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HutchMed’s Orpathys Receives Priority Review for NSCLC Treatment in China
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso…
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Zhaoke Ophthalmology’s TAB014 Achieves Positive Phase III Results for wAMD
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III study for its core candidate drug TAB014 in the treatment of wet (neovascularization) age-related macular degeneration (wAMD). The study successfully met all primary and key secondary endpoints,…
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Alphamab Oncology’s JSKN033 Advances to Phase III Trial for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III study for its drug candidate JSKN033. The study will compare JSKN033 against the investigator’s choice of chemotherapy in…
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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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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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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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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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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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BeiGene’s Tevimbra Receives FDA Approval for HER2-Negative Gastric Cancer Treatment
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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). This new approval allows the use of tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy to…
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Bristol-Myers Squibb’s Opdivo Qvantig Receives FDA Approval for Expanded Indications
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid…
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HitGen Inc. Initiates Phase II Clinical Trial for HG146 in Adenoid Cystic Carcinoma
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China-based HitGen Inc. (SHA: 688222) has announced the commencement of the first patient enrollment in a Phase II clinical study for its Category 1.1 anti-tumor drug, HG146. This study focuses on the treatment of recurrent or metastatic adenoid cystic carcinoma, a rare and aggressive form of cancer. HG146: A Promising…
