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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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Boao Lecheng and Shanghai Biomed Center Form Long-Term Partnership for Medical Innovation
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The Boao Lecheng Medical Tourism Pilot Zone of Hainan Province has entered into a long-term partnership with the Shanghai Center of Biomedicine Development. The collaboration will focus on various areas, including human genetic resources project management, international exchange and cooperation, translation of scientific and technological achievements, and enterprise innovation incubation…
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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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World Orphan Drug Alliance Expands to China with RareStone Group Partnership
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The World Orphan Drug Alliance (WODA) has announced its expansion to China for the first time, welcoming the addition of RareStone Group as a new member. RareStone Group is a China-based biopharma and patient platform focused on rare diseases. WODA is a global alliance of commercial distributors dedicated to providing…
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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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Singde Yiyang Secures Series A Financing to Expand Wellness Services in China
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Singde Yiyang, a leading wellness service provider based in Qingdao, reportedly raised “hundreds of millions” of renminbi in a Series A financing round led by Genertec Investment. The company plans to implement a “1+X+N” layout, covering key regions and cities in China, with a target of over 10,000 beds. Company…
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Meinian Onehealth and Astra Biotechnology Partner on Hypersensitive Blood Biomarker Detection
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China-based Meinian Onehealth Healthcare (Group) Co., Ltd (SHE: 002044) has entered into a partnership with compatriot firm Astra Biotechnology Co., Ltd to develop hypersensitive blood biomarker detection capabilities. The collaboration will focus on creating a humoral biomarker detection scheme and screening model for physical examinations targeting brain diseases and other…
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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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XtalPi and DP Technology Partner to Accelerate Pre-Clinical Drug Development with AI
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has entered into a partnership with Beijing-based DP Technology. The collaboration aims to leverage DP Tech’s AI for Science computation platform and XtalPi’s intelligent, automatic drug research and development (R&D) solutions to streamline the pre-clinical drug R&D process, thereby accelerating drug development. XtalPi’s…
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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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LanssonPharm’s Anti-Depression Drug LS21031 Receives CDE Approval for Clinical Trials
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China-based central nervous system (CNS) drug developer LanssonPharm has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-depression drug, LS21031. This PDE4 inhibitor is being developed to improve symptoms of depression and cognitive-related diseases. Mechanism of ActionLS21031 works by effectively inhibiting…
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GSK’s Nucala Gains NMPA Approval for Severe Eosinophilic Asthma in China
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UK-based GSK plc (NYSE: GSK) has announced that a market approval filing for Nucala (mepolizumab) has been accepted by the National Medical Products Administration (NMPA) in China. The anti-interleukin-5 (IL-5) monoclonal antibody is seeking a second indication approval for use as an add-on maintenance treatment for severe eosinophilic asthma (SEA)…
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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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Guangdong Zhongsheng’s RAY1225 Receives NMPA Approval for Clinical Study
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative polypeptide drug, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) drug features dual activation of the GLP-1 receptor and glucose-dependent…
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AnnJi Pharma Signs USD 250 Million Licensing Deal with Avenue Therapeutics for Kennedy’s Disease Drug
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Taiwan-based AnnJi Pharmaceutical Co., Ltd has announced the signing of a licensing agreement with US firm Avenue Therapeutics Inc. (NASDAQ: ATXI) for its innovative small-molecule drug candidate AJ201, targeting the rare Kennedy’s disease. Under the agreement, AnnJi Pharma will receive up to USD 250 million in licensing fees, including an…
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Vcanbio’s VUM02 Gains CDE Review for Liver Failure and ARDS Clinical Trials
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that two additional clinical trial filings for its VUM02 (human umbilical cord-derived mesenchymal stem cells) have been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking clinical approval for this Category 1 therapeutic…
