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Genmab’s HexaBody-CD38 Clinical Development Halted After J&J Opt-Out
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Denmark-based Genmab A/S (NASDAQ: GMAB) announced that US giant Johnson & Johnson (J&J, NYSE: JNJ) has decided not to exercise its option to obtain a worldwide license for the development, manufacturing, and commercialization of HexaBody-CD38 (GEN3014). Consequently, clinical development of the drug will be terminated. The decision was based on…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Wins New NMPA Approval for NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its sacituzumab tirumotecan (SKB264/MK-2870). The approval allows the use of this TROP2-targeted antibody drug conjugate (ADC) in adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell…
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Illumina Responds to Chinese MOFCOM Notice Amid Sequencing Instrument Export Ban
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US major Illumina (NASDAQ: ILMN), which was included in a list of unreliable entities issued by China’s Ministry of Commerce (MOFCOM) earlier this year, has responded to the notice from MOFCOM on March 4, 2025. The company faces a prohibition on exporting sequencing instruments into China and has stated its…
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Huadong Medicine Seeks Regular Approval for Elahere in Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to regular approval for Elahere (mirvetuximab soravtansine) has been accepted by the National Medical Products Administration (NMPA). This antibody drug conjugate (ADC) targets folate receptor α (FRα) and represents a significant step forward in the treatment…
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Hansoh Pharmaceutical’s Ameile Wins New NMPA Approval for Advanced NSCLC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Ameile (almonertinib). The epidermal growth factor receptor (EGFR) inhibitor is now approved to treat unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive non-small…
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IMEIK Technology Development Co.,Ltd Acquires Majority Stake in REGEN Biotech via Joint Venture
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China-based IMEIK Technology Development Co.,Ltd (SHE: 300896) announced the establishment of Imeik International Limited, a joint venture with Aisheng Shourui (HK) Limited. The primary objective of this joint venture is to acquire 85% stakes in South Korea-headquartered REGEN Biotech, Inc. for USD190 million. As part of this transaction, IMEIK will…
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Lundbeck’s Amlenetug Receives Orphan Drug Designation in Japan for Multiple System Atrophy
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Denmark-based pharmaceutical company Lundbeck A/S (OTCMKTS: HLUBF) announced receiving Orphan Drug Designation (ODD) from Japan’s Ministry of Health, Labor, and Welfare (MHLW) for its investigational drug amlenetug. This designation positions amlenetug as a promising new treatment option for patients with multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder.…
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Shenzhen GeneMind Biosciences Partners with Precisiongenes for Molecular Diagnostic Innovation
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China-based gene sequencer specialist Shenzhen GeneMind Biosciences Co., Ltd. has formed a partnership with compatriot firm Precisiongenes Technology, Inc., a high-tech company focused on gene identification and analysis. The collaboration aims to explore the innovation and clinical application of molecular diagnostic technology. Leveraging ExpertiseGeneMind brings to the partnership its extensive…
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Juvensis Therapeutics Secures RMB100 Million for Heart Gene Therapy Development
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Shanghai-based Juvensis Therapeutics, a specialist in anti-aging therapies, reportedly raised upwards of RMB100 million (USD13.8 million) via a Pre-Series A financing round. Led by Growth FoF, the funding included contributions from Nanjing Jiangbei New Area Sci-tech Investment Group, Henry WU, and Shanghai Healthcare Capital, among others. The proceeds will be…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-4029 in Acute Ischemic Stroke
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for HRS-4029. The novel neuroprotective agent will now be assessed in a clinical study as a treatment for acute ischemic stroke (AIS). Preclinical FindingsPreclinical studies have demonstrated that HRS-4029 can…
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InnoCare Pharma Presents Positive Phase II Results of ICP-488 in Psoriasis at AAD Meeting
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the oral presentation of results from the Phase II study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor ICP-488 in psoriasis vulgaris at the American Academy of Dermatology Annual Meeting (AAD). The results demonstrate significant improvements in patients treated with ICP-488…
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Nona Biosciences Launches Hu-mAtrIx: AI-Driven Engine for Accelerated Antibody Drug Discovery
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), announced the introduction of Hu-mAtrIx, an innovative AI-assisted drug discovery engine. This platform marks a significant advancement in the field of antibody development, leveraging cutting-edge technology to enhance efficiency and success rates. Integrated Antibody Discovery PlatformNona’s Hu-mAtrIx platform enables…
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Sichuan Biokin Pharmaceutical Plans RMB3.9 Billion Private Placement for Novel Drug R&D
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced plans to raise up to RMB3.9 billion (USD537 million) through a private placement. The funds will be allocated to various novel drug research and development programs, furthering the company’s commitment to innovation in the biopharmaceutical sector. Funding AllocationThe proceeds from the…
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LiteDD’s LIT0922 Approved for Phase I Trial in Marker-Expressing Advanced Solid Tumors
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The Center for Drug Evaluation (CDE) of China has approved LiteDD’s Category 1 product LIT0922 to enter a Phase I clinical study in advanced solid tumors expressing specific markers. This approval marks a significant milestone for LiteDD in developing innovative therapies for oncology patients. Mechanism of ActionLIT0922 is positioned as…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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Jiangsu Cowin Biotech Obtains NMPA License for Gene Methylation Detection Kit
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China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide…
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Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved by EU for Hepatocellular Carcinoma
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US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive…
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Roche Launches Genentech Innovation Center in Boston to Accelerate Drug Development
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Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced the launch of the Roche Genentech Innovation Center Boston at Harvard’s Enterprise Research Campus in Allston. This new facility aims to strengthen longstanding partnerships in disease biology, engineering, and artificial intelligence/machine learning. CVRM Hub and AI IntegrationThe center will serve as Roche’s…
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Sansure Biotech Plans RMB130 Million Investment in Shenzhen GeneMind for Gene Sequencing Expansion
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) announced plans to invest RMB130 million (USD17.9 million) in compatriot firm Shenzhen GeneMind Biosciences Co., Ltd., a gene sequencer specialist. This investment aims to enhance Sansure’s industry chain layout in the gene sequencing sector and boost its comprehensive competitiveness. Transaction DetailsThe…
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AbbVie’s Skyrizi Approved by China’s NMPA for Moderate to Severe Crohn’s Disease
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US giant AbbVie (NYSE: ABBV) announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its Skyrizi (risankizumab). The drug is approved to treat adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response, or intolerance to traditional or biologic treatments. The…
