Aleon Pharma International, Inc.

Congratulations to BeiGene on its impressive growth in 2024 and the continued success of its lead medicine, BRUKINSA??(zanubrutinib)?! I vividly remember the day when Aleon collaborated with the BeiGene team for the pre-IND meeting with the FDA a decade ago, setting the stage for many significant regulatory milestones. It’s been an honor to support the development of this medicine, which has made a profound impact on patients’ lives. In the 15 years since Aleon’s founding in 2010, we’ve proudly supported over 115 IND programs. Three of these programs have received FDA NDA approvals, and one is currently under FDA’s Priority Review. We’re confident that more investigational programs will achieve NDA/BLA approvals in the future. We are deeply grateful to be part of this journey. Through strong collaborations, we’re helping bring medicines to address unmet medical needs. Your Vision, Our Expertise, A Shared Future.

Congratulations to Aleon’s President, Andrew Jiang, on this accomplishment! We look forward to continued collaboration with our partners.

Aleon Pharma International, Inc. is pleased to announce that we will be attending Biotech Showcase in San Francisco, CA on January 13-15, 2025. If you are attending Biotech Showcase and would like to schedule a meeting with Aleon, please reach out to us at [email protected] or via the partneringONE platform. Event Website: https://lnkd.in/eZaESEs Aleon Website: https://lnkd.in/ehK7Qqcw #BiotechShowcase #RegulatoryAffairs #RAPS #TOPRA

Thanksgiving is a time to honor the people who make our work so fulfilling and impactful. Thank you to our wonderful Aleon staff for their hard work and dedication. Thank you to our clients for making our work rewarding and moving toward a healthier world, together. Thank you to friends and family of Aleon for supporting us in what we do. Happy holidays to all!

Check out Aleon’s Regulatory Insights article titled Assessment Aid: Why Should You Participate in this Voluntary FDA Oncology Center of Excellence Program? (https://bit.ly/4fAPZ6Z) where our team outlines the purpose of the Assessment Aid, why you should participate, how to get started on preparing the Assessment Aid, and how Aleon can support you with Assessment Aid preparation. Aleon’s team stands ready to evaluate your development goals and create a confident roadmap for success. Contact us for a complimentary consultation at [email protected]. #regulatoryaffairs #RAPS #TOPRA #FDA

Check out Aleon’s Regulatory Insights article: FDA Accelerated Approval Strategy for Oncology Drug Development (https://bit.ly/3MSfYdn) where our team outlines the current key considerations from FDA pertaining to accelerated approval, expectations for the oncology pivotal trial supporting accelerated approval, recent accelerated approvals, and confirmatory trials following accelerated approval. Aleon’s team stands ready to evaluate your development goals and create a confident roadmap for success. Contact us for a complimentary consultation at [email protected]. #regulatoryaffairs #RAPS #TOPRA #FDA #acceleratedapproval

Check out Aleon’s position paper: FDA Pre-IND Meeting: A Critical Step for Your Program (https://bit.ly/48kukgz) where our team outlines when a pre-IND meeting is critical, how your program might benefit from having a pre-IND meeting, the overall timeline leading up to a pre-IND meeting, and how Aleon can help to prepare your team for a successful pre-IND meeting with the FDA. Aleon’s team stands ready to evaluate your development goals and create a confident roadmap for success. Contact us for a complimentary consultation at [email protected]. #regulatoryaffairs #RAPS #TOPRA #FDA

Check out Aleon’s?Regulatory Insights article: Considerations in Seeking US FDA Oncology NDA/BLA Approval with Predominantly Asian Clinical Data? (https://bit.ly/4gLkXdL) where our team outlines 3 sponsor success stories and how they achieved US marketing approval in recent years based on predominantly Asian clinical data. Aleon’s team stands ready to evaluate your development goals and create a confident roadmap for success. Contact us for a complimentary consultation at [email protected]. #regulatoryaffairs #RAPS #TOPRA #FDA

Aleon Pharma International, Inc. is pleased to announce that we will be attending BIO-Europe in Stockholm, Sweden on November 4-6, 2024. If you are attending BIO-Europe and would like to schedule a meeting with Aleon, please reach out to us at [email protected] or via the BIO-Europe partneringONE platform. Event Website: https://lnkd.in/dnuNZ2D Aleon Website: https://lnkd.in/eZ845Aba #bioeurope #regulatoryaffairs #RAPS #TOPRA?

On September 27, Aleon Pharma International, Inc. received a Study May Proceed Letter from the FDA on behalf of our client for their Investigational New Drug (IND), an Antibody-Drug Conjugate (ADC) for oncology indications. Congratulations to our client, and we look forward to continuing to support them throughout their development journey!? Aleon has prepared and submitted multiple INDs for ADCs with a 100% success rate, and our team is actively supporting our clients on the development of their ADC products. Aleon’s team stands ready to evaluate your development goals and create a confident roadmap for success. Contact us for a complimentary consultation at [email protected] or visit us at https://lnkd.in/ehK7Qqcw where you can learn more about our recently achieved milestones. #regulatoryaffairs #RAPS #TOPRA #FDA