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Alloy Therapeutics Partners with Takeda on iPSC-Derived CAR-T and CAR-NK Therapies
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US-based Alloy Therapeutics Inc. has announced a strategic partnership with Japan-headquartered Takeda Pharmaceutical Co., Ltd (TYO: 4502) to develop Takeda’s proprietary induced pluripotent stem cell (iPSC) derived CAR-T cell platform (iCAR-T) and iPSC-derived CAR-NK platform (iCAR-NK). This collaboration aims to bolster the development of key therapies targeting solid and hematological…
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NK CellTech Partners with 3SBio to Advance NK Cell Therapy Technology
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China-based natural killer (NK) cell therapy developer NK CellTech has entered into a strategic partnership with 3SBio Inc. (HKG: 1530), a compatriot firm, to focus on advancing NK cell therapy technology. This collaboration aims to leverage the complementary technologies and resources of both companies, accelerating the research, development, and commercialization…
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Northeast Pharmaceutical to Acquire Majority Stake in Dingcheng Peptide Source for RMB 186.8 Million
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China-based Northeast Pharmaceutical Co., Ltd (SHE: 000597) has announced its intention to acquire a 70% stake in Beijing Dingcheng Peptide Source Biotechnology Co., Ltd, a fellow Chinese firm, for a consideration of RMB 186.8 million. This strategic move is aimed at bolstering Northeast Pharmaceutical’s presence in the cell therapy sector.…
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Legend Biotech Corporation Appoints Alan Bash as President of Carvykti
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China-based chimeric antigen receptor (CAR) T cell therapy specialist, Legend Biotech Corporation (NASDAQ: LEGN), has announced the appointment of Alan Bash as the President of Carvykti, a BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy. In this role, Mr. Bash will oversee the continued growth of Carvykti, managing Legend Biotech’s…
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Reprogenix Secures Over RMB100 Million in Series A Financing Led by China Venture Capital
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Hangzhou-based stem cell specialist Reprogenix has announced the successful completion of a Series A financing round, raising in excess of RMB100 million (USD14.04 million). The funding round was led by China Venture Capital, with participation from Betta Pharmaceuticals Co., Ltd (SHE: 300558) contributing RMB 20 million, Lenovo Capital and Incubator…
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CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume
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The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
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Tasly Pharmaceuticals Gets FDA Approval for Acute Ischemic Stroke Cell Therapy Clinical Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its investigational therapy, NR-20201. This allogeneic adipose-derived mesenchymal stem cell therapy is in development for the treatment of acute ischemic stroke. Preclinical study results…
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Beijing Aims to Build a Leading Cell and Gene Therapy Hub by 2026 with New Action Plan
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The Beijing Municipal Science & Technology Commission, in conjunction with the Administrative Commission of Zhongguancun Science Park, has unveiled the “Beijing Action Plan for Accelerating Collaborative Innovation in Medicine and Health (2024-2026)”. The plan is designed to cement Beijing’s position as a global hub for cell and gene therapy (CGT)…
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iRegene Therapeutics Secures Over USD 14 Million in Series B Financing to Advance Cell Therapies
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iRegene Therapeutics, a Wuhan-based biotechnology company specializing in the development of AI-enhanced chemically induced cell therapies, has announced the successful completion of its Series B financing round, raising over RMB 100 million (USD 14.15 million). The financing was co-led by Orinno Capital, with additional investments from Optics Valley Industrial Investment…
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Immupeutics Medicine Secures NMPA Approval for Personalized Liver Cancer Immunotherapy IPM001
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Immupeutics Medicine, a pioneer in tumor immunotherapy based in Beijing, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its proprietary therapy, IPM001. This marks a significant step forward in the field of cancer treatment in China. IPM001 is a groundbreaking multi-antigen targeted…
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Nona Biosciences Partners with OverT Bio to Develop Next-Generation Cell Therapies for Solid Tumors
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a partnership with US biotechnology company OverT Bio, Inc. to develop next-generation cell therapies targeting solid tumors. The collaboration will leverage Nona’s heavy-chain antibody (HCAb) Harbour Mice platform, with no financial specifics disclosed. Nona Bio’s HCAb…
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Legend Biotech Corporation to Establish Advanced R&D Center in Philadelphia for Next-Generation Cell Therapies
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Legend Biotech Corporation (NASDAQ: LEGN), a leading chimeric antigen receptor (CAR) T cell therapy specialist based in China, has announced plans to establish a state-of-the-art research and development center in Philadelphia, Pennsylvania. The new 31,000 sq. ft. facility, expected to open in the third quarter of 2025, will focus on…
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J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
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Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial data for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The data reveals long-term overall survival (OS) for the therapy’s use as a second-line treatment for multiple myeloma (MM). The three-year…
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2seventy bio and BMS Discontinue Phase III Trial for Multiple Myeloma Therapy Abecma
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2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating…
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Nona Biosciences and Umoja Biopharma Join Forces to Develop In Vivo CAR-T Therapies
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Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a strategic collaboration with US-based Umoja Biopharma to co-develop multi-target antibody therapies. The partnership will leverage Nona’s proprietary fully human heavy chain only antibody (HCAb) technology to create innovative CAR-T cell therapy drug candidates generated in vivo.…
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Carisma Therapeutics and Moderna Expand Partnership to Target Autoimmune Diseases with CAR-M Therapies
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Carisma Therapeutics Inc. (NASDAQ: CARM), a U.S.-based company specializing in chimeric antigen receptor (CAR) macrophage therapies, has announced an expansion of its collaboration with fellow U.S. firm Moderna Inc. (NASDAQ: MRNA). This strategic partnership extension will focus on the development of in vivo CAR macrophage and monocyte (CAR-M) therapies for…
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Jiyuan Biotechnology’s Stem Cell Therapy for Type 2 Diabetes Gains NMPA Tacit Approval for Clinical Trials
