available yet.
1
With respect to efficacy results, all 5 patients with early or acute PJI receiving intra-articular
injections of rifaquizinone (TNP-2092) completed the 6-month follow-up visit, with a treatment
success rate of 100%; among them, 4 patients completed the 12-month follow-up visit, also with
a treatment success rate of 100%. Among the 2 patients with chronic PJI receiving intra-articular
injection of rifaquizinone (TNP-2092), 1 of the 2 patients who completed the 6-month follow-up
visit achieved treatment success, corresponding to a treatment success rate of 50%, while the
12-month follow-up visit data were not yet available as of the Data Cutoff Date.
With respect to safety results, a total of 9 patients were included in the safety analysis, and no
treatment-emergent adverse events or serious adverse events related to rifaquizinone (TNP-2092)
were reported. For the remaining one patient still in follow-up visit, no treatment-emergent adverse
events or serious adverse events related to rifaquizinone (TNP-2092) were reported as of the Data
Cutoff Date.
The above results demonstrate the favorable efficacy and excellent safety profile of intra-articular
injection of rifaquizinone (TNP-2092), supporting the accelerated clinical development of this
novel non-surgical treatment option for PJI.
Initiation of a Multi-center Phase IIb Clinical Trial
Based on the positive data from the Phase IIa proof-of-concept clinical trial above, the Company
has received approval for a multi-center Phase IIb clinical trial from the NMPA and the trial has
recently been initiated.
About PJI
PJI is a serious complication following joint replacement surgery that can transform an initially
successful operation into a crisis for both the healthcare system and patients. In the United States,
there are approximately 45,000 new cases of PJI each year, while there are approximately 22,000
cases in China, with the incidence showing a rapid upward trend. However, the treatment of PJI
faces significant challenges as the formation of bacterial biofilms substantially reduces the efficacy
of conventional antimicrobial agents. Treatment regimens that rely solely on antimicrobial agents
without surgical intervention are not recommended in clinical practice due to their extremely high
failure rates.
Currently, all available treatment options for patients require surgical intervention, yet treatment
outcomes remain suboptimal: for early postoperative or acute hematogenous PJI, guidelines
recommend debridement, antibiotics, and implant retention (DAIR) procedures, but reported failure
rates exceed 30%; for chronic PJI, a two-stage revision arthroplasty is required, which involves
multiple surgeries, prolonged hospitalization and several months of functional loss postoperatively,
with failure rates still exceeding 10%. The economic burden of PJI is extremely heavy, with
treatment costs in the United States exceeding US$390,000 per patient. Meanwhile, the continued
growth in joint replacement surgeries further intensifies the clinical challenge, driving a rapid
increase in PJI incidence; it is estimated that by 2035, the number of new PJI cases globally will
reach 425,800 per year, of which China is projected to account for 86,500 cases.
2
About Rifaquizinone (TNP-2092)
Rifaquizinone (TNP-2092) is the world ’ s first new drug candidate developed specifically to
target biofilm infections associated with implantable medical devices through a triple-targeting
mechanism of action. Through its unique triple-targeting synergistic mechanism of action by
simultaneously inhibiting bacterial RNA polymerase, DNA gyrase and DNA topoisomerase IV.
Rifaquizinone (TNP-2092) not only demonstrates potent bactericidal activity against drug-resistant
pathogens (including methicillin-resistant S. aureus and quinolone-resistant S. aureus), but also
reduces the resistance frequency to an extremely low level (<10⁻12).
In the preclinical study, rifaquizinone (TNP-2092) has demonstrated strong in vitro and in vivo
biofilm bactericidal activity, and its efficacy is superior to that of current standard-of-care
antibiotics. The Company has successfully completed six Phase I and Phase II clinical trials in the
U.S. and China, and the intravenous administration of rifaquizinone (TNP-2092) has demonstrated
favorable safety and excellent efficacy profile in the treatment of acute bacterial skin and skin
structure infections.
The transformative potential of rifaquizinone (TNP-2092) has been highly recognized by regulatory
authorities. Rifaquizinone (TNP-2092) has been granted Qualified Infectious Disease Product,
Fast Track, and Orphan Drug designations by the United States Food and Drug Administration.
