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Beijing Aosaikang Pharmaceuticals Achieves Clinical Milestone for c-MET Inhibitor ASKC202
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced the presentation of promising data from a Phase I dosage escalation study (ASKC202-001) for its investigational small-molecule c-MET inhibitor, ASKC202, in advanced solid tumors at the American Association for Cancer Research (AACR) 2024 annual meeting. This development underscores the company’s commitment…
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Transcenta Holdings Ltd Collaborates with Agilent Technologies on Companion Diagnostic for Osemitamab
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced a strategic agreement with Agilent Technologies to co-develop Claudin18.2 companion diagnostic reagents, marking a significant step in the global development of osemitamab combined with nivolumab plus chemotherapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ)…
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CStone Pharmaceuticals Submits New Drug Application for Gavreto in China, Eyes Local Manufacturing
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has submitted a market approval filing to the National Medical Products Administration (NMPA) for Gavreto (pralsetinib), an oral, once-daily, highly selective RET inhibitor. The company plans to manufacture the drug locally, marking a strategic shift from overseas supply. Gavreto…
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Jiangsu Hengrui Pharmaceuticals Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Abbisko Therapeutics Achieves Milestone in Global Phase III Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the completion of subject enrollment and dosing in its ABSK021-301 study, a pivotal Phase III trial evaluating the efficacy and safety of its investigational drug ABSK021 (pimicotinib) in treating tendon sheath giant cell tumor (TGCT). This marks the first…
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Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
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Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
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AstraZeneca’s Imfinzi Achieves Positive Results in Late-Stage Trial for Small Cell Lung Cancer
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that a late-stage trial for its anti-PD-L1 drug Imfinzi (durvalumab) has successfully met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC). The trial’s success marks a significant milestone…
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Novartis’s Leqvio Showcases Real-World Efficacy in Managing Cholesterol in ASCVD Patients
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented compelling real-world data for its innovative small interfering RNA (siRNA) therapy, Leqvio (inclisiran), which is used for the treatment of atherosclerotic cardiovascular disease (ASCVD) in patients who have not responded well to statins. The data, unveiled last week, demonstrated that the early…
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AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
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Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
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Bristol Myers Squibb’s Abecma Receives FDA Approval for Wider Use in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
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Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Sichuan Kelun-Biotech Presents Positive Results for Sacituzumab Tirumotecan at AACR 2024
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
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Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
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Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
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Shanghai-based Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HP501 in combination with febuxostat for the treatment of primary gout with hyperuricemia. This marks a significant step forward in addressing…
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Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell…
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Ascletis Pharma Halts ASC42 Phase II Study in Primary Biliary Cholangitis
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced its decision to terminate the Phase II clinical study for ASC42 in primary biliary cholangitis (PBC) following a comprehensive data analysis. The farnesoid X receptor (FXR) agonist will also see the cancellation of studies in non-alcoholic steatohepatitis (NASH) and hepatitis B virus…
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IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
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China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.…
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Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed…
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Shanghai Henlius Reports Phase III Success for HLX14 in Osteoporosis Treatment
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Shanghai Henlius Biotech Inc. (HKG: 2696), based in China, has announced that its global, multi-center Phase III clinical trial for HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab), has successfully met its primary endpoints in treating postmenopausal osteoporosis in women at high risk of fracture. The Phase III study aims to…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
