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Clinical trials and research at Shanghai Henlius Biotech

• 27Clinical trials
• 18Countries

Newest trials

All recruiting trials (27)

• HLX316 first-in-human dose study in advanced/metastatic solid tumors

  A first-in-human, Phase 1 study tests HLX316 to see if it is safe and tolerable and to get early signs of how it behaves in the body and whether it shows any tumor-killing activity in adults with advanced solid tumors.

  Recruiting Phase 1 Shanghai Henlius Biotech · Chongqing and 4 other locations · NCT07541534

• HLX3902 first-in-human study in mCRPC and advanced solid tumors

  This early, open-label study tests HLX3902 in adults with metastatic castration-resistant prostate cancer or other advanced solid tumors to see if it is safe and how it behaves in the body.

  Recruiting at 5 sites Phase 1 Shanghai Henlius Biotech · Nanchang and 4 other locations · NCT07533708

• HLX18 vs OPDIVO for resected solid tumors

  This study tests HLX18 against OPDIVO to see if they have similar effects in patients who have had surgery for certain solid tumors.

  Recruiting at 7 sites Phase 1 Shanghai Henlius Biotech · Fuzhou and 6 other locations · NCT07518043

• HLX15-SC vs Darzalex FASPRO in transplant-ineligible, newly diagnosed multiple myeloma

  This study tests whether HLX15 given under the skin works similarly to Daratumumab FASPRO when added to lenalidomide and dexamethasone in adults with newly diagnosed multiple myeloma who can’t have transplant.

  Recruiting at 79 sites Phase 1 Shanghai Henlius Biotech · Springdale, Arkansas and 83 other locations · NCT07477587

• HLX48 first-in-human safety study in advanced solid tumors

  This early-phase study tests HLX48 in adults with advanced/metastatic solid tumors to see if it is safe and how it behaves in the body.

  Recruiting at 2 sites Phase 1 Shanghai Henlius Biotech · North Ryde, New South Wales and 6 other locations · NCT07473726

• HLX43 alone or with HLX07 vs docetaxel in advanced or metastatic squamous NSCLC

  This study tests HLX43 by itself or with HLX07 to see if it helps people whose squamous NSCLC has come back or spread after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, compared with docetaxel.

  Recruiting Phase 2/3 Shanghai Henlius Biotech · Beijing, Beijing Municipality · NCT07459751

• HLX3901 for advanced small cell lung cancer or neuroendocrine carcinoma

  This study will test whether IV HLX3901 is safe and how the body processes it in adults with advanced small cell lung cancer or neuroendocrine carcinoma who have progressed after platinum-based therapy.

  Recruiting Phase 1 Shanghai Henlius Biotech · Beijing and 1 other locations · NCT07416695

• HLX22 plus HLX87 as first-line treatment for HER2-positive recurrent or metastatic breast cancer

  This will test whether combining HLX22 with HLX87 helps adults with HER2-positive recurrent or metastatic breast cancer when given as a first-line treatment.

  Recruiting Phase 2/3 Shanghai Henlius Biotech · Beijing, Beijing Municipality · NCT07294508

• HLX37 treatment for advanced or metastatic solid tumors, including non-small cell lung cancer

  This trial tests HLX37, given alone or with chemotherapy, to see if it is safe and how the body handles it in adults with advanced or metastatic solid tumors including non-small cell lung cancer.

  Recruiting at 2 sites Early Phase 1 Shanghai Henlius Biotech · Shanghai and 1 other locations · NCT07274813

• HLX43 plus serplulimab before surgery for non-small cell lung cancer

  This study tests whether giving HLX43 together with serplulimab before surgery helps adults with stage II–IIIB non-small cell lung cancer who don't have targetable genetic mutations.

  Recruiting Phase 2 Shanghai Henlius Biotech · Shanghai · NCT07269782

• HLX43 with Serplulimab in advanced lung cancer

  This study tests whether HLX43 given with serplulimab can help adults with advanced NSCLC or SCLC who have had prior chemotherapy and immunotherapy.

  Recruiting at 10 sites Phase 2 Shanghai Henlius Biotech · Hefei, Anhui and 9 other locations · NCT07253142

• Comparing the ipilimumab biosimilar HLX13 with US-sourced YERVOY® as first-line treatment for unresectable liver cancer

  This study tests whether the ipilimumab biosimilar HLX13 works like US-sourced YERVOY® and is safe for adults with unresectable hepatocellular carcinoma who have not had prior systemic therapy.

  Recruiting at 46 sites Phase 1 Shanghai Henlius Biotech · Glendale, California and 50 other locations · NCT07176650

• HLX43 (an anti-PD-L1 antibody–drug conjugate) for advanced stomach or gastroesophageal junction adenocarcinoma

  This will try different IV doses of HLX43 to see if it helps adults with advanced stomach or gastroesophageal junction adenocarcinoma who have progressed after prior therapy.

  Recruiting Phase 2 Shanghai Henlius Biotech · Beijing · NCT07115485

• HLX43 (anti‑PD‑L1 antibody‑drug conjugate) treatment for advanced colorectal cancer

  This study will try three doses of HLX43, an anti‑PD‑L1 antibody‑drug conjugate, to see if it is safe and helps people with advanced colorectal cancer who have already received standard treatment.

