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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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Leman Biotech Secures Over USD 13.9 Million in Series A Financing for Next-Gen Cancer Immunotherapies
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China-based Leman Biotech Co., Ltd. has reportedly completed the first closing of its Series A financing round, raising over RMB 100 million (USD 13.9 million). The round was led by Fuho Capital, with additional contributions from Jun Yi Investment and AI-driven drug R&D leader XtalPi. The funds will be directed…
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CARSgen Therapeutics Presents Latest CAR-T Data at ASH Annual Meeting
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CARSgen Therapeutics Holdings Ltd (HKG: 2171), a China-based specialist in chimeric antigen receptor (CAR)-T cell therapies, has announced the presentation of the latest data for its CAR-T therapies, CT053 (zevorcabtagene autoleucel; zevor-cel), CT071, and CT0590, at the 66th American Society of Hematology (ASH) annual meeting. CT053 Phase II Study Subgroup…
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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 to Showcase CARTITUDE-4 Trial Data on Carvykti at ASH Annual Meeting
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China-based Legend Biotech Corporation (NASDAQ: LEGN) is set to present new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting in San Diego. The data will compare Carvykti (ciltacabtagene autoleucel; cilta-cel) treatment with the…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
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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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Sun-Novo Pharmaceuticals Gets Green Light for CAR-T Therapy Clinical Trial in Lupus Treatment
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd. (SHA: 688621) has secured approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials for ZM001, a CD19-targeted chimeric antigen receptor (CAR)-T therapy, in the treatment of systemic lupus erythematosus (SLE). The therapy, co-developed with Beijing-based gene therapy specialist Immunochina Pharmaceuticals, is…
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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Myasthenia Gravis Clinical Trial
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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 its SYS6020. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy intended for myasthenia gravis (MG). Notably,…
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GenScript Dissolves Merger with CAR-T Specialist Legend Biotech, Reclassifies as Associated Company
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GenScript Biotech Corporation (HKG: 1548), a comprehensive life science research and application service and product provider based in China, has announced the dissolution of its merger with Legend Biotech Corporation (NASDAQ: LEGN), a specialist in chimeric antigen receptor (CAR) T-cell therapy. The decision to dissolve the merger was influenced by…
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Juventas Cell Therapy’s CAR-T Therapy Clears for SLE-ITP Study in China
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The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia…
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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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JiCui Cell Therapy Forms Partnership with Fosun Kite to Advance Bispecific CAR-T Cell Therapy Industrialization
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JiCui Cell Therapy Drug Research Institute, also known as Jiangsu Jicui Juechuang Biotechnology Research Institute Co., Ltd, has entered into a strategic partnership with Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) and Gilead’s subsidiary Kite Pharma. The collaboration…
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Fosun Pharma to Acquire Full Stake in Fosun Kite Biotechnology for USD 27 Million
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has disclosed plans to acquire the remaining 50% stake in its joint venture, Fosun Kite Biotechnology Co., Ltd, from Gilead’s subsidiary Kite Pharma for USD 27 million. This transaction will see Fosun Pharma assume full ownership of Fosun Kite, with…
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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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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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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
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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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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Clinical Trials in Systemic Lupus Erythematosus
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SYS6020. This therapy is a BCMA-targeted chimeric antigen receptor (CAR)-T cell treatment designed for systemic lupus erythematosus (SLE),…
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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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China’s CDE Releases Draft Guidelines for CAR-T Cell Therapy Clinical Trials
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The Center for Drug Evaluation (CDE) in China has issued a draft proposal for “Technical Guidelines for Clinical Trials of Chimeric Antigen Receptor (CAR)-T Cell Therapy for Malignant Tumors of the Lymphatic and Hematological System.” These guidelines are designed to provide a framework for the design, protocol, and execution of…
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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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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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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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Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study
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Legend Biotech Corporation (NASDAQ: LEGN) has announced positive results from the CARTITUDE-4 study, a global, randomized, open-label Phase III trial. The study assessed the efficacy and safety of Legend Biotech’s BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel) compared to standard therapies of pomalidomide, bortezomib, and dexamethasone…
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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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GenScript Biotech Receives Over USD 410 Million in Milestone Payments for CAR-T Therapy from Janssen Biotech
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GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that it has received a total of USD 410 million in milestone payments from Janssen Biotech, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ). These payments are part of a licensing agreement with its…
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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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CARsgen Therapeutics’ Saikaize and CT071 Show Strong Results in EHA Clinical Trials
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CARsgen Therapeutics, a biopharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 2171), has announced promising results from two pivotal clinical trials at the 29th European Hematology Association Annual Meeting. The data presented highlights the potential of two CAR-T therapies: Saikaize (zevorcabtagene autoleucel), an autologous BCMA-targeted therapy for multiple…
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Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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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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FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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JW Therapeutics Presents Positive Clinical Data for Carteyva in SLE at EULAR 2024
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JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has presented new clinical data for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), at the European Alliance of Associations for Rheumatology (EULAR) 2024 annual meeting. The data was for adult patients in China with active…
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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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German Study Highlights Potential of Amgen’s Blinatumomab in Treating Rheumatoid Arthritis
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Researchers from Germany’s University of Erlangen-Nuremberg have unveiled promising clinical data on the use of bispecific T cell engagers (BiTes) in combating B-cell mediated autoimmune diseases, such as rheumatoid arthritis (RA). The study, titled “Bispecific T cell engager therapy for refractory rheumatoid arthritis,” published in Nature Medicine in December 2023,…
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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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JW Therapeutics Reports 19.3% YOY Revenue Growth in 2023, Driven by CAR-T Therapy Carteyva
