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Shanghai Henlius Biotech, Inc. — Investor Relations & Filings

Ticker · 2696 ISIN · CNE100003N76 LEI · 836800ZRCDRCBVC47C57 HKEX Manufacturing
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Filings indexed 3,833 across all filing types
Latest filing 2026-05-10 Regulatory Filings
Country CN China
Listing HKEX 2696

About Shanghai Henlius Biotech, Inc.

http://www.henlius.com

Shanghai Henlius Biotech, Inc. is a global biopharmaceutical company specializing in the research, development, manufacturing, and commercialization of high-quality, affordable, and innovative biologic medicines. The company focuses primarily on monoclonal antibodies (mAbs) for therapeutic areas including oncology, autoimmune diseases, and ophthalmic conditions. Henlius has successfully launched self-developed mAb biosimilars, notably HANLIKANG (rituximab, the first Chinese biosimilar) and HANQUYOU (trastuzumab). Operating under a full-chain layout encompassing R&D, production, supply, and commercialization, Henlius ensures international quality standards through GMP-certified facilities across China, Europe, and the US. Through strategic partnerships, its products reach over 50 countries and regions, addressing unmet clinical needs in both mainstream and emerging markets globally.

Recent filings

Filing Released Lang Actions
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 Classification · 75% confidence The document is a voluntary announcement regarding the approval of an investigational new drug application by the FDA. It contains no financial statements, no management/board changes, no dividends, and is not the text of any report. It does not fit any specialized category and thus defaults to the general ‘Regulatory Filings’ fallback category (RNS).
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 Classification · 89% confidence The document is a voluntary regulatory announcement to the Hong Kong Stock Exchange regarding the European Commission’s approval of two new drug indications. It does not contain financial results, management changes, or voting details, nor is it a report itself. It is a general corporate regulatory update, fitting the Regulatory Filings category (RNS).
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 Classification · 85% confidence The document is an HKEX ‘Inside Information Announcement’ regarding regulatory approval (European Commission marketing authorization) for the company’s product. It does not present financial results, management discussion, or detailed investor presentation, nor is it a report publication notice for a formal report. It is a general regulatory announcement falling into the catch-all Regulatory Filings category (RNS).
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 Classification · 85% confidence The document is a voluntary announcement by Shanghai Henlius Biotech informing shareholders about the approval to commence a Phase 2/3 clinical trial in Australia. It contains no financial results, tabled data, or notice of a formal report publication; instead, it is a general corporate/regulatory update. It does not fit any specific category such as earnings release, board change, share issue, or M&A. Therefore, it falls under the fallback category for miscellaneous regulatory announcements (RNS).
2026-04-24 English

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