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Guangzhou Doublle Bioproduct Receives IND Approval for E101 in Type 2 Diabetes
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Guangzhou Doublle Bioproduct Co., Ltd. has announced receiving Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for its E101, a human umbilical cord mesenchymal stem cells (HUC-MSCs) product. The approval allows the company to initiate clinical trials for the treatment of type 2 diabetes (T2D). Product…
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Suzhou Xueji Biotech’s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT
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China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd’s (HemaCell) XJ-MK-002, described as the world’s first platelet-related cell therapy, received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) last week. The designation is for the treatment of congenital amegakaryocytic thrombocytopenia (CAMT), a rare hereditary bone marrow…
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BMS’s Breyanzi Approved by EC for Relapsed or Refractory Follicular Lymphoma
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US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European Commission (EC) for its Breyanzi (lisocabtagene maraleucel; liso-cel). The approval allows the drug to be used in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Clinical…
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Tasly Pharma’s NR-20201 Receives NMPA Approval for Acute Ischemic Stroke Trial
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China-based Tasly Pharma Co., Ltd (SHA: 600535) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its NR-20201, an in-house developed allogeneic adipose-derived mesenchymal stromal cell-based therapy. This marks a significant step forward in the development of innovative treatments for acute ischemic stroke…
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Jiuzhitang’s Stem Cell Therapy for Autism Receives NMPA Clinical Trial Approval
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China-based Jiuzhitang Co. Ltd (SHE: 000989) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic product, human bone marrow mesenchymal stem cells (hBMSCs), to treat autism spectrum disorder (ASD). This marks a significant step forward in exploring novel therapeutic options for ASD.…
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Astellas Pharma and YASKAWA Establish JV for Cell Therapy Product Manufacturing Platform
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Japan-based Astellas Pharma Inc. (TYO: 4503) is set to establish a joint venture (JV) with compatriot firm YASKAWA Electric Corporation (TYO: 6506). The collaboration aims to develop a cell therapy product manufacturing platform utilizing Maholo, a cutting-edge dual-arm robot developed by YASKAWA’s subsidiary, the Robotic Biology Institute. This innovative platform…
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Bayer’s BlueRock Therapeutics Gets Fast Track for OpCT-001 Therapy
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German pharmaceutical giant Bayer (ETR: BAYN) and its wholly owned subsidiary BlueRock Therapeutics LP announced that they have received Fast Track Designation from the US Food and Drug Administration (FDA) for OpCT-001. The investigational therapy, derived from induced pluripotent stem cells (iPSC), is intended for the treatment of primary photoreceptor…
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CARsgen Therapeutics Administers KJ-C2219 in SLE Patient in IIT
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that it has administered its KJ-C2219 at the starting dose specified in the clinical protocol in the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). Therapy DetailsKJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, was developed via CARsgen’s THANK-u…
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Cell Store and Cygenta Forge Strategic Alliance in Cell and Gene Therapy Field
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Beijing-based biotech firms Cell Store, a biological sample cryopreservation technology platform, and Cygenta, a Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy (CGT), have entered into a long-term strategic alliance. Financial terms of the partnership were not disclosed. Partnership DetailsThe alliance aims to leverage Cell Store’s…
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Nuwacell Biotech’s NCR101 Approved for ILD Clinical Study by China’s CDE
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According to the Center for Drug Evaluation (CDE) website, China-based Nuwacell Biotechnology Co., Ltd. has obtained approval for its NCR101 to conduct clinical trials in interstitial lung disease (ILD). Drug ProfileNCR101 is an induced pluripotent stem cell (iPSC)-derived mesenchymal-like cells (MSCs) therapy. The product has achieved large-scale production and ensures…
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IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
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China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
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Lion TCR’s Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study
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Singapore-based clinical-stage biotechnology company Lion TCR, backed by Chinese investors, has received clearance from the US Food and Drug Administration (FDA) to initiate a global, multi-center Phase II study for its Liocyx-M00 therapy. The treatment involves autologous T-cells transfected with mRNA encoding hepatitis B surface antigen (HBsAg) specific toll cell…
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VectorBuilder and Eureka Bio Form Alliance to Advance CGT Solutions Globally
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China-based gene delivery technology developer VectorBuilder has formed a strategic alliance with compatriot firm Shenzhen Eureka Biotechnology Co., Ltd., a specialist in cell and gene therapy (CGT). The partnership, which leverages the companies’ respective expertise and successful track records in virus vector production, aims to deliver innovative solutions in the…
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IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
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China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Health Sciences Authority (HSA) of Singapore. The therapy is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM)…
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Shenzhen Beike Initiates First Chinese Stem Cell Study for Systemic Lupus Erythematosus
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China-based stem cell specialist Shenzhen Beike Biotechnology Co., Ltd has announced the initiation of a Phase I/II clinical study for human umbilical cord mesenchymal stem cells in patients with moderate to severe systemic lupus erythematosus (SLE). This marks the first regulatory study for stem cell therapy targeting SLE in China,…
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Simnova, Orna Expand Partnership to Develop BCMA-Targeted RNA Therapies
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Shanghai Simnova Biotech Co., Ltd. (Simnova), an affiliate of Simcere Investment Group, has expanded its strategic partnership with Cambridge, Massachusetts-based Orna Therapeutics. The collaboration now includes BCMA (B-cell maturation antigen) as a designated biological target for RNA-based therapeutics development. This partnership aims to leverage Orna’s groundbreaking circular RNA (oRNA) technology…
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Haichang Bio’s siRNA Drug HC016 Cleared for US Clinical Trials
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China-based Zhejiang Haichang Biotech Co., Ltd has announced that its siRNA drug, HC016 complex lipid, has been cleared by the US Food and Drug Administration (FDA) for clinical trials. This marks a significant milestone in the development of innovative treatments for solid tumors, leveraging Haichang Bio’s proprietary QTsome technology platform.…
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iMBIORAY Raises RMB 100 Million in Series A+ for NK Cell Therapies
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Hangzhou-based cell therapy specialist iMBIORAY has reportedly raised close to RMB 100 million (USD 13.7 million) in a Series A+ financing round. The round was led by Sinowisdom, with contributions from Tailong VC, HY Capital, and other investors. The proceeds will be used to advance the clinical development of universal…
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Bristol-Myers Squibb Exercises License for ArsenalBio’s AB-4000 Series
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US-based cell therapy company Arsenal Biosciences, Inc. has announced that Bristol-Myers Squibb (BMS, NYSE: BMY) has exercised its exclusive license option for the AB-4000 series. This program originated from a multi-year agreement between the two companies, which was initially established in December 2020, aimed at advancing next-generation T cell therapies…
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Immunochina Pharmaceuticals Raises Series E Funding for CAR-T Therapy IM19
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Beijing-based biotech Immunochina Pharmaceuticals has reportedly raised “hundreds of millions” of renminbi in a Series E financing round. The round was led by BTH Coordinated Development Industrial Investment Fund, with contributions from Taiping Medical and Health Industry Equity Investment Fund, Beijing Science and Technology Innovation Group, Beijing Sun-Novo Pharmaceutical Research…
