He Company Today Announces The Chinese National Medical Products Administration Nmpa Center For Drug Evaluation Cde Has Approveda Phasei Study Of Tlx101 Investigational Therapy 4l 131i Iodo Phenylalanine News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

MELBOURNE, Australia, April 11, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM). The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix's planned global pivotal registration trial for TLX101. This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma. The IPAX-1 study of TLX101 (ClinicalTrials.gov Identifier: NCT03849105)met its primary objective d ....

Zhou Chao , United Kingdom , United States , Davidn Cade , Kyahn Williamson , Telix Asia Pacific , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Australian Therapeutic Goods Administration , Australian Securities Exchange , Group Limited Grand Pharma , Health Canada , Telix Pharmaceuticals , Chinese National Medical Products Administration , Drug Administration , Pharmaceuticals Limited , Drug Evaluation , Greater China , Grand Pharmaceutical Group Limited , Grand Pharma , Asia Pacific , Telix Pharmaceuticals Limited , April 11 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces The Chinese National Medical Products Administration Nmpa Center For Drug Evaluation Cde Has Approveda Phasei Study Of Tlx101 Investigational Therapy 4l 131i Iodo Phenylalanine , R 131i Ipa In Chinese Patients With Newly Diagnosed Glioblastoma Gbm The Investigational New Drug Ind Application Was Submitted By Telix 39s Partner Greater China Region ,

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

MELBOURNE, Australia, April 11, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM). The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix's planned global pivotal registration trial for TLX101. This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma. The IPAX-1 study of TLX101 (ClinicalTrials.gov Identifier: NCT03849105)met its primary objective d ....

Zhou Chao , United States , United Kingdom , Davidn Cade , Telix Asia Pacific , Kyahn Williamson , Telix Pharmaceuticals , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Australian Securities Exchange , Chinese National Medical Products Administration , Australian Therapeutic Goods Administration , Group Limited Grand Pharma , Drug Administration , Health Canada , Pharmaceuticals Limited , Drug Evaluation , Greater China , Grand Pharmaceutical Group Limited , Grand Pharma , Asia Pacific , Telix Pharmaceuticals Limited , April 11 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces The Chinese National Medical Products Administration Nmpa Center For Drug Evaluation Cde Has Approveda Phasei Study Of Tlx101 Investigational Therapy 4l 131i Iodo Phenylalanine , R 131i Ipa In Chinese Patients With Newly Diagnosed Glioblastoma Gbm The Investigational New Drug Ind Application Was Submitted By Telix 39s Partner Greater China Region ,