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SKB BIO (06990.HK): seventh sac-TMT indication filing accepted, first-line PD-L1-negative non-squamous NSCLC

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SKB BIO 06990.HK New Drug Application

2026-10-27

LIVZON PHARMA (01513.HK): Leuprorelin 3-Month Formulation Approved

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LIVZON PHARMA 01513.HK New Drug Application

2026-09-29

CSPC PHARMA(01093.HK): NDA for Neoadjuvant Therapy of Anitumab Combined with HB1801 in HER2‑positive Breast Cancer Accepted and Granted Priority Review

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CSPC PHARMA 01093.HK ALPHAMAB-B New Drug Application

2026-08-04

SBP GROUP(01177.HK): NDA for BCL‑2 Inhibitor TQB3909 Accepted, for Treatment of CLL/SLL

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SBP GROUP 01177.HK New Drug Application

2026-08-04

CSPC PHARMA (01093.HK): NDA for Envi Trastuzumab Injection Accepted by NMPA

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CSPC PHARMA 01093.HK New 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 GROUP 01177.HK New 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-B 09887.HK New 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 BIOPHARM 01177.HK New 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-B 02575.HK New 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 PHARM 01652.HK New 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 BIOPHARM 01177.HK New 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-B 02171.HK New Drug Application

2026-06-22

AKESO(09926.HK): Qiyoukang® (Gumokimab) Approved by NMPA for Moderate-to-Severe Plaque Psoriasis

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AKESO 09926.HK New 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 PHARMA 03692.HK New Drug Application

2026-06-10

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