  Recruiting at 2 sites Phase 2 Shanghai Henlius Biotech · Beijing and 1 other locations · NCT07106892

• HLX79 with rituximab (HLX01) for active glomerulonephritis

  This trial will test whether adding HLX79 at different doses to rituximab (HLX01) helps adults with active membranous nephropathy or lupus nephritis.

  Recruiting Phase 2 Shanghai Henlius Biotech · Beijing and 16 other locations · NCT07038382

• Evaluating HLX43 for advanced non-small cell lung cancer

  This study is testing a new drug called HLX43 to see if it can help people with advanced non-small cell lung cancer who haven't had success with other treatments.

  Recruiting at 2 sites Phase 2 Shanghai Henlius Biotech · Houston, Texas and 1 other locations · NCT06907615

• Evaluating HLX43 for recurrent or metastatic head and neck cancer

  This study is testing a new drug called HLX43 to see if it can help people with recurrent or metastatic head and neck cancer feel better and improve their treatment options.

  Recruiting at 2 sites Phase 2 Shanghai Henlius Biotech · Jinan, Shandong and 1 other locations · NCT06857279

• Evaluating HLX43 with Serplulimab for Advanced Solid Tumors

  This study is testing a new combination of two cancer treatments, HLX43 and Serplulimab, to see if they can help people with advanced solid tumors feel better and improve their outcomes.

  Recruiting at 3 sites Phase 1/2 Shanghai Henlius Biotech · Hunan, Changsha and 2 other locations · NCT06848699

• HLX43 for recurrent or metastatic nasopharyngeal carcinoma after multiple prior treatments

  This trial will test whether the anti‑PD‑L1 antibody–drug conjugate HLX43 can help adults with recurrent or metastatic nasopharyngeal carcinoma who have not responded to or cannot tolerate at least two prior systemic therapies including prior PD‑1/PD‑L1 treatment.

  Recruiting at 15 sites Phase 2 Shanghai Henlius Biotech · Fuzhou, Fujian and 14 other locations · NCT06839066

• HLX22 plus trastuzumab deruxtecan for HER2-low, hormone receptor–positive advanced breast cancer

  This will test whether adding HLX22 to trastuzumab deruxtecan helps people with HER2-low, hormone receptor–positive advanced breast cancer who have progressed on or could not tolerate standard treatments.

  Recruiting Phase 2 Shanghai Henlius Biotech · Shanghai, Shanghai Municipality · NCT06832202

• Evaluating HLX43 for patients with recurrent cervical cancer who can't tolerate standard therapy

  This study is testing a new treatment called HLX43 for people with recurrent cervical cancer who can't handle standard therapies to see if it helps them feel better.

  Recruiting Phase 2 Shanghai Henlius Biotech · Ji'nan, Shandong · NCT06769152

• Evaluating HLX43 for patients with advanced esophageal cancer who have not responded to standard treatments

  This study is testing a new treatment called HLX43 to see if it can help patients with advanced esophageal cancer who haven't had success with standard therapies.

  Recruiting Phase 2 Shanghai Henlius Biotech · Jinan, Shandong · NCT06769113

• Evaluating HLX43 for advanced liver cancer patients who can't tolerate standard treatments

  This study is testing a new treatment called HLX43 for people with advanced liver cancer who can't handle standard therapies to see if it helps them.

  Recruiting Phase 2 Shanghai Henlius Biotech · Hunan, Hunan · NCT06742892

• Treatment for HER2-positive gastric and gastroesophageal junction cancer

  This study is testing a new treatment combining HLX22, trastuzumab, and chemotherapy to see if it helps people with advanced HER2-positive stomach cancer feel better compared to standard treatment.

  Recruiting at 206 sites Phase 3 Shanghai Henlius Biotech · Anaheim, California and 207 other locations · NCT06532006

• Exploring dosage and effectiveness of HLX10 and HLX04 in liver cancer patients

  This study is testing different doses of two new treatments for liver cancer to see how well they work and if they are safe for patients who haven't had treatment before.

  Recruiting Phase 2 Shanghai Henlius Biotech · Shanghai · NCT06349980

• Evaluating HLX42 for advanced solid tumors

  This study is testing a new drug called HLX42 to see if it's safe and tolerable for people with advanced solid tumors.

  Recruiting Phase 1 Shanghai Henlius Biotech · Guangdong, Guangzhou · NCT06210815

• Evaluating a new treatment for metastatic colorectal cancer

  This study is testing a new treatment combining Serplulimab, Bevacizumab, and chemotherapy to see if it helps people with advanced colorectal cancer feel better and live longer.

  Recruiting at 4 sites Phase 2/3 Shanghai Henlius Biotech · Guangzhou, Guangdong and 4 other locations · NCT04547166

Quick answers

How many clinical trials run by Shanghai Henlius Biotech are recruiting right now?

27, as of November 12, 2026. We update this list each time we refresh our data from ClinicalTrials.gov.

Where are these trials running?

In 18 countries. The most sites are in China (27 trials), United States (4 trials), Australia (3 trials), Japan (2 trials), Georgia (2 trials). Each study page lists its sites and which ones are recruiting.

What phases are they in?

Phase 2: 13, Phase 1: 8, Phase 2/3: 3, Phase 1/2: 1. Trials with no phase listed are usually device, behavioural or observational studies.

How do I join one?

Open a study, check the "Is this trial a fit for you?" section, then contact the study team listed on the page. They will ask a few screening questions. Asking is free and does not commit you to anything. Talk it over with your doctor first.

Find the studies that fit you

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