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Suzhou Zelgen Biopharmaceuticals Gets Orphan Drug Designation for Lung Cancer Drug
Zejing Pharmaceuticals (688266.SH): Injection ZG006 is granted FDA orphan drug qualification.
On August 8, Gelon Hui reported that Zejing Pharmaceutical (688266.SH) announced that its research and development product, injectable ZG006, has obtained orphan drug recognition from the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer. Injectable ZG006 is a three-specific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its dual/multispecific antibody development platform, and it is the company's fourth drug to simultaneously obtain FDA and pharmaceutical approvals.
Zelgen Biopharmaceutical Gets Nod to Trial Advanced Hepatocellular Carcinoma Drug Combination
Zejing Pharmaceutical (688266.SH): The approval notice for clinical trials of the combination of injection ZG005 and injection ZGGS18 has been obtained.
On August 5th, Gelon Hui announced that Zejing Pharmaceutical (688266.SH) has recently received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The clinical trial of ZG005 for injection and ZGGS18 for injection, used in combination for advanced solid tumors, has been approved. ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody powder for injection, an innovative tumor immunotherapy biological product, registered in Class 1, is expected to be used to treat a variety of solid tumors. ZGGS18 is a recombinant humanized anti-VEGF/TGF-β bispecific antibody fusion protein, registered...
Zelgen Biopharmaceutical's Phase II Trial of Gecaxitinib Hydrochloride Tablets Shows Positive Results
Zejing Pharmaceuticals (688266.SH): successful results of phase II clinical trial of Gefitinib Hydrochloride Tablets for the treatment of idiopathic pulmonary fibrosis.
On August 1st, Gelunhui announced that the Phase II clinical study of self-developed Type 1 new drug HCl Gexi substituted nicotinamide tablets (formerly known as HCl Jack substituted nicotinamide tablets) for the treatment of idiopathic fibrosis carried out by the company has achieved successful results. The results showed that the Gexi substituted nicotinamide tablets in the two dose groups (50mg Bid and 75mg Bid) could significantly delay the decline of forced vital capacity (FVC) of the subjects compared with the placebo group at 24 weeks. The tolerability and safety of each dose group were good. This trial is the first JAK inhibitor to be completed in patients with idiopathic fibrosis worldwide.
Suzhou Zelgen Biopharmaceuticals Co.,Ltd.'s (SHSE:688266) Popularity With Investors Under Threat As Stock Sinks 29%No Data
