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Grand Pharmaceutical’s STC3141 Sepsis Therapy Completes Phase II Patient Enrollment
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the completion of patient enrollment and dosing in its Phase II study for STC3141, a sepsis therapy developed by Grand Medical Pty Ltd, the company’s innovative drug R&D center in Australia. The preliminary results of the study are anticipated by…
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Innovent Biologics Initiates Phase I Trial for IBI3009 in Small Cell Lung Cancer and Neuroendocrine Tumors
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On December 13, 2024, Innovent Biologics, Inc. (HKG: 1801) registered a Phase I clinical trial for IBI3009 on the drug clinical trial registration and information public platform. The trial will investigate the efficacy of IBI3009 in treating small cell lung cancer (SCLC) and other neuroendocrine tumors. Exploring Biomarkers and Efficacy…
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Huahai Pharmaceutical’s Adalimumab Biosimilar Accepted by China’s CDE for Review
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On December 14th, the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) announced that it has accepted the market application for Zhejiang Huahai Pharmaceutical Co., Ltd’s (SHA: 600521) adalimumab biosimilar injection. Adalimumab is a fully human anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody. The Role of TNF-α in…
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Insilico Medicine Receives $10 Million Milestone Payment for XL309 Clinical Progress
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Chengdu-based, generative artificial intelligence (AI)-driven clinical stage biotech company, Insilico Medicine, has announced the receipt of a $10 million clinical milestone payment from Exelixis following the progress of its XL309 (ISM3091) project in the clinical stage. XL309 is a selective, oral USP1 small molecule inhibitor discovered by Insilico Medicine using…
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Ascendis Pharma’s TransCon hGH sBLA for Adult GHD Accepted by FDA
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Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for TransCon hGH (lonapegsomatropin-tcgd) for the treatment of adult growth hormone deficiency (GHD). The FDA’s decision is anticipated by the Prescription Drug User Fee…
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Alibaba Health Reports 10.2% Revenue Growth and 72.8% Profit Increase in 2024 H1 Financials
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China-based Alibaba Health Information Technology Ltd (HKG: 0241) has released its financial report for the first half of 2024, ending September 30, 2023. The company recorded revenues of RMB 14.273 billion (USD 1.96 billion) and profits of RMB 769 million (USD 106 million), marking an increase of 10.2% and 72.8%…
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Novo Nordisk’s Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication
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Danish pharmaceutical leader Novo Nordisk (NYSE: NVO) has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on its label extension bid for Ozempic (once-weekly subcutaneous semaglutide). The company is seeking to expand the indication of the GLP-1 receptor…
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Bayer AG Initiates Phase I Study Combining BAY3498264 with Sotorasib for KRAS-Mutated Tumors
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Germany-based pharmaceutical giant Bayer AG (ETR: BAYN) has announced the initiation of a Phase I study to assess the preliminary efficacy and safety of its BAY3498264, a selective SOS1 inhibitor, when combined with sotorasib in patients with advanced KRAS G12C-mutated solid tumors. BAY3498264: A Potential Therapeutic Agent for KRAS-Mutant CancersBAY3498264…
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CureGene Pharmaceutical Gets NMPA Approval for Antiplatelet Drug CG-0255
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Shanghai-based CureGene Pharmaceutical has announced receiving clinical trial approval from China’s National Medical Products Administration (NMPA) for its innovative antiplatelet drug, benzenesulfonate CG-0255. This development marks a significant step forward for the company and its efforts to bring a new treatment option to patients with acute coronary syndrome (ACS). Category…
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Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
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US major Johnson & Johnson MedTechhas announced receiving premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps. This approval expands their indications to include specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and…
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Pfizer’s Ibrance Demonstrates Significant PFS Improvement in Phase III PATINA Trial
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) and Alliance Foundation Trials, LLC (AFT) have announced positive results from the Phase III PATINA trial for Ibrance (palbociclib), a CDK4/6 inhibitor. The trial data indicated that incorporating Ibrance into the standard-of-care first-line maintenance therapy—following induction chemotherapy—resulted in a statistically significant and clinically…
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BeiGene Ltd Acquires Global Rights to CSPC’s MAT2A Inhibitor SYH2039
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BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has entered into a significant licensing agreement with CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093). The agreement secures BeiGene the global development, manufacturing, and commercialization rights to CSPC’s methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH2039. Financial Details and Milestones of the AgreementAs per…
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Gan & Lee Pharmaceuticals Gets FDA Approval for GZR18 Obesity/Overweight Phase II Study
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase II study for its investigational drug GZR18 in treating obesity and overweight conditions, with and without type 2 diabetes (T2D). GZR18: A Promising GLP-1…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with Tagrisso (osimertinib) for the…
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HutchMed to Receive Milestone Payment as Takeda’s Fruzaqla Gets Reimbursement Nod in Spain
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) is poised to receive another milestone payment from its partner Takeda (TYO: 4502, NYSE:TAK), following the Japanese firm’s achievement of a national reimbursement recommendation for Fruzaqla (fruquintinib) for patients with previously treated metastatic colorectal cancer (CRC) in Spain. This event marks the…
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Grand Pharmaceutical Group Receives NMPA Approval for NOVASYNC HYBRID SYSTM
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative intravascular dual-mode imaging system, NOVASYNC HYBRID SYSTM. Milestone in Vascular Intervention TechnologyNOVASYNC, a domestic substitute for Grand Pharma’s imported NOVASIGHT HYBRID SYSTEM, signifies a…
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HuidaGene Therapeutics Launches MUSCLE Study for CRISPR Therapy in Duchenne Muscular Dystrophy
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Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced the initiation of the MUSCLE study for its CRISPR-based DNA-editing therapy, HG302, which targets Duchenne muscular dystrophy (DMD), with the first subject now dosed. Understanding Duchenne Muscular Dystrophy and HG302Duchenne muscular dystrophy is a severe X-linked recessive disorder and a prevalent form…
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Sunshine Lake Pharma Files for HKEX IPO, Expanding Global Pharmaceutical Reach
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China-based Sunshine Lake Pharma Co., Ltd has submitted an initial public offering (IPO) filing to the Hong Kong Stock Exchange (HKEX), with the unit price and other key details yet to be announced. The exclusive sponsor for this IPO is CICC, a leading financial institution. Established Pharmaceutical Company with a…
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Transcenta’s LIV-1 ADCs Show Promising Results in Pre-Clinical Breast Cancer Study
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) announced updated results from a pre-clinical study for its LIV-1 antibody-based antibody drug conjugates (ADCs) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study focuses on the potential of LIV-1 as a therapeutic target in metastatic breast cancer. LIV-1 as…
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Mabwell Bioscience Secures Licensing Deal with TABUK Pharmaceutical for MENA Region
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has inked a licensing deal with TABUK Pharmaceutical Manufacturing Company, granting the Saudi Arabian company the regulatory filing and commercialization rights to two of Mabwell’s biosimilars in the Middle East and North Africa (MENA) region. The financial details of the agreement were…
