お知らせ • Feb 17
ImmunityBio, Inc. Reports Productive Regulatory Engagement with Saudi Food and Drug Authority At USA -Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia
ImmunityBio, Inc. announced that the Company held productive regulatory discussions with the Saudi Food and Drug Authority (SFDA) in Riyadh, convened under the Saudi-USA Biotech Alliance hosted by the Ministry of Investment of Saudi Arabia (MISA). Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the timing and acceptance of the rBCG regulatory submission to the SFDA and the outcome of any such review, (ii) risks and uncertainties regarding the potential expansion of ANKTIVA indications in Saudi Arabia, including whether the SFDA will accept additional submissions or grant additional approvals, (iii) the Company's ability to successfully commercialize ANKTIVA in Saudi Arabia or other markets, (iv) uncertainties relating to pricing, reimbursement, and market adoption in the Kingdom of Saudi Arabia and the broader Middle East region, (v) risks and uncertainties regarding commercial launch execution, success and timing, (vi) risks and uncertainties related to the regulatory submission, filing and review process in foreign jurisdictions and the timing thereof, (vii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (viii) whether clinical trials will result in registrational pathways, (ix) whether clinical trial data will be accepted by regulatory agencies, (x) the ability of immunityBio to continue its planned preclinical and clinical development of its development programs, and the timing and success of any such continued development, patient enrollment and planned regulatory submissions, (xi) potential delays in product availability and regulatory approvals, (xii) the risks and uncertainties associated with third party collaborations and agreements, including that with the Serum Institute of India, (xiii) ImmunityBio's ability to retain and hire key personnel, (xiv) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xv) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xvi) ImmunityBio's ability to successfully operate its wholly owned subsidiary in Saudi Arabia, (xvii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved products and future approved products, (xviii) competition from existing or new therapies, (xix) changes in foreign or domestic regulatory, political, or economic conditions, (x) changes in foreign or domestic Regulatory, or economic conditions, (X) and other conditions, (x) potential product shortages or manufacturing disruption that may impact the availability and scheduling of product, (xvi); ImmunityBio's ability to successfully operates its wholly owned subsidiary in Saudi Saudi Arabia, (xviii) ImmunityBio's ability To scale its manufacturing and commercial supply services for its approved products and future approval from existing or new therapies, ("xix) changes in international or new therapies, (x) changes in international regulatory, political, and economic conditions, (x) and other conditions. The QILT-3.055 basket trial has demonstrated that ANKTIVA rescues checkpoint inhibitor activity across multiple tumor types, including NSCLC, urothelial, head and neck, melanoma, renal, gastric, and cervical cancers, with a median overall survival of 14.1 months in CPI relapsed NSCLC patients; SFDA has now approved ANKTIVA across two indications in Saudi Arabia: BCG unresponsive non muscle invasive bladder cancer and metastatic NSCLC in combination with checkpoint inhibitors; Company expects to submit the rBCG regulatory package to the SFDA within the coming weeks.