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Drugs / Orelabrutinib
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Orelabrutinib

also known as ICP-022 · Innobruka · Obrutinib

Small molecule targets BTK

Developed for
marginal zone lymphoma · diffuse large B-cell lymphoma · mantle cell lymphoma · primary central nervous system lymphoma · autoimmune thrombocytopenia · chronic lymphocytic leukemia/small lymphocytic lymphoma · central nervous system non-hodgkin lymphoma · follicular lymphoma
+22 more · systemic lupus erythematosus · autoimmune hemolytic anemia · B-cell chronic lymphocytic leukemia · B-cell neoplasm · B-cell non-Hodgkin lymphoma · Burkitt lymphoma · central nervous system cancer · gastric mucosa-associated lymphoid tissue lymphoma · hematopoietic and lymphoid cell neoplasm · high grade B-cell lymphoma · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · lymphoma · MALT lymphoma · MCD diffuse large B-cell lymphoma · neuromyelitis optica spectrum disorder with anti-AQP4 antibodies · non-Hodgkin lymphoma · ocular adnexal lymphoma · primary progressive multiple sclerosis · primary thrombocytopenia · relapsing-remitting multiple sclerosis · secondary progressive multiple sclerosis · Waldenstrom macroglobulinemia
Investigated by
Beijing InnoCare Pharma Tech Co., Ltd. · Ruijin Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Peking Union Medical College Hospital · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital with Nanjing Medical University
+135 more · Beijing Tongren Hospital · Fujian Medical University Union Hospital · Qilu Hospital of Shandong University · The First Affiliated Hospital of Anhui Medical University · Affiliated Hospital of Jiaxing University · First Affiliated Hospital of Zhejiang University · Fudan University · Henan Cancer Hospital · Huzhou Central Hospital · Institute of Hematology & Blood Diseases Hospital, China · Second Affiliated Hospital of Wenzhou Medical University · Sun Yat-sen University · The Second Affiliated Hospital of Dalian Medical University · The Second Affiliated Hospital of Jiaxing University · The Third Xiangya Hospital of Central South University · Tianjin Medical University Cancer Institute and Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Zhejiang Cancer Hospital · Affiliated Hospital of Nantong University · Beijing Hospital · Dongyang People's Hospital · Fei Li · Fifth Affiliated Hospital of Guangzhou Medical University · First Affiliated Hospital of Wenzhou Medical University · First People's Hospital of Hangzhou · Fujian Cancer Hospital · Gansu Cancer Hospital · Huadong Hospital · Huashan Hospital · InnoCare Pharma Inc. · Jiangxi Provincial Cancer Hospital · Nanfang Hospital, Southern Medical University · Ningbo People's Hospital · Peking University People's Hospital · Peking University Third Hospital · Shandong Cancer Hospital and Institute · Shandong University · Shanxi Province Cancer Hospital · Shaoxing Central Hospital · Shaoxing People's Hospital · Taizhou First People's Hospital · Taizhou Hospital · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · The Affiliated Hospital of Xuzhou Medical University · The Central Hospital of Lishui City · The First Affiliated Hospital of Nanchang University · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital of Zhengzhou University · The First Hospital of Jilin University · The People's Hospital of Quzhou · Yantai Yuhuangding Hospital · Yuyao People's Hospital · Zenas BioPharma (USA), LLC · Zhejiang Provincial People's Hospital · Zhejiang Provincial Tongde Hospital · Zhuji People's Hospital of Zhejiang Province · Affiliated Cancer Hospital of Harbin Medical University · Affiliated Hospital of Guilin Medical College · Affiliated Hospital to Academy of Military Medical Sciences · Affiliated Zhongshan Hospital of Dalian University · Air Force Military Medical University, China · Anhui Provincial Cancer Hospital · Beijing Luhe Hospital · Beijing Tiantan Hospital · BioRay Pharmaceutical Co., Ltd. · Cancer Hospital Affiliated to Xinjiang Medical University · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Capital Medical University · Central South University · Changxing County Traditional Chinese Medicine Hospital · China-Japan Friendship Hospital · Chinese PLA General Hospital · Dongguan People's Hospital · Fifth Affiliated Hospital, Sun Yat-Sen University · all 141 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed chronic lymphocytic leukemia/small lymphocytic lymphoma 1 milestone
Filed China (NMPA) — chronic lymphocytic leukemia/small lymphocytic lymphoma 2019-11-20

