Drugs / HLX22
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03916094 | Jul 2019 → Jan 2021 | cancer | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07824869 | Oct 2026 → Mar 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07176702 | Sep 2025 → Mar 2027 expected | pancreatic ductal adenocarcinoma | Shanghai Zhongshan Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06832202 | Apr 2025 → Jun 2027 expected | hormone receptor-positive breast cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT04908813 | Sep 2021 → Dec 2024 | gastric cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07294508 | Feb 2026 → Jan 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07294534 | Jan 2026 → Sep 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06532006 | Nov 2024 → Jun 2027 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-05-22 | Alligator Bioscience AB | Results Alligator Bioscience comments on Henlius update on long-term follow-up data for HLX22 alligatorbioscience.se ↗
According to Henlius’ communication, long-term follow-up over more than 39 months indicates that patients treated with HLX22 continue to demonstrate extended progression-free survival (PFS) at the current observation point. |
| 2026-05-21 | AbClon | Results 글로벌 위암 1차치료제 신약 ‘HLX22’, 위암 무진행생존(PFS) ‘최소 39개월’ 확보 abclon.com ↗
39개월에 달하는 장기 추적 관찰 결과, 환자들의 무진행생존기간(PFS)이 현재 시점까지도 계속해서 연장(Prolonged)되고 있음을 확인했다 |
| 2026-01-15 | AbClon | Results 앱클론, 전환우선주 전량 보통주 전환, 오버행 불확실성 ‘완전 해소’ abclon.com ↗
헨리우스가 발표한 임상 2상(HLX22-GC-201) 장기 추적 결과에 따르면, HER2 양성 위암 환자 1차 치료에서 ‘HLX22 병용 투여군’은 무진행 생존기간 중앙값(mPFS)이 데이터 분석 시점까지 도달하지 않은(Not Reached) 반면, 대조군(표준요법)은 8.3개월에 그쳤다 |
| 2025-12-09 | Shanghai Henlius Biotech | Regulatory Henlius Receives NMPA Approval to Initiate Phase 2/3 Clinical Trials of HLX22 for Neoadjuvant and First-Line Treatment of HER2-Positive Breast Cancer henlius.com ↗
Henlius (2696.HK) announced today that the National Medical Products Administration (NMPA) has approved two phase 2/3 clinical trials evaluating the company’s novel-epitope HER2 monoclonal antibody HLX22 in combination with its innovative anti-HER2 antibody–drug conjugate (ADC) HLX87 for the neoadjuvant and first-line treatment of HER2-positive breast cancer. |
| 2025-12-09 | Alligator Bioscience AB | Regulatory Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer alligatorbioscience.se ↗
applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (an antibody-drug conjugate targeting HER2) have been approved by China’s National Medical Products Administration (NMPA). |
| 2025-06-04 | AbClon | Results 앱클론 “AC101으로 HER2 양성 위암 무진행 생존률 3배이상 향상…ASCO 발표” - 글로벌 1차치료제 구체화 abclon.com ↗
ASCO발표에 따르면 투여 후 2년까지의 추적조사에서 AC101 병용군은 대조군 대비 질병 진행 위험을 80% 낮추는 탁월한 효과를 보였다. |
| 2025-06-03 | Shanghai Henlius Biotech | Results Henlius Unveils Updated Phase 2 Results and Phase 3 Trial Design for Anti-HER2 mAb HLX22 in First-Line HER2+ Gastric Cancer henlius.com ↗
Updated data from the HLX22-GC-201 study demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up, outperforming previous data. |
| 2025-05-27 | AbClon | Regulatory 앱클론 “혁신 항체치료제 AC101, 미국 이어 유럽서도 위암 치료 희귀의약품 지정“ abclon.com ↗
앱클론은 중국 헨리우스 바이오텍에 기술이전한 항체치료제 AC101(헨리우스 코드명 HLX22)이 유럽 집행위원회(EC)로부터 위암 치료를 위한 희귀의약품 지정(Orphan Drug Designation, ODD)을 받았다고 27일 밝혔다. |
| 2025-05-26 | Shanghai Henlius Biotech | Regulatory Henlius Receives Orphan Drug Designation for Its Innovative Anti-HER2 mAb HLX22 in the European Union for Gastric Cancer henlius.com ↗
Shanghai, China, May 26, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Commission (EC) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. |
| 2025-04-28 | Shanghai Henlius Biotech | Regulatory Henlius Receives Clinical Approval in EU for Head-to-Head Phase 3 MRCT of Dual HER2 Blockade Therapy on First-Line HER2+ GC henlius.com ↗
