No Data
Brightgene Bio-Medical Technology Co.,Ltd. (688166.SH): Sodium Ferric Gluconate Injection has received approval from the FDA in the USA.
On December 23, Gelonghui reported that Brightgene Bio-Medical Technology Co., Ltd. (688166.SH) announced that the company received a notice from the USA Food and Drug Administration (referred to as "FDA"). The Abbreviated New Drug Application (ANDA, that is, the USA generic drug application) for Fondaparinux Sodium Injection submitted to the FDA has been officially approved. Fondaparinux is a fully synthetic anticoagulant indicated for preventing venous thromboembolism events in patients undergoing major orthopedic surgeries of the lower extremities, such as hip fractures, major knee surgeries, or hip replacements. It is used for emergency (<120 minutes) invasive treatments without indication.
Brightgene Bio-Medical Technology Co.,Ltd. (688166.SH): Participating in the national pharmaceutical centralized procurement and is expected to win the bid.
On December 13, 2023, Gelonghui reported that Brightgene Bio-Medical Technology Co.,Ltd. (688166.SH) announced that its wholly-owned subsidiary, Brightgene Pharmaceuticals (Suzhou) Co., Ltd., participated in the bidding organized by the Joint Procurement Office for the 10th batch of national centralized procurement of Pharmaceuticals. After the opening and evaluation of bids by the Joint Procurement Office, Brightgene Pharmaceuticals' product, Carboprost Tromethamine Injection, is expected to win the bid for this centralized procurement. The Carboprost Tromethamine Injection, which is expected to win the bid this time, received the drug registration certificate approved and issued by the National Medical Products Administration in March 2024, and is a new product launched by the company. There have been no sales revenues generated from January to September 2024.
BrightGene Bio-Medical Technology Gets Ethics Approval for Phase 3 Trial for Blood Sugar Injection
Brightgene Bio-Medical Technology Co.,Ltd. (688166.SH): BGM0504 injection indications have obtained ethical approval for Phase III clinical trials.
Ge Longhui December 4th, brightgene bio-medical technology co.,ltd. (688166.SH) announced that its wholly-owned subsidiary Brightgene New Creation Biomedical Technology (Wuxi) Co., Ltd. (referred to as "Brightgene New Creation") independently developed BGM0504 injection for lowering blood glucose indication Phase III clinical research protocol has been approved by the leading hospital Peking University People's Hospital Ethics Review Committee and obtained the "Peking University People's Hospital Ethics Review Committee Ethics Review Letter". BGM0504 injection is the company's independently developed GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) dual receptor stimulation.
Brightgene bio-medical technology co.,ltd. (688166.SH): Dinoprostone tablets and its active pharmaceutical ingredient, as well as the active pharmaceutical ingredient for levo-dihydroxyphenylserine, have been approved for marketing.
brightgene bio-medical technology co.,ltd. (688166.SH) announced that its wholly-owned subsidiary, brightgene pharmaceutical (suzhou) co., ltd...
Brightgene bio-medical technology co.,ltd. (688166.SH): Subsidiary obtains pharmaceutical registration certificate and approval notice for chemical raw materials listing application.
Brightgene Bio-Medical Technology Co.,Ltd. (688166.SH) announced on December 3 that its wholly-owned subsidiary Brightgene Pharmaceutical (Suzhou) Co., Ltd. has received the "Dienogest Tablets" pharmaceutical registration certificate issued by the National Medical Products Administration, as well as the "Dienogest" and "Succinylcholine Chloride" chemical raw materials for marketing approval notification letter.
BrightGene Bio-Medical Technology Co., Ltd.'s (SHSE:688166) 31% Share Price Plunge Could Signal Some Risk
