Clinical & Regulatory
Mabwell Announces the U.S. FDA approval of 9MW3811 for IND
SHANGHAI, June 15, 2023 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with the entire value chain of the pharmaceutical industry, announced the clinical trial application of its self-developed 9MW3811 injection for idiopathic pulmonary fibrosis has been approved by the United States Food and Drug Administration (FDA)
The U.S. FDA Approved the Phase I/II Clinical Trial Application to Evaluate LBL-033, An Anti-MUC16/CD3 Bispecific Antibody Developed by Leads Biolabs, in Advanced Solid Tumors Including Ovarian Cancer
NANJING, China, June 16, 2023 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") today announces that the phase I/II clinical trial application for LBL-033, an anti-MUC16/CD3 bispecific antibody, for the treatment of ovarian cancer and other malignant tumors, has been approved by the FDA (U.S. Food and Drug Administration).
TG ImmunoPharma Announces FDA Clearance for Clinical Trial of TGI-6 Bispecific Antibody
HEFEI, China, June 16, 2023 /PRNewswire/ -- TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of TGI-6, its groundbreaking bispecific antibody.
China Medical System: The first ‘Diazepam Nasal Spray’ Approved for Marketing in China
On June 12, China Medical System Holdings Limited ("CMS" or the "Group") announced that on June 7 2023, the New Drug Application (NDA) of Diazepam Nasal Spray (the "Product") received approval from the National Medical Products Administration of China (NMPA).
HighField Biopharmaceuticals Receives US FDA IND Clearance for Phase 1 Trial of Immunoliposome HF158K1 for Treatment of HER2 low and HER2+ Cancers
HANGZHOU, China--(BUSINESS WIRE)--HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the U.S. Food and Drug Administration has granted clearance of the company’s Investigational New Drug (IND) application for HF158K1, a drug encapsulated immunoliposome containing doxorubicin.
ITabMed announces the IND approval from NMPA for A-337, a CD3-activating bispecific antibody targeting EpCAM to treat solid tumors
ITabMed Ltd., a clinical-stage biotech company in China, announced the IND approval from China National Medical Products Administration (NMPA) for A-337, a CD3-activating bi-specific antibody targeting EpCAM.
Ractigen Therapeutics Announces Dosing of First Patient in First in Human Trial of RAG-17 for the Treatment of SOD1-ALS
Ractigen Therapeutics, a biopharmaceutical company focused on the discovery, development, and commercialization of novel oligonucleotide therapeutics, today announced the dosing of its first patient in the Company's First in Human (FIH) clinical trial for ALS patients with SOD1 mutation.
Harbour BioMed Announces First Patient Dosed in Phase I Study of First-in-Class Anti-B7H7 (HHLA2) Antibody HBM1020
Harbour BioMed (HKEX: 02142) announced that the first patient has been dosed in its ongoing phase I trial of the first-in-class anti-B7H7 (HHLA2) antibody HBM1020 (NCT05824663/Study 1020.1) in the United States.
Sirnaomics Reports Interim Results of STP705 Phase I Clinical Study for Medical Aesthetics Treatment in Adults Undergoing Abdominoplasty
Sirnaomics announced the interim results of an ongoing Phase I clinical trial of STP705, an siRNA (small interfering RNA) drug candidate, for fat reduction in adults undergoing abdominoplasty.
VVN539 met primary study endpoints in US phase IIa clinical study for the treatment of glaucoma
VivaVision announced that VN539 met primary study endpoints in US phase IIa clinical study for the treatment of glaucoma.