In addition, rifaquizinone (TNP-2092) has also received the outstanding award at the National
Disruptive Technology Innovation Competition in China (全國顛覆性技術創新大賽優勝獎).
About the Company
The Company is a near-commercial stage biotechnology company dedicated to the discovery,
development and commercialization of differentiated therapies to address unmet medical needs
in disease areas associated with bacterial infections and bacterial metabolism. Relying on its
proprietary multi-targeting conjugate molecule technology platform, the Company aims to deliver
therapeutic solutions to overcome the limitations of conventional treatments and improve patient
outcomes.
As at the date of this announcement, the Company had established a drug research and
development pipeline comprising eight innovative programs, including two core products, namely:
rifasutenizol (TNP-2198), a multi-targeting conjugated new molecular entity (“NME”) candidate
for the treatment of Helicobacter pylori infection when used in combination with amoxicillin
and a proton pump inhibitor, as well as monotherapy for bacterial vaginosis and Clostridioides
difficile infection; and rifaquizinone (TNP-2092) injection, a triple-targeting NME candidate for
the treatment of acute bacterial skin and skin structure infection and implant-associated bacterial
infections (such as PJI, left ventricular assist device infection and catheter-related bloodstream
infection).
3
We may not be able to ultimately develop and market rifaquizinone (TNP-2092) successfully.
Shareholders and potential investors of the Company are advised to exercise caution when
dealing in the shares of the Company.
By order of the Board
TenNor Therapeutics (Suzhou) Limited
Dr. Ma Zhenkun
Chairman of the Board, Executive Director,
Chief Executive Officer and General Manager
Hong Kong, 7 September 2026
As at the date of this announcement, the Board comprises: (i) Dr. Ma Zhenkun as an executive
Director; (ii) Dr. Song Gaoguang as a non-executive Director; and (iii) Mr. Lee Wai Kong, Albert,
Dr. Ni Lin and Dr. Li Leping as independent non-executive Directors.
4
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。
МԚ哦
TenNor Therapeutics (Suzhou) Limited
丹諾醫藥（蘇州）股份有限公司
（於中華人民共和國註冊成立的股份有限公司）
（股份代號：6872）
自願公告
利福喹酮(TNP-2092)治療人工關節感染IIa期概念驗證臨床試驗取得積
極結果及多中心IIb期臨床試驗啟動
本公告由丹諾醫藥（蘇州）股份有限公司（「本公司」）及其附屬公司（「本集團」）自
願作出，以向本公司股東及潛在投資者提供本集團最新業務發展狀況。
