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Shanghai-based KeChow Pharma has announced the official market launch of its groundbreaking drug, Keluping (tunlametinib), the world’s first targeted therapy designed specifically for NRAS mutant melanoma. Tunlametinib, a novel ATP noncompetitive MEK inhibitor that targets NRAS mutations, received marketing approval in China in March this year. The drug was granted…
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
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Kymera Therapeutics Inc. (NASDAQ: KYMR), a biopharmaceutical company based in the U.S., has announced that Sanofi intends to expand the clinical development program for the auto-immune skin disease drug KT-474 following a preliminary review that showed robust early data. Sanofi’s plan to broaden Phase II trials for the drug, which…
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Shanghai Vitalgen BioPharma Co., Ltd, a biopharmaceutical company based in China, has initiated a Phase I/II clinical study for its gene therapy candidate VGN-R09b at Huashan Hospital, targeting primary Parkinson’s disease (PD). VGN-R09b received clearance to proceed with clinical trials in China for primary PD and aromatic L-amino acid decarboxylase…
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Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the global launch of cosmetic products featuring pyrilutamide (KX-826) as the key ingredient. Pyrilutamide, an androgen receptor (AR) antagonist, is utilized as a topical application for the treatment of androgenic alopecia (AGA), a common condition leading to…
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Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
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Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter intensified competition in China following the approval of a generic version by local pharmaceutical company Qilu Pharmaceutical last month. Macitentan, classified as an endothelin receptor antagonist (ERA), initially received marketing approval in the US in…
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product BC008-1A. This product is intended for the treatment of glioblastoma and advanced…
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Jiangsu-based HOB Biotech Group Corp., Ltd (SHA: 688656) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its MM09 sublingual spray. The product is intended to target indications such as mild to moderate asthma and allergic rhinitis/nasal conjunctivitis, with a focus on…
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced the conclusion of the voluntary recall of its Susvimo (ranibizumab) 100mg/mL intravitreal ocular implant in the U.S. market. The implant, indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), has received approval from the U.S. Food and Drug Administration…
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid…
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its co-developed FH-2001 in combination with HanSiZhuang (serplulimab, HLX10) for the treatment of advanced…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate SYS6023. The study will initially focus on patients with general advanced solid tumors.…
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study. The study will assess the efficacy and safety of Allist’s furmonertinib in combination with chemotherapy compared to osimertinib (Tagrisso) in…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ⁹⁹ᵐTc tetrofosmin, a SPECT myocardial perfusion imaging agent. This radiopharmaceutical drug, which is utilized for myocardial perfusion imaging in…
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug, fotagliptin. This drug is intended to improve blood sugar control in adult patients with type 2 diabetes,…
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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Immorna (Hangzhou) Biotechnology, a biotech company specializing in mRNA-based vaccines and located in Hangzhou, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its self-replicating RNA cancer therapy, JCXH-211-IV (intravenous injection). JCXH-211-IV is a potential first-in-class…