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BEIJING—Jiyuan Biotechnology, a leading Chinese biopharmaceutical company, has secured tacit clinical trial approval from the National Medical Products Administration (NMPA) for its cutting-edge therapy targeting type 2 diabetes. This marks the first clinical trial approval in China for domestically developed gene-modified mesenchymal stem cells. The therapy in question involves the…
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JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
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JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
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Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
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Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
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CARsgen Completes Patient Enrollment for Phase II Trial of CT041 in Advanced Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a leading China-based developer of chimeric antigen receptor (CAR)-T cell therapies, has announced the completion of patient enrollment in a confirmatory Phase II clinical trial for its investigational CAR-T therapy, CT041. The study aims to evaluate CT041 as a potential treatment for advanced gastric…
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IASO Biotechnology’s CAR-T Therapy Fucaso Gets FDA Green Light for Lupus Treatment
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IASO Biotechnology, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis…
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WuXi Biologics Partners with Medigene for TCR TCE Development in Refractory Tumors
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WuXi Biologics (HKG: 2269), a leading Contract Research, Development and Manufacturing Organization (CRDMO) in China, has entered into a three-year strategic research cooperation agreement with Germany’s Medigene AG, an immuno-oncology platform company. The collaboration focuses on the design and research of T-cell receptor (TCR) mediated T cell engagers (TCEs) aimed…
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Northeast Pharmaceutical to Acquire Majority Stake in Cell Therapy Specialist Dingcheng Taiyuan
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Northeast Pharmaceutical Co., Ltd (SHE: 000597), a Chinese pharmaceutical company, has announced plans to acquire a 70% stake in Beijing Dingcheng Taiyuan Biotechnology Co., Ltd, a biotech firm specializing in cell therapies for solid tumors. Financial details of the transaction have not been disclosed. Established in 2014, Dingcheng Taiyuan has…
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Huadong Medicine Secures Exclusive Rights to Immunochina’s CAR-T Therapy in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has entered into a licensing agreement with Beijing-based gene therapy specialist Immunochina Pharmaceuticals. The agreement grants Huadong exclusive commercialization rights to Immunochina’s IM19, a promising CD19-targeted autologous chimeric antigen receptor (CAR) T cell therapy, within mainland China. Huadong will make an…
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IASO Biotechnology’s CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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China-based IASO Biotechnology has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
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ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
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ST Phi Therapeutics, a Hangzhou-based cell therapy specialist, has secured tacit approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial for its innovative cell therapy, CNK-UT002. This marks a significant milestone, as CNK-UT002 is the first universal cell therapy for solid tumors to be approved for…
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China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
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Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as potential candidates for breakthrough therapy designations (BTDs). Xiangxue’s TAEST16001, a T-cell receptor TCR affinity-enhanced specific T-cell (TAEST) therapy, and Innostellar’s…
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Fosun Pharma and Kite Pharma Inject USD 28.5 Million into Joint Venture for CAR-T Therapy Development
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196) and Kite Pharma, a subsidiary of Gilead, have announced plans to bolster their joint venture, Fosun Kite Biotechnology Co., Ltd, through a capital increase. This will be achieved by proportionally converting their existing debt into equity, amounting to USD 28.5…
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Shanghai Medicilon and Jiangsu Hengrui Join Forces to Advance Pre-Clinical Drug Evaluation
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Shanghai Medicilon Biomedical Co., Ltd, a leading biopharmaceutical company based in China, has entered into a strategic partnership with Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent player in the global pharmaceutical industry. This collaboration aims to leverage Medicilon’s pre-clinical research and development expertise with Hengrui’s innovative drive and…
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Celling Biotechnology’s CEL001 Earns Tacit Approval for Clinical Trials in China
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Celling Biotechnology Co., Ltd, a Guangzhou-based biopharmaceutical company, has announced that its pipeline candidate CEL001 has received tacit clinical trial approval in China. The drug candidate is an antibody fusion protein targeting PD-1, TIGIT, and IL-15, and is intended for the treatment of advanced solid tumors, with a particular focus…
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Nona Biosciences Partners with Alaya.bio to Revolutionize CAR-T Therapy Development
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Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a strategic cooperation agreement with Alaya.bio, a France-based polymer delivery platform company. This collaboration aims to harness their respective strengths to streamline the development, manufacturing, and administration of chimeric antigen receptor (CAR)-T therapies through precision targeting and…
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Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy Earns FDA Fast Track for Multiple Myeloma
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Oricell Therapeutics Co., Ltd, a leading biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative therapy, OriCAR-017. This chimeric antigen receptor (CAR)-T cell therapy is targeted at GPRC5D, aiming to treat recurrent refractory multiple myeloma…
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Legend Biotech’s Shares Leap on Acquisition Rumors; Parent Genscript Biotech Corp. Follows Suit
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Chinese biopharmaceutical firm Legend Biotech (NASDAQ: LEGN), a specialist in chimeric antigen receptor (CAR) T-cell therapy, has reportedly drawn the attention of a potential acquirer. This development sent Legend’s stock price climbing over 12% in a single day, as reported by the news platform Street Insider. The company has allegedly…
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GRIT Biotechnology and Quangang Pharmaceutical Co., Ltd Partner to Develop TIL and IL-2 Combination Therapy
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GRIT Biotechnology, a leading cell therapy specialist based in China, has entered into a strategic partnership with compatriot firm Quangang Pharmaceutical Co., Ltd. The collaboration aims to co-develop a combination therapy for solid tumors, leveraging tumor-infiltrating lymphocyte (TIL) therapy and recombination human interleukin-2 (IL-2). Interleukin-2 (IL-2) products, which are already…
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Innovent Biologics and IASO Biotechnology Amend Partnership, Focusing on CAR-T Therapy Fucaso
