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May 13, 2025 – BaoPharm announced that the U.S. Food and Drug Administration (FDA) has accepted the Drug Master File (DMF #041587) for its proprietary recombinant human hyaluronidase, HYSORPTASE. The FDA’s acknowledgment confirms that the submitted data—including chemistry, manufacturing, controls (CMC), analytical validation, and stability studies—meet preliminary review requirements and are now available for reference in regulatory submissions. Partners may incorporate this data into their applications for subcutaneous drug products by obtaining a Letter of Authorization (LOA) from BaoPharm, streamlining the approval pathway.
As BaoPharm's strategic regulatory partner, SDM Bioservices' global registration team delivered comprehensive support for this project, including gap analysis, technical dossier compilation, and submission management services. Our expertise facilitated the successful FDA review of this critical biologic, enabling BaoPharm's global market expansion for this product.
Mr. Zheng Wang, Co-founder, Executive Director, and CEO of BaoPharm, commented: "We sincerely appreciate SDM Bioservices' expert support throughout this process. Their deep regulatory expertise, innovative problem-solving approach, and operational excellence were instrumental in ensuring the success of this submission. The FDA DMF acceptance for our recombinant human hyaluronidase HYSORPTASE marks a significant milestone in our global development strategy. Moving forward, we remain committed to strengthening our quality systems in full compliance with cGMP standards, thereby enabling our partners' successful worldwide regulatory submissions."
Dr. Howard Yuwen, SVP Global Regulatory Affairs & CBO at SDM Bioservices, commented: “Congratulations to the BaoPharm team on this significant milestone. Our global regulatory team was honored to support this program, applying innovative approaches to overcome regulatory challenges while leveraging SDM's full regulatory capabilities. We remain committed to partnering with China's innovative biopharma companies, helping accelerate their global expansion through compliant and efficient registration strategies.”
About BaoPharm
Shanghai Bao Pharmaceuticals Co., Ltd. specializes in the industrialization and commercialization of recombinant protein and antibody-based therapeutics. We have established a cGMP-compliant manufacturing facility in Shanghai, covering an area of approximately 63,000 square meters. The facility is designed to include multiple drug substance production lines utilizing mammalian cell expression systems as well as bacterial/yeast expression systems. Additionally, it features production lines for finished dosage forms, including injectable solutions, lyophilized powder injections, and pre-filled syringes.
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As BaoPharm's strategic regulatory partner, SDM Bioservices' global registration team delivered comprehensive support for this project, including gap analysis, technical dossier compilation, and submission management services.
As a clinical development pioneer with twenty years of China-focused expertise, SDM Bioservices provides comprehensive clinical research solutions to pharmaceutical partners worldwide. Our integrated capabilities include proven regulatory submission experience across China, U.S. and EU markets, innovative early-phase development approaches, reliable bioanalytical services, and demonstrated expertise in managing large-scale clinical trials for therapeutic drugs, and specialized knowledge in vaccines and medical aesthetics.
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