Sponsor · clinical trials

Shanghai Henlius Biotech clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — current trials in our China, USA, Japan, Australia, Spain, Poland, Germany, Turkey, Egypt, Italy, Brazil, South Korea, Netherlands, Austria, Czechia and Israel registers with Shanghai Henlius Biotech as lead sponsor. Synced 11 Nov 2026

44Current trials

27Recruiting now

28Drugs in these trials

16Trial registers

Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany

Compiled from ClinicalTrials.gov and CTIS registry records · Synced 11 Nov 2026 · Editorial standards

At a glance

Shanghai Henlius Biotech is the lead sponsor of 44 current clinical trials in our China, USA, Japan, Australia, Spain, Poland, Germany, Turkey, Egypt, Italy, Brazil, South Korea, Netherlands, Austria, Czechia and Israel registers. 27 are recruiting patients now. The most common phase is Phase 2. The drugs named most often in its trials are Serplulimab, HLX43 1 and HLX43 2. The most-studied condition is Non Small Cell Lung Cancer.

ClinicalTrials.gov trials by status

Recruiting2761%
Not yet open818%
Active, closed818%
By invitation12%

Trials by phase

Phase 21636%
Phase 11534%
Phase 3511%
Phase 2/3511%
Phase 1/225%
Early Phase 112%

