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Likang Life Sciences’ Personalized Neoantigen Vaccine LK101 Receives IND Approval
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Likang Life Sciences has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its LK101, a personalized neoantigen-targeted vaccine. This marks the first personalized neoantigen vaccine and mRNA editing product to be approved for clinical trials by the NMPA. LK101 will…
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RemeGen Gains NMPA Approval for Phase I/IIa Study of RC88 with Junshi Bio’s PD-1 Inhibitor
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China-based pharmaceutical firm RemeGen (HKG: 9995) has received approval from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase I/IIa study. The study will assess the safety, tolerability, pharmacokinetics, and efficacy of RC88 combined with Junshi Bio’s (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab),…
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ImmuneOnco Gains NMPA Approval for Phase Ib/II Study of IMM27M in Advanced Tumors
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its IMM27M. This ADCC-enhanced CTLA-4 monoclonal antibody (mAb) will be combined with the programmed death-1 (PD-1) inhibitor tislelizumab for the treatment…
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Henlius’ OX40 Monoclonal Antibody HLX51 Gains NMPA Approval for Phase I Clinical Study
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in mainland China for its OX40 monoclonal antibody (mAb), HLX51. The study will focus on patients with advanced/metastatic solid tumors and lymphoma. Mechanism…
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Haisco Pharmaceutical’s EGFR-PROTAC HSK40118 Gains NMPA Approval for Clinical Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral small molecule EGFR-PROTAC, HSK40118. The drug is targeted for the treatment of advanced non-small cell lung cancer (NSCLC). Drug Mechanism and Pre-Clinical ResultsHSK40118…
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Astellas Pharma’s Xtandi Gains Momentum in China with Positive Phase III ARCHES Study Results
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that its prostate cancer therapy, Xtandi (enzalutamide), is poised to add a new indication for the China market following positive results from the Phase III China ARCHES study. The trial evaluated Xtandi in combination with androgen deprivation therapy (ADT) in men with…
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MabPharm Files NDA for CMAB009, Biosimilar to Erbitux, Targeting Metastatic Colorectal Cancer
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the filing of a New Drug Application (NDA) for its CMAB009, a biosimilar of Merck KGaA (ETR: MRK)/Bristol-Myers Squibb’s (BMS, NYSE: BMY) cetuximab (trade name: Erbitux). The filing has been accepted for review by the National Medical Products…
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Neowise Biotechnology Secures RMB 200 Million in Series A+ Financing Round
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Neowise Biotechnology Co., Ltd, a T cell receptor (TCR)-therapy developer based in Suzhou, reportedly raised close to RMB 200 million (USD 29 million) in a Series A+ financing round. This investment will support the company’s ongoing research and development efforts in TCR therapies. Investor ParticipationThe financing round was led by…
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Immorna Enrolls First Patient in Phase I Study of JCXH-211 for Malignant Tumors
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Immorna (Hangzhou) Biotechnology, an mRNA-based vaccine developer based in Hangzhou, has announced the enrollment of the first patient in a Phase I clinical study to assess the safety and efficacy of JCXH-211, a potential cancer therapeutic, in malignant solid tumors in China. The study will determine the recommended Phase II…
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CDE Issues Guidelines on Single-Arm Clinical Trials for Antitumor Drugs
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for the Applicability of Single-arm Clinical Trials to Support the Market Filing for Antitumor Drugs.” The document provides clarity on the limitations of single-arm clinical trials, their applicability, and the requirements for confirmatory clinical trials in support of both…
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Laekna Therapeutics Files for IPO on Hong Kong Stock Exchange, Aims to Expand Cancer and Hepatic Fibrosis Therapies
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China’s Laekna Therapeutics Shanghai Co., Ltd has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange (HKSE), according to the exchange. The offering will be sponsored by CICC. This move marks a significant step in Laekna’s growth strategy as it seeks to raise capital to further…
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Juventas Cell Therapy’s CNCT19 Receives FDA IND Approval for r/r B-ALL Treatment
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China-based Juventas Cell Therapy Ltd’s chimeric antigen receptor (CAR) T-cell therapy, CNCT19 (Inaticabtagene Autoleucel), has obtained Investigational New Drug (IND) approval from the US FDA for the treatment of recurrent or refractory B-cell acute lymphocytic leukemia (r/r B-ALL). Previous Approvals and StatusCNCT19, a CD19-targeted CAR-T therapy, has previously earned IND…
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Bio-Thera Solutions Initiates First Patient Dosing in Phase I Study of BAT8007
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China-based Bio-Thera Solutions, Ltd. (SHA: 688177) has announced the first patient dosing in a multi-center, open, Phase I clinical study to assess the safety, tolerability, and preliminary efficacy of BAT8007, an antibody-drug conjugate (ADC) targeting Nectin-4. The study’s primary indication is general advanced solid tumors, with the goal of determining…
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Antengene to Begin Phase I Clinical Study of ATG-022 for Advanced Solid Tumors
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China-based Antengene Corporation Ltd (HKG: 6996) is poised to commence a Phase I clinical study to assess the safety and tolerability of ATG-022 in patients with advanced and metastatic solid tumors. The study will also determine the bioactive dose, maximum tolerable dose (MTD), and recommended Phase II dose (RP2D). ATG-022…
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Akeso Biopharma Enrolls First Subject in Phase III Study of Cadonilimab for Gastric Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first subject in a pivotal Phase III study for its innovative bispecific antibody (BsAb), cadonilimab (AK104). The study will assess cadonilimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJC).…
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CSPC Pharmaceutical’s PD-1 Monoclonal Antibody Enlangsubai Completes NMPA Market Approval Filing
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for its programmed-death 1 (PD-1) monoclonal antibody (mAb), Enlangsubai. The targeted indication is recurrent or metastatic cervical cancer with positive PD-L1 expression that has failed…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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XtalPi and Chia Tai Tianqing Achieve Phase II Milestone in Cancer Drug Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has partnered with China’s Chia Tai Tianqing to reach the Phase II milestone in their small molecule cancer drug research and development (R&D) program. The collaboration leveraged Chia Tai Tianqing’s in-house innovative drug innovation platform and XtalPi’s AI drug discovery platform to achieve…
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Haihe Pharmaceutical Initiates Global Phase I Clinical Study for BET-BD2 Inhibitor HH3806
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the first patient dosing of a global multi-center Phase I clinical study for its in-house developed BET-BD2 inhibitor, HH3806, in Australia. This marks a significant milestone in the development of the drug, which targets the bromo and extra terminal (BET) binding domain 2…
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Zenshine Pharmaceuticals Raises RMB 100 Million in Series B Financing for Drug Development
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd reportedly raised over RMB 100 million in a Series B financing round. The round was led by Hankang Capital and included participation from Cybernaut, Yangzijiang Funds, Ennovation Ventures, and Matrix Partners China. The proceeds will be used to enhance the…
