-
Staidson Launches Phase Ia Trial for STSP-0902 Injection in Oligoasthenozoospermia
•
Staidson (Beijing) Pharmaceutical Co., Ltd. (SHE: 300204) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ia clinical trial for its STSP-0902 injection, targeting oligoasthenozoospermia. The randomized, double-blinded, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of STSP-0902…
-
Staidson Pharmaceutical Gets NMPA Green Light for Neurotrophic Keratitis Eye Drop Clinical Trial
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational STSP-0902 eye drops, which are intended for the treatment of neurotrophic keratitis (NK). Neurotrophic keratitis, also referred to as…
-
Staidson Pharmaceutical’s Bemiltenase Alfa Earns Orphan Drug Designation from US FDA for Hemophilia Treatment
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its Category 1 biologic bemiltenase alfa (STSP-0601). This designation is for the treatment of hemophilia A or B.…
-
Staidson Pharmaceutical Gets FDA Clearance for TNFR2-Targeted mAb SBT-1901
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its TNFR2-targeted monoclonal antibody (mAb), SBT-1901, for the treatment of locally advanced or metastatic solid tumors. Preclinical studies have demonstrated…
-
Staidson Pharmaceutical’s BDB-001 Earns Breakthrough Therapy Designation in China for AAV Treatment
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its drug candidate BDB-001 has been granted breakthrough therapy designation (BTD) status in China for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Research indicates that the downstream activation of C5a, a product of the…
-
Staidson Pharmaceutical Initiates Clinical Study for ARDS Treatment STSA-1002
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase Ib/II clinical study for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb). The drug candidate is under evaluation as a potential treatment for acute…
-
Staidson Receives NMPA Approval for Clinical Trial of STSA-1301 in Primary Immune Thrombocytopenia
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its STSA-1301 subcutaneous injection. The drug is targeted for the treatment of primary immune thrombocytopenia (ITP), a condition characterized by a low…
-
Staidson Pharmaceutical Plans RMB 580 Million Private Placement for Drug R&D
•
China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced plans to raise RMB 580 million (USD 84.1 million) through a private placement, with the net proceeds designated for innovative drug research and development (R&D). This move follows previous unsuccessful attempts to raise funds through private placements of RMB 1.08…
-
Staidson’s STSP-0601 Begins Phase II Study for Hemophilia Treatment
•
China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced the first subject dosing in a Phase II clinical study for its Category 1 biologic STSP-0601. The study aims to evaluate the drug as an on-demand treatment for bleeding in patients with hemophilia A or B without inhibitors. This marks…
-
Staidson’s Anti-C5a Monoclonal Antibody STSA-1002 Accepted for NMPA Review
•
China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced that the clinical trial filing for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb) for use in acute respiratory distress syndrome (ARDS), has been accepted for review by the National Medical Products Administration (NMPA). About ARDS…
-
InflaRx and Staidson Amend Deal to Advance Vilobelimab Regulatory Filing in China
•
Germany-based biopharma InflaRx N.V. (Nasdaq: IFRX) has revealed an amendment to its underlying deal with China-based Staidson BioPharma Inc. (STS) to push forward a regulatory filing in China for the anti-C5a antibody vilobelimab (BDB-001). InflaRx will supply Staidson with an exclusive license to access the German firm’s clinical, manufacturing, and…
-
Staidson’s STSP-0601 Receives Clinical Trial Approval for Hemophilia Treatment
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B…
-
Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
•
The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE: 300204) STSP-0601 and Johnson & Johnson’s teclistamab are set to receive breakthrough therapy designations (BTDs). STSP-0601 is indicated for on-demand treatment of bleeding in hemophilia A or B patients with inhibitors, while teclistamab targets relapsed…
