martes, 7 de julio de 2020

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) - Full Text View - ClinicalTrials.gov

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) - Full Text View - ClinicalTrials.gov

STAT China

Jonathan Chan

Two more Chinese biotech choose Hong Kong for IPO

Remegen and Genor Biopharma filed for IPO with the Hong Kong Stock Exchange last week.

Remegen is a Shandong-based biotech focusing on developing drugs for cancer and autoimmune diseases. Its lead product is RC18, or telitacicept, a TACI-Fc fusion protein that targets two cell signaling molecules — B-cell lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL) — both of which are associated with B-cell-mediated autoimmune diseases.

The drug is currently under priority review with the NMPA for treating systemic lupus erythematosus and will need to complete its confirmatory Phase 3 trial in order to be fully approved, which the company expects it can achieve by the end of this year. In April, the U.S. Food and Drug Administration granted telitacicept a fast-track designation.

Genor Biopharma is a cancer-focused drug developer based in Shanghai. Its most advanced program is GB221, a Herceptin-mimicking monoclonal antibody therapy for patients with HER2+ late-stage breast cancer. Currently in Phase 3 clinical trials, the company expects to file for its approval in 2020.

Two weeks ago, Genor penned an exclusive licensing agreement to develop and commercialize G1 Therapeutic’s cancer therapy, lerociclib, for the Asia-Pacific region.

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