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New Drug Application

CSPC PHARMA (01093.HK): NDA for Envi Trastuzumab Injection Accepted by NMPA
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CSPC PHARMA01093.HKNew Drug Application
2026-07-17
SBP GROUP (01177.HK): NDA Accepted for Category 1 Innovative Drug IDH1 Inhibitor TQB3454 for Advanced Biliary Tract Cancer
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SBP GROUP01177.HKNew Drug Application
2026-07-10
LEADS BIOLABS-B (09887.HK): VELIXIN™ Granted Priority Review by NMPA for Advanced Extrapulmonary Neuroendocrine Carcinoma
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LEADS BIOLABS-B09887.HKNew Drug Application
2026-07-10
SINO BIOPHARM(01177.HK): NDA for Class 2.2 New Drug Ropivacaine Hydrochloride Sustained-Release Solution Accepted, Indicated for Long-Acting Postoperative Analgesia
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SINO BIOPHARM01177.HKNew Drug Application
2026-07-03
XUANZHUBIO-B(02575.HK): NDA for Anaprazole Sodium in New Indication of Reflux Esophagitis Accepted by NMPA
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XUANZHUBIO-B02575.HKNew Drug Application
2026-06-30
FUSEN PHARM(01652.HK): Peramivir Injection Granted Marketing Approval; Domestic Market Size Exceeded RMB800 Million in 2025
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FUSEN PHARM01652.HKNew Drug Application
2026-06-26
SINO BIOPHARM (01177.HK): NDA for CLDN18.2 ADC Tecotabart Vedotin Accepted for Gastric Cancer Treatment
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SINO BIOPHARM01177.HKNew Drug Application
2026-06-23
CARSGEN-B(02171.HK): Kailimei® Secures NMPA Marketing Approval, the World’s First CAR-T Cell Therapy for Solid Tumors
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CARSGEN-B02171.HKNew Drug Application
2026-06-22
AKESO(09926.HK): Qiyoukang® (Gumokimab) Approved by NMPA for Moderate-to-Severe Plaque Psoriasis
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AKESO09926.HKNew Drug Application
2026-06-12
HANSOH PHARMA(03692.HK): NDA for HS-10568 Injection Accepted by NMPA for Secondary Hyperparathyroidism in Dialysis Patients
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HANSOH PHARMA03692.HKNew Drug Application
2026-06-10