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CStone Pharmaceuticals Partners with Rigen Biotech on Thyroid Cancer RET Gene Testing
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China-based CStone Pharmaceuticals (HKG: 2616) has entered into a partnership with Shanghai Rigen Biotech to collaborate on thyroid cancer RET gene testing business. Under the agreement, the two companies will jointly conduct thyroid cancer precision diagnosis and treatment academic activities, collaborate on thyroid cancer RET gene detection projects, and assist…
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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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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…
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Innovent’s Tyvyt Shows PFS Benefit in EGFR-Mutant NSCLC at ESMO
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China-based Innovent Biologics, Inc. (HKG: 1801) presented results of the ORIENT-31 study for its PD-1 inhibitor Tyvyt (sintilimab) at the 2022 European Society for Medical Oncology (ESMO) annual meeting. The study evaluated Tyvyt, with or without Bevagen (bevacizumab), a biosimilar version of Avastin, in combination with chemotherapy for EGFR-mutant non-squamous…
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Luye Pharma’s CD25 Monoclonal Antibody BA1106 Gains NMPA Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s in-house developed CD25 monoclonal antibody (mAb) BA1106 has received clinical trial approval from the National Medical Products Administration (NMPA). This makes BA1106 the first CD25-targeted drug to enter clinical trials in China for the treatment…
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HutchMed’s Elunate Shows Survival Benefit in Global CRC Study at ESMO
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the results of the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) at the European Society for Medical Oncology (ESMO) 2022 annual meeting. Study Design and ResultsThe multi-center…
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Jacobio’s KRAS G12C Inhibitor JAB-21822 Advances to Pivotal Phase II in NSCLC
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has received approval from the National Medical Products Administration (NMPA) to launch a pivotal Phase II trial of its KRAS G12C inhibitor, JAB-21822, for advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. The company plans to file…
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SciClone Pharmaceuticals Doses First Patient in RRx-001 Phase III Study for SCLC
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China-based SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) announced that the first patient has been dosed in the Phase III regulatory REPLATINUM study in China for its RRx-001, a next-generation small-molecule immunotherapy targeting CD47/SIRPα (signal-regulatory protein alpha). The drug, in-licensed from US firm EpicentRx Inc. in July 2020, is being evaluated as…
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Jacobio Pharmaceuticals Doses First Patient in JAB-BX102 Phase I/IIa Trial for CD73-Targeted Cancer Therapy
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase I/IIa trial of its CD73 monoclonal antibody (mAb), JAB-BX102, for advanced solid tumors. The study, cleared by Chinese regulators in March 2022, marks the drug’s global clinical debut after U.S. approval in October 2021.…
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Alphamab Oncology Highlights KN046, KN026 Advances at ESMO 2022
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China’s Alphamab Oncology (HKG: 9966) will present updated clinical data for its bispecific antibody candidates KN046 and KN026 at the European Society for Medical Oncology (ESMO) 2022 conference. The programs target multiple cancers, including non-small cell lung cancer (NSCLC) and HER2-positive gastric cancer, with results showing promising efficacy and safety…
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Medim Science Raises Funds for Macrophage-Targeting Biologics in Cancer Therapy
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Hangzhou-based Medim Science, China’s first pharma firm focused on macrophage-targeting biologics, has reportedly raised tens of millions of renminbi in a new financing round led by Ming Bioventures, with Cowin Venture Capital participating. The funds will support R&D, regulatory filings, and clinical trial applications for its pipeline targeting solid tumors.…
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U Protech Secures Angel Financing for PROTAC and Molecular Glue Drug Pipeline
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U Protech, a Hangzhou-based biotech focused on next-generation protein degradation therapies, has raised tens of millions of renminbi in Angel and Angel+ financing rounds. The funding, led by Shanghai Biomedical Industry Equity Investment Fund’s transformation fund and Zheshang Venture Capital, will accelerate development of its PROTAC and molecular glue drug…
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Henlius Biotech Plans US Bridging Study for Serplulimab in ES-SCLC
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Shanghai Henlius Biotech (HKG: 2696) is advancing its checkpoint inhibitor serplulimab toward the U.S. market, with plans to launch a bridging study in H2 2022 for extensive-stage small-cell lung cancer (ES-SCLC). The decision follows a meeting with the U.S. FDA, as the firm seeks to replicate its Phase III success…
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RedCloud Bio Doses First Patient in H002 EGFR TKI Phase I/IIa Trial for NSCLC
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Shanghai-based RedCloud Bio announced that the first patient has been dosed in a Phase I/IIa multi-center trial of H002, its fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for non-small cell lung cancer (NSCLC) patients with resistance to prior TKIs, including C797S mutations. Drug ProfileH002, discovered in-house by…
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Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
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China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan drug designation (ODD) to its antibody-drug conjugate (ADC) MRG002 for gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ). The drug is in a Phase I/II trial in the U.S. targeting HER2-positive, advanced or metastatic GC/GEJ. Drug…
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Jacobio Pharmaceuticals Doses First Patient in JAB-21822 Phase IIa Trial for KRAS G12C NSCLC
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase IIa trial of its KRAS G12C inhibitor, JAB-21822, for first-line non-small cell lung cancer (NSCLC) with KRAS G12C and STK11 co-mutations. The study follows a Phase I trial that showed a 56.3% objective response…
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Akeso Bio’s AK112 Wins Breakthrough Designation for First-Line NSCLC
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China’s Akeso Bio has secured a breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) for its bispecific antibody (BsAb) AK112, targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in first-line, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression (TPS≥1%). The drug…
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Sinocelltech’s Ripertamab Wins NMPA Approval for DLBCL Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its biosimilar ripertamab (SCT400), a CD20 monoclonal antibody (mAb) targeting newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin lymphoma (DLBCL). Drug ProfileRipertamab is a biosimilar of Roche’s Mabthera (rituximab) and…
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Hengrui Medicine’s Dalpiciclib Hits Superiority Criteria in Phase III Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast…
