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Frontera Therapeutics Advances to Phase II with FT-003 for Diabetic Macular Edema
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Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). This follows previous clearance for a Phase II…
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Johnson & Johnson’s Rybrevant Combo Approved by EC for First-Line NSCLC Treatment
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US healthcare giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that the European Commission (EC) has granted label extension approval for its Rybrevant (amivantamab) combined with Lazcluze (lazertinib) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 19 deletions…
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BeiGene Secures Global Rights to Duality Biologics’ B7H4 Targeted ADC DB1312/BG-C9074
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Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China, has announced that BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has exercised its exclusive option to secure global development, manufacturing, and commercialization rights to Duality’s B7H4 targeted antibody-drug conjugate (ADC), DB1312/BG-C9074. Terms…
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Novartis Announces Positive Results from Phase III STEER Study on SMA Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive topline results from the Phase III STEER study, which was designed to assess the efficacy and safety of its intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2. The study focused on patients aged two…
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10th National VBP Round Results Announced: Contracts Worth Over RMB1.3 Billion
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The national Volume-Based Procurement (VBP) authorities have released comprehensive details regarding the 10th VBP round, including volumes and regions awarded to winning bidders. According to Fineline Info & Tech‘s calculations, the full round, covering 196 companies with winning bids, was valued at over RMB1.3 billion (USD 178 million) in contracts.…
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Xtalpi Inc. Partners with Amazon Web Services to Accelerate Life Sciences Innovation
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Shenzhen-based QuantumPharm Inc., operating under the name Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with US-based Amazon Web Services (AWS). AWS will serve as Xtalpi’s cloud service provider, empowering the company to enhance its innovative development in life science, chemistry, and new materials through the use of artificial…
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Jiangxi Jemincare Group Gets NMPA Approval for Prostate Cancer Drug JMX-2006
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China-based Jiangxi Jemincare Group has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) to test its Category 2.2 modified drug, JMX-2006, in prostate cancer. JMX-2006: An Innovative Sustain-Released Preparation for Prostate CancerJMX-2006 is an innovative sustain-released preparation designed to offer less frequent dosages,…
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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2219 in China
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of an investigator-initiated-trial (ITT) for its chimeric antigen receptor (CAR)-T therapy candidate product, KJ-C2219, in China. The trial is aimed at treating recurrent/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). KJ-C2219: A Universal CAR-T Therapy Targeting CD19 and CD20KJ-C2219 is a…
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We Doctor Holdings Limited Files for IPO on Hong Kong Stock Exchange
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China-based We Doctor Holdings Limited, a subsidiary of Chinese internet giant Tencent Corporate Venture Capital (HKG: 0700), has made an initial public offering (IPO) filing with the Hong Kong Stock Exchange. At this stage, no unit price or additional details have been disclosed. We Doctor’s AI-Based Healthcare SolutionsWe Doctor offers…
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Shinva Medical Instrument to Acquire Stake in Wuhan Zhongzhi Biotechnologies for IVD Expansion
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China’s Shinva Medical Instrument Co., Ltd (SHA: 600587) has announced its intention to acquire a significant stake in Wuhan Zhongzhi Biotechnologies Inc. (836834), purchasing 36.1913% of the company’s shares for RMB166.5 million (USD22.8 million). Zhongzhi Bio’s Focus on RNA Molecule IVD KitsFounded in 2011, Zhongzhi Bio is a company dedicated…
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Hinova Pharmaceuticals’ HP568 Earns FDA Clinical Trial Approval for ER+/HER2- Breast Cancer
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Chengdu-based biotech Hinova Pharmaceuticals Inc., (SHA: 688302) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, HP568. The Chinese firm plans to test HP568 in patients with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative…
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CanSino Biologics’ Menhycia Receives Market Approval in Indonesia
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China-based CanSino Biologics (HKG: 6185) has received market approval from the Badan Pengawas Obat dan Makanan (BPOM) of Indonesia for its ACYW135 Meningococcal Conjugate Vaccine (CRM197), commercially known as Menhycia. Menhycia: Protection for Infants and Young ChildrenMenhycia is indicated for infants and young children aged between 3 months to 3…
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CSPC Pharmaceutical Group Receives NMPA Approval for SYH9016 Clinical Study in Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its GnRH receptor agonist, SYH9016, in the treatment of solid tumors. SYH9016: A Modified Leuprorelin Product for Solid TumorsSYH9016 is a novel modified…
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MicuRx Pharmaceuticals’ MRX-5 Receives FDA Orphan Drug Designation for NTM Infections
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its in-house developed antibiotic, MRX-5, for the treatment of non-tuberculosis Mycobacterium (NTM) infections. MRX-5: A Promising New Antibiotic for NTMMRX-5 is a novel benzodiazole antibiotic specifically designed to…
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Hengrui Pharmaceuticals and IDEAYA Biosciences Ink Licensing Deal for SHR-4849
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced a significant licensing agreement with US-based IDEAYA Biosciences Inc., (NASDAQ: IDYA). Under this agreement, Hengrui will grant IDEAYA development, manufacturing, and commercialization rights to its novel DLL3-targeting Topo-I-payload antibody drug conjugate (ADC), SHR-4849, for markets worldwide outside of Greater China. Financial…
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CARsgen Therapeutics’ Satricabtagene Autoleucel Shows Positive Results in Phase II Study
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing…
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argenx’s Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
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Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can…
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Daiichi Sankyo’s Datroway Approved in Japan for HR+, HER2- Breast Cancer
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Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…
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MabPharm’s CMAB807 Biosimilar Receives Market Approval in Indonesia and Peru
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Taizhou-based MabPharm Ltd (HKG: 2181), a specialist in monoclonal antibody (mAb) biosimilars, has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) Remicade (infliximab), in Indonesia, with a similar approval in Peru in July this year. The approval encompasses all six…
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Shanghai Ark Biopharmaceutical Partners with Partex to Advance AI-Driven Drug Development
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China’s Shanghai Ark Biopharmaceutical Co., Ltd. has formed a strategic alliance with Germany-based Partex, an artificial intelligence (AI)-empowered drug developer. This partnership aims to explore the potential of AK0707, an autotaxin inhibitor developed in-house by Ark Bio. Partex will utilize its AI-driven platform to uncover potential indications for the drug.…