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced a new set of agreements with IASO Biotechnology, a domestic firm, to adjust the terms of their earlier partnership. According to the new deals, IASO will acquire from Innovent its rights to the BCMA-targeted chimeric antigen…
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SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
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SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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Novo Nordisk Moves to Acquire 2seventy bio’s Hemophilia A Program and Gene-Editing Technology
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading Danish biopharmaceutical company, is transitioning from a partnership to an acquisition deal with U.S. biotech firm 2seventy bio Inc. (NASDAQ: TSVT) for the development of a hemophilia A drug candidate. The companies have entered into an asset purchase agreement that will see…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
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AstraZeneca’s Gracell Biotechnologies to Expand Cell Therapy Manufacturing in China
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Gracell Biotechnologies, a China-based cell therapy specialist owned by AstraZeneca (AZ; NASDAQ: AZN), is reportedly planning to expand its manufacturing capacity at its Suzhou BioBay life science cluster base, according to a report from Yicai Global. The construction of a 9,000 sq. m. expansion at the site is set to…
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Sinovac Biotech Commits USD 100 Million Investment in Brazil for Vaccine Research and Collaboration
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Sinovac Biotech Ltd. (NASDAQ: SVA), a leading vaccine specialist based in China, is reportedly set to invest USD 100 million in the Brazilian market to bolster collaborations with local partners and researchers. The company plans to conduct in-country research not only on vaccines but also on advanced therapeutics, including cell…
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OBiO Technology Partners with Shenzhen Innovation Immunotechnology for TCR-T Cell Therapy Development
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OBiO Technology (Shanghai) Co., Ltd (SHA: 688238), a leading Contract Research Organization (CRO) specializing in gene therapy based in China, has entered into a partnership with Shenzhen Innovation Immunotechnology Co., Ltd. As per the agreement, OBiO will offer preclinical pharmaceutical research services for Shenzhen Innovation’s TCR-T cell therapy candidate, SIIT-T002.…
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Legend Biotech’s Carvykti Shows Durable Responses in Multiple Myeloma Patients Post ASCT
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Legend Biotech Corporation (NASDAQ: LEGN) has announced results from the Phase II CARTITUDE-2 Cohort D study of its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in multiple myeloma (MM) patients. The data was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, along…
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Legend Biotech Gains Access to MaxCyte’s Cell Engineering Tech with New License Agreement
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China’s Legend Biotech Corporation (NASDAQ: LEGN) has entered into a strategic platform license (SPL) agreement with US-based cell-engineering company MaxCyte Inc., (NASDAQ: MXCT). The agreement grants Legend Bio a non-exclusive worldwide license to leverage MaxCyte’s Flow Electroporation technology and ExPERT platform. This access will facilitate Legend Bio’s research, clinical development,…
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NK CellTech’s NK-Cell Therapy Gets Green Light from China’s NMPA for Solid Tumor Treatment
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NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
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Astellas Pharma Considers Joint Cell Therapy Platform with Yaskawa Electric
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it is in advanced discussions with fellow Japanese firm Yaskawa Electric Corporation (OTCMKTS: YASKY) to explore a potential collaboration aimed at developing a cell therapy platform. This strategic partnership would integrate robotics technologies to expedite research and…
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Shanghai UniCAR-Therapy’s Innovative CAR-T Therapy Targets Breakthrough Designation with IL-6 Silencing
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Shanghai UniCAR-Therapy Bio-Medicine Technology Co., Ltd, a leading biopharmaceutical company based in China, is on track to secure breakthrough therapy designation (BTD) for its innovative autologous CD19 targeted chimeric antigen receptor (CAR) T-cell therapy. This therapy features a unique function of silencing interleukin-6 (IL-6) expression and is intended for the…
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Macera Therapeutics and Innorna Co., Ltd Collaborate on CAR-M mRNA-LNP Technology
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Macera Therapeutics, a company based in Nanjing specializing in the development of macrophage immunotherapies, has entered into a partnership with Shenzhen-based Innorna Co., Ltd, a platform company focused on delivery platforms for nucleic acid therapeutics. Under the agreement, Macera will leverage Innorna’s mRNA-LNP technology to advance the development of in…
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Biocytogen and BioCopy AG Collaborate on TCR-Mimic Antibody Development for Cancer Therapies
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based biopharmaceutical company, has announced an evaluation and potential licensing agreement with BioCopy AG, a research-driven biotechnology firm based in Basel, Switzerland. This agreement grants BioCopy access to a fully human library of TCR-mimic antibodies that target intracellular antigens. These antibodies are…
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iRegene’s Pioneering Cell Therapy NouvNeu001 Administered in Wuhan for Parkinson’s Disease
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Wuhan-based cell therapy developer iRegene has reached a clinical milestone with the administration of its novel treatment, NouvNeu001, to a patient at Zhongnan Hospital of Wuhan University. The patient’s postoperative condition has been reported as good. In August 2023, NouvNeu001 received approval to be evaluated in a multi-center, open Phase…
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CARsgen Therapeutics Submits CAPA Report to US FDA Following Clinical Hold
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced the filing of its Corrective And Preventive Actions (CAPAs) report with the US Food and Drug Administration (FDA). This follows a previous request by the FDA in December last year…
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AbelZeta Pharma’s CAR-T Therapy C-CAR031 Receives Implicit Approval for Clinical Study in China
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Sino-US biotechnology company AbelZeta Pharma Inc., operating in Rockville, Maryland, and Shanghai, China, has received implicit approval for its autologous armored GPC3-targeted chimeric antigen receptor (CAR) T cell therapy, C-CAR031, developed by its subsidiary, Shanghai Cellular Biopharmaceutical Group Ltd. The therapy is intended for the treatment of GPC3+ advanced or…
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Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
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Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic…
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Shenzhen Wingor Biotechnology Partners with Guangzhou Institute of Respiratory Health for MSC Exos Research
