Angitia Biopharmaceuticals

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Angitia Biopharmaceuticals Announces Completion of $46M Series B Extension Financing - Funding supports global clinical development of Angitia’s innovative drug candidates for musculoskeletal diseases. Angitia Biopharmaceuticals announced the closing of a US$46M Series B extension financing led by Morningside Group, and syndicated by 3H Health Investment, OrbiMed, Yonghua Capital, Legend Capital, Oriza Holdings and Elikon Venture. The Series B extension financing brings the total size of the funding round to US$170M. Proceeds from the financing will be used to accelerate the global development of Angitia’s innovative drug candidates for musculoskeletal diseases including AGA111, AGA2115 and AGA2118. "The support from these renowned life sciences investors is a testament to our team, science and pipeline,” said David Ke, M.D., Founder and CEO of Angitia. “We are eager to advance our pipeline of novel biologics to potentially address the large unmet medical needs of patients with serious musculoskeletal diseases, an area that deserves greater investment and innovation in new therapeutic approaches.” "Angitia continues to display impressive track records including building a superior international team and meeting key milestones for its pipeline molecules,” commented Morningside Group Dr. Lu Huang. “The global market for the treatment of musculoskeletal disorders is large and growing, especially as the population ages. We look forward to supporting Angitia team in advancing its exciting pipeline to address these major opportunities.” “In this aging society, the market value of musculoskeletal drugs will continue to increase. Angitia’s diversified therapeutics, backed by in-depth knowledge and thorough understanding of innovative drug development, could potentially enable patients to recover from serious musculoskeletal disease,” commented by Dr. Minchuan Wang, 3H Health. “We are delighted to support Angitia in developing its novel therapies for patients worldwide, which we believe will help people live higher quality and longer lives.” "OrbiMed invests in companies turning innovative discoveries into new therapies which meet significant unmet clinical needs. Angitia is well positioned to advance its pipelines and to build a leading company in global musculoskeletal therapeutics,” said Dr. David Guowei Wang, OrbiMed. “Since participating in Series A financing, we are excited to witness Angitia’s critical milestones and achievements. We believe Angitia will continue to rapidly develop therapeutics for important musculoskeletal diseases.” For more details: https://lnkd.in/d2yPdt2B

Angitia Biopharmaceuticals Announces the First Subject Dosed in the Phase Ⅰ trial of AGA2115, a novel biologic for the Treatment of Osteogenesis Imperfecta Woodland Hills, California, USA – 17 Oct 2023 Angitia Biopharmaceuticals, a global clinical-stage biotechnology company focused on the discovery and development of breakthrough therapies that address the unmet medical needs of patients with serious musculoskeletal disease, announced today that the first subject has been successfully dosed in the Phase Ⅰ clinical trial of AGA2115. The First-in-Human (FIH) trial is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115, an investigational therapy for the treatment of osteogenesis imperfecta (OI). The FDA has previously granted AGA2115 an Orphan Drug Designation (ODD) and a Rare Pediatric Disease Designation (RPDD). “Osteogenesis Imperfecta is a devastating genetic disorder that affects the skeleton resulting in bone brittleness and frequent debilitating fractures, and currently has no FDA-approved therapies” said David Ke, M.D., Founder and CEO of Angitia. “Dosing the first patient in our first-in-human study of AGA2115 represents an important milestone for the company, our scientists, and the patients we hope to serve.”   ABOUT AGA2115 AND THE PHASE I STUDY AGA2115 is a first-in-class, bispecific antibody being developed for the treatment of osteogenesis imperfecta. The U.S. Food and Drug Administration (FDA) has granted AGA2115 Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD). The Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy volunteers and in adults and adolescents with OI. Visit clinicaltrials.gov (NCT06086613) for more information.   ABOUT OSTEOGENESIS IMPERFECTA Osteogenesis imperfecta (OI) is an inherited connective tissue disorder with pathophysiology driven by abnormal collagen metabolism resulting in skeletal deformity, bone fragility, reduced bone mass, and variable extra-skeletal symptoms. OI occurs in approximately 1 in 15,000 births, with between 20,000 to 50,000 affected individuals in the US. As a rare pediatric disease, OI ranges in severity ranging from mild to severe and life-threatening. Disease manifestations occur in the neonatal and pediatric age groups, presenting with frequent and recurrent fractures, often elicited by little or no trauma. Severe OI cases manifest with multiple debilitating fractures resulting in loss of independent ambulation, deformity, and stunted growth, with the most severe cases resulting in perinatal mortality. Associated features may include muscle weakness, joint laxity, issues with dentition, hearing loss, and skeletal malformations.

