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Staidson (300204.SZ): Summary report of Phase I clinical study of STSA-1301 subcutaneous injection.
On August 8th, Gelon Hui announced that Staidson (300204.SZ) recently obtained the Phase I clinical study summary report of STSA-1301 subcutaneous injection for the treatment of primary immune thrombocytopenia. The Phase I clinical trial mainly evaluated the safety and pharmacokinetic characteristics of single-dose administration of STSA-1301 subcutaneous injection. The results showed that within the dose range of the designed regimen, the safety and tolerability of single-dose administration of STSA-1301 subcutaneous injection in healthy subjects were good and presented non-linear pharmacokinetic characteristics. It can reduce the total serum IgG level in a dose-dependent manner.
Staidson (300204.SZ): STSP-0902 eye drops obtained a new drug clinical trial notice.
On July 9th, Gelunhui reported that Staidson (300204.SZ) announced that in recent days, Staidson (Beijing) Biopharmaceutical Co., Ltd. (hereinafter referred to as "Staidson" or "the company") received the "Drug Clinical Trial Approval Notice" (Notice No. 2024LP01513, 2024LP01514, 2024LP01515) for STSP-0902 eye drops for the treatment of neurotrophic keratitis issued by the National Medical Products Administration, and was approved to conduct clinical trials for neurotrophic keratitis with this product. STSP-0902 is independently developed by Staidson for specific sites.
Staidson (300204.SZ): STSP-0902 Injection Obtains Clinical Trial Notification for New Drugs.
On June 25th, Gelon Hui announced that it has received the Drug Clinical Trial Approval Notice for STSP-0902 injection for the treatment of oligoasthenozoospermia issued by the National Medical Products Administration, which allows this product to undergo clinical trials for the indication. STSP-0902 is a recombinant human nerve growth factor Fc fusion protein designed for targeted modification at specific sites developed by Staidson, which can bind and activate the TrkA receptor pathway to exert biological effects. Preclinical experimental data showed that STSP-0902 can promote nerve growth, spermatogonial cells, and testicular support.
Staidson (300204.SZ): SBT-1901 injection obtained clinical trial permission from the US FDA.
On June 24th, Gelunhui reported that Staidson BioPharma Inc., a wholly-owned subsidiary of Shutaishen (California) Biotechnology Co., Ltd., received an official letter (Study May Proceed Letter) from the Food and Drug Administration (FDA) of the United States, agreeing to conduct clinical trials of SBT-1901 injection for the treatment of locally advanced or metastatic solid tumors. SBT-1901 injection is a humanized monoclonal antibody targeting human TNFR2 (hTNFR2). Preclinical studies have shown that
Staidson (300204.SZ): The summary report of Phase I clinical study of STSA-1201 subcutaneous injection (used for the treatment of asthma indications) has been obtained.
On June 18th, Gelunhui reported that Staidson (300204.SZ) recently issued a summary report on the Phase I clinical trial of STSA-1201 subcutaneous injection for the treatment of asthma indications conducted by Staidson (Peking) Biopharmaceutical Co., Ltd. The results of Phase I clinical trials showed that within the dose range of the plan design, STSA-1201 subcutaneous injection had good safety and tolerability in healthy subjects receiving single dose, no resistance antibodies were detected, and drug metabolism showed linear pharmacokinetic characteristics.
Shu Taishen (300204.SZ): Pharmaceutical production license change
Gelonghui, May 28, 丨 Shu Taishen (300204.SZ) announced that the company recently obtained a pharmaceutical production license issued by the Beijing Drug Administration and agreed to the “Pharmaceutical Production License” change application. The company reduced the commissioned production address, production workshop, production line and production scope: No. 18, Kechuang Avenue, Jiangbei New District, Nanjing (Nanjing Haina Pharmaceutical Co., Ltd.): oral emulsion (oral liquid workshop: oral emulsion production line), commissioned product type: Ximetyl silicone emulsion (under research). Other relevant content remains unchanged.
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