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Shenzhen Wingor Biotechnology Co., Ltd, a Chinese biotechnology company, has entered into a scientific research cooperation agreement with the Guangzhou Institute of Respiratory Health (GIRH). The partnership aims to collaborate on clinical studies focusing on the use of exosomes derived from mesenchymal stem cells (MSC exos) for the treatment of…
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GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
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Bristol Myers Squibb Enhances CAR-T Manufacturing with Cellares Platform, Securing Exclusive Access
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Pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) has secured a deal with Cellares, a U.S.-based cell therapy production platform, to bolster its manufacturing capacity for CAR-T therapies. In return for granting exclusive access to several of its fully automated systems, Cellares is set to receive up to USD 380…
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Carvykti CAR-T Therapy Sales Reach $157 Million in Q1 2024, Reports GenScript Subsidiary Legend Biotech
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GenScript Biotech Corporation (HKG: 1548), a leading Contract Research Organization (CRO) based in China, has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 157 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in the first quarter of 2024, which…
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Blue Shield Pharma Faces Bankruptcy Proceedings After Missing Debt Payments
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The Nanjing Qixia District People’s Court has accepted a bankruptcy liquidation case for Blue Shield Pharma, a China-based pharmaceutical company specializing in tumor drug development. The move comes after Blue Shield Pharma failed to meet its debt obligations. As of April 9, 2024, the company’s total employee debt stood at…
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IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
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China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.…
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Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r…
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Legend Biotech and Janssen Pharmaceutical Expand Partnership with Novartis for Carvykti Production
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Legend Biotech Corporation (NASDAQ: LEGN), a leading Chinese biotech firm, and its U.S. partner Janssen Pharmaceutical have entered into a comprehensive agreement with Swiss pharmaceutical giant Novartis. The agreement covers technology transfer, manufacturing, and clinical supply services for the co-developed therapy Carvykti (ciltacabtagene autoleucel; cilta-cel). As per the terms, Novartis…
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Novatim Immune Therapeutics’ KQ-2003 Gains Tacit Approval for POEMS Syndrome Clinical Trial in China
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Novatim Immune Therapeutics (Zhejiang) Co., Ltd, a China-based specialist in cancer immunotherapy, has received tacit clinical trial approval from Chinese regulatory authorities for its investigational therapy, KQ-2003. This autologous chimeric antigen receptor (CAR)-T cell therapy targets BCMA and CD19 and is poised to be evaluated for the treatment of recurrent/refractory…
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IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
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IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…
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Shanghai Medicilon Forms Strategic Partnerships with Binhui Biopharmaceutical and Innoforce Pharmaceuticals
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Shanghai Medicilon Biomedical Co., Ltd (SHA: 688202), a prominent Chinese biotech firm, has entered into separate partnerships with domestic companies Binhui Biopharmaceutical and Innoforce Pharmaceuticals Co., Ltd. In collaboration with Binhui, Medicilon aims to explore innovative areas including oncolytic viruses, nucleic acid drugs, and protein therapeutics. Meanwhile, the partnership with…
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Sanofi Projects EUR 13 Billion in Dupixent Sales for 2024 Despite Q1 Challenges
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has released its guidance for the first quarter of 2024. Despite expectations that its top-selling interleukin blocker Dupixent (dupilumab) will face challenges from a co-pay assistance program in the first quarter, the company projects that the drug’s sales will reach EUR 13…
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OBiO Technology Partners with Saierxin Bio to Support Treg Cell Therapy Development
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OBiO Technology (Shanghai) Co., Ltd (SHA: 688238), a Chinese Contract Research Organization (CRO) specializing in gene therapy, has entered into a strategic partnership with Shanghai Saierxin Biomedical Technology Co., Ltd. Under the terms of the agreement, OBiO will offer non-registered clinical trial sample preparation and testing services for Saierxin Bio’s…
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iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment
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Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA for its ophthalmic product NouvSight001, aimed at treating retinitis pigmentosa (RP). NouvSight001 is heralded as the world’s first universal ophthalmic cell therapy derived from induced pluripotent stem cells (iPSCs), developed through an innovative “AI+chemical induction”…
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Suzhou Porton Biologics Partners with Kunshi Biotech to Advance Third-Generation CAR-M Therapy
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Suzhou Porton Biologics Ltd, a China-based Contract Development and Manufacturing Organization (CDMO), has entered into a strategic partnership with Kunshi Biotechnology (Shenzhen) Co., Ltd. The collaboration aims to expedite the Investigational New Drug (IND) filing for Kunshi’s drug candidate RR-M01, marking a significant step forward in the development of third-generation…
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uBriGene Partners with XJTLU to Develop CAR-NK Cell Therapies for Solid Tumors
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uBriGene, a China-based biotechnology company, has entered into a partnership with Xi’an Jiaotong-Liverpool University (XJTLU) Wisdom Lake Academy of Pharmacy to develop innovative chimeric antigen receptor natural killer (CAR-NK) cell therapies. The collaboration aims to advance the field of immunotherapy by creating two distinct types of CAR-NK cell treatments. The…
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Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
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GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that its subsidiary Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), has received a recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC). Following a review…
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Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
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VectorBuilder Partners with Minaris Regenerative Medicine to Enhance Gene Therapy Solutions
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VectorBuilder, a specialist in genetic engineering based in China, has entered into a strategic partnership with Minaris Regenerative Medicine, a cell and gene therapy (CGT) Contract Development and Manufacturing Organization (CDMO) and a subsidiary of Japan-headquartered Showa Denko Materials Co., Ltd. This collaboration aims to integrate VectorBuilder’s superior R&D and…
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Legend Biotech Reports Q4 and Full-Year 2023 Financials with Focus on Carvykti Milestones
