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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Swiss giant Novartis’ Gilenya (fingolimod). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Drug Background…
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China-based single-use bronchoscope specialist Hunan Vathin Medical Instrument Co., Ltd reportedly raised “hundreds of millions” of renminbi in a Pre-Series B financing round led by IDG Capital. Other investors included Founder Securities and Hunan Xiangtan Caixin Chanxing Equity Investment Partnership. The proceeds will be used to ramp up the company’s…
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The National Medical Products Administration (NMPA) has released a set of Guiding Opinions on “Medical Device Manufacturing and Operation Grading Administration,” aimed at strengthening supervision of medical device manufacturing and operation under the medical device marketing authorization holder (MAH) system. The guidelines will take effect on January 1, 2023. Regulatory…
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China-based Luye Pharma Group (HKG: 2186) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study of its LY03015. The study will assess the safety, tolerability, and pharmacokinetics of the next-generation vesicular monoamine transporter 2 (VMAT2) inhibitor. LY03015 is…
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced plans to incentivize its employees through a share distribution program. The company will repurchase up to 12 million shares at an average price of RMB 29.37 (USD 4.22) per share, with the transfer price set at RMB 4.41 (USD 0.63).…
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UK-based QuantuMDx Group Ltd announced a global R&D, manufacturing, and commercial partnership with China’s Sansure Biotech Inc. The collaboration aims to accelerate the market penetration and commercialization of QuantuMDx’s Q-POC platform and related assays in China. Q-POC is a rapid, portable multiplex PCR device designed for real-world healthcare settings and…
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China’s Beijing InnoCare Pharma (HKG: 9969) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed BCL2 inhibitor, ICP-248. This Category 1 innovative drug becomes the company’s fifth drug to reach clinical trials in the blood cancer field…
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) presented the latest results of the global Phase III RATIONALE 301 study evaluating tislelizumab in first-line unresectable hepatocellular carcinoma (HCC) at the 2022 European Society for Medical Oncology (ESMO) meeting. The study, which enrolled 674 patients in the US, Europe, and Asia, met…
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s BA-CovMab, a broad-spectrum neutralizing antibody against COVID-19, has obtained clinical trial approval from the National Medical Products Administration (NMPA). Mechanism of ActionBA-CovMab is a recombinant fully human monoclonal neutralizing antibody obtained through sequential immunization and…
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Beijing-based neuromodulation medical device maker Leadinno Medical Valley reportedly raised over RMB 100 million (USD 14.4 million) in a Series A financing round led by Proxima Ventures and Med-Fine Capital. Other investors included TigerYeah Capital, Maron Investment, and Cowin Capital. The proceeds will be used for research and development (R&D)…
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) announced interim safety and efficacy data from a Phase I/II study of TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody (mAb), in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.…
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct separate clinical trials for its Category 1 biologic product TG103 in non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease (AD). This marks a significant step forward in the development…
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020) announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its in-licensed products JBPOS0101 and JX7002. JBPOS0101 is being assessed for focal epilepsy in adults, while JX7002 is under development for hypercholesterolemia and mixed hyperlipidemia. JBPOS0101: A First-in-Class…
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Chinese researchers have published 66-month follow-up data from a Phase III clinical study for the bivalent human papillomavirus (HPV) vaccine Cecolin, co-developed by Xiamen Innovax Biotech Co., Ltd and Xiamen University. The vaccine, approved in China since December 2019, demonstrated 100% protective efficacy against high-grade genital lesions associated with HPV…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) combined with bevacizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. Ongoing…
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The Ministry of Commerce (MofCOM) released its annual statistical review of the pharma distribution industry for 2021, highlighting steady growth and recovery to pre-pandemic levels. The report indicates that the national pharmaceutical distribution market has rebounded, with total sales of the seven major categories of pharmaceutical commodities (including devices and…
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The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in…
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China-based Realcan Pharmaceutical Group Co., Ltd (SHE: 002589) and Amazon Web Services (AWS) have agreed on a second phase partnership, with AWS becoming Realcan’s preferred cloud service provider to support its digital transformation. Financial details of the deal were not disclosed. Building on a Strong FoundationThe two companies first partnered…
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Sweden-based Salipro Biotech AB announced that its core technology for stabilizing membrane proteins for drug development has been granted patent protection in China and the United States. The patent, titled “Saposin lipoprotein particles and libraries from crude membranes,” has been awarded by the China National Intellectual Property Administration (Chinese Patent…
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the first subject dosing in a Phase I clinical study for its STP705, targeting adult abdominal fat reduction. The study, expected to report results during the first half of 2023, marks a significant step forward in the development of non-invasive…