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Innovent Biologics Publishes Mazdutide Phase Ib Study Results for Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the results of the higher-dose cohorts in a Phase Ib study for mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in overweight or obese Chinese participants have been published online at eClinicalMedicine. Licensing Deal and Drug ProfileInnovent struck…
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BeiGene’s Brukinsa Receives Positive CHMP Opinion for CLL Approval
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). This recommendation is…
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Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
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Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
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RemeGen’s Telitacicept Gains EU, China Approvals for Global Phase III Study
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China-based pharma firm RemeGen (HKG: 9995) has announced receiving approvals from authorities in the European Union (EU) and China to conduct a global multi-center Phase III clinical study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE). This marks a significant step forward in the development of innovative…
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Zelgen’s Jacktinib Shows Strong Efficacy in Phase III Myelofibrosis Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has published major data from a Phase III clinical study for its Janus kinase (JAK) inhibitor, jacktinib, in patients with medium- to high-risk myelofibrosis (MF). The results indicate an excellent efficacy and safety profile for the drug. A New Drug Application (NDA) for…
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Kintor’s Dual c-Myc/GSPT1 Degradation Therapy GT19715 Shows Promise in Pre-Clinical Studies
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published positive results from a pre-clinical study of its dual c-Myc/GSPT1 degrader GT19715 in acute myeloid leukemia (AML) and lymphomas. The findings highlight the potential of GT19715 as a targeted therapy for these challenging cancers. Pre-Clinical Study ResultsCell-free, cellular assays, and animal studies…
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CARsgen’s BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China
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The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd’s (HKG: 2171) B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy CT053 (zevor-cel) is set for priority review. This status relates to a market approval filing to treat adult patients with recurrent…
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LianBio Cancels Phase III Trial for Truseltiq in China Amid Global Halt
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China-based LianBio (OTCMKTS: LIANY) revealed in an SEC filing that it is canceling work on a Phase III trial in China for Truseltiq (infigratinib). The decision follows an announcement by BridgeBio Pharma Inc. (NASDAQ: BBIO), the drug’s discoverer, that the ongoing global Phase III PROOF-301 trial is being closed. This…
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Accutar Biotechnology Initiates Phase I Trial for ERα Targeting Degradation Molecule AC0682
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New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0682, an orally bioavailable chimeric degrader molecule targeting the ERα protein. The molecule, which previously entered a Phase I study in the US, is the firm’s…
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RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
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China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD) status from the US FDA for its fusion protein drug telitacicept in myasthenia gravis (MG). This designation highlights the potential of telitacicept in treating this rare and chronic autoimmune disease. The drug previously concluded a…
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BeiGene’s Brukinsa Outperforms Imbruvica in Phase III ALPINE Study
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) demonstrated superior progression-free survival (PFS) in the Phase III ALPINE study compared to Johnson & Johnson’s Imbruvica (ibrutinib). The 12-month PFS rate for Brukinsa was 94.9%, compared to 84%…
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Aosaikang’s Neratinib Maleate API Market Filing Accepted by NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its neratinib maleate active pharmaceutical ingredient (API) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the company’s efforts to bring this important drug to the…
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Azvudine Included in China’s COVID-19 Treatment Protocol
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The National Healthcare Commission and the National Administration of Traditional Chinese Medicine have released a notification indicating the inclusion of Henan Genuine Biotech Co., Ltd’s COVID-19 therapy azvudine in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (9th Edition). The drug is now approved for the treatment of adult…
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NMPA Approves IND Filing for Henan Genuine Biotech’s Long-Acting HIV Drug CL-197
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China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting HIV drug candidate CL-197 has been approved by the National Medical Products Administration (NMPA). CL-197 is a novel nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcription by simulating endogenous purine nucleotides, thus having potential…
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Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and…
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NMPA Introduces Electronic Certificates for Biologics and Narcotic Drugs
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The National Medical Products Administration (NMPA) has released a notification regarding the initiation of electronic certificates for biologic product releases and electronic approvals of narcotic drugs, as well as the establishment of a psychotropic substances study program. These measures aim to streamline regulatory processes and enhance efficiency in the management…
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Pfizer’s Zavicefta Approved in China for Pediatric Complex Intra-Abdominal Infections
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its avibactam sodium + ceftazidime product, marketed under the brand name Zavicefta, in China. The indication is for children three months and older with complex intra-abdominal infection (cIAI).…
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HutchMed Initiates Phase II/III Study of Sovleplenib for Warm AIHA
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initiation of a Phase II/III study for its sovleplenib (HMPL-523) in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The first patient was dosed on September 30. This marks a significant step forward in the…
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Guangdong Zhongsheng Receives USPTO Patent for FGFR4 Inhibitor ZSP1241
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced receiving a patent award from the United States Patent and Trademark Office (USPTO) for ZSP1241, a home-grown fibroblast growth factor receptor 4 (FGFR4) inhibitor. The patent, titled “Salt form and crystal form of compound as FGFR4 inhibitor and preparation method…
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Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023. PRESERVE…