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Legend Biotech Corporation (NASDAQ: LEGN) has released its financial results for the fourth quarter and full year of 2023, along with key business highlights. The company reported licensing income of USD 35.2 million and cooperation income of USD 249.8 million, primarily attributed to milestone payments related to the Carvykti (ciltacabtagene…
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Simnova Secures RMB 200 Million in Series A+ Funding to Advance CAR Therapy Pipeline
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Simnova, a Shenzhen-based developer of chimeric antigen receptor (CAR) adoptive cell therapies, has successfully raised RMB 200 million (approximately USD 27.8 million) in a Series A+ financing round. The round was led by Youshan Capital, with participation from SIP Oriza Seed Fund, PagodaTree Partners, and Triwise. The company’s pipeline features…
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Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its universal NK cell therapy, GCK-01. This Category 1 innovative therapeutic…
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CARsgen Launches BCMA-Targeted CAR-T Therapy in China with High Price Point
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China-based CAR-T cell therapy specialist CARsgen Therapeutics Holdings Ltd. (HKG: 2171) has launched its BCMA-targeted CAR-T cell therapy, CT053 (zevorcabtagene autoleucel; zevor-cel), with a price tag of RMB 1.15 million (USD 160,000), as reported by The Paper, a local media outlet. The company anticipates that the drug’s annual end sales…
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Sino-Biocan Secures Series B Funding to Boost Cell and Gene Therapy Production Platforms
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Sino-Biocan (Shanghai) Biotech Ltd, a provider of automated, modularized, closed cell production platforms for the cell and gene therapy (CGT) sector, has reportedly secured RMB 100 million (USD 14.5 million) in a Series B financing round. The round was led by Dalton Venture, with additional investment from Qikun Fund and…
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Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
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The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular…
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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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GenScript’s Subsidiary Legend Biotech Gets CHMP Nod for Carvykti Label Expansion in Multiple Myeloma
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the label expansion of its (BCMA)-directed chimeric antigen receptor T…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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Shenzhen Eureka Biotechnology Secures RMB 300 Million in Series B+ Funding for CGT Expansion
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Shenzhen Eureka Biotechnology Co., Ltd., a specialist in cell and gene therapy (CGT) based in China, has successfully raised over RMB 300 million (approximately USD 41.7 million) in a Series B+ financing round. The funding was led by Yuexiu Capital, with notable participation from Fortune Capital, Guangdong Technology Financial Group,…
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ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
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ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its aT19 injection. The treatment is designed as a sequential therapy for patients…
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Astellas Pharma Partners with Kelonia Therapeutics to Advance CAR-T Cell Therapies
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Astellas Pharma Inc. (TYO: 4503) has announced a strategic research collaboration and licensing agreement with U.S.-based biotech company Kelonia Therapeutics. The partnership, established through Astellas’ subsidiary Xyphos Biosciences, will leverage Kelonia’s proprietary in vivo gene placement system (iGPS) to engineer advanced lentiviral particles for targeted genetic delivery, in conjunction with…
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AstraZeneca Announces $300 Million Investment in Next-Gen Cell Therapies Manufacturing in the U.S.
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has announced a significant investment of $300 million to establish a next-generation cell therapies manufacturing facility in the United States. This new site is set to enhance support for global clinical trials and facilitate local product launches. This strategic move follows AstraZeneca’s…
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Gilead’s Kite Subsidiary Reduces CAR T-Cell Therapy Turnaround Time with FDA Approval
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Kite, a subsidiary of Gilead (NASDAQ: GILD), has announced a significant enhancement in the treatment process for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). The median turnaround time (TAT) for this life-saving therapy is set to decrease from 16 days to 14 within the United States, following an approval by…
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Regeneron Pharmaceuticals Acquires 2seventy Bio to Boost Cell Therapy Capabilities
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Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the acquisition of U.S. biotechnology company 2seventy Bio Inc. (NASDAQ: TSVT), securing all development and commercialization rights to the latter’s drug discovery platform, clinical manufacturing platform, and investigational innovative cell therapies. In conjunction with this acquisition, Regeneron will establish a new unit, Regeneron Cell…
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Ping An Good Doctor Partners with Vcanbio to Pioneer Cell Health Management Services in China
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Ping An Healthcare and Technology Co., Ltd (HKG: 1833), commonly referred to as PingAn Good Doctor, has entered into a strategic partnership with Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645), another Chinese firm. The collaboration aims to combine the business acumen and technical prowess of both companies to…
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3D Medicines Partners with Sino Cellbiomed to Advance Tumor Immunotherapy Development
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3D Medicines (HKG: 1244), a China-based oncology specialist, has entered into a partnership with Sino Cellbiomed, a Qingdao-based cell therapy firm, to collaborate on the development of tumor immunotherapies. Financial terms of the agreement have not been disclosed. Since its debut on the Hong Kong Stock Exchange in December 2022,…
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EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies.…
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IASO Biotechnology Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
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China-based IASO Biotechnology has received clinical trial approval from the National Medical Products Administration (NMPA) for its BCMA-directed CAR T cell therapy, Fucaso (equecabtagene autoleucel), now indicated for the treatment of refractory systemic myasthenia gravis (MG). Originally approved for marketing in China in June 2022 for recurrent and refractory multiple…
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GSK In-Licenses Elegen’s Cell-Free DNA Tech to Advance Next-Gen Gene Therapies and Vaccines
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has this week in-licensed US partner Elegen’s cell-free DNA manufacturing technology to bolster the potential development of next-generation mRNA, cell, and viral gene therapies, as well as RNA-based vaccines. Elegen will receive upfront fees, purchase commitments, potential equity investment, and milestone payments…
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Tcelltech’s B7-H3 Targeting CAR-T Therapy TX103 Gets Tacit Clinical Approval for Glioblastoma
