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Sansure Biotech’s Pertussis Detection Kit Approved by NMPA
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) announced that it has obtained medical device approval from the National Medical Products Administration (NMPA) for its pertussis nucleic acid detection kit (PCR fluorescence probe method). Product and ApplicationThe product, used for the auxiliary diagnosis of patients with respiratory tract infection…
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Simcere’s Edaravone, Borneol Sublingual Tablets Reach Phase III Efficacy Endpoint
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) announced that a Phase III clinical study for its edaravone, borneol sublingual tablets in acute ischemic stroke (AIS) has reached the pre-set efficacy endpoint. Preliminary analysis showed that, compared with a placebo, edaravone, borneol sublingual tablets could significantly improve the neurological recovery and…
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XJTLU and University of Liverpool Launch Joint Centre for Pharmacology and Therapeutics
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The Suzhou-based Xi’an Jiaotong-Liverpool University (XJTLU) and the UK’s University of Liverpool earlier this month held the inauguration of the Joint Centre for Pharmacology and Therapeutics. The Joint Center will allow scientists from both countries to carry out research into disease mechanisms and develop novel drugs for currently relevant diseases.…
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Yifan Pharmaceutical Licenses F-627 to Acrotech for US Distribution
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the establishment of a licensing agreement with US firm Acrotech Biopharma, Inc., granting the latter exclusive distribution rights to its efbemalenograstim alfa (F-627) in the United States. The drug is an in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion…
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Nans Tech Secures Series A Funding for Brain Dysfunction Digital Therapies
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Nans Tech, a brain dysfunction digital therapy developer based in Hangzhou, reportedly raised “tens of million” of renminbi in a Series A financing round, solely led by Shulan Junjie Capital. Proceeds will go towards product industrialization and regulatory filing, technology and product research and development, and clinical promotion. Company Background…
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Aclaris Therapeutics Licenses JAK Inhibitor ATI-1777 to Pediatrix for Greater China
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US-based Aclaris Therapeutics Inc. (NASDAQ: ACRS) and Shanghai firm Pediatrix Therapeutics Inc. entered into a license agreement, with Pediatrix taking on development, manufacturing, and commercial rights in Greater China to Aclaris’s ATI-1777. ATI-1777 is a Janus kinase (JAK) 1/3 inhibitor, while Pediatrix is granted rights for any indication including atopic…
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ImmuneOnco Initiates Phase II Clinical Study for CD47 Antibody IMM01
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the initiation of a Phase II clinical study for its investigational drug IMM01, an antibody targeting the cluster of differentiation 47 protein (CD47), in combination with a programmed-death 1 (PD-1) inhibitor for the treatment of solid tumors and lymphomas. This marks a significant…
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Luye Pharma’s Shandong Boan Bio Files for Hong Kong IPO
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange. Key details of the IPO filing remain undisclosed at this stage. Company BackgroundFounded in 2013, Boan Bio has previously raised a total of…
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Luca Healthcare Partners with Cambridge Cognition to Launch Cognitive Tools in China
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China-based digital health solutions provider Luca Healthcare has announced a strategic partnership and license agreement with UK firm Cambridge Cognition. Under the agreement, Luca has secured a 10-year exclusive license to commercialize Cambridge Cognition’s suite of cognitive assessment tools in mainland China. Financial details of the agreement were not disclosed.…
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Luye Pharma’s Biosimilar to Amgen’s Xgeva Launched in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the…
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Double-Crane Pharma Gains NMPA Approval for COVID-19 Drug CX2101A Clinical Trials
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China. CX2101A Technology and DevelopmentCX2101A is a…
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Assure Tech Wins Japanese PDMA Approval for Pen-Type COVID-19 Antigen Test
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China-based Assure Tech (Hangzhou) Co., Ltd (SHA: 688075) has announced receiving marketing approval from Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) for its novel coronavirus antigen detection reagent (pen type). This approval marks a significant milestone for the company in expanding its presence in the global diagnostics market. Product DetailsThe…
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Lepu Medical Wins NMPA Approval for Disposable Pressure Microcatheter
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced receiving Category III device approval (No. 20223071559) from the National Medical Products Administration (NMPA) for its in-house developed disposable pressure microcatheter. This approval marks a significant milestone in the company’s efforts to enhance precision in…
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Hainan Hospital Launches IBI’s Smartbone ORTHO for Bone Repair
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The clinical application of Smartbone ORTHO, a polyester collagen bone repair material introduced by Hainan Susheng Biotechnology from Swiss firm IBI, has been indicated on the website of China’s National Development and Reform Commission (NDRC). The material is being used at Ruijin Hospital’s branch in the Bo’Ao Lecheng Medical Tourism…
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CSL Vifor and Fresenius Kabi Win China Approval for Ferinject
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Swiss firm CSL Vifor and Germany’s Fresenius Kabi have announced the first regulatory approval in China for Ferinject (ferric carboxymaltose), an iron deficiency treatment used to manage anemia in patients with chronic kidney disease and those undergoing surgery. The drug is indicated for adults with iron deficiency for whom oral…
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China’s Pharma Firms Collaborate on Generic Version of Sun Pharma’s Carbamazepine
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Several China-based pharmaceutical companies, including Shanghai Zhongxi Sunve Pharmaceutical Co. Ltd, Shanghai Anbison Lab Co., Ltd, Qingdao BAHEAL Pharmaceutical Co., Ltd, and SPH Pharmaceutical Sales Co., Ltd, have agreed to collaborate on the development and marketing of Anbison Lab’s first generic version of carbamazepine sustained-release tablets (II) in China. The…
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Youcare’s YKYYO17 Aerosol Inhalation Agent Approved for COVID-19 Clinical Study
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China-based Youcare Pharmaceutical Group’s YKYYO17 aerosol inhalation agent, a broad-spectrum coronavirus membrane fusion inhibitor polypeptide drug, has been approved in China for a clinical study in COVID-19 infection. Drug Mechanism and DevelopmentThe Category 1 drug candidate, co-developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences, can play…
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Henan Celnovte Biotechnology Raises RMB 100M in New Financing Round
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China-based Henan Celnovte Biotechnology Co., Ltd, a tumor in vitro diagnostic reagents (IVDs) and instruments maker, reportedly raised RMB 100 million (USD 14.15 million) via another financing round. Investors included Puhua Capital, Henan Hi-Tech Venture Capital, Zhengzhou High Tech Industry Investment Fund, and Zhong Yuan Lian Chuang Capital. Company Background…
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Clover Biopharmaceuticals’ SCB-2019 Vaccine Reduces Household Transmission of COVID-19
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China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced that Clinical Infectious Diseases has published additional data from SPECTRA, a global Phase II/III clinical trial, that showed vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of transmitting SARS-CoV-2 infection to household members, compared to placebo participants. Trial Results and ImplicationsThere…
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Ascletis Pharma Completes Enrollment for ASC40 Phase II Acne Study
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the completion of enrollment of 180 patients in a Phase II clinical study for ASC40 (denifanstat). The molecule is set to be assessed in treating moderate to severe acne. The study is currently still blinded. Study Design and ObjectivesThe randomized, double-blind, placebo-controlled, multicenter…