Clinical trials sponsored by Shanghai Henlius Biotech

44 on ClinicalTrials.gov

Study	Phase	Status	Start	Registers
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer NCT06532006 · Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer Drugs: Capecitabine, HLX22, Oxaliplatin	Phase 3	Recruiting	2024-11	USA, China, Germany, Spain, Italy, Poland, Turkey, Brazil, Japan, South Korea, Australia
A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors NCT06848699 · ClinicalTrials.gov ↗ · Solid Tumor Cancer, Non Small Cell Lung Cancer Drugs: HLX43 1, HLX43 2, HLX43 3	Phase 1/2	Recruiting	2025-02	China
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma NCT07115485 · ClinicalTrials.gov ↗ · Gastric or Gastroesophageal Junction Adenocarcinoma Drugs: HLX43 1, HLX43 2, HLX43 3	Phase 2	Recruiting	2025-09	China
A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy NCT06742892 · ClinicalTrials.gov ↗ · Carcinoma, Hepatocellular Drugs: HLX43 1, HLX43 2, HLX43 3	Phase 2	Recruiting	2025-03	China
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) NCT04547166 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer Drugs: Bevacizumab, HLX04, Serplulimab	Phase 2/3	Recruiting	2021-03	China, Japan
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer NCT07459751 · ClinicalTrials.gov ↗ · Advanced or Metastatic Squamous Non-Small Cell Lung Cancer Drugs: Docetaxel, HLX07, HLX43	Phase 2/3	Recruiting	2026-05	China
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma NCT07477587 · Multiple Myeloma (MM)	Phase 1	Recruiting	2026-05	USA, China, Australia
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors NCT07473726 · ClinicalTrials.gov ↗ · Advanced/Metastatic Solid Tumors	Phase 1	Recruiting	2026-06	China, Australia
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients NCT06832202 · ClinicalTrials.gov ↗ · HER2-low Hormone Receptor Positive Breast Cancer Drugs: HLX22, Trastuzumab deruxtecan	Phase 2	Recruiting	2025-04	China
A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy NCT06839066 · ClinicalTrials.gov ↗ · Nasopharyngeal Carcinoma (NPC) Drugs: HLX43 1, HLX43 2, HLX43 3	Phase 2	Recruiting	2025-04	China
A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours NCT07533708 · ClinicalTrials.gov ↗ · mCRPC or Advanced/Metastatic Solid Tumors	Phase 1	Recruiting	2026-07	China
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) NCT06907615 · Non Small Cell Lung Cancer Drugs: HLX43 1, HLX43 2	Phase 2	Recruiting	2025-06	USA, China
Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma NCT07176650 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma (HCC) Drugs: Opdivo, Yervoy	Phase 1	Recruiting	2025-11	USA, China
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors NCT06769152 · ClinicalTrials.gov ↗ · Cervical Cancer, Ovarian Cancer Drug: HLX43	Phase 2	Recruiting	2025-02	China
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy NCT06769113 · ClinicalTrials.gov ↗ · Esophageal Cancer Drug: HLX43	Phase 2	Recruiting	2025-01	China
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC NCT07416695 · ClinicalTrials.gov ↗ · SCLC, NEC	Phase 1	Recruiting	2026-04	China
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer NCT07294508 · ClinicalTrials.gov ↗ · HER2 + Breast Cancer Drugs: HLX22, Pertuzumab, Trastuzumab deruxtecan	Phase 2/3	Recruiting	2026-02	China
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma NCT06857279 · ClinicalTrials.gov ↗ · Carcinoma of Head and/or Neck Drugs: HLX07, HLX43 1, HLX43 2	Phase 2	Recruiting	2025-04	China
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. NCT06349980 · ClinicalTrials.gov ↗ · Carcinoma, Hepatocellular Drugs: Bevacizumab, HLX04, Serplulimab	Phase 2	Recruiting	2024-08	China
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC NCT07269782 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer Drugs: HLX43 1, HLX43 2, Serplulimab	Phase 2	Recruiting	2026-01	China
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors NCT07274813 · ClinicalTrials.gov ↗ · Advanced/Metastatic Solid Tumors, NSCLC	Early Phase 1	Recruiting	2025-12	China
A Study of HLX42 in Advanced/Metastatic Solid Tumors NCT06210815 · ClinicalTrials.gov ↗ · Solid Tumor and NSCLC	Phase 1	Recruiting	2024-03	China
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors NCT07518043 · ClinicalTrials.gov ↗ · Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC) Drug: Opdivo	Phase 1	Recruiting	2026-07	China
A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer NCT07253142 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer, Small Cell Lung Cancer Drugs: HLX43 1, HLX43 2, Serplulimab	Phase 2	Recruiting	2026-02	China
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis NCT07038382 · ClinicalTrials.gov ↗ · Membranous Nephropathy, Lupus Nephritis (LN)	Phase 2	Recruiting	2025-08	China
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer NCT07106892 · ClinicalTrials.gov ↗ · Colorectal Cancer (CRC) Drugs: HLX43 1, HLX43 2, HLX43 3	Phase 2	Recruiting	2025-09	China
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors NCT07541534 · ClinicalTrials.gov ↗ · Advanced/Metastatic Solid Tumors	Phase 1	Recruiting	2026-05	China
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects NCT07484893 · ClinicalTrials.gov ↗ · Healthy Adult Male Drug: Recombinant Human Hyaluronidase	Phase 1	Not yet open	2026-05	China
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11 NCT07776132 · ClinicalTrials.gov ↗ · Health Adult Subjects Drug: Pertuzumab	Phase 1	Not yet open	2026-11	Australia
A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer NCT07865910 · ClinicalTrials.gov ↗ · NSCLC (Advanced Non-small Cell Lung Cancer) Drugs: Carboplatin, Nab-paclitaxel, Paclitaxel	Phase 2/3	Not yet open	2026-11	China
Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. NCT07487519 · ClinicalTrials.gov ↗ · Breast Cancer (Triple Negative Breast Cancer (TNBC)) Drugs: HLX43 1, Serplulimab	Phase 2	Not yet open	2026-04	China
A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer NCT07358585 · ClinicalTrials.gov ↗ · Colon Cancer Adenocarcinoma Drugs: HLX07, HLX43 1, HLX43 2	Phase 1/2	Not yet open	2026-01	China
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma NCT06895512 · ClinicalTrials.gov ↗ · Newly Diagnosed Multiple Myeloma Drug: Darzalex	Phase 3	Not yet open	2025-04	China
A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer NCT07318883 · Squamous NSCLC Drugs: Carboplatin, HLX07, Keytruda	Phase 2/3	Not yet open	2026-03	China
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® NCT07495930 · ClinicalTrials.gov ↗ · Health Adult Subjects	Phase 1	Not yet open	2026-04	China
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors NCT06115642 · ClinicalTrials.gov ↗ · Advanced/Metastatic Malignant Solid Tumors Drugs: HLX43, Serplulimab	Phase 1	By invitation	2023-11	USA, China, Japan
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors NCT07160335 · Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma Drugs: Pembrolizumab, US-sourced Keytruda	Phase 1	Active, closed	2025-09	USA, China, Turkey, Israel
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer NCT05346224 · ClinicalTrials.gov ↗ · Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer Drug: Pertuzumab	Phase 3	Active, closed	2022-04	China, Spain, Poland
A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer NCT05353257 · Limited-Stage Small Cell Lung Cancer Drug: Serplulimab	Phase 3	Active, closed	2022-05	USA, China, Germany, Spain, Netherlands, Poland, Austria, Czechia
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC NCT05468489 · Extensive Stage Small Cell Lung Cancer Drugs: Atezolizumab, Serplulimab	Phase 3	Active, closed	2022-11	USA, Egypt
A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC NCT06812260 · ClinicalTrials.gov ↗ · SCLC, Extensive Stage Drug: Serplulimab	Phase 2	Active, closed	2025-06	Japan
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics NCT06980454 · ClinicalTrials.gov ↗ · Cancer, mCRC	Phase 1	Active, closed	2025-06	China
A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients NCT05787613 · ClinicalTrials.gov ↗ · NSCLC Stage IV Drug: Serplulimab	Phase 2	Active, closed	2023-07	China
A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects NCT06309043 · ClinicalTrials.gov ↗ · EGFR Overexpression	Phase 1	Active, closed	2024-04	China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