本公司董事會（「董事會」）欣然宣佈，本公司在研新藥候選物利福喹酮(TNP-2092)
通過關節腔內注射給藥治療人工關節感染（「PJI」）的IIa期概念驗證臨床試驗取得
積極頂線結果。利福喹酮(TNP-2092)為一款全球首創、專門針對植入醫療器械感
染開發的三靶點作用機制的在研新藥。基於該等概念驗證數據，一項多中心IIb期
臨床試驗已獲中國國家藥品監督管理局（「國家藥監局」）許可，且該試驗已於近期
啟動。
IIa期概念驗證臨床試驗取得積極結果
該項在中國開展的IIa期概念驗證臨床試驗評估了利福喹酮(TNP-2092)關節腔內注
射在不進行手術清創的情況下，用於早期術後、急性血源性或慢性PJI患者的療效
與安全性。
截至2026年7月1日（「數據鎖定日」）的中期分析，該試驗共入組10例患者，其中7
例經細菌培養或下一代基因測序確認為革蘭氏陽性菌感染者並納入療效分析集，
2例因培養結果陰性被排除出療效分析，另有1例於數據鎖定日時為新入組患者，
尚無療效數據。
1
療效結果方面，在接受利福喹酮(TNP-2092)關節腔內注射治療的5例早期或急性
PJI患者中，全部患者均已完成6個月隨訪，治療成功率為100%；其中4例患者完
成12個月隨訪，治療成功率亦為100%。在接受利福喹酮(TNP-2092)關節腔內注射
治療的2例慢性PJI患者中，完成6個月隨訪的2例患者中有1例治療成功，治療成
功率為50%，而12個月隨訪數據截至數據鎖定日尚待取得。
安全性結果方面，共9例患者納入安全性分析，未報告與利福喹酮(TNP-2092)相
關的治療期不良事件或嚴重不良事件；其餘1 例仍在隨訪中的患者，截至數據鎖
定日亦未報告與利福喹酮(TNP-2092)相關的治療期不良事件或嚴重不良事件。
以上研究結果顯示了利福喹酮(TNP-2092)關節腔內注射良好的療效和優異的安全
性特徵，支持這一新型非手術PJI治療方案的加速臨床開發。
多中心IIb期臨床試驗啟動
基於上述IIa期的積極概念驗證數據，本公司一項多中心IIb期臨床試驗方案已獲國
家藥監局許可，該試驗於近期啟動。
關於PJI
PJI是關節置換術後一種嚴重的併發症，可令原本成功的手術演變為醫療系統與患
者的雙重危機。美國每年新增PJI病例約45,000例，中國約22,000例，並且呈快速
增長趨勢。然而，由於細菌生物膜的形成導致傳統抗菌藥物療效顯著降低，PJI的
治療面臨極大挑戰。單純依靠抗菌藥物，不進行手術干預的治療方案因失敗率極
高，臨床不予推薦。
目前患者面臨的治療選擇均為手術路徑，但治療效果並不理想：對於早期術後或
急性血源性PJI，指南建議施行清創、抗菌藥物治療及假體保留手術(DAIR)，但報
導的失敗率在30%以上；對於慢性PJI，則需進行二期翻修手術，該方案涉及多次
手術、長期住院及術後數月的功能喪失，而失敗率仍超過10%。PJI帶來的經濟負
擔極為沉重，美國每例患者的治療費用超過39萬美元。與此同時，關節置換手術
量的持續增長進一步加劇了臨床挑戰，推動PJI發病率快速上升；據估算，到2035
年全球每年新增PJI病例將達到425,800例，其中中國預計為86,500例。
2
關於利福喹酮(TNP-2092)
利福喹酮(TNP-2092)是一款全球首創、三靶點作用機制的在研新藥，專門針對植
入醫療器械相關生物膜感染而設計。其獨特三靶點協同作用可協同抑制細菌RNA
聚合酶、DNA旋轉酶和拓撲異構酶IV－ 這一機制不僅能針對耐藥病原體（包括耐
甲氧西林金黃色葡萄球菌和耐喹諾酮金黃色葡萄球菌）展現強效抗菌活性，還能
將耐藥頻率降至極低水準（<10⁻12）。
在臨床前研究中，利福喹酮(TNP-2092)在體外和體內模型中均展現出強效的生物
膜殺菌活性，效果優於當前標準治療抗菌藥物。本公司已在美國和中國成功完成
六項I期和II期臨床試驗，利福喹酮(TNP-2092)靜脈注射在急性細菌性皮膚及皮膚
結構感染中顯示出良好的安全性和優異的療效。
利福喹酮(TNP-2092)的變革性潛力已獲得監管機構的高度認可。美國食品藥品監
督管理局已授予利福喹酮(TNP-2092)合格感染性疾病產品、快速通道及孤兒藥
資格認定。此外，利福喹酮(TNP-2092)還榮獲中國全國顛覆性技術創新大賽優勝
獎。
關於本公司
本公司是一家臨近商業化階段的生物科技公司，專注於發現、開發及商業化差異
化的創新藥產品，以解決細菌感染及細菌代謝相關疾病領域的未被滿足醫療需
求。本公司依託其專有的多靶點偶聯分子技術平台，旨在提供治療解決方案，突
破傳統療法的局限並改善患者預後。
截至本公告日期，本公司已構建由八個創新項目組成的研發管線，其中包括兩款
核心產品：利福特尼唑(TNP-2198)，一款多靶點偶聯新分子實體（「NME」）候選
藥物，通過與阿莫西林和質子泵抑制劑聯合使用治療幽門螺桿菌感染，亦作為單
藥療法治療細菌性陰道病及艱難梭菌感染；及利福喹酮(TNP-2092)注射劑，一款
三靶點NME候選藥物，用於治療急性細菌性皮膚及皮膚結構感染和植入體相關細
菌感染（如PJI、左心室輔助裝置感染及中心靜脈導管相關血流感染）。
3
我們可能無法最終成功開發並上市利福喹酮(TNP-2092)。本公司股東及潛在投資
者於買賣本公司股份時務請審慎行事。
承董事會命
丹諾醫藥（蘇州）股份有限公司
董事會主席、執行董事、首席執行官兼總經理
馬振坤博士
香港，2026年9月7日
於本公告日期，董事會包括：(i)執行董事馬振坤博士；(ii)非執行董事宋高廣博
士；及(iii)獨立非執行董事李維剛先生、倪琳博士及李樂平博士。
4
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.
