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Dizal Pharma’s DZD1516 Receives NMPA Green Light for HER2+ Breast Cancer Trial
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192), spun out from AstraZeneca’s China drug discovery unit in 2017, announced that the National Medical Products Administration (NMPA) has approved a Phase II clinical study for its pipeline candidate DZD1516. The trial will evaluate DZD1516, a small-molecule HER2-targeted tyrosine kinase inhibitor, in combination…
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WuXi XDC Partners with AbTis to Advance ADC Development and Manufacturing
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WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA (SHA: 603259), announced a partnership with Korean biotech AbTis to accelerate the development and manufacturing of antibody drug conjugates (ADCs). The collaboration will leverage WuXi XDC’s integrated services and AbTis’s proprietary ADC platform technology. Partnership DetailsAbTis will…
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GenScript Biotech’s Legend Biotech Terminates LB1901 CAR-T Phase I Trial
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Hong Kong-based GenScript Biotech Corporation (HKG: 1548) announced that its subsidiary Legend Biotech Corporation (NASDAQ: LEGN) has terminated a Phase I clinical study for LB1901, a chimeric antigen receptor (CAR) T cell therapy candidate targeting CD4. The decision follows the FDA’s clinical hold in February 2022 and the lifting of…
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Gritgen Therapeutics Secures Hundreds of Millions in A-Round Financing for Gene Therapy Pipeline
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Gritgen Therapeutics, a leading gene therapy drug developer based in Suzhou, has announced the successful completion of a A-round financing round worth several hundred million yuan. The financing was led by Sequoia China, with participation from Sunlight Insurance, Qingsong Capital, and Beijing Life Science Park Venture Fund. Existing shareholders including…
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Shenzhen-Based Pregbio Raises Funds for Non-Invasive Prenatal Gene Detection
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Pregbio, a Shenzhen-based non-invasive prenatal gene detection company, has reportedly raised an undisclosed amount of money in an angel financing round. The sole contributor to the round was ASB Ventures. The proceeds will be used to promote early screening and diagnosis of preterm labor and pre-eclampsia, non-invasive prenatal screening, and…
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Novartis Cuts Back on US Development of BeiGene’s PD-1 Inhibitor Tislelizumab
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Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended…
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Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
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Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
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Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
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Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC. FDA FeedbackThe FDA cited inadequate representation…
