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Shanghai Henlius Biotech, Inc. — 2026 filings

All 62 regulatory filings released by Shanghai Henlius Biotech, Inc. (2696) in 2026, sourced directly from the official regulator.

62 Filings
2026 Period
2026 filings (62)
Filing Released Lang
INSIDE INFORMATION ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION APPROVED HANBEIYOU (PERTUZUMAB INJECTION) FOR THE NEOADJUVANT/ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER AND
Regulatory Filings
2026-05-29 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN AN INTERNATIONAL MULTICENTRE PHASE 2/3 CLINICAL STUDY OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) AS MONOTHERAPY OR IN C
Regulatory Filings
2026-05-28 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN AN INTERNATIONAL MULTICENTER PHASE 2/3 CLINICAL STUDY COMPARING PIMURTAMAB HLX07 (RECOMBINANT ANTI-EGFR HUMANIZED MONOCLONAL ANTIBODY INJE
Regulatory Filings
2026-05-26 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN AN INTERNATIONAL MULTICENTER PHASE 1 CLINICAL STUDY OF HLX15-SC (RECOMBINANT ANTI-CD38 FULLY HUMAN MONOCLONAL ANTIBODY INJECTION-SUBCUTANE
Regulatory Filings
2026-05-26 English
VOLUNTARY ANNOUNCEMENT - SERPLULIMAB INJECTION (TRADE NAME IN CHINESE MAINLAND: HANSIZHUANG; TRADE NAME IN THE EUROPEAN UNION: HETRONIFLY) RECEIVED POSITIVE OPINION FROM THE COMMITTEE FOR MEDICINAL PR
Regulatory Filings
2026-05-22 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN A PHASE 1 CLINICAL STUDY OF HLX316 FOR INJECTION (B7-H3-TARGETING SIALIDASE FC FUSION PROTEIN) IN PATIENTS WITH ADVANCED/METASTATIC SOLID
Regulatory Filings
2026-05-22 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT IN AN EU COUNTRY (SPAIN) HAS BEEN DOSED IN AN INTERNATIONAL MULTICENTRE PHASE 2 CLINICAL STUDY OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE)
Regulatory Filings
2026-05-21 English
VOLUNTARY ANNOUNCEMENT - THE PHASE 1 CLINICAL TRIAL OF HLX3902 INJECTION (STEAP1xCD3xCD28 TRISPECIFIC ANTIBODY) FOR THE TREATMENT OF METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND OTHER ADVANCED
Regulatory Filings
2026-05-21 English
VOLUNTARY ANNOUNCEMENT - THE INVESTIGATIONAL NEW DRUG APPLICATION FOR THE PHASE 1 CLINICAL TRIAL OF HLX48 FOR INJECTION (AN ANTIBODY-DRUG CONJUGATE TARGETING EGFR AND C-MET) FOR THE TREATMENT OF ADVA
Regulatory Filings
2026-05-21 English
POLL RESULTS OF THE RESOLUTIONS PROPOSED AT THE ANNUAL GENERAL MEETING HELD ON TUESDAY, 19 MAY 2026
Declaration of Voting Results & Voting Rights Announcements
2026-05-19 English
VOLUNTARY ANNOUNCEMENT - THE PHASE 1 CLINICAL TRIAL OF HLX48 FOR INJECTION (AN ANTIBODY-DRUG CONJUGATE TARGETING EGFR AND C-MET) FOR THE TREATMENT OF ADVANCED/METASTATIC SOLID TUMORS HAS BEEN APPROVED
Regulatory Filings
2026-05-13 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN A PHASE 1 CLINICAL STUDY OF HLX97 (KAT6A/B SMALL MOLECULE INHIBITOR) IN PATIENTS WITH ADVANCED/METASTATIC SOLID TUMOURS IN CHINESE MAINLAND
