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Jacobio’s KRAS G12C Inhibitor JAB-21822 Receives Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) website indicates that China-based Jacobio Pharmaceuticals Group Co., Ltd’s (HKG: 1167) KRAS G12C inhibitor JAB-21822 has received breakthrough therapy designation (BTD) status for its potential as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS p.G12C mutation. The…
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Yuanmai Cell Biotechnology Secures Angel Funding for Macrophage Immunotherapy
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Yuanmai Cell Biotechnology Co., Ltd, a macrophage immunotherapy developer based in Nanjing, reportedly raised “tens of millions” of renminbi in an angel financing round. CDH Investments and Renai Group led the funding, which included contributions from Nanjing Jiangbei New Area Sci-tech Investment Group and Nanjing Laoyan Venture Capital. Proceeds will…
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SciClone’s Danyelza Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that SciClone Pharmaceuticals Inc’s (Nasdaq: SCLN) Danyelza (naxitamab) has been approved for marketing in China. Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc., and was fast-tracked for marketing approval in November 2020. SciClone struck a licensing deal with Y-mAbs…
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Enhertu Confirmed as New Standard of Care for Breast Cancer in Phase III Study
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AstraZeneca PLC (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) released the latest data supporting the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) as a new standard of care for breast cancer. An update from the DESTINY-Breast03 Phase III study assessing Enhertu head-to-head against Roche’s Kadcyla (trastuzumab emtansine, TDM-1) in patients with…
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Westgene Biopharma Secures RMB 150M Series A Financing for mRNA Drug Development
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Westgene Biopharma, an mRNA drug developer based in Chengdu, reportedly raised RMB 150 million (USD 21.49 million) in a Series A financing round, led by Chengdu Wenjiang Emerging Industry Venture Capital Fund Partnership Limited, Tigermed Consulting, Yingke PE, Huaxin Asset Management, and Sichuan Mansaisi Pharma. Company Background and PipelineFounded in…
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Hainan’s First Integrated Bladder Cancer Center Launched at Provincial Urology Meeting
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The first Integrated Bladder Cancer Center (IBCC) in Hainan province was inaugurated in Hainan General Hospital at the Hainan Provincial Urology Annual Meeting. A patient-centered facility, the IBCC is designed to improve inpatient experiences as well as medical service efficiency through a full-course management model. IBCC Initiatives and ServicesIBCC will…
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Junshi Biosciences Files for EMA Approval of Tuoyi for Nasopharyngeal and Esophageal Cancers
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that a market approval filing has been made for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) with the European Medicines Agency (EMA). The biotech is seeking approval for the checkpoint inhibitor in combination with chemotherapy as a first-line treatment for locally recurrent…
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Henlius Biotech Doses First Patient in Phase I Study for HLX60 in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing of a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. Study Design and ObjectivesThe open, dose escalation, first-in-human Phase I study is designed to assess the safety and tolerability of the drug…
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Fudan Team Presents Ribociclib Phase II Bridging Study Results at ESMO Asia
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A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation of results from a Phase II bridging study for ribociclib at the European Society for Medical Oncology (ESMO) Asia Congress 2022. Ribociclib (trade name: Kisqali) is a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor developed by Swiss…
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Hansoh’s EGFR Inhibitor Ameile Filed for EMA Review by Partner EQRx
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a market filing for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been filed for review with the European Medicines Agency (EMA) by US-based partner EQRx Inc. Hansoh/EQRx’s targeted indication is as a first-line treatment of locally advanced…
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Daiichi Sankyo Doses First Patient in Global Phase III TROPION-Lung08 Study
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced the first patient dosed in the global multi-center Phase III TROPION-Lung08 study in China. The trial is assessing the efficacy and safety of Dato-DXd combined with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 without…
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Yifan Pharma Transfers F-627 Distribution Rights in Germany to Apogepha
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the transfer of exclusive distribution rights in Germany to its efbemalenograstim alfa (F-627), to Apogepha Arzneimittel GmbH. The German firm will pay Yifan Pharma a USD 400,000 upfront payment, up to USD 1 million development milestone payment, and up to USD 37.5…
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Pyxis Oncology Receives FDA Approval for Biosion’s PYX-106 Clinical Trials
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China-based Biosion, Inc’s US partner Pyxis Oncology, Inc. (NASDAQ: PYXS) announced receiving clinical trial approval from the US FDA for its PYX-106 (BSI-060T). The anti-Siglec-15 monoclonal antibody (mAb) can now be assessed in clinics in bladder cancer, bile duct cancer, colorectal cancer, kidney cancer, and more. Preclinical Data and Drug…
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Eli Lilly Ends License for Innovent’s Tyvyt Outside China
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Eli Lilly & Co’s (NYSE: LLY) Q3 2022 SEC filing released last month revealed that the US major has decided to end its license to develop the programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab) in markets outside of China. In a single sentence, Lilly noted that the license deal signed with…
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Yifan Pharmaceutical Licenses F-627 to Acrotech for US Distribution
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the establishment of a licensing agreement with US firm Acrotech Biopharma, Inc., granting the latter exclusive distribution rights to its efbemalenograstim alfa (F-627) in the United States. The drug is an in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion…
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ImmuneOnco Initiates Phase II Clinical Study for CD47 Antibody IMM01
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the initiation of a Phase II clinical study for its investigational drug IMM01, an antibody targeting the cluster of differentiation 47 protein (CD47), in combination with a programmed-death 1 (PD-1) inhibitor for the treatment of solid tumors and lymphomas. This marks a significant…
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Luye Pharma’s Biosimilar to Amgen’s Xgeva Launched in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the…
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Henan Celnovte Biotechnology Raises RMB 100M in New Financing Round
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China-based Henan Celnovte Biotechnology Co., Ltd, a tumor in vitro diagnostic reagents (IVDs) and instruments maker, reportedly raised RMB 100 million (USD 14.15 million) via another financing round. Investors included Puhua Capital, Henan Hi-Tech Venture Capital, Zhengzhou High Tech Industry Investment Fund, and Zhong Yuan Lian Chuang Capital. Company Background…
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Fosun Pharma Weighs Sale of India’s Gland Pharma Amid Market Interest
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Shanghai Fosun Pharmaceutical Group Co. (HKG: 2196, SHA: 600196) is reportedly considering the sale of its India-based majority-owned Gland Pharma Ltd (BOM: 543245), according to a Bloomberg report. This follows interest from potential buyers, as cited by insiders. Market Interest and Early StagesFosun is reportedly in the early stages of…
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Luye Pharma Initiates Phase II Study for LY 03014 in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug candidate, LY 03014. The multi-center, randomized, double-blind, placebo-controlled, and positive drug parallel control study aims to assess the preliminary efficacy and safety of the drug in treating…
