NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4)...
Rare / orphan disease drugs
Santhera and ReveraGen Submit NDA for Vamorolone in Duchenne Muscular Dystrophy
Swiss firm Santhera Pharmaceuticals and US-based ReveraGen BioPharma, Inc have announced the rolling submission of...
WinHealth’s Ravicti Receives Orphan Drug Designation in Taiwan
China-based Hong Kong WinHealth Pharma Group Ltd announced that its Swiss partner Immedica Pharma AB’s...
OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor...
Mabwell Bioscience’s 9MW3011 Accepted for Review by China’s NMPA
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that its clinical filing for...
Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA)...
RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD)...
WuXi Biologics Partners with neoX Biotech to Advance AI-Driven Drug Development
China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into...
Humanwell’s Generic Clobazam Approved for Lennox-Gastaut Syndrome in China
China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version of Sanofi’s clobazam (trade name: Frisium) has...
Heilongjiang Launches ‘Longjiang Huiminbao’ Supplementary Health Insurance Scheme
Heilongjiang province has launched its first provincial-level supplementary commercial health insurance scheme, branded “Longjiang Huiminbao.”...
Joincare’s Modified Drug XYP-001 Gains NMPA Approval for IPF Trial
China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received...
Antengene’s ATG-101 Receives Orphan Drug Designation for Pancreatic Cancer
China-based biotech Antengene Corp., Ltd (HKG: 6996) has announced that its pipeline candidate ATG-101, a...
Huahai Pharmaceutical Gains FDA Approval for Generic Fingolimod
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New...
Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan...
Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE:...
Henlius Biotech’s PD-1 Inhibitor Serplulimab Secures NMPA Review for Esophageal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has...
Lee’s Pharma Expands Global Rights to Windtree’s KL4 Surfactant Products
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has expanded its licensing agreement with US-based Windtree...
CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received...
Spinraza’s NRDL Inclusion Boosts SMA Patient Treatment in China
The Meier Advocacy & Support Center for Spinal Muscular Atrophy (SMA) and the Shenzhen Research...
Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG:...