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China-based JW Therapeutics (HKG: 2126) has announced its financial results for 2023, with revenues reaching RMB 173.9 million (USD 24 million), marking a 19.3% year-on-year (YOY) increase. The company’s research and development (R&D) expenditure for the year was RMB 413.6 million (USD 57.08 million), up 1.4% YOY. Sales expenses were…
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Bristol Myers Squibb Reports 6% YOY Revenue Growth in Q1 2024, Driven by Eliquis and Reblozyl
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Pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) has reported a 6% year-on-year (YOY) increase in revenues for the first quarter of 2024, excluding the impact of foreign exchange, reaching USD 11.9 billion, according to the company’s latest financial report. The U.S. market contributed USD 8.5 billion, marking a 7%…
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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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Bristol Myers Squibb’s Abecma Receives FDA Approval for Wider Use in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
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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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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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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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FDA Advisory Committee Backs Wider Use of Abecma in Relapsed or Refractory Multiple Myeloma
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An advisory committee to the US Food and Drug Administration (FDA) has recommended the use of Abecma (idecabtagene vicleucel), a CAR-T therapy developed by Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy bio (NASDAQ: TSVT), for the treatment of triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/rMM). This recommendation…
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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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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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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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AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
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The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca (AZ, NASDAQ: AZN) has received approval from Gracell’s shareholders during an extraordinary general meeting held on February 19, 2024. An overwhelming 99.9% of shareholders voted in favor of AstraZeneca’s $1 billion acquisition, with potential total…
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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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AbbVie Expands Licensing Agreement for Innovative sCAR-T Platform with Scripps Research
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AbbVie (NYSE: ABBV) has expanded its collaboration with Scripps Research’s Calibr-Skaggs Institute, securing licensing rights to the institute’s investigational switchable CAR-T (sCAR-T) platform, which has shown promising early-stage results. The agreement entails an upfront payment, along with potential milestone payments and royalties, allowing AbbVie to access the program for up…
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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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Hengrui Medicine Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
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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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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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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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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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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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CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its chimeric antigen receptor (CAR)-T therapy, CT011. The study will focus on patients with GPC3 positive stage IIIa hepatocellular carcinoma (HCC) who are…
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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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International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation
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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after…
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AbbVie Partners with Umoja Biopharma to Develop Next-Generation CAR-T Therapies
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AbbVie (NYSE: ABBV) has entered into a collaboration agreement with Umoja Biopharma, a US-based company specializing in next-generation in-situ CAR-T cell therapies. Under the partnership, the two companies will develop up to four programs targeting selected cancer therapies chosen by AbbVie. AbbVie has also secured an exclusive option to license…
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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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CATUG Biotechnology Partners with PersonGen to Advance Global CAR-T Cell Therapies
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China-based CATUG Biotechnology (Suzhou) Co., Ltd. has entered into a partnership with fellow Suzhou firm PersonGen BioTherapeutics (Suzhou) Co., Ltd. to collaboratively develop in vivo chimeric antigen receptor (CAR)-T cell therapies utilizing CATUG’s mRNA-lipid nanoparticle (LNP) technology for global markets. As of November 2023, a total of ten CAR-T therapies…
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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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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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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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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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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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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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CASI Pharmaceuticals Reports Q3 2023 Results with Mixed Fortunes and Positive Developments
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China-based CASI Pharmaceuticals Inc., (NASDAQ: CASI) has unveiled its financial results for the third quarter of 2023. The company reported a 13.5% decrease in sales, amounting to USD 8.8 million. Despite this downturn, several positive developments indicate a promising outlook for the company in the near future. Revenue Generator and…
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Novartis Pharma AG Partners with Legend Biotech Corp. for CAR-T Therapies in $1.1 Billion Deal
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China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets…
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China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
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The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
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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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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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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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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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OrbiMed Raises Over USD 4.3 Billion for Private Investment Funds Focused on Healthcare
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US-based investment fund giant OrbiMed has announced the successful raising of over USD 4.3 billion for its latest private investment funds. The capital will be distributed among OrbiMed Private Investments IX, OrbiMed Asia Partners V, and OrbiMed Royalty & Credit Opportunities IV, reflecting the firm’s commitment to expanding its reach…
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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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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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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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JW Therapeutics and 2seventy Bio Expand Partnership for Cell Therapy Development
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China-based cell therapy firm JW Therapeutics (HKG: 2126) and US biotech 2seventy Bio Inc., (NASDAQ: TSVT) have announced plans to build on their 2022 collaboration agreement. The latest deal grants JW Therapeutics the option to develop up to two additional candidate drugs from 2seventy Bio’s product portfolio, including a T…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (1548.HK), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent or…