Regulatory Filings
2026-05-13 English
VOLUNTARY ANNOUNCEMENT - THE INVESTIGATIONAL NEW DRUG APPLICATION FOR THE PHASE 1 CLINICAL TRIAL OF CETUXIMAB INJECTION BIOSIMILAR HLX05-N (RECOMBINANT ANTI-EGFR CHIMERIC HUMAN-MONOCLONAL ANTIBODY IN
Regulatory Filings
2026-05-10 English
VOLUNTARY ANNOUNCEMENT - EUROPEAN COMMISSION (EC) APPROVED TWO NEW INDICATIONS FOR SERPLULIMAB INJECTION (TRADE NAME IN CHINESE MAINLAND: HANSIZHUANG; TRADE NAME IN THE EUROPEAN UNION: HETRONIFLY)
Regulatory Filings
2026-05-10 English
Monthly Return of Equity Issuer on Movements in Securities for the month ended 30 April 2026
Regulatory Filings
2026-05-07 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN A PHASE 1 CLINICAL STUDY OF HLX3901 INJECTION (DLL3xDLL3xCD3xCD28 TETRA-SPECIFIC ANTIBODY) FOR THE TREATMENT OF PATIENTS WITH ADVANCED SMAL
Regulatory Filings
2026-04-30 English
INSIDE INFORMATION ANNOUNCEMENT - EUROPEAN COMMISSION (EC) APPROVED HLX11 (PERTUZUMAB, TRADE NAME IN THE UNITED STATES AND EUROPE: POHERDY) FOR TREATMENTS INCLUDING NEOADJUVANT/ADJUVANT TREATMENT OF H
Regulatory Filings
2026-04-28 English
VOLUNTARY ANNOUNCEMENT - THE PHASE 2/3 CLINICAL TRIAL OF PIMURUTAMAB HLX07 (RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION) IN COMBINATION WITH HANSIZHUANG (SERPLULIMAB INJECTION) AND C
Regulatory Filings
2026-04-24 English
PROXY FORM FOR THE ANNUAL GENERAL MEETING TO BE HELD ON TUESDAY, 19 MAY 2026 (OR ANY ADJOURNMENT THEREOF)
Proxy Solicitation & Information Statement
2026-04-24 English
NOTICE OF ANNUAL GENERAL MEETING
AGM Information
2026-04-24 English
(1) ANNUAL REPORT 2025 (2) BOARD REPORT 2025 (3) BOARD OF SUPERVISORS REPORT 2025 (4) FINAL ACCOUNTS REPORT 2025 (5) PROFIT DISTRIBUTION PROPOSAL 2025 (6) RE-APPOINTMENT OF AUDITORS (7) REMUNERATIONS
Proxy Solicitation & Information Statement
2026-04-24 English
ANNUAL REPORT 2025
Annual Report FY 2025
2026-04-24 English
2025 Environmental, Social and Governance Report
Environmental & Social Information
2026-04-24 English
Notification Letter and Reply Form to Non-Registered Shareholders - Reminder letter regarding the Arrangement of Electronic Dissemination of Corporate Communications
Regulatory Filings
2026-04-24 English
Notification Letter and Reply Form to Registered Shareholders - Reminder letter regarding the Arrangement of Electronic Dissemination of Corporate Communications
Regulatory Filings
2026-04-24 English
GRANTS OF OPTIONS AND RSUS
Capital/Financing Update
2026-04-17 English
VOLUNTARY ANNOUNCEMENT - PHASE 1 CLINICAL TRIAL APPLICATION OF CETUXIMAB INJECTION BIOSIMILAR HLX05-N (RECOMBINANT ANTI-EGFR CHIMERIC HUMAN-MONOCLONAL ANTIBODY INJECTION) FOR METASTATIC COLORECTAL CAN
Regulatory Filings
2026-04-14 English
VOLUNTARY ANNOUNCEMENT - THE FIRST SUBJECT HAS BEEN DOSED IN A PHASE 1 CLINICAL STUDY OF PERTUZUMAB AND TRASTUZUMAB INJECTION (SUBCUTANEOUS INJECTION) BIOSIMILAR HLX319 IN CHINESE MAINLAND
