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Immunotech Biopharm’s CAR-T-19-D2 IND Filing Accepted by NMPA
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that an Investigational New Drug (IND) filing for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is recurrent and refractory diffuse large B-cell lymphoma…
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Acotec Scientific Holdings Receives NMPA Approvals for YAN and P-Conic Balloon
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving market approvals from the National Medical Products Administration (NMPA) for its products YAN and P-Conic balloon. These approvals mark significant milestones in the company’s product development and market expansion efforts. Product Details and ApplicationsYAN is a product designed to expand…
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CanSino Biologics Updates Data from COVID-19 Vaccine Clinical Studies
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China-based CanSino Biologics (HKG: 6185) has provided data updates from three clinical studies for its adenovirus type-5 vector-based COVID-19 vaccines. The studies assess the safety and immunogenicity of CanSino’s vaccines in various age groups and vaccination scenarios. Study 1: Bivalent Inhaled Vaccine for AdultsThe first study focused on CanSino’s bivalent…
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Fortune Care Raises Over RMB 100 Million in Series C+ Financing Round
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China-based household healthcare and nursing brand Fortune Care reportedly raised over RMB 100 million (USD 14.33 million) in a Series C+ financing round. The round was solely led by a central government-owned enterprise. The proceeds will be used for commercial service and digital operation system construction, as well as nationwide…
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Guangzhou Mygene Raises ‘Hundreds of Millions’ in Series C Financing Led by Efund Capital
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China-based molecular diagnostic product developer Guangzhou Mygene Medical Technology Co., Ltd reportedly raised “hundreds of millions” of renminbi in a Series C financing round led by Efund Capital. Other investors included Anggu Fuge Investment, Juyo Capital, Benchi Capital, and Hongtu Runda Capital. The proceeds will be used for research and…
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WuXi Biologics Receives First GMP Certificate from Ireland HPRA
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced receiving its first GMP certificate from the Ireland Health Products Regulatory Authority (HPRA) for clinical-and commercial-stage product release testing in Dundalk, Ireland. This marks the first Manufacturer’s/Importation Authorization (MIA) and Investigational Medicinal Product (IMP) license for…
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SciClone Pharmaceuticals’ Vaborem IND Filing Accepted by NMPA
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that an Investigational New Drug (IND) filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been accepted for review by the National Medical Products Administration (NMPA). The IND application covers a Phase III clinical study to evaluate the efficacy and safety…
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Luye Pharma’s Paliperidone Palmitate Accepted for NMPA Review
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China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for…
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Carrier Biomed Raises ‘Tens of Millions’ in Series A+ Financing Round
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Carrier Biomed (Soohow) Co., Ltd, an exosome technology developer based in Suzhou, has reportedly raised “tens of millions” of renminbi in a Series A+ financing round. The funding was led by existing investors Qingnuo Capital and Tianjin Qingzhi Technology Partnership, along with Suzhou Industrial Park Science and Technology Innovation Investment…
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Everest Medicines Launches First Phase of Global mRNA Vaccine Manufacturing Site
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China-based Everest Medicines (HKG: 1952) has announced the initiation of the operation of the first phase of its global manufacturing site dedicated to mRNA vaccine production in Jiashan, Zhejiang province. The first phase of the project, covering an area of 58,000 square meters and with an investment of more than…
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InnoCare Pharma Receives Hong Kong Approval for Tafasitamab in DLBCL
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China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Department of Health in Hong Kong for its tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).…
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LeadArt Biotechnologies Raises USD 6 Million in Pre-Series A Round
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LeadArt Biotechnologies Inc., a chemical proteomics specialist based in Ningbo, has reportedly raised close to USD 6 million in a Pre-Series A financing round. The funding was led by Bluerun Ventures, with participation from Yong Chao Venture Capital. The proceeds will be used for the development of a chemical proteomics…
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Simcere Receives NMPA Clearance for SIM0237 Clinical Study
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0237, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and interleukin-15 (IL-15). The molecule is set for development against locally advanced, unresectable, metastatic…
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CStone Pharmaceuticals Publishes Ayvakit Study Results on Oncologist Website
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China-based CStone Pharmaceuticals (HKG: 2616) has published the results of the China-based bridging NAVIGATOR study for its Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), on the Oncologist website. The open-label, multi-center Phase I/II study was designed to assess the safety, pharmacokinetics, and anti-tumor efficacy…
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Biosion Completes Series B Financing Round Led by Guangfa Xinde Investment
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Biosion, a global, clinical-stage biotech committed to developing antibody-based therapies targeting immune and oncologic diseases, has announced the completion of a Series B financing round at upwards of RMB 100 million (USD 14.33 million). The funding was led by Guangfa Xinde Investment, with contributions from FangFund, Addor Capital, and Suxin…
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BGI Genomics Receives ANVISA Approval for Colorectal Cancer Detection Kit
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China-based genomics giant BGI Genomics Co., Ltd (SHE: 300676) has reported receiving product approval from Brazil’s National Health Surveillance Agency (ANVISA) for its colorectal cancer (CRC) early detection real-time PCR product. The diagnostic kit, used for the auxiliary diagnosis of CRC, is a non-invasive product that detects human genes SDC2,…
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InflaRx and Staidson Amend Deal to Advance Vilobelimab Regulatory Filing in China
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Germany-based biopharma InflaRx N.V. (Nasdaq: IFRX) has revealed an amendment to its underlying deal with China-based Staidson BioPharma Inc. (STS) to push forward a regulatory filing in China for the anti-C5a antibody vilobelimab (BDB-001). InflaRx will supply Staidson with an exclusive license to access the German firm’s clinical, manufacturing, and…
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Elpiscience Receives IND Approval for ES014 in China
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Shanghai-based Elpiscience Biopharmaceuticals Inc. has announced receiving Investigational New Drug (IND) approval in China to initiate a Phase I clinical trial for its bispecific antibody (BsAb) ES014 in patients with advanced solid tumors. ES014 is a potential first-in-class anti-CD39 x TGF-beta immunotherapeutic designed to activate T cells and overcome resistance…
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Ablaze Pharma and Yonghe Partner for Targeted Radiotherapy Development
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China-based Ablaze Pharma and Yonghe Pharmaceutical have struck a partnership agreement for the research and development (R&D) and commissioned manufacturing of targeted radiotherapy (TRT). Yonghe, Ablaze’s Contract Development and Manufacturing Organization (CDMO) partner, will provide R&D and cGMP-compliant manufacturing services from the pre-clinical to clinical stages. Company Background and Partnership…
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InnoCare Pharma’s Orelabrutinib Placed on Partial Clinical Hold by FDA
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that the US FDA has placed orelabrutinib for use in multiple sclerosis (MS) on partial clinical hold. As a result, new enrollment of the Phase II study in the United States will not be initiated. Participants in the US who have…
