As the project partner, BLA congratulates Hangzhou Hanx Biopharmaceuticals on receiving IND may proceed letter for HX009 project
Gaithersburg, MD (June 08, 2023) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, congratulates Hangzhou Hanx Biopharmaceuticals, Ltd. on receiving US FDA IND may proceed letter to start Phase IB/II clinical study in lymphoma patients who have failed standard therapy.
HX009 is the global first-in-class bispecific PD-1/CD47 antibody developed by HanxBio. Phase I clinical studies have been conducted in Australia and China. The company is expanding the next phase clinical development globally in various clinical indications.
About BLA Regulatory, LLC
BLA Regulatory, LLC, is a full-service drug regulatory consultancy focusing on the US with global reach to other major markets. BLA provides comprehensive regulatory strategy and operation services from pre-IND strategic planning, IND preparation & submission, all the way to submission and approval of BLA/NDA. Our goal is to help move your product through the development cycle efficiently. With credits of 300+ INDs and 50+ NDAs/BLAs to our senior consultants, BLA brings clients a broad range of experiences from Big Pharma, CROs, and the FDA. Our services expand across regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission. We have extensive experience across therapeutic areas such as oncology, respiratory, addiction, autoimmune, inflammatory, metabolic, and cardiovascular diseases.
For further information contact:
 Hans Aitel “Hans Altec Announces FDA Approval for HX009 IND”, 01 Jun. 2023, https://mp.weixin.qq.com/s/sHsuHG61kBiWufPnfLNSrg.