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Guangdong Zhongsheng Starts Phase III Trial for COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild…
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Yabao Receives FDA Clearance for Generic Nexavar
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence…
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Hansoh Pharmaceutical Licenses Biotheus’ Bispecific Antibody PM1080 for Greater China
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a licensing agreement with fellow Chinese biotech firm Biotheus, securing exclusive development and commercialization rights to Biotheus’ bispecific antibody (BsAb) PM1080 in Greater China, including Hong Kong, Macau, and Taiwan. Under the terms of the agreement, Hansoh will be responsible…
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Sansure Biotech Partners with UBC to Manufacture in Indonesia
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) has entered into a local manufacturing memorandum of understanding (MoU) with its Indonesia partner UBC. The agreement will enable Sansure’s molecular diagnostics technology to be manufactured in Indonesia, aimed at enhancing infectious disease prevention and control, as well as diagnosis and…
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HutchMed Shifts Focus to Late-Stage Pipeline for Regulatory Approvals
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Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced a strategic shift to focus on obtaining regulatory approvals for its late-stage product pipelines. The move aims to accelerate profit-making and establish a long-term, sustainable business model for the Chinese biopharmaceutical company. Focus on Late-Stage DevelopmentHutchMed will prioritize advancing its…
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Harbour BioMed and WuXi Biologics Announce Strategic Collaboration
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Harbour BioMed (HKG: 2142), a global biotechnology company with operations in the United States, the Netherlands, and Suzhou, China, has announced a strategic collaboration with China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269). Under the agreement, WuXi Biologics’ controlling subsidiary, WuXi Vaccines, will take over Harbour…
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Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
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The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276) pyrotinib has been granted priority review status. The drug is being evaluated for use in combination with trastuzumab and docetaxel for the treatment of recurrent or metastatic breast cancer that is human epidermal growth factor…
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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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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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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…