МԚ哦
TenNor Therapeutics (Suzhou) Limited
丹諾醫藥（蘇州）股份有限公司
(A joint stock company incorporated in the People ’s Republic of China with limited liability)
(Stock code: 6872)
VOLUNTARY ANNOUNCEMENT
POSITIVE RESULTS FROM A PHASE IIA PROOF-OF-CONCEPT
CLINICAL TRIAL OF RIFAQUIZINONE (TNP-2092) FOR THE
TREATMENT OF PROSTHETIC JOINT INFECTION AND INITIATION OF
A MULTI-CENTER PHASE IIB CLINICAL TRIAL
This announcement is made by TenNor Therapeutics (Suzhou) Limited (the “Company”) and its
subsidiaries (the “Group”) on a voluntary basis to keep the shareholders and potential investors of
the Company informed of the latest business developments of the Group.
The board of directors (the “Board”) of the Company is pleased to announce that positive top-line
results were obtained from the Phase IIa proof-of-concept clinical trial of the Company’s new drug
candidate, rifaquizinone (TNP-2092), administered via intra-articular injection for the treatment
of prosthetic joint infection ( “PJI”). Rifaquizinone (TNP-2092) is the world ’s first new drug
candidate developed specifically to target infections associated with implantable medical devices
through a triple-targeting mechanism of action. Based on those proof-of-concept data, the Company
has received approval for a multi-center Phase IIb clinical trial from the National Medical Products
Administration of the PRC (the “NMPA”) and the trial has recently been initiated.
Positive Results from a Phase IIa Proof-of-Concept Clinical Trial
The Phase IIa proof-of-concept clinical trial conducted in China evaluated the efficacy and safety
of intra-articular injection of rifaquizinone (TNP-2092) without surgical debridement in patients
with early postoperative, acute hematogenous, or chronic PJI.
According to the interim analysis as of 1 July 2026 (the “Data Cutoff Date”), the trial enrolled a
total of 10 patients, of whom 7 were patients with confirmed Gram-positive bacterial infections by
bacterial culture or next-generation gene sequencing and were included in the efficacy analysis set;
2 patients were excluded from the efficacy analysis due to negative culture results, and 1 newly
enrolled patient at the Data Cutoff Date had no efficacy data available yet.
1
With respect to efficacy results, all 5 patients with early or acute PJI receiving intra-articular
injections of rifaquizinone (TNP-2092) completed the 6-month follow-up visit, with a treatment
success rate of 100%; among them, 4 patients completed the 12-month follow-up visit, also with
a treatment success rate of 100%. Among the 2 patients with chronic PJI receiving intra-articular
injection of rifaquizinone (TNP-2092), 1 of the 2 patients who completed the 6-month follow-up
visit achieved treatment success, corresponding to a treatment success rate of 50%, while the
12-month follow-up visit data were not yet available as of the Data Cutoff Date.
With respect to safety results, a total of 9 patients were included in the safety analysis, and no
treatment-emergent adverse events or serious adverse events related to rifaquizinone (TNP-2092)
were reported. For the remaining one patient still in follow-up visit, no treatment-emergent adverse
events or serious adverse events related to rifaquizinone (TNP-2092) were reported as of the Data
Cutoff Date.
