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Suzhou Zelgen Receives NMPA Approval for Jacktinib Cream Trial in Vitiligo Patients
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study for its Category 1 product, jacktinib cream, in adolescent and adult patients suffering from non-segmental vitiligo. Jacktinib, a Janus kinase (JAK) inhibitor, exhibits…
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Haisco Pharmaceutical Gets NMPA Green Light for HSK31858 COPD Trial
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has received additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK31858. The drug, a reversible dipeptidyl peptidase 1 (DPP1) inhibitor, is now approved for assessment in chronic obstructive…
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Teva’s Ajovy Achieves Positive Results in Phase III Migraine Prevention Trial in China
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Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has announced positive results from a Phase III study for Ajovy (fremanezumab) as a preventive treatment for migraine in adult Chinese patients. The study met its primary and all secondary endpoints, demonstrating Ajovy’s efficacy in reducing the number of migraine days…
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Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
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The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI:…
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Yantai Dongcheng Secures Approval for Phase I Study of 68Ga-LNC1007 in Singapor
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Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has received approval from the Health Sciences Authority of Singapore to initiate a Phase I clinical study for its radiopharmaceutical candidate, 68Ga-LNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3, and is being developed to aid in the treatment…
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Sino Biopharmaceutical to Present Phase II Data for Garsorasib at AACR 2024
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Sino Biopharmaceutical Ltd. (HKG: 1177) announced that it will present the results of a Phase II study for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd., at the American Association for Cancer Research (AACR) 2024 annual meeting. The study focuses on non-small cell lung cancer (NSCLC)…
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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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Pfizer Reports Positive Phase III Results for RSV Vaccine Abrysvo in Younger Adults
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Pfizer (NYSE: PFE) has announced interim results from a Phase III trial evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18 to 59 at risk of severe RSV-associated lower respiratory tract disease (LRTD). Currently, the vaccine is approved for preventing RSV-associated LRTD in older adults and for…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Simcere Pharmaceutical’s SIM0500 Earns FDA Fast-Track Designation for Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), a leading China-based pharmaceutical company, has announced that its trispecific antibody SIM0500 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). The drug targets GPRC5D, BCMA, and CD3, and is intended for patients who have…
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Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
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Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2…
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Sichuan Biokin Pharmaceuticals Initiates Phase III Trial for BL-M05D1 in Esophageal Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets…
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Jiangsu Hengrui Pharmaceuticals Advances Pipeline with NMPA Approvals for Three Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received clinical trial approvals from China’s National Medical Products Administration (NMPA) for three of its pipeline drugs: HRS-9231, SHR-4597, and SHR-2173. This regulatory milestone marks a significant step forward in the company’s commitment to innovate and address unmet medical needs in China…
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Jiangsu Hengrui Pharmaceuticals Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
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Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
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Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum…
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Gan & Lee Pharmaceuticals Commences Clinical Trial for Innovative GLP-1 Agonist GZR18
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading Chinese pharmaceutical company, has announced the commencement of dosing in a Phase I clinical study for its investigational GLP-1 receptor agonist, GZR18 tablets. This oral formulation is designed to target GPRC5D, BCMA, and CD3, and is intended to treat patients with recurrent…
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Shanghai’s 9th People’s Hospital Launches Groundbreaking Gene Therapy Trial for Congenital Deafness
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In a medical first, Shanghai’s 9th People’s Hospital has initiated the world’s inaugural clinical trial for a gene-editing therapy targeting congenital deafness attributed to otoferlin (OTOF) gene mutations. The therapy, developed by HuidaGene Therapeutics Co., Ltd, represents a significant advance in the treatment of auditory neuropathy, a leading cause of…
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GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
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GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food and Drug Administration (FDA) for its antiretroviral treatment Dovato (dolutegravir + lamivudine). The drug is now approved for use in virologically suppressed or treatment-naive adolescents aged 12 years and older with HIV-1 infection, a demographic…
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Clover Bio’s SCB-1019 Vaccine Candidate Shows Promising Results in Phase I Trial
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Clover Biopharmaceuticals (HKG: 2197), a leading biotechnology company based in China, has announced robust preliminary data from the Phase I clinical trial of its bivalent RSV candidate vaccine, SCB-1019. The vaccine, which targets both RSV-A and RSV-B, demonstrated significant increases in neutralizing titers, a key indicator of immune response. Specifically,…
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Bristol Myers Squibb Reports Positive Long-Term Data for KarXT in Schizophrenia Trial
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Pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced preliminary long-term data from a late-stage extension trial of its muscarinic antipsychotic drug KarXT (xanomeline + trospium) in adult patients with schizophrenia. The 52-week study demonstrated significant improvements, with participants showing an average reduction of 34% in the positive and…