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The Center for Drug Evaluation (CDE) website in China has indicated that Tcelltech’s TX103, a chimeric antigen receptor (CAR) T cell therapy targeting B7-H3, has received tacit approval to proceed with clinical trials for the treatment of malignant glioblastoma. Suzhou Porton Biologics Ltd, Tcelltech’s Contract Development and Manufacturing Organization (CDMO)…
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BriSTAR Immunotech’s LILRB4-Targeted Cell Therapy YTS104 Gets Tacit Approval for Clinical Trial in China
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BriSTAR Immunotech, a clinical-stage cell therapy company based in Beijing, has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) in China for its YTS104, a specific LILRB4-targeted cell therapy based on its STAR-T platform. The targeted indications for YTS104 include recurrent/refractory acute myeloid leukemia (AML), chronic…
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Legend Biotech’s Carvykti Files for European Approval as Second-Line MM Treatment
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GenScipt Biotech Corp. (HKG: 1548), a China-based Contract Development and Manufacturing Organization (CDMO), through its subsidiary Legend Biotech Corporation (NASDAQ: LEGN), has announced a market approval filing in Europe for its chimeric antigen receptor (CAR)-T therapy Carvykti (ciltacabtagene autoleucel). The therapy is proposed as a second-line treatment for recurrent/refractory (R/R)…
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Suzhou Jade Biomedical Partners with Hopstem Biotechnology for Cell Therapy Advancements
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Suzhou Jade Biomedical Co., Ltd, a prominent player in the Chinese biotech industry, has entered into a strategic partnership with Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by a team of neuroscientists and stem-cell biologists from Johns Hopkins University. The collaboration aims to enhance the quality and…
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Guangdong Aims to Boost Biomedicine Industry with Incentives and Strategic Development
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The Guangdong Provincial Development and Reform Commission has unveiled an ambitious set of measures aimed at fostering high-quality development in the biomedicine industry. The initiative seeks to propel Guangzhou’s biopharmaceutical sector to overcome challenges, enhance metropolitan coordination, and spearhead industry growth in the Greater Bay Area (GBA). The program extends…
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Tasly Pharmaceuticals Gets NMPA Go-Ahead for Clinical Trial of Stem Cell Therapy in Heart Failure
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Tasly Pharmaceuticals (SHA: 600535), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its human umbilical cord mesenchymal stem cell injection, B2278. The study aims to evaluate the efficacy of this therapy…
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CARsgen Therapeutics’ CT041 Shows Promising Results in Advanced Solid Tumors at ASCO GI 2024
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is…
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FDA Approves Casgevy, the First CRISPR-Based Gene Editing Therapy for β-Thalassemia
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Casgevy (exagamglogene autotemcel), the pioneering gene editing therapy based on CRISPR technology, has received approval from the US Food and Drug Administration (FDA) for the treatment of patients aged 12 and above with transfusion-dependent β-Thalassemia (TDT). This marks a significant milestone as Casgevy becomes the world’s first CRISPR-based gene editing…
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Shanghai-Based NK CellTech Earns FDA IND Clearance for Non-Genetically Modified NK Cell Therapy
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NK CellTech, a Shanghai-based developer of NK cell therapies, has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its proprietary non-genetically modified natural killer cell therapy, NK010, for the treatment of ovarian cancer. This milestone marks NK CellTech as…
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Boai NKY Medical Holdings Partners with HuaDao Biopharma for CAR-T Therapy Incubator
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Boai NKY Medical Holdings Ltd (SHE: 300109), a Chinese biotech company, has announced a strategic partnership with compatriot firm HuaDao Biopharma. Under the agreement, HuaDao will guide Boai NKY in establishing a GMP-aligned chimeric antigen receptor (CAR) T-cell therapy development incubator. HuaDao has agreed to prioritize Boai NKY for the…
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Fosun Kite and Medi Cover Launch First Value-Based Payment Plan for Lymphoma Treatment
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Fosun Kite and Medi Cover, a health management and patient service platform under Sinopharm (HKG: 1099), have jointly introduced the first value-based payment (VBP) plan for lymphoma associated with Fosun Kite’s chimeric antigen receptor (CAR) T cell therapy, Yescarta (axicabtagene ciloleucel). Under this innovative plan, eligible patients who do not…
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Lion TCR Partners with MaxCyte to Develop mRNA-Based TCR-T Therapies for Solid Tumors and Viral Diseases
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Lion TCR, a Singapore-based clinical-stage biotechnology company with backing from Chinese investors, has entered into a partnership with U.S. firm MaxCyte Inc. to harness mRNA technology for the development of TCR-T therapies. These therapies are aimed at treating solid tumors and virus-related diseases. The collaboration will enable Lion to utilize…
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JW Therapeutics Secures NMPA Review for CAR-T Therapy in Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an additional indication application for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), targeting recurrent or refractory mantle cell lymphoma (r/r MCL). The National Medical Products Administration (NMPA) has accepted the filing…
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ImmunoTech Biopharm Commences Patient Enrollment in Phase II Study for CAR-T-19 Injection
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ImmunoTech Biopharm Ltd, a China-based specialist in chimeric antigen receptor T-cell (CAR-T) therapies (HKG: 6978), has announced the enrollment of the first patient in a Phase II clinical study for its CAR-T-19 injection. The treatment is under development for children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).…
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GenScipt Subsidiary Legend Biotech Finalizes Licensing Deal with Novartis for DLL3 CAR-T Therapies
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GenScipt Biotech Corp., a China-based Contract Development and Manufacturing Organization (CDMO) (HKG: 1548), has announced that the closing conditions for a licensing agreement between its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), and the Swiss pharmaceutical giant Novartis AG (NYSE: NVS) have been met. The agreement, initially revealed in November 2023,…
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JW Therapeutics and 2seventy Bio Ink Exclusive Deal for CAR-T Cell Therapy in Greater China
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JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has announced an exclusive collaboration agreement with US biotech firm 2seventy Bio Inc. (NASDAQ: TSVT) to jointly develop, manufacture, and commercialize an unspecified chimeric antigen receptor (CAR)-T cell therapy product for autoimmune diseases in the Greater China region. JW will…
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China’s CDE Releases Guidelines for CGT Clinical Trials Communication
