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Innovent Biologics’ Tyvyt Approved for First-Line Esophageal Squamous Cell Carcinoma
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The National Medical Products Administration (NMPA) website indicates that China-based Innovent Biologics, Inc. (HKG: 1801) has received approval for a new indication of its PD-1 inhibitor Tyvyt (sintilimab) for the treatment of first-line esophageal squamous cell carcinoma (ESCC). This marks the fifth indication approval for the drug in China. Drug…
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China’s Seventh National Volume-based Procurement Round Kicks Off with Revised Rules
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China’s health authorities have resumed the seventh national volume-based procurement (VBP) round after a pandemic-related delay. The Shanghai Sunshine Medical Procurement All-in-One (SMPA) platform has issued a notification outlining the bidding and procurement rules for 61 drug varieties across 147 specifications. The round will involve nearly 300 manufacturers, with competitive…
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Shenzhen AXBio Closes USD 100 Million Series B Round for Sequencing Tech Expansion
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Shenzhen-based fourth-generation sequencing company Anxuyuan Biotechnology (shenzhen) Company Limited (AXBio) has reportedly secured close to USD 100 million in a Series B financing round. The funding was co-led by AstraZeneca CICC Medical Fund and YF Capital, with participation from C-Bridge Capital, SDIC China Merchants Capital, and 5Y Capital. The proceeds…
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Boston Scientific Launches Expect Airway Ultrasound Needle in China for Lung Cancer Diagnosis
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US-based Boston Scientific Corporation (NYSE: BSX) has announced the official market launch of its Expect airway ultrasound needle in mainland China. The product is designed for use in transbronchial needle aspiration biopsies guided by endoscopic ultrasonography, offering a significant advancement in lung cancer diagnosis. Product Innovation and AdvantagesThe Expect airway…
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Iomics Biosciences Secures RMB 100 Million for Proteomics and Spatialomics Expansion
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Beijing-based Iomics Biosciences Co., Ltd, a developer of gene sequencing and diagnostic equipment, has reportedly secured close to RMB 100 million (USD 14.96 million) in a Series A financing round co-led by Oriza Seed and Apricot Capital. The proceeds will be directed toward advancing technology platforms in proteomics and spatialomics,…
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InnoCare and Keymed Biosciences’ CCR8-Targeted mAb CM369 Accepted by NMPA
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China-based InnoCare (HKG: 9969) and Keymed Biosciences Inc. (HKG: 2162) announced that an Investigational New Drug (IND) filing for CM369, a monoclonal antibody targeting C-C chemokine receptor 8 (CCR8), has been accepted for review by the National Medical Products Administration (NMPA). This potential first-in-class drug is designed to enhance tumor-targeted…
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CDE Releases 58th and 59th Batches of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 58th and 59th batches of chemical generic reference preparations, adding 15 and 59 new specifications respectively. The public feedback deadlines for these batches are May 10 and June 30, 2022. Updates and FeedbackThe 58th and 59th batches saw 28 and 32…
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Shenzhen’s LWPOCT Secures RMB 100 Million in Series A Round for CDMO Expansion
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Shenzhen-based medical devices and reagents manufacturer Shenzhen Living Water POCT Co., LTd (LWPOCT) has reportedly secured RMB 100 million in a Series A financing round. The funding was led by Shenzhen Guochuang Zhiyuan Private Equity Fund Management, Shenzhen Ruihai Private Equity Investment Fund Management, VDO Biotech, Shenzhen Qianhai Zhouyu Investment…
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Henlius Biotech Begins Global Phase III Trial for Denosumab Biosimilar HLX14
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first patient dosing in a global multi-center Phase III clinical study for its drug candidate HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab). The study targets the treatment of postmenopausal osteoporosis in women at high risk of fracture. Clinical Trial DesignThe…
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Cellular Biomedicine Group’s C-CAR039 Receives NMPA Approval for B-Cell NHL Study