“中国国家药品监督管理局（NMPA）已受理奥布替尼（ICP-022）用于治疗复发/难治慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)患者的新药上市申请(NDA)。” innocarepharma.com ↗
Filed mantle cell lymphoma 1 milestone
Filed China (NMPA) — mantle cell lymphoma 2020-03-06

“公司自主研发的化学1类新药奥布替尼（ICP-022）用于治疗复发/难治性套细胞淋巴瘤(MCL) 患者的新药上市申请（NDA）于2020年3月获中国国家药品监督管理局（NMPA）受理并被纳入优先审批” innocarepharma.com ↗

“中国国家药品监督管理局 (NMPA) 已受理奥布替尼 (ICP-022) 用于治疗复发/难治性套细胞淋巴瘤(MCL) 患者的新适应症上市申请(NDA)。” innocarepharma.com ↗

Trials 102 · started per year

today
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2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07574073 Jun 2026 → May 2028 expected autoimmune hemolytic anemia, autoimmune thrombocytopenia Qi deng Not yet recruiting No outcome recorded
Phase 1 NCT05684653 Mar → Dec 2023 — Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05728658 Mar 2023 → Aug 2025 overdue hematopoietic and lymphoid cell neoplasm Beijing InnoCare Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT05660720 Nov 2022 → Jun 2023 — Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05316857 Dec 2021 → Jan 2022 — Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 1 NCT05036577 Oct 2021 → Dec 2023 overdue primary central nervous system lymphoma Huashan Hospital Active not recruiting No outcome recorded
Phase 1 NCT03189017 Jul 2017 → Feb 2018 rheumatoid arthritis, systemic lupus erythematosus Innocare Pharma Australia Pty Ltd Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT05124028 Dec 2021 → Mar 2022 autoimmune thrombocytopenia Peking University People's Hospital Unknown No outcome recorded
Phase 1/2 NCT05021770 Dec 2021 → Dec 2022 non-Hodgkin lymphoma, primary central nervous system lymphoma Huiqiang Huang Unknown No outcome recorded
Phase 1/2 NCT04831658 Mar 2021 → Sep 2023 primary central nervous system lymphoma Mingzhi Zhang Unknown No outcome recorded
Phase 1/2 NCT04304040 Jul 2020 → Dec 2025 B-cell non-Hodgkin lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04305197 Jul 2020 → Apr 2022 systemic lupus erythematosus Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT04014205 Nov 2019 → Jun 2026 overdue B-cell neoplasm Beijing InnoCare Pharma Tech Co., Ltd. Active not recruiting No outcome recorded
Phase 1/2 NCT03493217 Apr 2018 → Dec 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03494179 Apr 2018 → Apr 2020 mantle cell lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 264 trials
Phase 2 NCT07677813 Jun 2026 → Dec 2029 expected MCD diffuse large B-cell lymphoma Ou Bai, MD/PHD Not yet recruiting No outcome recorded
Phase 2 NCT07554898 Apr 2026 → Feb 2028 expected MALT lymphoma Zhejiang Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07585747 Apr 2026 → Dec 2029 expected follicular lymphoma Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 2 NCT07400250 Apr → Oct 2026 expected autoimmune thrombocytopenia Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07680933 Mar 2026 → Jun 2027 expected diffuse large B-cell lymphoma The Affiliated Hospital of Xuzhou Medical University Recruiting No outcome recorded
Phase 2 NCT07453368 Mar 2026 → Mar 2027 expected autoimmune hemolytic anemia Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 2 NCT07410520 Feb 2026 → Dec 2028 expected central nervous system non-hodgkin lymphoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2 NCT07441993 Jan 2026 → Dec 2027 expected marginal zone lymphoma Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2 NCT07499271 Jan 2026 → Dec 2027 expected diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 2 NCT07372365 Oct 2025 → Apr 2028 expected marginal zone lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07185373 Oct 2025 → Sep 2028 expected primary central nervous system lymphoma Huashan Hospital Not yet recruiting No outcome recorded
Phase 313 trials · 1 met primary
Phase 3 NCT07559331 Apr 2026 → Apr 2027 expected primary thrombocytopenia Shandong University Recruiting No outcome recorded
Phase 3 NCT07299019 Mar 2026 → Jun 2030 expected secondary progressive multiple sclerosis Zenas BioPharma (USA), LLC Recruiting No outcome recorded
Phase 3 NCT07067463 Mar 2026 → Jun 2030 expected primary progressive multiple sclerosis Zenas BioPharma (USA), LLC Recruiting No outcome recorded