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The Center for Drug Evaluation (CDE) in China has released the “Technical Guiding Principles for Cell and Gene Therapy (CGT) Product Clinical Communication and Exchange,” addressing the unique considerations of personalized and specific CGT products. Applicants are advised to focus on critical factors such as product characteristics, clinical positioning, target…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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Simcere Affiliate Xianbo Biotech Gets China Nod for CAR-T Therapy SNC109
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Shanghai Xianbo Biotech Co., Ltd, known as Simnova outside of China and an affiliate of Simcere Investment Group, has received tacit clinical trial approval from Chinese authorities for its SNC109, an in-house developed treatment for recurrent glioblastoma. SNC109 is a dual chimeric antigen receptor (CAR)-T cell therapy designed on Xianbo…
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AstraZeneca to Acquire China’s Gracell Biotechnologies in $1.2 Billion Deal
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Pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced its intention to fully acquire Gracell Biotechnologies Inc., (NASDAQ: GRCL), a China-based developer of chimeric antigen receptor (CAR) T cell therapies. This marks the first major merger and acquisition (M&A) deal by a foreign company targeting one of China’s newest generation biotechs.…
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Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), will update the warning label for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), to account for the potential risk of myeloid neoplasms in patients…
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AbelZeta Pharma Expands Janssen Partnership to Include Commercial Rights in China
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AbelZeta Pharma Inc., a Sino-US biotechnology company with operations in Rockville, Maryland, and Shanghai, China, has announced an updated global collaboration and licensing agreement with Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ). According to the revised agreement, Janssen will now secure commercialization rights to CAR-T therapies C-CAR039…
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J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy,…
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CARsgen Therapeutics Halts Clinical Studies for Three CAR-T Therapies in the US Following FDA Request
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug Administration (FDA) has requested its US subsidiary, CARsgen Therapeutics Corporation, to place clinical studies for CT053, CT041, and CT071 on hold. These chimeric antigen receptor (CAR)-T therapies are on hold pending the FDA’s conclusion after…
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Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
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Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for C-13-60 cell preparations as a local treatment in the abdominal cavity for CEA+ advanced malignant tumors, including a range of cancers such as colorectal, esophageal, gastric,…
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Taiwan Bio and TRACT Therapeutics Forge Partnership to Combat Organ Rejection
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Taiwan Bio Therapeutics Co., Ltd. has entered into a strategic partnership with U.S.-based TRACT Therapeutics, focusing on cell therapies aimed at preventing allograft rejection in solid organ transplants. Under the agreement, Taiwan Bio will leverage its manufacturing expertise in cell therapy to enhance TRACT’s immune-modulating regulatory T cell therapy platform.…
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Stem-Cell Startup Xellsmart Earns FDA Orphan Drug Designation for ALS Therapy
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Xellsmart, a stem-cell startup headquartered in Suzhou, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its induced pluripotent stem cell (iPSC) derived subtype neural precursor cell therapy, targeting amyotrophic lateral sclerosis (ALS). ALS is a devastating motor neuron disease…
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CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received clinical trial approval from the U.S. FDA for its chimeric antigen receptor (CAR)-T cell product, CT071, aimed at treating recurrent/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (PCL). CT071 is developed using the…
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China’s State Council Unveils Comprehensive Plan to Boost Beijing’s Healthcare Sector
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The State Council has unveiled a comprehensive “Work Plan” aimed at enhancing Beijing’s service industry capabilities, with a particular focus on healthcare and medical services. Titled “Work Plan Supporting the Construction of Comprehensive Demonstration Zones to Deepen National Service Industry Openness in Beijing,” the document outlines several key proposals that…
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JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy. Relmacabtagene autoleucel is an autologous…
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Gracell Biotechnologies Gets FDA Green Light for FasTCAR-T Therapy in Systemic Lupus Erythematosus
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Gracell Biotechnologies Inc., a Suzhou-based biotech company (NASDAQ: GRCL), has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical study for its FasTCAR-T GC012F in the United States. The CAR-T therapy is set to be assessed as a treatment for refractory systemic lupus…
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AstraZeneca to Open R&D Center in Hong Kong, Focusing on Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has concluded a roughly 12-month discussion period with local authorities and is proceeding to establish a research and development (R&D) center in Hong Kong, marking a significant step as it becomes the first leading global Big Pharma to do so in the city.…
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SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
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China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s SCG101 autologous T cell therapy has obtained tacit clinical trial approval in China. This marks a world-first clinical indication for the treatment of cholangiocarcinoma. SCG101’s Expanding Clinical IndicationsSCG101, a TCR-T cell therapy, targets specific hepatitis…
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BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
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The US Food and Drug Administration (FDA) has postponed the target action date for Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy Bio (NASDAQ: TSVT)’s CAR-T cell therapy Abecma (idecabtagene vicleucel) from December 16. The decision affects the therapy’s filing for earlier lines of triple-class exposed relapsed or refractory multiple…
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Suzhou Porton Biologics Partners with Asclepius Technology for NK Cell Project
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China-based Contract Development and Manufacturing Organization (CDMO) Suzhou Porton Biologics Ltd has entered into a partnership with compatriot firm Asclepius Technology Company Group. The agreement, with financial details undisclosed, will see Porton provide development, production, and application services in China for Asclepius’s NK cell project, which has applications in cancer…
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Gilead’s Kite Expands Partnership with Arcellx for Innovative Cell Therapies
