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I-Mab’s Lemzoparlimab Gains CDE Approval for HR-MDS Phase III Trial
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China-based I-Mab (NASDAQ: IMAB) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) in China and obtained approval to initiate a Phase III registrational trial assessing lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) as a first-line treatment for…
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Takeda’s Modakafusp Alfa and TAK-981 Gain NMPA Clinical Trial Approvals
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The National Medical Products Administration (NMPA) website indicates that Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) modakafusp alfa and subasumstat (TAK-981) have obtained tacit clinical trial approvals. The targeted indications are multiple myeloma (MM) and CD20-positive relapsed/refractory non-Hodgkin’s lymphoma (NHL) combined with rituximab, respectively. TAK-573: A First-in-Class Drug for Relapsed/Refractory…
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Huahai Pharmaceutical Gains FDA Approval for Generic Fingolimod
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Swiss giant Novartis’ Gilenya (fingolimod). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Drug Background…
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Luye Pharma’s LY03015 Receives FDA Approval for Phase I Clinical Study
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China-based Luye Pharma Group (HKG: 2186) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study of its LY03015. The study will assess the safety, tolerability, and pharmacokinetics of the next-generation vesicular monoamine transporter 2 (VMAT2) inhibitor. LY03015 is…
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InnoCare Pharma’s BCL2 Inhibitor ICP-248 Gains NMPA Approval for Clinical Study
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China’s Beijing InnoCare Pharma (HKG: 9969) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed BCL2 inhibitor, ICP-248. This Category 1 innovative drug becomes the company’s fifth drug to reach clinical trials in the blood cancer field…
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BeiGene’s Tislelizumab Meets Primary Endpoint in HCC Study at ESMO
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) presented the latest results of the global Phase III RATIONALE 301 study evaluating tislelizumab in first-line unresectable hepatocellular carcinoma (HCC) at the 2022 European Society for Medical Oncology (ESMO) meeting. The study, which enrolled 674 patients in the US, Europe, and Asia, met…
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Luye Pharma’s BA-CovMab Receives NMPA Approval for COVID-19 Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s BA-CovMab, a broad-spectrum neutralizing antibody against COVID-19, has obtained clinical trial approval from the National Medical Products Administration (NMPA). Mechanism of ActionBA-CovMab is a recombinant fully human monoclonal neutralizing antibody obtained through sequential immunization and…
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Transcenta’s TST001 Shows Promise in Gastric Cancer Trial with 73.3% Response Rate
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) announced interim safety and efficacy data from a Phase I/II study of TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody (mAb), in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.…
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CSPC Pharmaceutical’s TG103 Gains NMPA Approval for NASH and Alzheimer’s Trials
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct separate clinical trials for its Category 1 biologic product TG103 in non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease (AD). This marks a significant step forward in the development…
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Jingxin Pharmaceutical Receives NMPA Approval for JBPOS0101 and JX7002 Trials
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020) announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its in-licensed products JBPOS0101 and JX7002. JBPOS0101 is being assessed for focal epilepsy in adults, while JX7002 is under development for hypercholesterolemia and mixed hyperlipidemia. JBPOS0101: A First-in-Class…
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China’s Retail Pharmacy O2O Sales Surge to USD 2.9B in 2021
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According to the “China Retail Pharmacy O2O Development Report” released by Minenet, the “online drug purchase” model has gained significant traction due to the COVID-19 pandemic and online prescription drug sales policies, with O2O becoming a mainstream retail pharmacy online business approach. By the end of 2021, approximately 200,000 pharmacies…
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China’s Cecolin HPV Vaccine Shows 100% Efficacy in 66-Month Study
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Chinese researchers have published 66-month follow-up data from a Phase III clinical study for the bivalent human papillomavirus (HPV) vaccine Cecolin, co-developed by Xiamen Innovax Biotech Co., Ltd and Xiamen University. The vaccine, approved in China since December 2019, demonstrated 100% protective efficacy against high-grade genital lesions associated with HPV…
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Dizal Pharma’s Sunvozertinib Gains NMPA Approval for EGFR Mutation NSCLC Trial
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) combined with bevacizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. Ongoing…
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Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
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The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in…
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Sirnaomics Initiates Phase I Study of STP705 for Abdominal Fat Reduction
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the first subject dosing in a Phase I clinical study for its STP705, targeting adult abdominal fat reduction. The study, expected to report results during the first half of 2023, marks a significant step forward in the development of non-invasive…
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Laekna Therapeutics Doses First Patient in LAE001/LAE002 Study for Prostate Cancer
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China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea. Study DetailsLAE201INT2101 is a multi-center,…
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Innovent’s Tyvyt Combo Shows PFS Benefit in EGFR-Mutant NSCLC
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China-based Innovent Biologics Inc. (HKG: 1801) announced positive results from the Phase III ORIENT-31 study evaluating the combination of its PD-1 inhibitor Tyvyt (sintilimab) and Byvasda (bevacizumab biosimilar) in patients with EGFR-mutated non-squamous non-small cell lung cancer (nsqNSCLC) who have progressed after EGFR tyrosine kinase inhibitor (TKI) treatment. The study…
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Hainan Yuekang’s YK-029A Biosimilar Set for BTD in EGFR ex20ins NSCLC
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The Center for Drug Evaluation (CDE) website indicates that China-based Hainan Yuekang Biological Medicine Co., Ltd’s YK-029A, a biosimilar of Tagrisso (osimertinib), is set to gain Breakthrough Therapy Designation (BTD) status for use in advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (EGFR ex20ins). YK-029A, an…
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Walvax Biotech Enrolls First Subject in Phase III HPV Vaccine Study
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) announced the first subject enrollment for a Phase III clinical study assessing the immunogenicity of its in-house developed nine-valent human papillomavirus (HPV) vaccine compared with Merck Sharp & Dohme’s (MSD) Gardasil 9. The vaccine is designed for the prevention of cervical cancer, vulvar…
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Sinocelltech’s Ripertamab Officially Launched in China for DLBCL Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the first deliveries and prescriptions of its ripertamab (SCT400), marking the official national launch of the drug in China. The innovative CD20 monoclonal antibody (mAb) is described as similar in efficacy and safety to rituximab and was approved on August 31 for treating…
