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AstraZeneca’s Voydeya Receives South Korean Approval for PNH Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has reportedly secured market approval in South Korea for its drug Voydeya (danicopan), the world’s first-in-class oral D-factor inhibitor. The Ministry of Food and Drug Safety (MFDS) in Korea approved Voydeya for use as an adjunct therapy for extravascular hemolysis (EVH) in…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Eslicarbazepine Makes First Appearance in China at Sichuan University’s West China Lecheng Hospital
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Eslicarbazepine, a voltage-gated sodium channel blocker, co-developed by Bial-Portela, Eisai, and Sumitomo Pharma, was first prescribed at the West China Lecheng Hospital of Sichuan University late last month. This epilepsy therapy marks the first special novel drug program implemented through the “first pilot, first trial” policy of the Boao Lecheng…
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China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
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Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in…
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MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
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MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has announced that it has received market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J)’s Remicade (infliximab), in Peru. The approval encompasses all six indications, which include adult ulcerative colitis, ankylosing spondylitis, rheumatoid…
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Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study
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Legend Biotech Corporation (NASDAQ: LEGN) has announced positive results from the CARTITUDE-4 study, a global, randomized, open-label Phase III trial. The study assessed the efficacy and safety of Legend Biotech’s BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel) compared to standard therapies of pomalidomide, bortezomib, and dexamethasone…
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Lilly’s Kisunla Poised to Shake Up Alzheimer’s Treatment Market with FDA Approval
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Eli Lilly & Co. (NYSE: LLY) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for donanemab as a treatment for adults with early symptomatic Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and individuals with mild AD-related dementia, confirmed to have amyloid pathology.…
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Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome…
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Eli Lilly & Co. Strikes Deal for Radionetics’ GPCR-Targeted Radiopharmaceuticals
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company based in the US, has entered into a strategic partnership with fellow US firm Radionetics Oncology to gain access to Radionetics’ pipeline of innovative small molecule G protein coupled receptor (GPCR) targeted radiopharmaceuticals. Under the terms of the agreement, Lilly…
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Boehringer Ingelheim Initiates Clinical Trial for Novel Anti-Obesity Drug
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Boehringer Ingelheim (BI), a German pharmaceutical company, has announced the commencement of clinical development for BI 3034701, a potential first-in-class anti-obesity drug. The molecule was originally developed by Denmark-based Gubra A/S (XCSE: GUBRA) and is a long-acting triple-agonist peptide designed to target receptors associated with inducing weight loss, positioning it…
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Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
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Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
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Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
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Yantai Dongcheng Pharmaceutical’s 177LuLNC1011 Gets FDA Green Light for Prostate Cancer Clinical Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its prostate specific membrane antigen (PSMA)-targeted radioactive in vivo therapeutic drug, 177LuLNC1011. The molecule is intended for evaluation…
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SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
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SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
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Boao Lecheng Approves Use of Sanofi’s Tzield as First-Line Therapy for Type 1 Diabetes Delay
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Tzield (teplizumab), recognized as the world’s first and only targeted therapy for delaying the onset of type 1 diabetes, has received approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. Developed by French pharmaceutical giant Sanofi, Tzield is indicated for use…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
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Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
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China’s Sichuan Huiyu Pharmaceutical Halts Generic Cytosar Launch Following Strategy Review
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a pharmaceutical company based in China, has announced the withdrawal of its market filing for a generic version of Cytosar (cytarabine), a drug originally developed by US firm Viatris. The decision to withdraw the filing, which was initially submitted in September 2022, is…
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Eisai and Biogen Launch Alzheimer’s Drug Leqembi in China Following Market Approval
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, in partnership with Biogen Inc. (NASDAQ: BIIB), has announced the official market launch of Leqembi (lecanemab), a therapy for Alzheimer’s disease (AD), in China. This follows the drug’s official market approval in China in January this year. Leqembi is a humanized…
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Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC). The Category 1 innovative drug candidate, HP518,…