Regulatory Filings
2026-04-10 English
VOLUNTARY ANNOUNCEMENT - THE SUPPLEMENTARY APPLICATIONS FOR INDICATION EXPANSION OF HANLIKANG (RITUXIMAB INJECTION) APPROVED BY NMPA
Regulatory Filings
2026-04-09 English
Monthly Return of Equity Issuer on Movements in Securities for the month ended 31 March 2026
Share Issue/Capital Change
2026-04-08 English
VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG APPLICATION FOR CLINICAL TRIAL OF HLXTE-HAase02 (RECOMBINANT HUMAN HYALURONIDASE INJECTION) APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
Regulatory Filings
2026-03-31 English
VOLUNTARY ANNOUNCEMENT - SERPLULIMAB INJECTION (TRADE NAME IN CHINESE MAINLAND: HANSIZHUANG; TRADE NAME IN THE EUROPEAN UNION: HETRONIFLY) RECEIVED POSITIVE OPINIONS FROM THE COMMITTEE FOR MEDICINAL P
Regulatory Filings
2026-03-30 English
VOLUNTARY ANNOUNCEMENT - THE FIRST PATIENT HAS BEEN DOSED IN A PHASE 1B/2 CLINICAL STUDY OF HLX701 (RECOMBINANT HUMAN SIRPa-IgG4 Fc FUSION PROTEIN INJECTION) IN COMBINATION WITH CETUXIMAB AND CHEMOTHE
Regulatory Filings
2026-03-26 English
ANNUAL RESULTS ANNOUNCEMENT FOR THE YEAR ENDED 31 DECEMBER 2025
Earnings Release FY 2025
2026-03-20 English
VOLUNTARY ANNOUNCEMENT - THE INVESTIGATIONAL NEW DRUG APPLICATION FOR THE PHASE 1 CLINICAL TRIAL OF NIVOLUMAB BIOSIMILAR HLX18 (RECOMBINANT ANTI-PD-1 HUMANIZED MONOCLONAL ANTIBODY INJECTION) FOR THE
Regulatory Filings
2026-03-20 English
CHANGE OF JOINT COMPANY SECRETARY, PROCESS AGENT AND AUTHORISED REPRESENTATIVE
Board/Management Information
2026-03-20 English
CONTINUING CONNECTED TRANSACTIONS - PROMOTIONAL SERVICES AGREEMENT
Regulatory Filings
2026-03-20 English
VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG APPLICATION FOR CLINICAL TRIAL OF PIMURUTAMAB HLX07 (RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION) IN COMBINATION WITH HANSIZHUANG (
Regulatory Filings
2026-03-16 English
VOLUNTARY ANNOUNCEMENT - THE INVESTIGATIONAL NEW DRUG APPLICATION OF HLX316 FOR INJECTION (B7-H3-TARGETING SIALIDASE FC FUSION PROTEIN) FOR THE TREATMENT OF PATIENTS WITH ADVANCED/METASTATIC SOLID TUM
Regulatory Filings
2026-03-09 English
VOLUNTARY ANNOUNCEMENT - THE INVESTIGATIONAL NEW DRUG APPLICATION OF HLX3901 INJECTION (DLL3xDLL3xCD3xCD28 TETRA-SPECIFIC ANTIBODY) FOR THE TREATMENT OF PATIENTS WITH ADVANCED/METASTATIC SOLID TUMOURS
Regulatory Filings
2026-03-09 English
VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG APPLICATION FOR CLINICAL TRIAL OF HLX97 (KAT6A/B SMALL MOLECULE INHIBITOR) FOR THE TREATMENT OF PATIENTS WITH ADVANCED/METASTATIC SOLID TUMOURS APPROV
Regulatory Filings
2026-03-05 English
Monthly Return of Equity Issuer on Movements in Securities for the month ended 28 February 2026
Regulatory Filings
2026-03-04 English
DATE OF BOARD MEETING
Report Publication Announcement
2026-03-03 English
VOLUNTARY ANNOUNCEMENT - PERTUZUMAB BIOSIMILAR HLX11 (RECOMBINANT ANTI-HER2 DOMAIN II HUMANIZED MONOCLONAL ANTIBODY INJECTION) RECEIVED POSITIVE OPINION FROM THE COMMITTEE FOR MEDICINAL PRODUCTS FOR H
