According to the website of the Pharmaceutical Review Center of the National Drug Administration of China (NMPA), Jiahe Bio's PD-1 monoantinomonotagated (geptanolimab, research and development code GB226) was included in the priority list for review on July 28, citing "conformity with the attached approval".
Geno monotomatopathy is the treatment of peripheral T-cell lymphoma (PTCL), which is understood to be the first PD-1 monotophoid to be applied for in China.
it is worth mentioning that this time it is only seven days before the listing application is accepted.
Screenshot Source: CDE Official Website Geno Monogenocybis is a humanized IgG4 monoclonal antibody that targets immune cell PD-1, and Jiahe Bio has core intellectual property rights.
, Genomono can restore the immune system's ability to recognize and kill cancer cells by selectively blocking dual ligands (PD-L1 and PD-L2), and is to be developed to treat a variety of late-stage solid tumors.
currently, Jiahe Bio is conducting a number of clinical trials on Genomono, involving anisotopic T-cell lymphoma, primary large B-cell lymphoma, cervical cancer, non-small cell lung cancer (NSCLC), adenosystsar soft tissue sarcoma and other indications.
include two key Phase 2 clinical studies: one designed to assess the effectiveness and safety of Geno supret sepsis treatment recurrence and incurable exophral T-cell lymphoma, which is also the indication that the Geno supad application is on the market, and the other designed to assess the overall remission rate (ORR) of Geno supma relapse or refractive primary b cell lymphoma.
At this year's American Cancer Research Association (AACR) online meeting, Professor Shi Yuankai, vice president of the Oncology Hospital of the Chinese Academy of Medical Sciences and deputy director of the National Cancer Center, released data on a multi-centered, open, single-arm phase 2 clinical trial for relapsed and incurable peripheral T-cell lymphoma.
the study recruited 102 patients in China, with the main study endpoint being objective mitigation rate, and secondary studies including mitigation duration, disease control rate, progression-free survival, total survival, safety and immunogenicity.
studies have shown significant efficacy in patients with relapsed or refracted peripheral T-cell lymphoma: the Independent Imaging Evaluation Board (IRC) assessed an ORR of 36.3 percent, and the primary subtype of peripheral T-cell lymphoma benefited, with ALK-negative transcell lymphoma ORR of up to 58.3%;
it is worth mentioning that, while studying the efficacy of Geno synvirus, Jiahe Bio is also actively exploring the combined therapeutic effects of Genosaandandand and other drugs: in October 2018, Jiahe Bio and Hutchison Whampoa Pharmaceuticals, which is owned by Hehuang Pharmaceuticals, reached a partnership to explore the effects of Genosa and the latter's VEG-FR inhibitor enosinibin in advanced solid tumors; In December 2018, Jiahe Biology and AXA Pharmaceuticals reached a strategic partnership to explore the combined effects of Genosa and the latter's MDM2-p53 inhibitor APG-115 in the field of solid tumor and malignant blood tumor treatment;
References to the Drug Review Center of the State Drug Administration of China. Retrieved Jul 28,2020, from Jiahe Biopharmaceuticals announced that the application for the listing of the new drug Geptanolimab has been accepted, retrievedJul 21,2020, from the 2020 AACR annual meeting of Jiahe Bio announced Geptanolimab mono-antitherapy PTCL and ASPS two results. Retrieved April 29, 2020, from.