The above results demonstrate the favorable efficacy and excellent safety profile of intra-articular
injection of rifaquizinone (TNP-2092), supporting the accelerated clinical development of this
novel non-surgical treatment option for PJI.
Initiation of a Multi-center Phase IIb Clinical Trial
Based on the positive data from the Phase IIa proof-of-concept clinical trial above, the Company
has received approval for a multi-center Phase IIb clinical trial from the NMPA and the trial has
recently been initiated.
About PJI
PJI is a serious complication following joint replacement surgery that can transform an initially
successful operation into a crisis for both the healthcare system and patients. In the United States,
there are approximately 45,000 new cases of PJI each year, while there are approximately 22,000
cases in China, with the incidence showing a rapid upward trend. However, the treatment of PJI
faces significant challenges as the formation of bacterial biofilms substantially reduces the efficacy
of conventional antimicrobial agents. Treatment regimens that rely solely on antimicrobial agents
without surgical intervention are not recommended in clinical practice due to their extremely high
failure rates.
Currently, all available treatment options for patients require surgical intervention, yet treatment
outcomes remain suboptimal: for early postoperative or acute hematogenous PJI, guidelines
recommend debridement, antibiotics, and implant retention (DAIR) procedures, but reported failure
rates exceed 30%; for chronic PJI, a two-stage revision arthroplasty is required, which involves
multiple surgeries, prolonged hospitalization and several months of functional loss postoperatively,
with failure rates still exceeding 10%. The economic burden of PJI is extremely heavy, with
treatment costs in the United States exceeding US$390,000 per patient. Meanwhile, the continued
growth in joint replacement surgeries further intensifies the clinical challenge, driving a rapid
increase in PJI incidence; it is estimated that by 2035, the number of new PJI cases globally will
reach 425,800 per year, of which China is projected to account for 86,500 cases.
2
About Rifaquizinone (TNP-2092)
Rifaquizinone (TNP-2092) is the world ’ s first new drug candidate developed specifically to
target biofilm infections associated with implantable medical devices through a triple-targeting
mechanism of action. Through its unique triple-targeting synergistic mechanism of action by
simultaneously inhibiting bacterial RNA polymerase, DNA gyrase and DNA topoisomerase IV.
Rifaquizinone (TNP-2092) not only demonstrates potent bactericidal activity against drug-resistant
pathogens (including methicillin-resistant S. aureus and quinolone-resistant S. aureus), but also
reduces the resistance frequency to an extremely low level (<10⁻12).
In the preclinical study, rifaquizinone (TNP-2092) has demonstrated strong in vitro and in vivo
biofilm bactericidal activity, and its efficacy is superior to that of current standard-of-care
antibiotics. The Company has successfully completed six Phase I and Phase II clinical trials in the
U.S. and China, and the intravenous administration of rifaquizinone (TNP-2092) has demonstrated
favorable safety and excellent efficacy profile in the treatment of acute bacterial skin and skin
structure infections.
The transformative potential of rifaquizinone (TNP-2092) has been highly recognized by regulatory
authorities. Rifaquizinone (TNP-2092) has been granted Qualified Infectious Disease Product,
Fast Track, and Orphan Drug designations by the United States Food and Drug Administration.
In addition, rifaquizinone (TNP-2092) has also received the outstanding award at the National
Disruptive Technology Innovation Competition in China (全國顛覆性技術創新大賽優勝獎).
About the Company
The Company is a near-commercial stage biotechnology company dedicated to the discovery,
development and commercialization of differentiated therapies to address unmet medical needs
in disease areas associated with bacterial infections and bacterial metabolism. Relying on its
proprietary multi-targeting conjugate molecule technology platform, the Company aims to deliver
therapeutic solutions to overcome the limitations of conventional treatments and improve patient
outcomes.
