RECBIO-B Announces NDA Acceptance for REC610 Shingles Vaccine; Reschedules HPV 9-Valent Filing

Bulletin Express07-23 18:42

Jiangsu Recbio Technology Co., Ltd. (RECBIO-B) reported two significant R&D updates:

REC610 Shingles Vaccine Progress • The National Medical Products Administration’s Center for Drug Evaluation formally accepted the new drug application (NDA) for REC610, an adjuvanted recombinant shingles vaccine produced in CHO cells, on 29 December 2025 (acceptance No. CXSS2500145). • Both the clinical trial site inspection and the manufacturing site inspection required for drug registration have been completed. RECBIO-B is cooperating with regulators as the review advances.

HPV 9-Valent Vaccine Timeline Adjustment • The company previously targeted 30 June 2026 for submitting the marketing application for its recombinant HPV 6/11/16/18/31/33/45/52/58 9-valent vaccine (Hansenula polymorpha). • Submission was not achieved by the planned date due to additional work needed on clinical follow-up data and manufacturing process validation. • RECBIO-B has reorganised the core management team of the HPV manufacturing segment to strengthen coordination across clinical, regulatory and process-validation functions and will set a revised timetable for filing.

Risk Considerations The company cautions that NDA acceptance and successful inspections do not guarantee final marketing approval for REC610. The revised schedule for the HPV vaccine remains subject to uncertainties inherent in pharmaceutical R&D and regulatory review.

Investors are advised to exercise caution when dealing in RECBIO-B securities.

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