the application for clinical trial for head-to-head phase 3 international multicenter clinical study (HLX22-GC-301) of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved in Germany. |
| 2025-03-25 | AbClon | Regulatory 앱클론, HLX22 美 FDA 3상 진행중 희귀의약품 지정…글로벌 상업화 청신호 abclon.com ↗
앱클론은 AC101(코드명 HLX22)이 HER2 양성 국소 진행성 및 전이성 위암을 대상으로 미국 식품의약국(FDA)으로부터 희귀의약품 지정을 받았다고 25일 밝혔다. |
| 2025-03-19 | Shanghai Henlius Biotech | Regulatory Henlius Receives Orphan-Drug Designation for HLX22(Innovative anti-HER2 mAb) in the U.S. for Gastric Cancer henlius.com ↗
Shanghai, China, March 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. |
| 2025-01-26 | Shanghai Henlius Biotech | Results Results from Clinical Trials of Two Henlius’ Innovative Products Released at ASCO GI 2025 henlius.com ↗ |
| 2025-01-23 | AbClon | Results 앱클론 “AC101, HER2 양성 위식도암 생존률 향상…1차 치료제 기대감 고조” abclon.com ↗
발표한 임상 연구 결과에 따르면 HLX22∙트라스트주맙∙제록스(이하 HLX22) 병용요법을 받은 그룹은 플라시보∙트라스트주맙∙제록스(이하 플라시보) 그룹에 비해 월등히 높은 생존률을 보였다. |
| 2024-12-11 | AbClon | Regulatory 앱클론, “AC101, 글로벌 위암 임상 3상에 더불어 다른 고형암에도 확장 임상시험 승인” abclon.com ↗
앱클론은 11일 다양한 고형암 적응증 치료제로 개발하는 AC101(헨리우스 코드명 HLX22)의 새로운 임상 2상에 대해 중국 국가약품감독관리국(NMPA)으로부터 임상시험계획(IND)을 승인받았다고 밝혔다. |
| 2024-12-04 | Shanghai Henlius Biotech | Regulatory Henlius Receives Approval form NMPA for a Phase 2 Clinical Trial of Its Novel Anti-HER2 mAb HLX22 henlius.com ↗
the investigational new drug (IND) application for a phase 2 clinical trial of the company’s novel anti-HER2 monoclonal antibody (mAb), HLX22, in combination with trastuzumab and chemotherapy or combined with trastuzumab deruxtecan (T-DXd) has been approved by the China National Medical Products Administration (NMPA), for the treatment of HER2-expressing solid tumours. |
| 2024-10-23 | Shanghai Henlius Biotech | Results HLX22 Dual HER2 Blockade Therapy Featured on the Cover of Med henlius.com ↗
The study reveals that the treatment regimen significantly extended progression-free survival and improved antitumor response in these patients, with manageable safety profiles, supporting the clinical benefits of dual HER2 blockade. |
| 2024-10-21 | Shanghai Henlius Biotech | Regulatory Henlius Receives Approval in Japan for Phase 3 MRCT of Dual HER2 Blockade Therapy on First-Line HER2+ GC henlius.com ↗ |
| 2024-08-12 | AbClon | Results 앱클론 “헨리우스, AC101 항암치료 효과 작용기전 국제 학술지 2곳에 발표” - 독특한 작용기전으로 키투르다 병용 뛰어넘어...HER2 양성 위암 1차 치료제 기대 abclon.com ↗
헨리우스의 임상 2상 결과에 따르면 HLX22+허셉틴+화학요법(XELOX) 조합은 HLX22를 25ppm(킬로그램당 밀리그램)의 고농도로 투여했을 때 무진행생존기간 중앙값이 15.1개월을 기록했다. |
| 2024-07-11 | Shanghai Henlius Biotech | Results Publication in Journal of Translational Medicine Highlighting Henlius' Dual HER2 Blockade Therapy Mechanism of Action henlius.com ↗
Both in vitro and in vivo studies demonstrated that HLX22 in combination with trastuzumab (HLX02) exhibit enhanced anti-tumour activity and induced cancer cell apoptosis in HER2-positive human gastric cancer cell lines, gastric cancer CDX models, and PDX models. |
| 2024-07-10 | Shanghai Henlius Biotech | Results Advances in HER2+ GC: Dual HER2 Blockade Therapy Presented on MED and ESMO GI henlius.com ↗
The results showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. |
| 2024-07-02 | AbClon | Results 앱클론 “위암 치료제 AC101, 표준요법 대비 7배 ORR 확인…우수성 입증” abclon.com ↗
약물 투여 후 75주에 측정된 객관적 반응률(ORR)은 HLX22 저용량군에서 41.2%, 고용량군에서 16.7%, 비교 대조군에서 5.6%로 나타났다. |
| 2024-05-16 | Shanghai Henlius Biotech | Regulatory Henlius to Showcase at BIO 2024 henlius.com ↗
Recently, Henlius' investigational new drug (IND) application for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, has been approved by the FDA. |
| 2024-05-08 | AbClon | Regulatory 앱클론 "헨리우스바이오텍, 위암 항체 치료제 美 임상 3상 승인" abclon.com ↗
