Clinical research is an important stage of innovative 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) or Biologics License Applications (BLA). 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, operation, 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 40 clinical studies currently.
Donafenib for first-line treatment of advanced hepatocellular carcinoma has been approved for marketing. Donafenib as first-line treatment for advanced hepatocellular carcinoma has been included in the "Guideline for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" by the National Health Commission (Evidence level 1, Recommendation A), "CSCO Guideline for the Diagnosis and Treatment of Primary Liver Cancer 2022" (Level I Expert Recommendation and Class 1A Evidence) and other seven Guidelines. Donafenib for the treatment of locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer indication NDA has been submitted and accepted by CDE after the completion of Phase III clinical trial, and the company will accelerate the marketing process of this indication.
Jacktinib Tablet is a Class 1 new drug as a JAK inhibitor. The company is developing Jacktinib Tablet for myelofibrosis (Phase III) and ruxolitinib-intolerant myelofibrosis (Phase IIB, registration clinical trial), ruxolitinib relapsed/refractory myelofibrosis (phase IIB), and for autoimmune diseases such as severe alopecia areata (phase III), ankylosing spondylitis (Phase II), moderate to severe atopic dermatitis (phase II), idiopathic pulmonary fibrosis (Phase II), graft-versus-host disease (stage II), and moderate-to-severe plaque psoriasis (Phase II). Jacktinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of myelofibrosis, and a Phase I clinical trial for MF in the U.S. has been initiated.
Recombinant human thrombin for Topical Use has completed Phase III clinical trial and BLA was submitted. It is the first recombinant human thrombin product that has completed Phase III clinical trial in China, and is expected to fill the gap in the domestic market and meet urgent clinical needs.
Recombinant human thyroid-stimulating hormone for Injection has entered two phase III clinical trials for thyroid cancer auxiliary diagnosis and adjuvant treatment indications, and there is no recombinant human thyroid-stimulating hormone product on the Chinese market.
Zelgen Clinical Trial Subject Recruitment Information and WeChat Posting Platform
Multicenter Phase II Clinical Trial of Jaktinib Tablets to Evaluate the Safety and Effectiveness for the Treatment of Middle and High-risk Myelofibrosis