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China-based Cellular Biomedicine Group Inc. (CBMG), a private company following a merger deal in February last year, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study of its chimeric antigen receptor (CAR)-T cell therapy C-CAR039 in patients with relapsed or refractory…
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Global Cord Blood Corp’s Cellenkos Gets FDA Nod for Myelofibrosis Trial
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Global Cord Blood Corporation (GCBC; NYSE: CO) announced receiving Investigational New Drug (IND) approval from the US FDA for its subsidiary Cellenkos’ pipeline candidate CM0804. The FDA clearance allows Cellenkos to initiate a Phase Ib, open-label study for CM0804 as an add-on therapy to ruxolitinib in patients with myelofibrosis who…
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Hangzhou Tongee Medical Closes RMB 100 Million Series B Round for Gastric Bypass Stent
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Hangzhou Tongee Medical Technology Co., Ltd, a Chinese device maker specializing in metabolic disease treatments, has secured close to RMB 100 million (USD 14.9 million) in a Series B financing round. The funding, led by Topping Capital and Guolian Group, will support a regulatory clinical study for its gastric bypass…
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Walvax’s mRNA Vaccine AWcorna Shows Superior Immune Response in Phase III Trial
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Walvax Biotechnology Co., Ltd’s (SHE: 300142) mRNA vaccine against SARS-CoV-2, named AWcorna, has reached the Phase III stage in multiple trial centers. The randomized trial (ChiCTR2100053701), led by the Academy of Military Medical Sciences and the Guangzhou Institute of Respiratory Health, enrolled 300 adults who had previously received two doses…
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Tianhe-2 Supercomputer Aids Drug Discovery with Deep-Learning Biosynthetic Tool
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China’s Tianhe-2 supercomputer, ranked among the top-10 fastest computers globally, has demonstrated potential in enhancing drug discovery through a Sino-US research collaboration. Scientists from Sun Yat-sen University, Beijing-based AI startup Galixir, and researchers from the Georgia Institute of Technology and the Massachusetts Institute of Technology developed a deep-learning-based toolkit called…
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Shanghai Pharmaceuticals Licenses Benapenem and Plazomicin from Xuanzhu Bio for Greater China
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China-based pharmaceutical giant Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) announced a licensing agreement with compatriot firm Xuanzhu Biopharmaceutical Co., Ltd. Under the terms, Shanghai Pharma secures exclusive rights (including sub-licensing, manufacturing, development, and sales) to Xuanzhu Bio’s benapenem and plazomicin in Greater China (mainland China, Hong Kong, Macau, and Taiwan).…
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Sichuan Meida’s Phentolamine Gains Priority Review for Pheochromocytoma Treatment
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Meida Kangjiale Pharmaceutical Co., Ltd’s phentolamine has obtained priority review status as a “clinically urgent, in-shortage drug.” This non-selective alpha-adrenoceptor antagonist is used to control paroxysmal hypertension in patients with pheochromocytoma before and during surgery. Clinical Application and MechanismPhentolamine is…
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Mabwell’s 6MW3511 Accepted by NMPA for Advanced Solid Tumor Treatment
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that a clinical trial filing for its 6MW3511 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company’s innovative oncology pipeline. Drug Mechanism and Innovation6MW3511 is a bifunctional protein linking an…
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NMPA Approves 164 Medical Devices in May 2022, Including Medtronic and Boston Scientific Products
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The National Medical Products Administration (NMPA) approved a total of 164 medical devices for marketing in May 2022. The approvals included 109 domestic Class III products, 23 imported Class III products, 30 imported Class II products, and 2 products from “special administrative regions.” Notable ApprovalsAmong the approved devices were offerings…
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Boao Lecheng Sees Surge in Drug Use and Medical Tourism Amid Global Partnerships
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The Boao Lecheng Medical Tourism Pilot Zone reported a significant increase in special drug and device users, up 431% year-on-year (YOY) in 2021. Medical tourist numbers surged 90.57% YOY to 127,300, according to China News, with the area welcoming 40,000 medical tourists in Q1 of this year, marking a 60%…
