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Duality Biologics, Inc., a biopharmaceutical company based in China, has reached a significant milestone with the dosing of the first patient in its Phase I/IIa clinical study for the in-house developed antibody drug conjugate (ADC) DB-1419. The study is aimed at evaluating the safety and efficacy of DB-1419 in patients…
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AbbVie Sues BeiGene Over Alleged Trade Secret Theft in BTK Degrader ProgramU.S. pharmaceutical titan AbbVie Inc. (ABBV) has initiated legal proceedings against BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), accusing the Chinese biotech firm of pilfering trade secrets vital to its Bruton’s tyrosine kinase (BTK) degrader program. According to…
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Terns Pharmaceuticals Inc. (NASDAQ: TERN), a U.S.-based biotechnology company originally spun out from Eli Lilly’s China R&D center, has unveiled early data for its oral, once-daily glucagon-like peptide-1 receptor (GLP-1R) agonist, TERN-601. The top-line data originates from a Phase I clinical trial, which was a double-blind, placebo-controlled study involving single…
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GSK plc (LON: GSK, NYSE: GSK), a leading UK-based pharmaceutical company, has announced positive results from a Phase III trial for its auto-immune therapy Nucala (mepolizumab) in treating chronic obstructive pulmonary disorder (COPD). The MATINEE trial demonstrated that GSK’s interleukin-5 (IL-5) inhibitor met the primary endpoint, showing a significant and…
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China Isotope & Radiation Corporation’s (CIRC) subsidiary, HTA Co., Ltd. (HKG: 1763), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its sodium fluoride [18F]. This product is primarily utilized in positron emission tomography (PET) to identify areas of altered osteogenic activity in…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has granted market approval for its product Daxxify (daxibotulinumtoxin, RT002). This type A botulinum toxin is now approved for the temporary improvement of moderate to severe eyebrow wrinkles in adults in…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s Center for Drug Evaluation (CDE) for its drug candidate SHR-1918. This in-house developed monoclonal antibody (mAb) targeting angiopoietin-like protein 3 (ANGPTL3) is intended for the…
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AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645), a biotechnology company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 therapeutic biologic product, VUM02. This product, derived from human umbilical cord mesenchymal stem cells, is designed…
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial results for Dupert (fulzerasib) have been selected for an oral presentation at the 2024 World Conference on Lung Cancer (WCLC). The study, known as HARMONi-2 (AK112-303), focuses on the treatment…
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The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released a draft proposal titled “Questions and Answers on Pharmaceutical Similarity Research of Biosimilars,” seeking public feedback until October 9th. This document, applicable to Category 3.3 biologics, provides clarity on common issues and technical requirements for…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced positive preliminary results from a Phase I/II clinical study assessing the tolerability, safety, efficacy, and pharmacokinetics of ZG006 in patients with advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma. The study, which included a dosage…
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its co-development partner Daiichi Sankyo (TYO: 4568), have announced preliminary data from a Phase II clinical trial for the investigational B7-H3-directed antibody-drug conjugate (ADC) ifinatamab deruxtecan. The trial has identified a recommended dosage of 12mg/kg for…
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China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for generic quality and consistency evaluation (GQCE), seeking public commentary until September 20, 2024. The latest draft opinion expands the list by incorporating 23 new drugs and 27 specifications, aiming to enhance the standardization and reliability…
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
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Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for SCTV04C, its proprietary recombinant herpes zoster vaccine. Herpes zoster, commonly known as shingles, is an infectious skin condition that results from the reactivation of…
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical studies for its investigational drug KYS202004A for the treatment of psoriasis. This Category 1 biologic is a novel, dual-targeted…
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Viatris Inc. (NASDAQ: VTRS), a leading global pharmaceutical company based in the U.S., has announced the official launch of its nasal spray combination therapy, Dymista (azelastine, fluticasone), in China. This medication is now available to treat moderate to severe seasonal and perennial allergic rhinitis in adults and children aged 12…
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Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Sogroya (somapacitan), a long-acting somatotropin. This once-weekly treatment is designed to address adult growth hormone deficiency (AGHD) and has already received approval in the US in…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…