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Sanjin Pharma’s Subsidiary Gets NMPA Nod for BC007 Cancer Study
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China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Biopharmaceutical (Shanghai) Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of BC007. The study will assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy…
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I-Mab and AbbVie End CD47 Antibody Trial but Continue Collaboration
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China-based biotech I-Mab (NASDAQ: IMAB) filed with the US Securities and Exchange Commission (SEC) that its co-development partner AbbVie Inc. (NYSE: ABBV) has decided to end a Phase Ib clinical trial of the CD47 monoclonal antibody (mAb) lemzoparlimab. The trial, which assessed the drug in combination with azacitidine and venetoclax,…
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Menovo Pharmaceutical Plans RMB892m Private Placement to Boost API Production
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China-based Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has announced plans to raise up to RMB892 million (USD131.6 million) through a private placement. The net proceeds will be used for the creation of an active pharmaceutical ingredients (APIs) and intermediates program with an annual output of 3,760 tons, as well…
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BeiGene Partners with Ontada to Accelerate RWE Development in US Oncology Market
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China-based biotech company BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced that it has signed a strategic agreement with Ontada, a subsidiary of McKesson Corporation, to accelerate the development and use of real-world evidence (RWE) in support of BeiGene’s oncology products in the US market. The financial details of the…
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Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG: 0512) generic carglumic acid is set for priority review. The indications include hyperammonemia due to N-acetylglutamate synthase deficiency, hyperammonemia due to isovaleric acidemia, hyperammonemia due to methylmalonic acidemia, and hyperammonemia due to propionic acidemia. Reason…
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Ascletis Pharma’s Gannex Initiates DDI Study for ASC42 in PBC
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Ascletis Pharma Inc. (HKG: 1672) announced that its wholly – owned US unit, Gannex, has initiated the first subject dosing in a drug – drug interaction (DDI) study for its drug candidate ASC42 in primary biliary cholangitis (PBC) in the United States. The study is designed to provide additional evidence…
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Venus Medtech’s VenusP-Valve Used Again in US Compassionate Case
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Venus Medtech (Hangzhou) Inc. (HKG: 2500) announced the second US market compassionate use of its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system. The system is intended to treat patients with moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis. The procedure was conducted at…
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Luye Pharma’s Goserelin Acetate Injectable Accepted for Breast Cancer Review
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China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate sustained-release injectable microspheres (LY01005) as a treatment for breast cancer has been accepted for review by China’s Center for Drug Evaluation (CDE). The drug is already under review for its use in treating prostate cancer.…
