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Peijia Medical Enrolls First Patient in GeminiOne TEER System Study
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China’s Peijia Medical Ltd (HKG: 9996) announced first patient enrollment in a multi-center clinical study for its transcatheter edge-to-edge repair (TEER) system GeminiOne in China. The first operation went smoothly, with the whole device being manipulated for a mere 30 minutes. The prospective regulatory, multi-center, target value study is designed…
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NMPA Approves Henlius’ HLX04 Biosimilar for Lung and Colorectal Cancer
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The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth…
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Yifan Pharma Transfers F-627 Distribution Rights in Germany to Apogepha
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the transfer of exclusive distribution rights in Germany to its efbemalenograstim alfa (F-627), to Apogepha Arzneimittel GmbH. The German firm will pay Yifan Pharma a USD 400,000 upfront payment, up to USD 1 million development milestone payment, and up to USD 37.5…
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Pyxis Oncology Receives FDA Approval for Biosion’s PYX-106 Clinical Trials
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China-based Biosion, Inc’s US partner Pyxis Oncology, Inc. (NASDAQ: PYXS) announced receiving clinical trial approval from the US FDA for its PYX-106 (BSI-060T). The anti-Siglec-15 monoclonal antibody (mAb) can now be assessed in clinics in bladder cancer, bile duct cancer, colorectal cancer, kidney cancer, and more. Preclinical Data and Drug…
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Eli Lilly Ends License for Innovent’s Tyvyt Outside China
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Eli Lilly & Co’s (NYSE: LLY) Q3 2022 SEC filing released last month revealed that the US major has decided to end its license to develop the programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab) in markets outside of China. In a single sentence, Lilly noted that the license deal signed with…
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Novartis Partners with Sinopharm for Commercial Promotion of Gleevec and Exjade in China
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Swiss giant Novartis (NYSE: NVS) entered into a promotion agreement with China-based Sinopharm Group Co., Ltd, handing the latter commercial promotion rights to its Gleevec (imatinib) and Exjade (deferasirox) in China. The tie-up will explore innovative business cooperation models, make use of domestic third-party commercialization platforms to maximize the accessibility…
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Luye Pharma Partners with Nhwa and Fine Hin to Commercialize Toludesvenlafaxine
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China-based Luye Pharma Group (HKG: 2186), Jiangsu Nhwa Pharmaceutical Co., Ltd (SHE: 002262), and Beijing Fine Hin Mobile Medical Technology Co., Ltd have agreed to leverage their respective expertise, platform advantages, and commercialization resources to bolster the commercialization of Luye’s Category 1 chemical drug toludesvenlafaxine (LY03005), an extended-release treatment for…
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Pediatrix Therapeutics Licenses Tris Pharma’s ADHD Portfolio for Greater China
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China-based Pediatrix Therapeutics announced a licensing agreement with US firm Tris Pharma, Inc., obtaining exclusive commercialization rights to the latter’s entire FDA-approved attention-deficit hyperactivity disorder (ADHD) portfolio, as well as pipeline products. The deal covers the territory of greater China, including mainland China, Hong Kong, Macau, and Taiwan. No financial…
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Hainan’s New Regulations on Medical Devices in Boao Lecheng to Take Effect in 2023
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The “Regulations on the Administration of Medical Devices in Boao Lecheng International Medical Tourism Pilot Zone, Hainan Free Trade Port,” approved by the Standing Committee of Hainan Provincial People’s Congress, is set to take effect as of January 1, 2023. The document is applicable to medical and health services, and…
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Kintor’s KX-826 Reaches Primary Endpoint in Phase II Study for Female AGA
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced that the Phase II clinical study for its AR antagonist KX-826 (pyrilutamide) in female patients with androgenetic alopecia (AGA) in China has reached the primary endpoint. Study Design and ResultsThe randomized, double-blind, placebo-controlled, multicenter study, with 160 patients enrolled, is designed to assess…
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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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AI Model for Early Alzheimer’s Detection Using Retinal Photographs Published
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A joint Singapore-UK-Hong Kong research team has published details of an AI-based deep learning model that will help the early detection of Alzheimer’s disease using retinal photographs. The team trained a model by enrolling 648 people with Alzheimer’s and 3,240 without, taking over 12,000 retinal photographs. The model achieved an…
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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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China’s NMPA Issues New GSP Appendix for Drug Retailing Quality Management
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China’s National Medical Products Administration (NMPA) has released “Good Supply Practice (GSP) Appendix 6: Quality Management of Drug Retailing Delivery,” which will be effective from January 1, 2023. The new regulation aims to further standardize drug retailing delivery activities and ensure the quality and safety of drugs throughout the supply…
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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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China’s NMPA Seeks Feedback on Drug Quality Management Provisions
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China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Provisions on the Supervision and Administration of Marketing Authorization Holder Implementing Drug Quality Subject Responsibilities,” and is soliciting public feedback until December 9. The document aims to enhance the quality management responsibilities of Marketing Authorization Holders (MAHs) in…
