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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 3,845 across all filing types
Latest filing 2026-05-29 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
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 Classification · 82% confidence The document is an announcement made under the Listing Rules and Inside Information Provisions of the Hong Kong Stock Exchange, notifying the market of a new drug approval by the National Medical Products Administration. It is not a financial report, earnings release, or proxy statement, nor does it contain financial statements. It is a regulatory announcement of inside information, fitting the fallback category for miscellaneous regulatory filings. Therefore, it is classified as Regulatory Filings (RNS).
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 Classification · 86% confidence The document is a voluntary corporate announcement on the Hong Kong Exchange about the first patient dosed in a Phase 2/3 clinical trial. It contains no financial statements, no voting results, no management changes, no regulatory stress test, and is not presenting a formal report (annual, interim, audit, ESG, etc.). It is a business development update, which does not fit any specific category, so by default it is classified under General Regulatory Filings (RNS).
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 Classification · 80% confidence The document is a voluntary corporate announcement made pursuant to HKEX listing rules, providing an update on a clinical trial (first patient dosed). It does not include financial results, board changes, dividends, capital transactions, ESG disclosures, or call transcripts. It is not a formal report (e.g., interim or annual report) but a general regulatory disclosure. Therefore, it falls under the catch-all Regulatory Filings category (RNS).
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 Classification · 82% confidence The document is a voluntary announcement on the Hong Kong Exchange regarding a clinical trial milestone (first patient dosed) and contains no financial statements, regulatory stress tests, voting results, board changes, or M&A details. It is not an earnings release, interim report, or investor presentation. It serves as a general corporate disclosure under exchange rules. No specific category (e.g., CAP, ER, IR, MANG) applies, so it falls under the fallback category of general regulatory announcements (RNS).
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 Classification · 85% confidence The document is a voluntary corporate announcement to Hong Kong Exchanges and Clearing Limited concerning a positive CHMP opinion for the company’s drug candidate Serplulimab. It contains no financial statements, no share transactions, no board changes, no dividends, and no proxy materials—just a regulatory update on drug development. It is therefore a general regulatory announcement, best classified as RNS.
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 Classification · 75% confidence The document is a voluntary announcement by Shanghai Henlius Biotech regarding the dosing of the first patient in a Phase 1 clinical study of HLX316. It is not a financial report, earnings release, regulatory form certification, board change, M&A, dividend, nor proxy solicitation. It contains no substantive financial statements or regulatory form content—it is a general announcement about clinical trial progress. Therefore, it falls under the fallback category of General Regulatory Filings (RNS).
2026-05-22 English

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