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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has disclosed that its controlling shareholder, Harbin Gloria Group Co., Ltd, has entered “bankruptcy liquidation” status. Previously, the group had been undergoing a “reorganization” process. The bankruptcy is expected to result in a change of control at Gloria Pharmaceuticals; however, the company…
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China-based HitGen Inc. (SHA: 688222) has announced a research collaboration agreement with South Korea’s Daewoong Pharmaceutical Co., Ltd. Under the deal, HitGen will leverage its DNA-encoded library (DEL) technology platform to discover compounds that bind to specific targets identified by Daewoong. Financial details of the collaboration were not disclosed. Daewoong…
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a Phase Ib/II clinical study for its BRAF V600E inhibitor HLX208. The study will evaluate the combination of HLX208 with HaiSiZhuang (serplulimab) plus standard therapies (cetuximab or trametinib) for the treatment of advanced…
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) released its Q3 2022 earnings report, showing continued growth with a 19% year-on-year (YOY) expansion in product revenues to USD 10.98 billion (all growth figures in constant exchange rate terms). Business Unit PerformanceGrowth was led by the Oncology division, which saw a…
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that it has received approval from the US FDA to conduct a Phase Ib clinical study for its drug candidate APL1401. The trial will evaluate APL1401 as a treatment for moderate to severe active ulcerative colitis…
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a partnership with AstraZeneca (AZ, NASDAQ: AZN), securing commercial operation rights to the UK major’s Onglyza (saxagliptin). This strategic move aims to enhance the distribution and accessibility of the diabetes treatment in China. Saxagliptin ProfileSaxagliptin, a dipeptidyl peptidase-4 (DPP4)…
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US-based EQRx Inc. (Nasdaq: EQRX), a biopharma originally established with the aim of “radically” disrupting pricing in the US market using China-licensed products, has rejigged its strategy in light of recent communications with the US FDA. The firm is abandoning a low-price strategy and will apply “market-based pricing” to any…
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The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs, including Jiedi Pharma’s mitotane, Pfizer’s ritlecitinib, Northrop Grumman’s trientine, and Ark Bio’s ziresovir, have been prioritized for review. This move highlights the CDE’s efforts to expedite the approval process for drugs with significant therapeutic potential.…
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Morocco. This marks a significant milestone in the global deployment of innovative COVID-19 vaccines. Convidecia ProfileConvidecia, the recombinant novel coronavirus vaccine…
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of…
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Lundbeck’s (FRA: LDBB) Eptinezumab has been launched in the Boao Lecheng International Medical Tourism Zone, marking it as the first innovative drug available in the region for migraine treatment. This milestone was announced on November 10, 2022, at a joint press conference held by the Hainan Boao Lecheng International Medical…
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The 5th China International Import Expo (CIIE) saw the announcement of a partnership between Swiss pharmaceutical giant Novartis (NYSE: NVS) and China-based Alibaba Health Information Technology Ltd (HKG: 0241). The collaboration aims to utilize digitization to enhance patient medication accessibility and provide one-stop health management services. Financial details of the…
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The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995, SHA: 688331) novel fusion protein telitacicept is set to receive breakthrough therapy designation (BTD) status for the treatment of myasthenia gravis (MG). This marks a significant step forward in addressing a rare and challenging autoimmune…
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Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands, and Suzhou, China, has announced a licensing agreement between its wholly owned subsidiary Nona Biosciences and US mRNA specialist ModernaTX, Inc. (NASDAQ: MRNA). The collaboration will focus on discovering and developing nucleic acid-based immunotherapies for…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that its GEMSTONE-303 study for the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab, combined with chemotherapy as a first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with PD-L1 expression ≥ 5%, has reached the primary endpoint of progression-free survival (PFS). This…
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL)…
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein…
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China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group’s superiority…
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Autoimmune disease drug developer Zenas BioPharma, which is based in the US and China, has announced the completion of a Series B financing round at USD 118 million. The round was led by Enavate Sciences, with participation from Longitude Capital, Vivo Capital, Rock Springs Capital, Perceptive Advisors, Agent Capital, Pivotal…