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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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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…
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Kanghong Pharma Receives FDA Approval for KH631 Gene Therapy Trial
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. KH631 ProfileKH631…
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Saint Medical Raises Pre-Series B Funding for Structural Heart Disease Solutions
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Saint Medical Technology, a Nanjing-based medical device maker specializing in valvular disease solutions, has reportedly raised “tens of millions” of renminbi in a Pre-Series B financing round. The round was led by Jinpu Intelligent Manufacturing Fund, with participation from Wuxi Capital and Hexingcheng Fund. The proceeds will be used to…
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Frontier Biotechnologies Gains CDE Approval for FB2001 COVID-19 Inhalant Study
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China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase II/III clinical study assessing its FB2001 atomized inhalant bofutrelvir in mild and common COVID-19 patients. This marks a significant step forward in the development of innovative treatments for COVID-19.…
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Alphamab Oncology and CSPC Announce Positive Phase II Data for KN026 in HER2-Positive Gastric Cancer
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The…
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Kexing Pharma Receives Ethical Approval for Phase II Study of SHEN26 COVID-19 Drug
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China-based Kexing Pharmaceutical (SHA: 688136) has announced receiving ethical approval to conduct a Phase II clinical study for its SHEN26, an oral small-molecule COVID-19 drug co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. The study aims to assess the efficacy and safety of SHEN26 in mild and common COVID-19 cases. Study…
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Kintor Pharma’s GT20029 Shows Positive Results in Phase I Study for Androgenetic Alopecia and Acne
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive results from a Phase I clinical study in China for its GT20029, which is being developed to treat androgenetic alopecia and acne. The study demonstrated that GT20029 has a good safety, tolerability, and pharmacokinetics profile. Study DetailsThe randomized, double-blind, placebo-controlled Phase…
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FibroGen Sues Former Employees and Two Pharma Firms for Trade Secret Theft
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US-based FibroGen Inc. has filed a lawsuit against two former employees, Liu Dong and Deng Shaojiang, accusing them of trade secret theft. The case, filed with the US District Court for the Northern District of California, also names two pharmaceutical firms as co-defendants: US-based Kind Pharmaceuticals LLC and China-based Hangzhou…
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JS InnoPharm and Strategia Holdings Form JSI Ventures in Boston
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Shanghai-based JS InnoPharm Ltd has announced an agreement with US firm Strategia Holdings LLC to establish JSI Ventures Inc. (JSV) in Boston, Massachusetts. The new venture aims to comprehensively integrate management teams and new drug research and development (R&D) projects from both companies. Dr. Keizo Koya, founder of Strategia, will…
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Jianke.com Files for Hong Kong IPO with Focus on Chronic Disease Management
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China-based smart healthcare service platform Jianke.com (Fangzhou Inc.) has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. Citibank, UBS, and ABC International will act as co-sponsors. The filing marks a significant step in the company’s expansion plans, aiming to leverage its comprehensive healthcare services and…
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China’s First Gene Therapy for Deafness, RRG-003, Begins Clinical Study
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RRG-003, an adeno-associated virus (AAV) gene therapy co-developed by China’s Shanghai Dingxin Gene Technology Co., Ltd and the Eye & ENT Hospital of Fudan University, has initiated a clinical study targeting hearing loss in the country. This marks the first gene therapy trial for deafness, with the first patient expected…