As at the date of this announcement, the Company had established a drug research and
development pipeline comprising eight innovative programs, including two core products, namely:
rifasutenizol (TNP-2198), a multi-targeting conjugated new molecular entity (“NME”) candidate
for the treatment of Helicobacter pylori infection when used in combination with amoxicillin
and a proton pump inhibitor, as well as monotherapy for bacterial vaginosis and Clostridioides
difficile infection; and rifaquizinone (TNP-2092) injection, a triple-targeting NME candidate for
the treatment of acute bacterial skin and skin structure infection and implant-associated bacterial
infections (such as PJI, left ventricular assist device infection and catheter-related bloodstream
infection).
3
We may not be able to ultimately develop and market rifaquizinone (TNP-2092) successfully.
Shareholders and potential investors of the Company are advised to exercise caution when
dealing in the shares of the Company.
By order of the Board
TenNor Therapeutics (Suzhou) Limited
Dr. Ma Zhenkun
Chairman of the Board, Executive Director,
Chief Executive Officer and General Manager
Hong Kong, 7 September 2026
As at the date of this announcement, the Board comprises: (i) Dr. Ma Zhenkun as an executive
Director; (ii) Dr. Song Gaoguang as a non-executive Director; and (iii) Mr. Lee Wai Kong, Albert,
Dr. Ni Lin and Dr. Li Leping as independent non-executive Directors.
4
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。
МԚ哦
TenNor Therapeutics (Suzhou) Limited
丹諾醫藥（蘇州）股份有限公司
（於中華人民共和國註冊成立的股份有限公司）
（股份代號：6872）
自願公告
利福喹酮(TNP-2092)治療人工關節感染IIa期概念驗證臨床試驗取得積
極結果及多中心IIb期臨床試驗啟動
本公告由丹諾醫藥（蘇州）股份有限公司（「本公司」）及其附屬公司（「本集團」）自
願作出，以向本公司股東及潛在投資者提供本集團最新業務發展狀況。
本公司董事會（「董事會」）欣然宣佈，本公司在研新藥候選物利福喹酮(TNP-2092)
通過關節腔內注射給藥治療人工關節感染（「PJI」）的IIa期概念驗證臨床試驗取得
積極頂線結果。利福喹酮(TNP-2092)為一款全球首創、專門針對植入醫療器械感
染開發的三靶點作用機制的在研新藥。基於該等概念驗證數據，一項多中心IIb期
臨床試驗已獲中國國家藥品監督管理局（「國家藥監局」）許可，且該試驗已於近期
啟動。
IIa期概念驗證臨床試驗取得積極結果
該項在中國開展的IIa期概念驗證臨床試驗評估了利福喹酮(TNP-2092)關節腔內注
射在不進行手術清創的情況下，用於早期術後、急性血源性或慢性PJI患者的療效
與安全性。
截至2026年7月1日（「數據鎖定日」）的中期分析，該試驗共入組10例患者，其中7
