Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline drug candidate, ZG005. The trial will evaluate the efficacy of ZG005 in combination with the Category 1 anti-cancer drug donafenib for the treatment of various solid tumors.
ZG005: A Promising Anti PD-1/TIGIT BsAb for Solid Tumors
ZG005 is an innovative anti PD-1/TIGIT bispecific antibody (BsAb) injection that is being developed as a targeted therapy for solid tumors. Pre-clinical studies have demonstrated that ZG005 has a significant and durable anti-tumor effect, outperforming the curative effects of single-agent anti-PD-1/anti-TIGIT use or the combination of the two monotherapies. This suggests that ZG005 has the potential to revolutionize treatment outcomes for patients with solid tumors.
Pharmacokinetics and Safety Profile
ZG005 has shown a good pharmacokinetic and safety profile, particularly in terms of drug half-life in non-human primates. The absence of similar products on the market makes ZG005 a unique candidate with significant potential in the field of oncology.
Donafenib: Zelgen’s Multi-Kinase Inhibitor
Donafenib, developed in-house by Suzhou Zelgen, is a small-molecule oral multi-kinase inhibitor that has been approved in China for first-line treatment of advanced hepatocellular carcinoma (HCC) and locally advanced/metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) since 2021. Its inclusion on the National Reimbursement Drug List (NRDL) and multiple clinical guidelines underscores its importance in the treatment of these cancers.
Conclusion
The clinical trial approval for ZG005 by the NMPA is a significant milestone for Suzhou Zelgen Biopharmaceuticals, marking the company’s commitment to advancing innovative cancer therapies. With the potential to improve upon existing treatments, ZG005 and donafenib may offer new hope for patients battling solid tumors.-Fineline Info & Tech
