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Shanghai Haihe Pharmaceutical Co., Ltd from China and its South Korean partner Daehwa Pharmaceutical have received approval from the National Medical Products Administration (NMPA) for their co-developed paclitaxel oral solution RMX3001. This new drug is intended for use in patients with advanced gastric cancer who have experienced disease progression during…
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Eli Lilly & Co. (NYSE: LLY) has announced that its Alzheimer’s disease (AD) treatment, Kisunla (donanemab), has been granted market approval in Japan. The drug is indicated for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and/or mild dementia stage, who have confirmed amyloid pathology. Kisunla…
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Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
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Elevation Oncology, Inc. (NASDAQ: ELEV), a biopharmaceutical company based in the U.S., has announced that it has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy EO-3021 (SYSA1801). This antibody-drug conjugate (ADC) targets Claudin 18.2 and is being developed for the treatment…
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China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
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Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
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HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505), a leading biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its hemoporfin photo-dynamic therapy (PDT) in the United States. The study is focused on treating port wine stain (PWS),…
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that its marketing application for HSK21542, a Category 1 drug, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of moderate to severe itching associated with…
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its investigational gene therapy, FT-002. This recombinant adeno-associated virus (rAAV) gene therapy candidate marks a significant milestone as the…
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has reported Phase IIa trial results for monlunabant, an oral small-molecule cannabinoid receptor 1 (CB1) inverse agonist being developed for the treatment of obesity. The trial data, which showed statistically significant weight loss across all tested doses compared to placebo, did not…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…