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European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
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The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have shown disease progression after at least three prior…
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Jiangsu Hengrui Pharmaceuticals’ Fluzoparib Files for New Indication with China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for its poly (ADP-ribose) polymerase (PARP) inhibitor, fluzoparib. The filing seeks to expand the use of fluzoparib as a maintenance therapy for patients with advanced epithelial ovarian…
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Kintor Pharmaceutical Completes Enrollment in Phase II Study of GT20029 for Androgenetic Alopecia
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China-based Kintor Pharmaceutical Limited (HKG: 9939) has announced the completion of patient enrollment in a Phase II clinical study for its proprietary first-in-class proteolysis targeting chimera (PROTAC) compound, GT20029. The molecule is under development as a treatment for male androgenetic alopecia (AGA), and this marks the first time a topical…
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Novartis’s Leqvio (Inclisiran) Approved in China for Hypercholesterolemia Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received approval from the National Medical Products Administration (NMPA) for its cholesterol-lowering drug Leqvio (inclisiran). The drug is approved for use as an adjunct treatment with diet for adult patients with primary hypercholesterolemia, including heterozygous familial and non-familial cases, or mixed type dyslipidemia.…
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Novatim’s KQ-2003 and KY-0118 Advance with Clinical Trial Approvals in China
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China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd has recently obtained clinical trial clearances for two of its products in China. The products are KQ-2003, an autologous chimeric antigen receptor (CAR) T cell therapy for the fourth-line treatment of recurrent/refractory multiple myeloma, and KY-0118, a therapy aimed at…
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Sichuan Huiyu Pharmaceutical’s Plerixafor Gains Marketing Approval from Italian Medicines Agency
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received marketing approval for its plerixafor from the Italian Medicines Agency (AIFA). The drug is approved for use in combination with granulocyte colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) into the…
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Lifetech Scientific Corporation Receives NMPA Approval for Epione Navigation System
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its product, Epione. Epione is an in-licensed puncture surgery navigation and positioning system designed for navigation and positioning in adult abdominal solid organ puncture surgery. Origin and Commercialization…
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Jiahui Health and Gleneagles Hong Kong Hospital Partner for Integrated Healthcare Services
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China-based Jiahui Health has entered into a strategic partnership with Gleneagles Hong Kong Hospital to enhance remote consultation, patient referral, cross-regional doctor visits, medical communication, and training. The collaboration also focuses on cutting-edge diagnosis and treatment methods, as well as drug use, among other areas. Financial details of the agreement…