Phase 3 NCT06496308 Jul 2024 → Jul 2027 expected mantle cell lymphoma Ruijin Hospital Recruiting No outcome recorded
Phase 3 NCT06082102 Dec 2023 → Aug 2028 expected marginal zone lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06004856 Oct 2023 → Dec 2025 autoimmune thrombocytopenia Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05234684 Nov 2022 → Jul 2024 diffuse large B-cell lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05351346 Jun 2022 → Jun 2026 diffuse large B-cell lymphoma Ruijin Hospital Unknown No outcome recorded
Phase 3 NCT05051891 Dec 2021 → Jun 2025 mantle cell lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 3 NCT05334238 Dec 2021 → May 2024 primary central nervous system lymphoma Ruijin Hospital Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT07355699 Nov 2025 → Sep 2027 expected marginal zone lymphoma Beijing Tongren Hospital Recruiting No outcome recorded
Phase not applicable8 trials
— NCT07191431 Sep 2025 → Sep 2027 expected central nervous system non-hodgkin lymphoma Ruijin Hospital Recruiting No outcome recorded
— NCT07257510 Aug 2025 → Aug 2028 expected mantle cell lymphoma Peking University Third Hospital Recruiting No outcome recorded
— NCT07072208 Nov 2024 → May 2027 expected diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
— NCT06478472 Jun 2024 → Jun 2027 expected marginal zone lymphoma The First Affiliated Hospital of Xiamen University Recruiting No outcome recorded
— NCT05784987 Apr 2023 → Jan 2024 diffuse large B-cell lymphoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
— NCT05809180 Jan 2023 → Jul 2025 diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Unknown No outcome recorded
— NCT05284175 Apr 2022 → Aug 2023 neuromyelitis optica spectrum disorder with anti-AQP4 antibodies Peking Union Medical College Hospital Unknown No outcome recorded
— NCT04441450 Jul → Aug 2019 — Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Comparator or background therapy6 trials
Phase 2 NCT07350850 Comparator Dec 2025 → Dec 2028 expected primary central nervous system lymphoma Tongji Hospital Recruiting No outcome recorded
Phase 2 NCT06958705 Background Dec 2025 → Dec 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2/3 NCT06378138 Background May 2024 → Nov 2030 expected hematopoietic and lymphoid cell neoplasm Beijing InnoCare Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT07377578 Comparator Feb 2026 → May 2031 expected mantle cell lymphoma Guangzhou Lupeng Pharmaceutical Company LTD. Recruiting No outcome recorded
Phase 3 NCT06363994 Comparator May 2024 → Jun 2031 expected mantle cell lymphoma InnoCare Pharma Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2025-12-15 Zenas BioPharma (USA), LLC Results Zenas BioPharma’s Partner, InnoCare Pharma, Announces Achievement of Primary Endpoint in Phase 2b Study of Orelabrutinib, a BTK Inhibitor, for Systemic Lupus Erythematosus zenasbio.com ↗
At week 48, the orelabrutinib 75 mg QD group achieved a statistically significant improvement in SRI-4 response rate compared with placebo (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint.
2023-05-01 Beijing InnoCare Pharma Tech Co., Ltd. Results 《Blood》子刊发表奥布替尼针对套细胞淋巴瘤的临床研究结果 innocarepharma.com ↗
该文章总结，在长期治疗随访下，奥布替尼在r/r MCL患者中显示出持久显著的疗效，且耐受性良好。
2020-03-06 Beijing InnoCare Pharma Tech Co., Ltd. Regulatory 国家药监局受理诺诚健华奥布替尼用于治疗复发/难治性套细胞淋巴瘤患者的新适应症上市申请 innocarepharma.com ↗
诺诚健华宣布，中国国家药品监督管理局 (NMPA) 已受理奥布替尼 (ICP-022) 用于治疗复发/难治性套细胞淋巴瘤(MCL) 患者的新适应症上市申请(NDA)。
2019-12-10 Beijing InnoCare Pharma Tech Co., Ltd. Results 诺诚健华在第61届美国血液学协会(ASH)年会首次公布奥布替尼临床研究数据 innocarepharma.com ↗
由IRC基于CT评估的总体ORR为85.9%，其中完全缓解率(CR)为27.3%，部分缓解率(PR)为58.6%，中位DOR和PFS尚未达到。
2019-11-20 Beijing InnoCare Pharma Tech Co., Ltd. Regulatory 诺诚健华奥布替尼(ICP-022)新药上市申请获得国家药监局受理 innocarepharma.com ↗
2019年11月20日，诺诚健华宣布，中国国家药品监督管理局（NMPA）已受理奥布替尼（ICP-022）用于治疗复发/难治慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)患者的新药上市申请(NDA)。
2019-08-27 Beijing InnoCare Pharma Tech Co., Ltd. Regulatory 诺诚健华和天广实达成合作 奥布替尼联合MIL62治疗CD20+B细胞淋巴瘤 innocarepharma.com ↗
8月27日，北京诺诚健华医药科技有限公司（以下简称“诺诚健华“）和北京天广实生物技术股份有限公司（以下简称”天广实“）联合宣布，诺诚健华和天广实获得国家药品监督管理局药品审评中心（CDE）临床试验默示许可，许可新型选择性BTK抑制剂ICP-022片（奥布替尼）联合重组人源化II型CD20单克隆抗体MIL62注射液治疗复发/难治CD20+B细胞淋巴瘤。

