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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…