例經細菌培養或下一代基因測序確認為革蘭氏陽性菌感染者並納入療效分析集，
2例因培養結果陰性被排除出療效分析，另有1例於數據鎖定日時為新入組患者，
尚無療效數據。
1
療效結果方面，在接受利福喹酮(TNP-2092)關節腔內注射治療的5例早期或急性
PJI患者中，全部患者均已完成6個月隨訪，治療成功率為100%；其中4例患者完
成12個月隨訪，治療成功率亦為100%。在接受利福喹酮(TNP-2092)關節腔內注射
治療的2例慢性PJI患者中，完成6個月隨訪的2例患者中有1例治療成功，治療成
功率為50%，而12個月隨訪數據截至數據鎖定日尚待取得。
安全性結果方面，共9例患者納入安全性分析，未報告與利福喹酮(TNP-2092)相
關的治療期不良事件或嚴重不良事件；其餘1 例仍在隨訪中的患者，截至數據鎖
定日亦未報告與利福喹酮(TNP-2092)相關的治療期不良事件或嚴重不良事件。
以上研究結果顯示了利福喹酮(TNP-2092)關節腔內注射良好的療效和優異的安全
性特徵，支持這一新型非手術PJI治療方案的加速臨床開發。
多中心IIb期臨床試驗啟動
基於上述IIa期的積極概念驗證數據，本公司一項多中心IIb期臨床試驗方案已獲國
家藥監局許可，該試驗於近期啟動。
關於PJI
PJI是關節置換術後一種嚴重的併發症，可令原本成功的手術演變為醫療系統與患
者的雙重危機。美國每年新增PJI病例約45,000例，中國約22,000例，並且呈快速
增長趨勢。然而，由於細菌生物膜的形成導致傳統抗菌藥物療效顯著降低，PJI的
治療面臨極大挑戰。單純依靠抗菌藥物，不進行手術干預的治療方案因失敗率極
高，臨床不予推薦。
目前患者面臨的治療選擇均為手術路徑，但治療效果並不理想：對於早期術後或
急性血源性PJI，指南建議施行清創、抗菌藥物治療及假體保留手術(DAIR)，但報
導的失敗率在30%以上；對於慢性PJI，則需進行二期翻修手術，該方案涉及多次
手術、長期住院及術後數月的功能喪失，而失敗率仍超過10%。PJI帶來的經濟負
擔極為沉重，美國每例患者的治療費用超過39萬美元。與此同時，關節置換手術
量的持續增長進一步加劇了臨床挑戰，推動PJI發病率快速上升；據估算，到2035
年全球每年新增PJI病例將達到425,800例，其中中國預計為86,500例。
2
關於利福喹酮(TNP-2092)
利福喹酮(TNP-2092)是一款全球首創、三靶點作用機制的在研新藥，專門針對植
入醫療器械相關生物膜感染而設計。其獨特三靶點協同作用可協同抑制細菌RNA
聚合酶、DNA旋轉酶和拓撲異構酶IV－ 這一機制不僅能針對耐藥病原體（包括耐
甲氧西林金黃色葡萄球菌和耐喹諾酮金黃色葡萄球菌）展現強效抗菌活性，還能
將耐藥頻率降至極低水準（<10⁻12）。
在臨床前研究中，利福喹酮(TNP-2092)在體外和體內模型中均展現出強效的生物
膜殺菌活性，效果優於當前標準治療抗菌藥物。本公司已在美國和中國成功完成
六項I期和II期臨床試驗，利福喹酮(TNP-2092)靜脈注射在急性細菌性皮膚及皮膚
結構感染中顯示出良好的安全性和優異的療效。
利福喹酮(TNP-2092)的變革性潛力已獲得監管機構的高度認可。美國食品藥品監
督管理局已授予利福喹酮(TNP-2092)合格感染性疾病產品、快速通道及孤兒藥
資格認定。此外，利福喹酮(TNP-2092)還榮獲中國全國顛覆性技術創新大賽優勝
獎。
關於本公司
本公司是一家臨近商業化階段的生物科技公司，專注於發現、開發及商業化差異
化的創新藥產品，以解決細菌感染及細菌代謝相關疾病領域的未被滿足醫療需
求。本公司依託其專有的多靶點偶聯分子技術平台，旨在提供治療解決方案，突
破傳統療法的局限並改善患者預後。
截至本公告日期，本公司已構建由八個創新項目組成的研發管線，其中包括兩款
核心產品：利福特尼唑(TNP-2198)，一款多靶點偶聯新分子實體（「NME」）候選
藥物，通過與阿莫西林和質子泵抑制劑聯合使用治療幽門螺桿菌感染，亦作為單
藥療法治療細菌性陰道病及艱難梭菌感染；及利福喹酮(TNP-2092)注射劑，一款
三靶點NME候選藥物，用於治療急性細菌性皮膚及皮膚結構感染和植入體相關細
菌感染（如PJI、左心室輔助裝置感染及中心靜脈導管相關血流感染）。
3
我們可能無法最終成功開發並上市利福喹酮(TNP-2092)。本公司股東及潛在投資
者於買賣本公司股份時務請審慎行事。
承董事會命
丹諾醫藥（蘇州）股份有限公司
董事會主席、執行董事、首席執行官兼總經理
馬振坤博士
香港，2026年9月7日
於本公告日期，董事會包括：(i)執行董事馬振坤博士；(ii)非執行董事宋高廣博
士；及(iii)獨立非執行董事李維剛先生、倪琳博士及李樂平博士。
4
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