-
Merck Launches Noxafil in China for Antifungal Treatment
•
US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced the official market launch of its Noxafil (posaconazole) in China. Noxafil is an antifungal agent used to prevent invasive aspergillosis and candida infection and treat invasive aspergillosis. Drug Profile and Dosage FormsNoxafil is a next-generation triazole antifungal drug with…
-
Hinova’s PROTAC Drug HP518 Accepted for FDA Review in mCRPC
•
China-based biopharma Hinova Pharmaceuticals has announced that a clinical trial filing for its androgen receptor (AR) targeted proteolysis-targeting chimeric (PROTAC) drug HP518 in metastatic castration-resistant prostate cancer (mCRPC) has been accepted for review by the US FDA. The study in question is an open-label study assessing the safety, pharmacokinetics, and…
-
Fosun Kite’s CAR-T Therapy FKC889 Approved for Clinical Trials in China
•
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its subsidiary Fosun Kite Biotechnology Co., Ltd’s chimeric antigen receptor (CAR)-T cell therapy FKC889 has obtained clinical trial approval in mainland China to treat adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).…
-
Yantai Dongcheng Receives NMPA Approval for F18 PET Imaging Study
•
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for an F18 product for use in positron emission tomography (PET) imaging of fibroblast activating protein (FAP)-positive lesions. This marks a significant step forward in…
-
Yipinhong’s AR882 Receives NMPA Approval for Gout Clinical Trial
•
China-based Yipinhong Pharmacy Co., Ltd (SHA: 300723) has announced that its pipeline candidate AR882, under co-development with Arthrosi Therapeutics Inc., has obtained clinical trial approval from the National Medical Products Administration (NMPA). The targeted indication is gout, a condition characterized by high levels of uric acid in the blood. Drug…
-
Shaanxi Panlong Receives Patents for Coronavirus 3CL Protease Inhibitor
•
China-based Shaanxi Panlong Pharmaceutical Group Co., Ltd (SHE: 002864) has announced receiving two patents (US11518759B1, US11530195B1) in relation to a development project titled “Coronavirus 3CL Protease Inhibitor Development,” in collaboration with Shaanxi University of Science and Technology. The patents cover “PROTACs [proteolysis-targeting chimeric molecules] based on VHL ligand targeting coronavirus…
-
InnoCare Receives CDE Approval for Phase II Trial of Orelabrutinib Combination
•
China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving approval from China’s Center for Drug Evaluation (CDE) to start a Phase II clinical trial assessing a combination of orelabrutinib with tafasitamab and lenalidomide in patients with relapsed/refractory (r/r) non-Hodgkin’s lymphoma (nHL). This approval marks a significant step in…
-
Sirnaomics’ Lead Candidate STP707 Shows Promising Phase I Data
•
Sino-US small interfering RNA (siRNA) specialist Sirnaomics (HKG: 2257) has revealed that its lead pipeline candidate STP707 has produced strong early safety and efficacy data in a Phase I clinical trial. STP707, which is comprised of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA and formulated in a peptide nanoparticle…
-
Kira Pharmaceuticals Gains NMPA and TGA Approvals for KP104 Phase II Study
•
Sino-US biotech Kira Pharmaceuticals has announced receiving approvals from China’s National Medical Products Administration (NMPA) and the Australian Therapeutic Goods Administration (TGA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of its KP104 pipeline candidate. This marks a significant milestone in…
-
Aosaikang Receives FDA Approval for ASKG915 Clinical Trial
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the US FDA. The intended indication is advanced solid tumors, marking a significant step forward in the development of innovative therapies for this condition. Drug Profile and DevelopmentASKG915 is…
-
CStone’s Sugemalimab MAA Accepted by UK MHRA for NSCLC Treatment
•
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab in combination with chemotherapy as a first-line treatment of patients with metastatic non-small cell lung…
-
Ascletis Pharma Receives USPTO Notice for ASC10 Patent
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the Notice of Issuance from the United States Patent and Trademark Office (USPTO) for the patent application of oral viral polymerase inhibitor ASC10 and its derivatives, and their uses to treat multiple virus infections including SARS-CoV-2, monkeypox virus, and respiratory syncytial…
-
HutchMed Initiates Rolling NDA Submission for Elunate to US FDA
•
Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the initiation of a rolling submission of a New Drug Application (NDA) to the US FDA for Elunate (fruquintinib) for the treatment of refractory metastatic colorectal cancer (CRC). HutchMed plans to complete the NDA submission in the first half of…
-
Simcere Pharmaceutical Completes Enrollment for SIM0417 COVID-19 Drug Trial
•
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of enrollment of 1,208 patients in a Phase II/III clinical study for its SIM0417, an oral COVID-19 drug candidate being co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology. Study…
-
Neurophth’s NFS-02 Gene Therapy Gets FDA IND Approval for LHON Treatment
•
China-based gene therapy specialist Neurophth Biotechnology Ltd has announced obtaining Investigational New Drug (IND) approval from the US FDA for its second ophthalmology gene therapy, NFS-02 (rAAV2-ND1). The intended indication is Leber’s hereditary optic neuropathy (LHON) caused by the ND1 mutation. NFS-02: A Promising Gene Therapy for LHONNFS-02, a recombinant…
-
TG ImmunoPharma Gains FDA Approval for Phase I Study of Anti-PVRIG Antibody
•
China-based TG ImmunoPharma Co., Ltd has announced receiving the go-ahead from the US FDA to carry out a Phase I clinical study for its TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody, in patients with advanced solid tumors. Currently, no drugs targeting PVRIG have been approved globally. TGI-2/NM1F: A Promising Anti-PVRIG Therapeutic…
-
Adagene Initiates International Study for ADG126 in Hepatocellular Carcinoma
•
China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced the initiation of a randomized, international, multi-center clinical study to assess the effects of its anti-CTLA-4 monoclonal antibody (mAb) ADG126, combined with Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab), in first-line advanced hepatocellular carcinoma (HCC).…
-
Jiangsu Recbio’s Herpes Zoster Vaccine REC610 Gets Clinical Trial Approval in Philippines
•
China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced receiving clinical trial approval for its new adjuvant recombinant herpes zoster vaccine, REC610, in the Philippines. The randomized, observer-blinded, Shingrix-positive controlled Phase I study is designed to assess the safety and immunogenicity of REC610 in healthy subjects aged…
-
GenFleet and Merck KGaA Partner on European Clinical Study for KRAS G12C Inhibitor
•
China-based GenFleet Therapeutics Inc. has announced a European multi-center clinical study and drug supply agreement with Germany’s Merck KGaA. The collaboration will conduct an open, multi-center, Phase Ib/II clinical study to assess the efficacy of combining GenFleet’s KRAS G12C inhibitor, GFH925, with Merck’s Erbitux (cetuximab) in treatment-naïve advanced non-small cell…
-
Henlius’ Serplulimab Receives Orphan Drug Designation in Europe for SCLC
•
Shanghai Henlius Biotech (HKG: 2696) has announced receiving orphan drug designation (ODD) status from the European Committee for its HanSiZhuang (serplulimab) for the treatment of small-cell lung cancer (SCLC). The programmed death-1 (PD-1) inhibitor, previously awarded ODD status in the US for the same indication, is expected to become the…
