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On December 24, 2024, China Isotope & Radiation Corporation (HKG: 1763) announced that its subsidiary, HTA Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for their Class 1 innovative drug, [18F] Piramide Injection. [18F] Piramide: A PET Imaging Agent for Enhanced Melanoma…
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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China’s Shanxi C&Y Pharmaceutical Group Co., Ltd (SHE: 300254) has announced the initiation of a clinical study for its generic version of UK firm Shield TX(UK)Limited’s iron supplement ferric maltol, following approval from the National Medical Products Administration (NMPA). The study aims to evaluate the drug’s efficacy in treating iron…
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China-based Clinical Research Organization (CRO) Boji Medical Technology Co., Ltd. (SHE: 300404) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for TBA, a novel treatment for drug-resistant pulmonary tuberculosis. TBA: A New Approach to Combating Drug-Resistant TuberculosisThe Category 1 chemical drug, co-developed…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA). One trial will test the combination of HRS-4357 with ADT and a novel androgen receptor pathway inhibitor for prostate cancer. The other trial will assess SHR-4602 in combination with…
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical approval from the National Medical Products Administration (NMPA) to test its Category 1 biologic product, ZG005, in combination with gecaicitinib for the treatment of advanced solid tumors and recurrent refractory lymphomas in China. ZG005: A Pioneering Bispecific Antibody for…
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China’s Center for Drug Evaluation (CDE) website has indicated that a market filing by local firm ProteLight Pharma for its Category 1 product peceleganan (PL-5) has been accepted for review by the bureau. This development follows a licensing deal in January 2023, through which Chia Tai Tianqing obtained the exclusive…
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from the pivotal Phase III POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) studies for its drug Sotyktu (deucravacitinib). These studies assessed the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA). Achievement of Primary and…
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth…
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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 I/II study for its investigational drug, JSKN033. Design and Objectives of the Upcoming Phase I/II StudyThe imminent open, multi-center…
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, SYH2062. SYH2062: A Novel siRNA Therapy for HypertensionSYH2062 is an N-acetyl-galactosamine (GalNAc)-conjugated small interfering RNA (siRNA) that targets the inhibition of…
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody (mAb), Kangyueda (stapokibart), to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). This approval follows the NMPA’s endorsement for moderate to severe atopic dermatitis…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to proceed with clinical trials for its innovative tetra-specific antibody, GNC-038. The trials will focus on the treatment of systemic lupus erythematosus and rheumatoid arthritis.…
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China-based Changchun High & New Technology Industries (Group) Inc., (SHE: 000661) has received the green light from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its Category 1 chemical drug, GS1-144, in treating menopausal vasomotor symptoms (VMS). Understanding Menopausal Vasomotor Symptoms and the…
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that the European Commission (EU) has granted another indication approval for its drug Tagrisso (osimertinib). The approval is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR)…
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China-based biopharmaceutical company ETERN Therapeutics has announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its YAP/TEAD inhibitor, ETS-006, which targets multiple advanced solid tumors. ETS-006: A Promising Oral YAP/TEAD PPI InhibitorETS-006 is an oral YAP/TEAD protein-protein interaction (PPI) inhibitor that has shown…
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that it has received marketing approval from the European Commission (EC) for its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab). This treatment is indicated for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient…