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Antengene’s CD73 Inhibitor ATG-037 Greenlit for Phase I Study by NMPA
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China-based Antengene Corporation Limited (HKG: 6996) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study assessing its ATG-037, a small molecule inhibitor of CD73, in patients with locally advanced or metastatic solid tumors. This marks a significant step forward in the development…
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Hengrui’s Pyrotinib Granted Breakthrough Therapy Designation by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Hengrui Medicine Co., Ltd’s (SHA: 600276) pyrotinib has been granted breakthrough therapy designation (BTD) status for use in combination with trastuzumab plus docetaxel in recurrent or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) positive in…
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Baidu Health Partners with Shanghai Epiprobe for Cancer Early Screening
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China Internet giant Baidu’s Health Internet Hospital unit has announced a partnership with Shanghai Epiprobe Biotechnology Co., Ltd. The collaboration aims to enhance the promotion and popularization of universal cancer early screening in clinics. No financial details were disclosed. Partnership ObjectivesThe partnership will leverage the respective strengths of both companies…
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Eli Lilly’s Peresolimab and LOXO-783 Gain Tacit Clinical Trial Approvals in China
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approvals to two investigational drugs from US-based Eli Lilly (NYSE: LLY): peresolimab, a PD-1 agonist, and LOXO-783, a PI3Kα H1047R inhibitor. These approvals pave the way for further clinical development of the drugs in China. Peresolimab: Targeting…
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Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
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Antengene Corporation has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its ATG-017, an extracellular regulated protein kinase 1/2 (ERK1/2) inhibitor. The Shanghai-based biotech company will commence the joint part of the Phase I ETASER study, assessing the safety,…
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Eucure Biopharma Partners with ISU ABXIS to Develop Tri-Specific Antibodies Using YH003
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Eucure Biopharma, a wholly-owned subsidiary of Sino-US contract research organization (CRO) Biocytogen, has entered into a partnership agreement with South Korea-based ISU ABXIS Co., Ltd (ISU ABXIS, KOSDAQ: 086890). Under the agreement, ISU ABXIS has been granted the use of Eucure’s YH003 sequence to develop multiple tri-specific antibodies for the…
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Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step…
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Simcere’s SIM0235 Begins US Phase I Trial for Anti-Tumor Therapy
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the enrollment of the first patient in a Phase I clinical study for its novel anti-tumor drug candidate SIM0235 (formerly SIM1811-03) in the United States. This marks a significant milestone in the global development of the drug. SIM0235: Mechanism and PotentialSIM0235 is…
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NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
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The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Henlius Biotech (HKG: 2696). The drug is now approved for the treatment of first-line squamous non-small cell lung cancer (sqNSCLC). Previous Approvals and Clinical ProgressSerplulimab was initially…
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Innovent’s CLDN18.2 ADC IBI343 Begins Phase I Trial in Australia
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Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study for its IBI343, a CLDN18.2 antibody drug conjugate (ADC), in Australia. This marks the first ADC from the Chinese biotech company to enter clinical trials. Phase I Clinical Study DesignThe open-label, multi-center Phase…
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Eli Lilly Cancels Licensing Deal for Fosun Pharma’s FCN-338
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Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its US partner Eli Lilly has decided to cancel the licensing deal struck with its subsidiary Fochon Pharmaceuticals Ltd in relation to FCN-338, a selective B-cell lymphoma 2 (Bcl-2) small-molecule inhibitor. The decision was cited as a “product…
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Junshi Biosciences Reports 55% Drop in Q3 Revenues
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Shanghai-based biotech Junshi Biosciences (HKG: 1877) released its financial report for the third quarter of 2022, showing revenues over the nine months down 55.18% year-on-year (YOY) to RMB 1.218 billion (USD 167.2 million). The decline was primarily due to decreasing technology licensing income, which could not be offset by increasing…
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Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
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China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY) announced that the PD-1 inhibitor Tyvyt (sintilimab) has been approved by the National Medical Products Administration (NMPA) for a new indication. The drug is now approved to treat first-line unresectable locally advanced, recurrent, or metastatic…
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Innovent’s Parsaclisib Filed for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics Inc’s (HKG: 1801) PI3Kδ inhibitor parsaclisib. The product candidate has been granted priority review status. The targeted indication is relapsed or refractory follicular lymphoma (r/r FL) in patients who have previously received at least two…
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HutchMed Initiates Phase II/III Study for Elunate and Tyvyt in Renal Cell Carcinoma
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase II/III clinical study for Elunate (fruquintinib) combined with Tyvyt (sintilimab) as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China. The first patient was dosed this week. Study Design and…
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Alphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial
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Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ia/Ib clinical study for its JSKN003. The study will assess the safety and tolerability of JSKN003 in patients with advanced malignant solid tumors and determine the maximum tolerable dose…
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CSPC’s Antibody-Drug Conjugate SYS6002 Gains CDE Approval for Clinical Study
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for SYS6002, an antibody-drug conjugate (ADC) developed in-house by its subsidiary CSPC Jushi Biopharmaceutical Co., Ltd. The intended indication for SYS6002 is advanced solid…
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InxMed and Huaota Bio Partner to Develop Novel Solid Tumor Combination Therapy
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China-based InxMed (Nanjing) Co., Ltd has entered into a strategic partnership with Shanghai Huaota Biopharmaceutical Co., Ltd to collaborate on pre-clinical and clinical studies for a combination therapy targeting various solid tumors. The partnership will focus on combining InxMed’s IN10018, a selective oral inhibitor of focal adhesion kinase (FAK), with…
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OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
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Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). The therapy targets GPRC5D, a receptor highly expressed in multiple myeloma (MM) cells, and is being developed…
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ImmVira Secures Series C+ Financing to Advance Oncolytic Virus and Exosome Programs
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China-based biotech ImmVira has successfully secured its Series C+ financing, entering into agreements with a first batch of investors, including China Merchants China Direct Investments Ltd, Wuzhong Biomedical Industry Development Fund, and Qiandao Fund. The proceeds will be used to advance clinical studies of three product pipelines in the US…
