1. R&D Centers
  2. R&D Strength
  3. Clinical Research
  4. Pipeline

Clinical research is an important stage of new pharmaceutical product development, providing drug regulatory agencies (e.g., National Medical Products Administration, NMPA) with adequate safety and efficacy data from human studies to support New Drug Applications (NDA). Typically, clinical research includes four phases: Phase I trials are first-in-human (FIH) studies for safety and pharmacokinetics at multiple dose levels of a drug in a small number of patients or healthy volunteers ; Phase II determine the efficacious and safe dose in a moderate number of patients; Phase III trials generally include a large number of patients to confirm efficacy and safety of a drug and support marketing approval; and Phase IV trials including post marketing studies that further expand product features. Throughout the drug clinical development from Phase I to final marketing approval, the activities consist of trial design, investigator selection, communication and training, trial operation and data management, medical monitoring safety of trial subjects, data collection and management, data analysis and summary, and study report preparation. All clinical research activities are performed in compliance with Good Clinical Practice (GCP) and NMPA regulations.

The majority of Zelgen clinical team members have experience with global clinical trial design, conduct, and management. Zelgen’s clinical team consistently applies high quality standards in every aspect of the clinical trial activities performed, makes safety and benefit to our trial subjects the first priority, as well as dedicates efforts towards successful collaborations with key opinion leaders, investigators, CRO partners and vendors. This ensures the development of safe and effective drugs that will benefit patients.

Zelgen is conducting approximately 30 clinical studies currently.

Donafenib tosilate tablets has proven a successful Phase III clinical trial as first-line treatment of hepatocellular carcinoma, with topline data showing that the drug achieved the primary endpoint of significantly prolonging mOS in Donafenib group compared with the Sorafenib control group, which was also with clinical significance; the Donafenib treatment group also showed a better safety proflie. Donafenib tablets are being tested in  Phase III clinical trials as third-line treatment of advanced colorectal cancer, first-line treatment of locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer. Additionally, the drug candidate is in a Phase Ib clinical trial for the treatment of advanced nasopharyngeal cancer, a Phase I clinical trial for the treatment of relapsed acute myeloid leukemia, and a Phase I/II clinical trial for the combined treatment with Donafenib  and anti-PD-1/PD-L1 antibodies in the treatment of solid tumors. A Phase III clinical trial of topical use of recombinant human thrombin for intraoperative hemostasis is ongoing.

Jaktinib tablets are being tested in two Phase III clinical trials for the treatment of mid- and high-risk myelofibrosis and for the treatment of myelofibrosis that cannot tolerate Ruxolitinib. The Company is also conducting multiple Phase II clinical trials of Jaktinib tablets for the treatment of severe alopecia areata, idiopathic pulmonary fibrosis, ankylosing spondylitis, moderate to severe  plaque psoriasis, moderate to severe atopic dermatitis et al.

Alkotinib Capsules are being tested in two Phase II clinical trials for the efficacy and safety of ALK-positive patients with advanced NSCLC for whom the Crizotinib therapy fails and for ALK-positive, non-small cell lung cancer patients with brain metastases.

Recombinant human thyroid stimulating hormone for injection is being tested in a Phase II clinical dose escalation study for the safety, tolerability, pharmacokinetics, and improvement of iodine uptake for patients after surgery for thyroid cancer.

Phase I/II clinical trials for the treatment of mild to moderate alopecia areata and mild to moderate dermatitis atopic dermatitis of Jaktinib Hydrochloride Cream is ongoing.

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