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 109 sources stand behind the page.

FieldValueCited text
Known as Orelabrutinib “This study was an open-label, single-arm, phase 1/2 trial evaluating orelabrutinib combined with an anti-programmed cell death protein-1 (PD-1) antibody and a non-methotrexate...” PMID 41485126 ↗ Jan 2026
96

“During the induction therapy phase, patients will receive 90 mg/m2 of bendamustine and 375 mg/m2 zuberitamab from cycles 1 to 3, followed by 150 mg of orelabrutinib and 375...” NCT07008053 ↗

“This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options.” NCT07574073 ↗

“Covalent BTK inhibitor (Ibrutinib 560 mg qd, Zanubrutinib 160 mg bid, or Orelabrutinib 150 mg qd) orally on Days 1-21.” NCT07350850 ↗

“Orelabrutinib is a newly developed BTK inhibitor with high selectivity and have received its approval in China.” NCT05020392 ↗

“First-line Treatment of PCNSL With the Combination of Orelabrutinib, Rituximab, and Methotrexate (ORM Regimen)” NCT06454266 ↗

“Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle” NCT07072208 ↗

“Orelabrutinib 150mg, po, gd, D1-D28, every 28 days, cycle 1-12” NCT06985472 ↗

NCT04989621 ↗

NCT07078500 ↗

NCT05020288 ↗

Show 86 more sources
Known as ICP-022 “Orelabrutinib (ICP-022)” NCT07247383 ↗
12

“Orelabrutinib (ICP-022)” NCT04014205 ↗

NCT03797456 ↗

NCT03493217 ↗

NCT03189017 ↗

NCT03494179 ↗

NCT04441450 ↗

NCT04438044 ↗

NCT04438005 ↗

NCT04440059 ↗

NCT04305197 ↗

Show 2 more sources
Known as Innobruka ChEMBL registry synonym — accepted as the source's own label CHEMBL4650321 ↗
Known as Obrutinib “Orelabrutinib + rituximab for a total of 6 cycles of 28 days each Obrutinib (O) 150mg oral d1-28 Rituximab (R) 375mg/m2 IV d0” NCT06478472 ↗
Action Inhibit “novel BTK inhibitor” NCT04014205 ↗
Modality Small molecule “highly selective oral small-molecule BTK inhibitor” NCT07441993 ↗
Route Oral “oral single and multiple escalating dose administration” NCT03189017 ↗
Target BTK “novel BTK inhibitor” NCT04014205 ↗