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Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for its drug neracorvir (GST-HG141), which is intended to treat chronic hepatitis B virus (HBV). GST-HG141:…
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Accropeutics Gets FDA Green Light for Phase II UC Study of RIPK2 Inhibitor AC-101
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Accropeutics Inc., a clinical-stage biotechnology company with operations in New York, US, and Suzhou, China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence a Phase II clinical study for its RIPK2 inhibitor, AC-101, in the treatment of ulcerative colitis (UC). Design…
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EMA’s CHMP Supports Approval of Eli Lilly’s Omvoh (Mirikizumab) for Crohn’s Disease
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended the potential approval of Omvoh (mirikizumab) by US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). This treatment is intended for adults with moderately to severely active Crohn’s disease who have not responded adequately…
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Wepon Medical’s WP107 for Myasthenia Gravis Accepted for FDA Review
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Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced that the US Food and Drug Administration (FDA) has accepted its clinical filing for WP107 (huperzine A), an in-house developed drug, for review. The drug is intended to treat generalized myasthenia gravis (gMG), a serious neuromuscular disorder. WP107: A Promising…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Lupus Nephritis Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has obtained approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its therapeutic biologic product, SHR-2173, in the treatment of lupus nephritis (LN). SHR-2173: A Novel Treatment for Lupus NephritisSHR-2173 is an in-house developed…
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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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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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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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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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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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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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ImmunoTech Biopharm’s CAR-T-19 Earns Breakthrough Therapy Designation for B-ALL Treatment
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its CAR-T-19 injection. This designation is awarded for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) patients aged 25 and under, marking…