Angitia Announces that NMPA has Granted Phase III IND Approval for AGA111, a Drug Candidate for Spinal Fusion Guangzhou, China, and Woodland Hills, California, USA –16 Oct 2023: Angitia Biopharmaceuticals, a global clinical-stage biotechnology company focused on the discovery and development of breakthrough therapies that address the unmet medical needs of patients with serious musculoskeletal disease, announced today that National Medicinal Product Administration (NMPA) has approved Angitia Biopharmaceuticals’ Investigational New Drug (IND) application of the Phase III study for AGA111. Angitia has previously announced the encouraging results from AGA111’s Phase I/II trial, which demonstrated excellent safety and preliminary efficacy in lumbar interbody fusion. The Phase III, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion. “We are delighted to share this exciting news, which is an important milestone for Angitia, as our first program to initiate a pivotal trial. Based on the encouraging Phase I/II study results, we believe that AGA111 has the potential to significantly accelerate bony fusion, reduce nonunion rate, and meaningfully improve patient outcomes.” said David Ke, M.D., Founder and CEO of Angitia. About Spinal Fusion Spinal fusion is a widely used surgical treatment for spinal disorders. The incidence of nonunion after spinal fusion surgery has been reported as high as 56% in the lumbar spine [1]. A large case report shows that up to 23.6% of spinal revision surgery is related to nonunion [2]. Nonunion of the spine can have significant adverse impact on postoperative function and clinical outcomes [3]. Reference     1.   Lee C, Dorcil J, Radomisli TE. Nonunion of the spine: a review. Clin Orthop Relat Res. 2004;(419):71-75. doi:10.1097/00003086-200402000-00012 2.   Raizman NM, O'Brien JR, Poehling-Monaghan KL, Yu WD. Pseudarthrosis of the spine. J Am Acad Orthop Surg. 2009;17(8):494-503. doi:10.5435/00124635-200908000-00003 3.   Tsutsumimoto T, Shimogata M, Yoshimura Y, Misawa H. Union versus nonunion after posterolateral lumbar fusion: a comparison of long-term surgical outcomes in patients with degenerative lumbar spondylolisthesis. Eur Spine J. 2008;17(8):1107-1112. doi:10.1007/s00586-008-0695-9

Hooray 🎉 SCM’s Ninth Honorary Professorship Conferment Ceremony-cum-Seminar concludes successfully!! Thought-provoking lectures were presented by the honorary professors, covering topics: 🌟 The culture and theories of traditional Chinese medicine 🌟 Integrative Chinese and Western medicine 🌟 Innovative drug discovery 🌟 Medical research and future healthcare advancement Congratulations to the Honorary Professors!! 🎖Prof Paul Unschuld (Director, Institute of Chinese Life Sciences, Charité - University Medicine Berlin） 🎖Mr Wu Ting Yuk, Anthony (Former Chairman, Hospital Authority, Hong Kong) 🎖Prof Zhang Zhongde (President, Guangdong Provincial Hospital of Chinese Medicine) 🎖Prof Tang Xudong (Chief Professor, Fellow, Former Vice President, China Academy of Chinese Medical Sciences) 🎖Prof Hua Zhu (David) Ke (Chairman of the Board and Chief Executive Officer, Angitia Biopharmaceuticals) 🎖Prof SHEN Hanming (Associate Dean (Teaching) and Chair Professor, Faculty of Health Sciences, University of Macau) 🎖Prof Shinya Goto (Professor, Department of Medicine (Cardiology), Tokai University, School of Medicine, Japan) 🎖Prof Xiao Wei (Academician, Chinese Academy of Engineering; President, Modern Chinese Medicine Research Institute, Jiangsu Kanion Pharmaceutical Co., Ltd.) 🎖Prof Xu Hongxi (Distinguished Professor, Shanghai University of Traditional Chinese Medicine (上海中医药大学） 🎖Prof Wang Qingguo (National TCM Master; Tenured Professor, Beijing University of Chinese Medicine) A big thank you to HKBU Century Club, C&C Charitable Fund Limited, Dr. Chiu Cook, and HKBU Research Office for their tremendous support in the event. #HKBU #HonoraryProfessors #ChineseMedicine #HKBUSCM #SCM #SchoolofChineseMedicine #BUResearch