Shanghai Henlius Biotech

This early-stage trial tests a new drug called HLX48 in 72 people with advanced or metastatic solid tumors that have not responded to standard treatments. HLX48 is designed to target two cancer-related proteins (EGFR and c-MET) and deliver a toxic payload directly to cancer cells…

This study tests whether a new biosimilar drug, HLX319, works as well as the approved drug Phesgo for people with HER2-positive early or locally advanced breast cancer. About 258 participants will receive either the biosimilar or the original drug before surgery to compare how th…

This Phase 1 trial tests a new drug called HLX05-N, which is a biosimilar (a copy) of the cancer drug Erbitux, in 387 people with metastatic colorectal cancer. Participants will receive either HLX05-N or Erbitux (from the US or EU) along with standard chemotherapy. The study aims…

This Phase 1 trial tests whether HLX18, a biosimilar of the cancer drug OPDIVO, works similarly in people with esophageal, melanoma, or bladder cancer after their tumors have been surgically removed. About 174 participants will receive either HLX18 or OPDIVO to compare how the dr…

This early-phase study tests a new drug called HLX3902 in about 48 people with advanced prostate cancer or other solid tumors that have stopped responding to standard treatments. The main goal is to check the drug's safety and find the best dose. The drug is designed to help the …

This Phase 2 trial tests a new drug called HLX43, which is designed to seek out and destroy cancer cells in people with advanced triple-negative breast cancer (TNBC). The study will test HLX43 alone or combined with other immune-boosting drugs. About 180 adults with TNBC that has…

This early-stage trial tests a new oral drug called HLX97 in 138 people with advanced solid tumors (breast, prostate, or lung cancer) that have stopped responding to standard treatments. The main goals are to check safety, find the right dose, and see if the drug can slow tumor g…

This phase 2 trial tests a new drug called HLX43 in 60 people with a common type of advanced breast cancer (HR+ HER2-) that has worsened despite standard hormone therapy. The drug is an antibody-drug conjugate that targets PD-L1 to deliver chemotherapy directly to cancer cells. T…

This study tests a new drug combination (HLX43 plus HLX07 or serplulimab) in people with advanced or metastatic colorectal cancer that has stopped responding to standard first-line treatment. About 126 participants will receive the experimental therapy to see if it can shrink tum…

This study tests whether adding an experimental drug called HLX07 to standard immunotherapy and chemotherapy helps people with advanced squamous non-small cell lung cancer. About 720 adults with stage 3B/4 disease will receive either the new combo or a placebo with standard treat…

This study tests a new drug called HLX43 in 100 adults with advanced pancreatic cancer that has not responded to other treatments. The drug is designed to target and attack cancer cells while limiting harm to healthy cells. The goal is to see if it can shrink tumors or slow the d…

This study tests whether a new drug combination (HLX87 plus HLX22 or pertuzumab) works better than standard chemotherapy before surgery for people with HER2-positive early or locally advanced breast cancer. About 817 participants will be randomly assigned to one of three treatmen…

This phase 2 trial tests a combination of two drugs—HLX43 and serplulimab—in 120 people with advanced lung cancer (non-small cell or small cell). The goal is to see if the combo can shrink tumors and control the disease. Participants must have cancer that has spread or come back …

This early-stage study will test a new drug called HLX319 against an already approved drug, EU-Phesgo®, in 24 healthy Chinese men. The goal is to see how the body processes each drug and check for side effects. Participants receive a single injection and are monitored closely. Th…

This early-stage trial will test a new drug called recombinant human hyaluronidase in 24 healthy Chinese men. The drug is an enzyme that may help other medications spread more easily under the skin. The main goal is to check safety, how the body processes the drug, and whether it…