Drugs in Shanghai Henlius Biotech trials

28 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

Conditions in Shanghai Henlius Biotech trials

52 conditions

Non Small Cell Lung Cancer4 Advanced/Metastatic Solid Tumors3 Melanoma2Carcinoma, Hepatocellular2Health Adult Subjects2Advanced/Metastatic Malignant Solid Tumors1Extensive Stage Small Cell Lung Cancer1 Multiple Myeloma (MM)1 Hepatocellular Carcinoma (HCC)1 Gastroesophageal-junction Cancer1Monoclonal Antibody1Gastric Cancer1 HER2-positive Gastric Cancer1 Limited-Stage Small Cell Lung Cancer1 Non-small Cell Lung Cancer1 Renal Cell Carcinoma1 Solid Tumor Cancer1Healthy Adult Male1Gastric or Gastroesophageal Junction Adenocarcinoma1Advanced or Metastatic Squamous Non-Small Cell Lung Cancer1Breast Cancer1 Breast Neoplasms1 HER2-positive Breast Cancer1HER2-low Hormone Receptor Positive Breast Cancer1

By trial register

Register	Trials	Recruiting
Clinical trials in China	41	27
Clinical trials in USA	8	4
Clinical trials in Japan	4	2
Clinical trials in Australia	4	3
Clinical trials in Spain	3	1
Clinical trials in Poland	3	1
Clinical trials in Germany	2	1
Clinical trials in Turkey	2	1
Clinical trials in Egypt	1	0
Clinical trials in Italy	1	1
Clinical trials in Brazil	1	1
Clinical trials in South Korea	1	1
Clinical trials in Netherlands	1	0
Clinical trials in Austria	1	0
Clinical trials in Czechia	1	0
Clinical trials in Israel	1	0

A trial with sites in more than one country appears in each of those registers.

Other sponsors in Non Small Cell Lung Cancer

Sponsor	Trials
Hunan Province Tumor Hospital	7
MediLink Therapeutics (Suzhou)	4
Intergroupe Francophone de Cancerologie Thoracique	4
Fundación GECP	4
Nuvation Bio	3
Shanghai Pulmonary Hospital, Shanghai, China	3
Guangdong Association of Clinical Trials	3
ETOP IBCSG Partners Foundation	2
Verastem	2
HUYABIO International	2

Sponsors with the most current trials registered for this condition.

Questions about Shanghai Henlius Biotech trials

How many clinical trials does Shanghai Henlius Biotech sponsor?

Shanghai Henlius Biotech is the lead sponsor of 44 current trials on ClinicalTrials.gov in our China, USA, Japan, Australia, Spain, Poland, Germany, Turkey, Egypt, Italy, Brazil, South Korea, Netherlands, Austria, Czechia and Israel registers, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.

Are Shanghai Henlius Biotech trials recruiting?

Yes. 27 of its 44 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Shanghai Henlius Biotech testing?

Its current trials name 28 drugs and biologicals as interventions. The most frequent are Serplulimab (14), HLX43 1 (11), HLX43 2 (10), HLX43 3 (7) and HLX07 (4). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, lead sponsor, phase, overall status, start date, conditions and intervention names
EU Clinical Trials Information System (CTIS) ↗ EU trial numbers, titles, sponsor, phase, status, therapeutic area and member-state countries

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.