Hengrui Remimazolam ICU Sedation NMPA Application Accepted
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) announced that China’s National Medical Products...
Market approval filings
Henlius HLX14 Denosumab Biosimilar NDA Accepted by China CDE
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the National Medical Products Administration’s Center for...
BeOne’s Sotoclax Wins FDA Priority Review for Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. FDA has accepted its...
Humanwell’s Lisdexamfetamine NDA Accepted by NMPA for ADHD, First Generic Potential
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration (NMPA)...
Innovent’s mazdutide 9mg Obesity Application Accepted by NMPA
Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has accepted...
Fosun’s Luvometinib Gets NMPA Priority Review for Pediatric LCH
Fosun Pharma (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration (NMPA) has...
Hengrui’s Ivarmacitinib NDA Accepted for Non‑Radiographic Axial Spondyloarthritis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical...
Biokin’s iza-bren NDA Accepted for Nasopharyngeal Carcinoma, Advancing Bispecific ADC
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its New Drug Application (NDA) for...
Cutia’s CU-40105 Topical Finasteride Spray NDA Accepted by NMPA, a China First
Cutia Therapeutics (HKG: 2487) announced that the National Medical Products Administration (NMPA) has accepted its...
Lundbeck’s Vyepti Secures Chinese NDA, Expands Asian Footprint
Lundbeck A/S (OTCMKTS: HLUBF) announced that the Center for Drug Evaluation (CDE) of China’s National...
Huadong Medicine Files NDA for Roflumilast Cream (ZORYVE) – First PDE‑4 Topical for Atopic Dermatitis in Greater China
Huadong Medicine Co., Ltd. (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has...
Sinotau Receives FDA NDA Approval for MK‑6240 Tau PET Imaging Agent
Beijing Sinotau International Pharmaceutical Technology Co., Ltd. announced today that the New Drug Application (NDA) for...
Daiichi Sankyo’s Enhertu Wins CDE Acceptance for First‑Line HER2‑Positive Breast‑Cancer Indication in China
Daiichi Sankyo Co., Ltd. (TYO: 4568) announced that China’s Center for Drug Evaluation (CDE) of...
Transcenta Partner Inhibrx Reports Positive ChonDRAgon Results for Ozekibart, Plans FDA BLA Filing in 2026
Transcenta Holding Limited (HKG: 6628) announced that its joint venture, Inhibrx Biosciences, Inc. (NASDAQ: INBX),...
Hengrui Pharmaceuticals Secures NMPA Acceptance for Fluzoparib in First‑Line Therapy of DNA‑Repair‑Defect Positive mCRPC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that the China National...
LEO Pharma Submits NDA for Anzupgo in China for Chronic Hand Eczema
LEO Pharma announced on October 17, 2025, that it has submitted a New Drug Application...
Hansoh Pharmaceutical Submits HS‑10365 NDA to NMPA for RET‑Positive NSCLC
China‑based Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced today that it has filed a New Drug Application...
Indetek Laboratory Secures NMPA Approval for IDT‑001 Gel, a Novel Film‑Forming Therapy for SSTIs
Indetek Laboratory announced that the National Medical Products Administration (NMPA) has formally accepted the New...
Summit Therapeutics Plans U.S. FDA BLA Submission for Ivonescimab + Chemotherapy in EGFR‑Mutated NSCLC
Summit Therapeutics, the former China partner of Akeso Inc. (HKG: 9926), announced today that it...