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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
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Nuance Pharma, a China-based pharmaceutical company, has announced the completion of patient enrollment for the Phase III ENHANCE-CHINA study (NCT05743075) for its drug Ohtuvayre (ensifentrine). This Phase III trial is a randomized, double-blind, placebo-controlled investigation assessing the efficacy and safety of Ohtuvayre over a 24-week period in adult patients diagnosed…
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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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…