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

Clinical research is the later stage of new pharmaceutical product development, and provides drug regulatory agencies (eg, China Food and Drug Administration, CFDA) with adequate safety and efficacy data obtained from human studies to support a product market application (New drug application, NDA). Typically, the clinical researches include four phases : Phase I trials such as first in human(FIH) study, pharmacokinetics studies ; Phase II trials including safety, dose range or exploratory studies in small sample size; Phase III trials usually refer to large scale efficacy and safety confirmatory studies ; and Phase IV trials including post marketing studies that further expand product features. Throughout the drug clinical development from Phase I to final approval, the activities consist of trial design, investigators selection, communication and training, trial operation and management, medical monitoring of trial subjects’ safety, data collection and management, data analysis and summary and study report preparation. All clinical research activities must be in compliance with Good Clinical Practice (GCP) and CFDA regulations.

The majority of Zelgen clinical team members have global clinical trial design, conduction and management experience. Zelgen clinical team consistently applies the high quality criteria in every aspect of clinical trial activities we carry on, keeps trial subjects’ safety and benefits as our first priority, and dedicates our efforts on collaboration with key opinion leaders, investigators, CRO partners and vendors to facilitate development of safe and efficacious innovative drugs to benefit patients. In the past few years, we have completed several clinical trials of Donafeinib, one of our patented Class 1 new anti-cancer drugs, including one Phase I trial in solid tumor patients, one Phase Ib/IIa trial in patients with advanced liver cancer and one Phase Ib/IIa trial in patients with late stage colon rectal cancer. Since the beginning of 2016, we have initiated six new clinical trials, including Phase III study for the first line treatment of late stage hepatocellular carcinoma(HCC), Phase III study for the third line treatment of metastatic colon rectal cancer (mCRC), Phase II study in patients with advanced iodine resistance differentiated thyroid cancer, Phase Ib study for late stage nasopharyngeal carcinoma, gastric cancer and esophageal carcinoma. In addition, Zelgen obtained clinical trial permits for its JAK inhibitor Class I new drug and its biologics product Human Recombinant Thrombin and the clinicl trials are underway.

Ongoing Clinical Trials

  • Phase I Studies

    Donafenib--Late-stage gastric cancer

    Donafenib--Late-stage esophageal cancer

    Donafenib--Late-stage nasopharyngeal cancer

    Recombinant human thrombin--Surgical bleeding

    Jaktinib--Myelofibrosis, autoimmune diseases

  • Phase Ⅱ Studies


    Donafenib--Advanced thyroid carcinoma

  • Phase Ⅲ Studies

    Donafenib--First-line treatment for HCC

    Donafenib--Third-line treatment for CRC

Zelgen Clinical Trial Recruitment Information Release Platform And WeChat