Regulatory Filings
2026-02-27 English
VOLUNTARY ANNOUNCEMENT - FIRST PATIENT HAS BEEN DOSED IN THE PHASE 2/3 CLINICAL STUDY OF HLX22 (RECOMBINANT HUMANISED ANTI-HER2 MONOCLONAL ANTIBODY INJECTION) IN COMBINATION WITH HLX87 FOR INJECTION (
Regulatory Filings
2026-02-27 English
INSIDE INFORMATION ANNOUNCEMENT - AMENDMENTS TO LICENSE AGREEMENTS WITH ABBOTT AND KGBIO FOR HANSIZHUANG
Regulatory Filings
2026-02-24 English
VOLUNTARY ANNOUNCEMENT - THE INVESTIGATIONAL NEW DRUG APPLICATION OF HLX15-SC (RECOMBINANT ANTI-CD38 FULLY HUMAN MONOCLONAL ANTIBODY INJECTION-SUBCUTANEOUS INJECTION) FOR THE TREATMENT OF MULTIPLE MYE
Regulatory Filings
2026-02-12 English
INSIDE INFORMATION ANNOUNCEMENT - LICENSE AGREEMENT WITH EISAI IN RESPECT OF HANSIZHUANG
M&A Activity
2026-02-05 English
Next Day Disclosure Returns
Share Issue/Capital Change
2026-02-04 English
INSIDE INFORMATION ANNOUNCEMENT - COMPLETION OF THE H SHARE FULL CIRCULATION
Share Issue/Capital Change
2026-02-04 English
Monthly Return of Equity Issuer on Movements in Securities for the month ended 31 January 2026
Share Issue/Capital Change
2026-02-03 English
MONTHLY RETURN OF EQUITY ISSUER ON MOVEMENTS IN SECURITIES FOR THE MONTH ENDED 31 JANUARY 2026
Share Issue/Capital Change
2026-02-02 English
VOLUNTARY ANNOUNCEMENT PRODUCTION AND SALES VOLUME FOR JANUARY 2026
Earnings Release Q1 2026
2026-02-01 English
VOLUNTARY ANNOUNCEMENT - APPLICATION FOR CLINICAL TRIAL OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) IN COMBINATION WITH HLX07 (RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY I
Regulatory Filings
2026-01-27 English
VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG APPLICATION FOR A PHASE 1B/2 CLINICAL TRIAL OF HLX701 (RECOMBINANT HUMAN SIRPa - IgG4 Fc FUSION PROTEIN INJECTION) IN COMBINATION WITH CETUXIMAB
Regulatory Filings
2026-01-20 English
INSIDE INFORMATION ANNOUNCEMENT - LISTING APPROVAL GRANTED BY THE STOCK EXCHANGE FOR THE H SHARE FULL CIRCULATION OF THE COMPANY
Regulatory Filings
2026-01-19 English
INSIDE INFORMATION ANNOUNCEMENT - ISSUANCE OF THE FILING NOTICE BY THE CSRC FOR THE H SHARE FULL CIRCULATION BY THE COMPANY
Regulatory Filings
2026-01-16 English
VOLUNTARY ANNOUNCEMENT - BIOLOGICS LICENSE APPLICATION (BLA) FOR HANBEITAI (BEVACIZUMAB INJECTION) HAS BEEN ACCEPTED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA)
Regulatory Filings
2026-01-13 English
Monthly Return of Equity Issuer on Movements in Securities for the month ended 31 December 2025
Regulatory Filings
2026-01-06 English
(REVISED TITLE)VOLUNTARY ANNOUNCEMENT PRODUCTION AND SALES VOLUME FOR DECEMBER 2025
Regulatory Filings
2026-01-01 English
VOLUNTARY ANNOUNCEMENT PRODUCTION AND SALES VOLUME FOR DECEMBER 2025
Regulatory Filings
2026-01-01 English
MONTHLY RETURN OF EQUITY ISSUER ON MOVEMENTS IN SECURITIES FOR THE MONTH ENDED 31 DECEMBER 2025
Share Issue/Capital Change
2026-01-01 English