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Peijia Medical Announces First Patient Implant in MonarQ TTVR System Clinical Study
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China’s Peijia Medical Limited (HKG: 9996) has announced the first patient implant in a global first-in-man (FIM) clinical study of its MonarQ transcatheter tricuspid valve replacement (TTVR) system. This marks a significant milestone in the development of innovative treatments for tricuspid regurgitation. MonarQ TTVR System ProfileThe MonarQ TTVR system is…
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Zhejiang Dian Diagnostics Partners with Chengdu Eastern New Area for IVD Hub
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China-based Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244) has announced a strategic partnership with Chengdu Eastern New Area, focusing on medical diagnosis services, diagnostics development, and other related areas. The collaboration includes plans to establish a domestic in vitro diagnostics (IVD) manufacturing center in the region. Financial details of the…
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Anyeep Raises RMB 100 Million in Series A Financing for Mass Spectrometry Development
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Anyeep, a Suzhou-based developer of mass spectrometers, has reportedly raised close to RMB 100 million (USD 13.96 million) in a Series A financing round. The round was led by Greenriver Capital, with participation from Dunhang Investment, PEAKVEST FOF, and existing investors Frees Fund and Yuanbio Venture Capital. The proceeds will…
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Shanghai Henlius Biotech to Provide R&D Services for COVID-19 Therapy Azvudine
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China-based Shanghai Henlius Biotech (HKG: 2696) has entered into an agreement to provide clinical study research and development (R&D) services for the COVID-19 therapy azvudine to compatriot firms HeNan Genuine Biotech Co., Ltd and Shanghai Fosun Pharmaceutical Development Co., Ltd. The services will focus on COVID-19 prevention and include clinical…
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China Resources Double-Crane Gains Approval for Definity in China
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving market approval from the National Medical Products Administration (NMPA) to act as the domestic agent for Definity (perflutren lipid microsphere injection). The contrast agent can now be used to enhance the recognition of the left ventricular endocardial boundary when…
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XtalPi Partners with CK Life Sciences to Develop AI Cancer Vaccine Platform
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has struck a partnership with China-based CK Life Sciences to develop an AI cancer vaccine research and development (R&D) platform. The collaboration aims to leverage the respective strengths of both companies to advance the development of AI-driven cancer vaccines. Financial details of the…
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Bliss Bio’s BB-1709 Accepted for Review by China’s CDE
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Hangzhou-based oncology-focused clinical stage biotech Bliss Bio has announced that its clinical filing for the Category 1 therapeutic biologic product injectable BB-1709 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BB-1709, a potential first-in-class antibody drug conjugate…
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Xiling Lab Raises RMB 100 Million for ADC Development and IND Filing
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Xiling Lab, a Chengdu-based drug developer specializing in catalytic synthesis technology, has reportedly raised close to RMB 100 million (USD 13.96 million) in a Pre-Series B financing round. Investors included Chengdu Bio City No. 1 Equity Investment Fund, Chengdu Gaoxin New Economy Venture Capital, Pengzhou Global Biomedical Technology Achievement Transformation…
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PrimeLink Bio Raises Funds for ADC Development and R&D Expansion
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Shenzhen-based drug developer PrimeLink Bio has reportedly raised “hundreds of millions” of renminbi in a new financing round led by Vertex Ventures. Fosun Pharma and Kaitai Capital also participated in the round. The proceeds will be used to support technology research and development (R&D), talent recruitment, and laboratory construction. Company…
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AnchorDx’s UriFind Receives Breakthrough Therapy Designation for Urothelial Carcinoma
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China-based Guangzhou AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing, has obtained a breakthrough therapy designation for its urothelial carcinoma (UC) early diagnostic product UriFind. This marks the first such designation for a Chinese product in this category. The urine DNA methylation detection is being fast-tracked for approval…
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Visen Pharmaceuticals Files for Hong Kong IPO with Focus on Growth Hormone
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Visen Pharmaceuticals, a China-based joint venture between Denmark-headquartered Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange. Morgan Stanley and Jefferies are acting as co-sponsors. The proceeds will be used to support research and development (R&D)…
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Junshi Biosciences Files for UK Approval of PD-1 Inhibitor Tuoyi
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has filed for market approval with the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The filing seeks approval for the checkpoint inhibitor in combination with chemotherapy as a…
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CSPC Pharmaceutical Reports Q3 2022 Financials with 13.8% Revenue Growth
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has released its Q3 2022 financial results, reporting a 13.8% year-on-year (YOY) increase in revenues to RMB 23.496 billion (USD 2.87 billion). The growth was driven by increases across multiple business segments, including on-patent medicines, raw material products, and functional food. Revenue Breakdown…
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Tianjin Tianyao Fined for Anti-Monopoly Violations in Carmustine Sales
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China-based Tianjin Tianyao Pharmaceutical Co., Ltd (SHA: 600488) has been fined RMB 27.72 million (USD 3.77 million) by the Tianjin Administration for Market Regulation. The fine was imposed for the “abuse of market domination of carmustine in China by selling the product at an unfairly high price,” which violates Item…
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China Releases Third Batch of VAT Discounts for Anti-Tumor and Rare Disease Drugs
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The Ministry of Finance, General Administration of Customs, State Taxation Administration, and National Medical Products Administration have jointly released the third batch list of anti-tumor drugs and rare disease drugs eligible for a value-added tax (VAT) discount. Starting from December 1, 2022, a total of 46 anti-tumor drugs and 19…
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OrbusNeich Files for IPO on Hong Kong Stock Exchange
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Vascular intervention specialist OrbusNeich Medical Group Limited, a Wholly Owned Foreign Enterprise (WOFE) based in Shenzhen, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange (HKSE). Details regarding the pricing and timing of the IPO have yet to be released. Company ProfileOrbusNeich is a leading…
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Immorna’s JCXH-221 mRNA Vaccine Cleared by FDA for Phase I/II Study
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Immorna (Hangzhou) Biotechnology Co., Ltd has announced that the US FDA has cleared its investigational new drug (IND) application to conduct a Phase I/II multi-center study assessing the safety and immunogenicity of JCXH-221, a lipid nanoparticle (LNP) complex broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases, in healthy adult…
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Henlius Biotech Partners with Shantou Central Hospital for Clinical Study Collaboration
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced a strategic clinical study cooperation agreement with Shantou Central Hospital. The partnership aims to leverage Henlius’s clinical development and operational expertise with Shantou Central Hospital’s leading disciplinary advantages and comprehensive medical service capabilities. The collaboration will focus on scientific research exchange, personnel…
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AnchorDx Initiates US Registrational Study for UriFind Urothelial Carcinoma Diagnostic
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China-based AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing, has announced the initiation of a registrational clinical study for its urothelial carcinoma (UC) early diagnostic product UriFind in the United States, alongside the enrollment of the first patient. The study aims to verify UriFind’s performance and support the…
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Biocytogen Announces Successful Development of Fully-Human Nano Antibody RenNano
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Biocytogen (Beijing) Co., Ltd has announced the successful research and development of a fully-human nano antibody RenNano, following its previous achievements with RenMab and RenLite. The China-based Contract Research Organization (CRO) is now capable of developing fully-human monoclonal antibodies (mAbs), fully-human bispecific antibodies (BsAbs), and fully-human nano antibodies. RenNano ProfileThe…
