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AstraZeneca to Launch Soliris in Hangzhou After Regulatory Approval
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has revealed plans to sell Soliris (eculizumab) in Hangzhou for the first time. The drug, originally developed by Alexion Pharmaceuticals, received conditional approval in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and…
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Akeso Biopharma’s AK112 Receives Two New Breakthrough Therapy Designations
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The Center for Drug Evaluation (CDE) website indicates that China-based Akeso Biopharma (HKG: 9926) has obtained two additional Breakthrough Therapy Designations (BTDs) for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). These designations follow last month’s BTD for AK112 in combination with…
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CStone Launches Patient Assistance Program for IDH1 Inhibitor Tibsovo
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CStone Pharmaceuticals (HKG: 2616) has announced the launch of a patient assistance scheme to support access to Tibsovo (ivosidenib), the world’s first-in-class IDH1 inhibitor used to treat leukemia. The initiative was launched this month by the Shanghai Life Oasis Public Service Center, with support from the Beijing Health Alliance Charitable…
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HutchMed Announces Initial Results from FRUTIGA Phase III Study
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initial results from the FRUTIGA Phase III study, which evaluated Elunate (fruquintinib) combined with paclitaxel in 703 Chinese patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). The study aimed to assess the efficacy and safety of…
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BRL Medicine Raises RMB 200M in Series B Financing for CGT Development
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BRL Medicine Inc., a cell and gene therapy (CGT) developer based in Shanghai, has reportedly raised over RMB 200 million (USD 28.3 million) in a Series B financing round. The round was led by Shanghai FTZ Fund, with participation from Oriental Fortune Capital, Tasly Capital, Betta Biomedical Industry Fund, and…
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Peijia Medical Enrolls First Patient in HighLife TSMVR Study
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China’s Peijia Medical Limited (HKG: 9996) has announced the enrollment of the first patient and the implantation in a regulatory clinical study for its HighLife transcatheter septal mitral valve replacement (TSMVR) system. This marks a significant step forward in the development and potential market approval of the device. Study Design…
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Acotec Scientific Secures FDA 510(k) Approval for Vericor Catheter
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received a 510(k) license from the US FDA for its Vericor, a peripheral support catheter designed to improve peripheral vascular pathways. This approval marks a significant milestone for Acotec in expanding its presence in the US medical device…
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CStone Pharmaceuticals Suspends Operations at Suzhou Plant to Cut Costs
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CStone Pharmaceuticals (HKG: 2616) has decided to suspend manufacturing operations at its Suzhou industrialization plant, according to a recent statement. The decision was made due to the lack of a clear plan for mass production at present and to reduce enterprise operating costs. According to Healthcare Executive, the Chinese firm…
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Daxiang Biotech Raises RMB 100M in Pre-Series B Financing for Organoid-on-a-Chip
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Beijing-based Daxiang Biotech Co., Ltd., a leading domestic company in the organoid-on-a-chip field, has reportedly raised close to RMB 100 million (USD 14.18 million) in a Pre-Series B financing round. The round was led by Proxima Venture Capital, with participation from Qiandao Investment Fund, Shaanxi Growth Enterprise Guide Fund, and…
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Harbin Gloria Pharmaceuticals Faces Change in Control Amid Bankruptcy
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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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HitGen Partners with Daewoong Pharmaceutical for Drug Discovery
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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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AstraZeneca and CICC Capital Launch RMB 3 Billion Fund in Hangzhou
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The joint venture (JV) between UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) and China’s CICC Capital has launched its Hangzhou unit, backed by an RMB 3 billion (USD 425.5 million) fund. The fund is supported by multiple local government guidance funds, funds of funds, and medical industry funds, including Hangzhou…
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Henlius Biotech’s BRAF V600E Inhibitor HLX208 Approved for Clinical Study in China
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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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China Updates Hypertension Guidelines, Lowers Diagnostic Threshold
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The National Center for Cardiovascular Diseases, the Chinese Medical Doctor Association (CMDA), and other organizations have released the revised “Clinical Practice Guidelines for Hypertension in China.” The updated guidelines adjust the diagnostic criteria for hypertension and provide detailed evidence-based recommendations for treating the disease, including both primary and secondary hypertension.…
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AstraZeneca Reports 19% YOY Revenue Growth in Q3 2022
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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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FDA Approves Phase Ib Study for Jiangsu Yahong’s APL1401 in Ulcerative Colitis
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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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Baheal Partners with AstraZeneca for Commercial Rights to Onglyza
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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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EQRx Shifts Strategy Amid FDA Feedback on China-Sourced Data
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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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Peking University Study Identifies Liver Cancer Immune Microenvironment Subtypes
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Researchers at Peking University have uncovered several subtypes in the tumor immune microenvironment (TIME) relevant to liver cancer, according to a study published in Nature this week (title: Liver tumour immune microenvironment subtypes and neutrophil heterogeneity). The research focused on exploring the heterogeneity of the TIME and its impact on…
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CDE Prioritizes Review for Jiedi Pharma’s Mitotane and Other Key Drugs
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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.…