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Gilead (NASDAQ: GILD), a leading biopharmaceutical company, has announced an expansion of its 2022 partnership with Arcellx (NASDAQ: ACLX), a US-based biotechnology firm. The collaboration includes the in-licensing of ACLX-001, a multiple myeloma (MM) engineered cell therapy, and the extension of their CART-ddBCMA program to include lymphomas . Financial Terms…
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Biosmelt Pharma Partners with Shenzhen Eureka Biotechnology for Cell and Gene Therapy Advancements
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Shanghai-based cell and gene therapy (CGT) specialist, Biosmelt Pharma, has entered into a partnership with Shenzhen Eureka Biotechnology Co., Ltd, a domestic CGT-focused Contract Development and Manufacturing Organization (CDMO) service provider. Combining Expertise for Large-Scale Virus Vector ProductionThe collaboration aims to capitalize on Biosmelt’s GMP grade lentivirus vector suspension production…
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Senti Biosciences and Celest Therapeutics Partner on CAR-NK Cell Therapy Clinical Trial in China
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Senti Biosciences Inc., (NASDAQ: SNTI), a San Francisco-based biotech company, has announced a strategic collaboration and license agreement with Shanghai-based Celest Therapeutics Co., Ltd. The partnership will see Celest manage a pilot clinical trial in mainland China for Senti’s SENTI-301A, an off-the-shelf CAR-NK cell therapy targeting GPC3-expressing tumors. Senti will…
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Bayer and Shanghai Pharmaceuticals Launch Co.Lab to Incubate Life Sciences Innovation in China
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Bayer, the Germany-headquartered multinational pharmaceutical and life sciences company (ETR: BAYN), has entered into a partnership with Shanghai Pharmaceuticals, a leading China-based pharmaceutical distribution giant (SPH; HKG: 2607; SHA: 601607), to co-construct a new life sciences incubator named Co.Lab. This collaboration is designed to foster cutting-edge innovation in cell and…
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Shanghai Pharmaceuticals Gets NMPA Approval for Phase I Clinical Study of B019 CAR-T Cell Injection
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for its proprietary B019 injection. B019 is a chimeric antigen receptor (CAR) autologous T cell injection that targets CD19…
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AstraZeneca Partners with Cellectis for Next-Generation Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced a strategic partnership with Cellectis (EPA: ALCLS; NASDAQ: CLLS) to develop next-generation therapeutics, focusing on areas of high unmet need such as oncology, immunology, and rare diseases. This collaboration aims to leverage Cellectis’s gene editing technologies and manufacturing capabilities to advance…
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Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
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The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive…
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ImmuXell Biotech Secures Over RMB 100 Million in Series A Funding for Cell Therapy Development
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ImmuXell Biotech Co., Ltd, a Shanghai-based cell therapy developer, has reportedly secured over RMB 100 million (USD 13.7 million) in a Series A financing round. The round was led by SDIC Venture Capital, with significant participation from Huangpu Pharmaceutical Fund and Yuanxi Haihe Fund. The funds will be instrumental in…
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Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
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Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment…
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Strategic Alliance Formed by uBriGene, Fraserna, and Virogin for Cell and Gene Therapy Services
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In a significant move to bolster the cell and gene therapy (CGT) sector, China-based biotechnology firms uBriGene, Fraserna, and Virogin have entered into a strategic partnership agreement. While the financial details of the agreement remain undisclosed, the collaboration is poised to integrate the global resources of the three companies, offering…
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GenScript Reports $152 Million in Sales for Carvykti as of September 30, 2023
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 152 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), as of September 30, 2023. This represents a year-on-year growth rate…
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Vcanbio Receives NMPA Approval for Stem Cell Therapy VUM02 Clinical Trial
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China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind, placebo-controlled Phase I/II study. The study will assess the efficacy and safety of its innovative product VUM02, a…
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BMS Expands CAR-T Collaboration with Cellares on Automation Tech
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Bristol-Myers Squibb (BMS; NYSE: BMY) has entered into a technology transfer agreement with US-based Cellares, a company specializing in automated manufacturing platforms for cell therapies. This marks the second collaboration between the two entities, focusing on the production of an unnamed CAR-T cell therapy. The agreement highlights BMS’s commitment to…
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Bayer Opens First Cell Therapy Production Facility in the U.S. to Advance Research
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Bayer AG (ETR: BAYN) has inaugurated its first production site dedicated to cell therapies, marking a significant step in the company’s commitment to advancing research in this innovative field. The new facility, spanning 9,290 square meters, represents a substantial investment of $250 million and enhances Bayer’s biotechnology network, which includes…
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Kyowa Hakko Kirin to Acquire Orchard Therapeutics for $477.6 Million
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Japan-based Kyowa Hakko Kirin is poised to acquire UK-headquartered Orchard Therapeutics plc for a total consideration of USD 477.6 million. The deal comprises USD 387.4 million in cash and USD 90.2 million in Contingent Value Rights (CVRs), with the transaction expected to close in the first quarter of 2024. Acquisition…
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Suzhou Novoprotein and Shanghai Model Organisms Center Ink Global Partnership
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Suzhou Novoprotein Scientific Co., Ltd, (SHA: 688137) a leading provider of protein technology and application solutions in China, has entered into a strategic partnership with Shanghai Model Organisms Center, Inc. (SHA: 688265). The collaboration aims to combine the companies’ expertise on a global scale, focusing on technology and commerce. Novoprotein…
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Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
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Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of its CAR-T therapy, Yescarta (axicabtagene ciloleucel), for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The study achieved a primary endpoint…
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Suzhou Porton Biologics Partners with BRL Medicine to Advance Gene and Cell Therapy Pipeline
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China-based Contract Development and Manufacturing Organization (CDMO) Suzhou Porton Biologics Ltd has entered into a strategic partnership with compatriot firm BRL Medicine Inc. The collaboration aims to deepen their involvement in the gene and cell therapy (GCT) pipeline, enhance clinical studies, and expedite the commercialization of novel therapies. BRL Medicine’s…
