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Henlius Completes First Dosing in Global Phase III Study for HanSiZhuang in LS-SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC).…
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Boehringer Ingelheim Enrolls First Patient in Phase II/III Study for BI 907828
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German pharmaceutical giant Boehringer Ingelheim has announced the enrollment of the first patient in the Phase II/III Brightline-1 study for its investigational MDM2-p53 antagonist BI 907828. The study is taking place at the West China Hospital and aims to assess the efficacy and safety of BI 907828 compared to doxorubicin…
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Simnova Partners with Orna Therapeutics for In Situ CAR Therapies
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Shanghai Simnova Biotech Co., Ltd. (Simnova), an affiliate of Simcere Investment Group, has announced a partnership with Cambridge, Massachusetts-based Orna Therapeutics. The deal grants Simnova access to certain of Orna’s in situ chimeric antigen receptor (isCAR) therapies in the China market, including the CD19-targeted isCAR program ORN-101. This collaboration aims…
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WuXi Biologics and GSK Ink Licensing Agreement for T-Cell Engaging Antibodies
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China-based WuXi Biologics (HKG: 2269) has announced a licensing agreement with GSK plc (NYSE: GSK), granting the UK-based pharmaceutical giant exclusive licenses to up to four bi- and multi-specific T-cell engaging (TCE) antibodies. These antibodies were developed using WuXi Biologics’ proprietary technology platforms. The deal includes a pre-clinical bispecific antibody…
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Antengene Acquires Full Rights to Calithera’s CD73 Inhibitor CB-708
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China-based Antengene Corporation Ltd (HKG: 6996) has unveiled a transfer agreement with US-headquartered Calithera Biosciences Inc. (OTCMKTS: CALA), expanding on an earlier license agreement. Under the new agreement, Antengene will acquire all remaining rights to CB-708 (ATG-037), Calithera’s small-molecule CD73 inhibitor. This move underscores Antengene’s commitment to advancing innovative cancer…
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Haisco’s EGFR-PROTAC HSK40118 Accepted for Review by China’s NMPA
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing for the oral small molecule EGFR-PROTAC HSK40118 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is EGFR mutant advanced non-small cell lung cancer (NSCLC). This marks a significant…
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Duality Biologics Licenses ADC Platform to Denmark’s Adcendo for Mesenchymal Tumor Program
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Duality Biologics, a developer of novel modality drugs operating in the United States and China, has announced a technology license agreement with Denmark-based Adcendo ApS. Under the agreement, Adcendo has been granted a license to use Duality’s antibody drug conjugate (ADC) platform, DITAC, in its mesenchymal tumor product uPARAP program.…
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EOC Pharma’s Entinostat NDA Accepted by China’s NMPA for Breast Cancer
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EOC Pharma, a biotech company operating in the US and China, has announced that its New Drug Application (NDA) filing for entinostat has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced…
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Zhongchao Partners with Natco Pharma to Distribute Drugs in China
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Zhongchao Inc. (NASDAQ: ZCMD), a Shanghai-based online health education provider, has announced multiple agreements with India-headquartered Natco Pharma Limited to become its distribution agent for certain drugs in mainland China. The collaboration aims to address domestic demand for influenza drugs, cancer therapies, and rare disease treatments. The two companies will…
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Transcenta’s TST003 Receives Clinical Trial Approval in China and US
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China – based biopharma Transcenta Holding Ltd (HKG: 6628) has announced that it has received clinical trial approval in China for TST003, its potential first – in – class monoclonal antibody (mAb) targeting Gremlin1. The drug candidate has already received IND clearance from the US FDA in September this year,…
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Henlius’ Hanbeitai Gains NMPA Approval for Expanded Indications
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a supplementary Biologic License Application (sBLA) for its biosimilar Hanbeitai (bevacizumab). The approval expands the indications for which Hanbeitai can be used, now including cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and…
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HutchMed Completes Enrollment for Phase III ESLIM-01 Study of Sovleplenib in ITP
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in the ESLIM – 01 study, a pivotal Phase III trial assessing the efficacy and safety of sovleplenib in treating adult patients with primary immune thrombocytopenia (ITP) in China. This marks a significant milestone in…
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RemeGen’s RC48 Gains NMPA Approval for Phase II Study in Bladder Cancer
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China – based biopharmaceutical company RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II study of its antibody – drug conjugate (ADC) candidate RC48 (disitamab vedotin). The study will assess the efficacy and safety of RC48…
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Zai Lab Appoints Dr. Rafael Amado as President of Cancer R&D
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Chinese biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the appointment of Dr. Rafael G. Amado as President and Global Head of Cancer Research and Development (R&D), effective December 30, 2022. Dr. Amado will join the company’s management committee as a core member, reporting directly to Dr.…
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Jiangxi Jemincare Gains FDA Approval for Clinical Trial of JYB1907 in Solid Tumors
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China – based Jiangxi Jemincare Group has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug JYB1907. The monoclonal antibody (mAb) targets glycoprotein A dominant repeat (GARP) and transforming growth factor – β1 (TGF –…
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BeiGene’s Tislelizumab Receives NMPA Review for First-Line HCC Indication
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that a supplementary Biologic License Application (sBLA) for its programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the National Medical Products Administration (NMPA). The latest prospective indication is for the drug’s use in first-line unresectable or metastatic hepatocellular…
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Immunohead Biotech Raises RMB 200 Million in Series A+ Financing Round
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Immunohead Biotechnology Co., Ltd, a cell therapy developer based in Suzhou, has reportedly raised close to RMB 200 million (USD 28.89 million) in a Series A+ financing round. The round was led by SDIC Venture Capital, with participation from the Bio-Town Equity Investment Fund. The proceeds will be used to…
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CStone Pharmaceuticals Achieves Primary Endpoint in GEMSTONE-304 Study for Sugemalimab
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the achievement of the primary endpoint in the regulatory GEMSTONE-304 study for its sugemalimab in first-line unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This makes sugemalimab the first PD-1 inhibitor to generate positive data in this indication globally. Study…
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3D Medicines Gains FDA Approval for Phase II Study of Envafolimab in dMMR Tumors
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving approval from the US FDA to conduct a single-arm, multi-center Phase II study assessing the safety and efficacy of envafolimab (KN035) in treating deficient mismatch repair (dMMR) advanced solid tumors. The study will involve one subcutaneous injection every three weeks.…
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Changzhou Qianhong Completes Phase I Study of QHRD107 for Acute Myeloid Leukemia
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced the completion of enrollment and clinical observation in a Phase I clinical study for its Category 1 drug QHRD107, targeting acute myeloid leukemia (AML). Preliminary findings indicate that the QHRD107 capsule is safe for AML patients, with controllable overall risk…
