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Hangzhou-based artificial intelligence (AI)-driven biotech MindRank AI has announced obtaining approval from the US FDA to conduct a clinical study for its oral, small molecule GLP-1 receptor agonist (RA) drug MDR-001 in obesity. This marks a significant milestone in the development of MDR-001, positioning MindRank AI to advance its innovative…
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The World Health Organization (WHO) has lowered the age limit for Sinovac Biotech Ltd’s (NASDAQ: SVA) COVID-19 vaccine, CoronaVac, to three years old. This makes it the first vaccine on the WHO’s Emergency Use List (EUL) to be approved for such a young age group and the only one recommended…
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that another indication approval filing for its avatrombopag has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is chronic immune thrombocytopenia (ITP). Drug Profile and DevelopmentAvatrombopag is a thrombopoietin (TPO) receptor…
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China-based Shanghai Shyndec Pharmaceutical Co., Ltd (SHA: 600420) has announced that its generic version of Pfizer’s (NYSE: PFE) Cytosar-U (cytarabine) has obtained marketing approval in China. This marks the first generic to pass the generic quality consistency evaluation among similar products in the country. Product Profile and Market ContextCytarabine for…
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Antengene Corp., Ltd (HKG: 6996) has announced market filings for its Xpovio (selinexor) in Macau, Malaysia, and Thailand, with indications for relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The China-based biopharma also plans to make another market filing in Indonesia…
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Japan-based Eisai Co., Ltd (TYO: 4523) and its US co-development partner Biogen Inc. (NASDAQ: BIIB) have revealed that Eisai has initiated a Biologics License Application (BLA) in China for lecanemab, their innovative Alzheimer’s disease therapy. The filing is supported by data from the Phase II Study 201 trial in mild…
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 3 chemical product escitalopram oral solution. The product is approved to treat depression and panic disorder with or without agoraphobia, marking a significant milestone in the…
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its dual-targeted drug candidate THDBH151 in gout and hyperuricemia. This marks a significant step forward in the development of innovative treatments for these conditions. Existing Therapies and…
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BioNTech is reportedly in the process of shipping the first batches of its COVID-19 vaccines to China, following a state-level agreement between China and Germany that allows German expats access to the product. The news was confirmed by a German government spokesperson, as reported by Reuters. Agreement and Vaccine AccessChancellor…
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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…
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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…
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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).…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…