앱클론은 8일 중국 헨리우스바이오텍(이하 헨리우스)의 HLX22가 미국 식품의약국(FDA)로부터 임상 3상 시험계획서(IND) 제출을 승인받았다고 밝혔다. |
| 2024-05-06 | Shanghai Henlius Biotech | Regulatory Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA henlius.com ↗ |
| 2024-04-18 | AbClon | Results 앱클론 "헨리우스, 앱클론 항체 치료제 올해 임상 2상 마무리...파이프라인 경쟁력 강화" abclon.com ↗
HLX22 요법은 치료효과 지표인 객관적 반응률(ORR)에서 표준요법 대비 3배 이상의 우수함을 입증했으며 올해 안으로 임상 2상을 마무리할 예정이다. |
| 2024-01-19 | AbClon | Results 앱클론, 항체지료제 'AC101' 전이성 위암서 1차 치료제 가능성 높여 abclon.com ↗
앱클론이 상하이 헨리우스 바이오텍(이하 헨리우스)에 기술이전한 HER2 양성 위암환자 대상 1차 치료제 AC101(헨리우스 코드명: HLX22)이 임상2상 중간결과를 발표했다. |
| 2024-01-17 | Shanghai Henlius Biotech | Results Results from Clinical Trials of Two Henlius’ Novel Products Released at ASCO GI 2024 henlius.com ↗ |
| 2023-05-17 | Shanghai Henlius Biotech | Results Phase I Clinical Results of Henlius HLX22, an innovative anti-HER2 mAb, Published in Investigational New Drugs henlius.com ↗
The results of this study demonstrated the safety and tolerability of HLX22, and laid the foundation to explore more therapies such as HLX22 combined with trastuzumab. |
| 2022-11-08 | Alligator Bioscience AB | Regulatory Alligator Bioscience Announces IND Approval for Second Phase 2 Clinical Trial of AC101 (HLX22) in Gastric Cancer developed by Shanghai Henlius Biotech in China alligatorbioscience.se ↗
Shanghai Henlius Biotech, Inc. has received investigational new drug (IND) approval from China's National Medical Products Administration (NMPA) for a Phase 2 clinical trial of AC101 (HLX22) |
| 2022-10-28 | Shanghai Henlius Biotech | Regulatory The Phase 2 IND Application of Henlius’ Novel Anti-HER2 mAb HLX22 Combined with Anti-PD-1 mAb HANSIZHUANG and HANQUYOU for the Treatment of HER2+ Gastric Cancer Approved by NMPA henlius.com ↗ |
| 2022-10-11 | AbClon | Results 앱클론, AC101 임상1상 결과 안전성 등 최종 확보…임상 가속화 기대 abclon.com ↗
발표된 자료에 따르면, AC101(헨리우스의 코드명: HLX22)의 임상1상은 3mg/kg, 10mg/kg, 25mg/kg의 3가지 용량군으로 진행됐으며, 용량제한독성(dose limiting toxicity, DLT)이 발견되지 않아 AC101의 안전성과 내약성이 확인됐다. |
| 2022-09-30 | Shanghai Henlius Biotech | Results Henlius completed the phase 1 clinical trial of HLX22 for the treatment of HER2 overexpressing advanced solid tumours henlius.com ↗
The results showed that HLX22 was safe and well tolerated. |
| 2022-09-16 | AbClon | Results 앱클론, HER2 양성 위암 표적 AC101 임상2상에서 탁월한 효능 확인 abclon.com ↗
헨리우스에 따르면, AC101과 허셉틴 바이오시밀러 및 화학요법의 병용 투여 임상에서 AC101 저용량(15mg/kg) 및 고용량(25mg/kg) 투여군의 객관적 반응률(ORR)이 85% 이상이라는 예측 결과가 도출됐다. |
| 2019-02-12 | Shanghai Henlius Biotech | Regulatory New progress! Henlius HLX22 Received Clinical Approval from NMPA henlius.com ↗
Henlius has recently received a clinical approval from the National Medical Products Administration (NMPA) for its HLX22, a monoclonal antibody injection, for the treatment of gastric cancer (GC) and breast cancer (BC). |
| 2018-11-26 | Shanghai Henlius Biotech | Regulatory Henlius HLX22 Received IND Application Acceptance Notification from NMPA henlius.com ↗
Henlius has recently received an investigational new drug (IND) application acceptance notification from the National Medical Products Administration (NMPA) for its HLX22, a monoclonal antibody injection, for the treatment of gastric cancer (GC) and breast cancer (BC). |
All press releases naming this drug 57 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX22 | “HLX22 is a novel monoclonal antibody targeting HER2” NCT07294534 ↗ |
| Action | Inhibit | “a novel anti-HER2 antibody” PMID 38986608 ↗ Jul 2024 |
| Modality | Monoclonal antibody | “HLX22 is a novel monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2).” PMID 37140695 ↗ May 2023 |
| Route | Intravenous | “received intravenous HLX22 once every 3 weeks” PMID 37140695 ↗ May 2023 |
| Target | ERBB2 | “HLX22 is a novel monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2).” PMID 37140695 ↗ May 2023 |