Tonghua Golden-Horse, UCB Seek China Approvals for Alzheimer’s, Myasthenia Gravis Drugs
China’s Tonghua Golden-Horse Pharmaceutical Industry Co. Ltd. and Belgium-based UCB (FRA: UNC) are seeking marketing...
Rare / orphan disease drugs
China’s Supreme Court Deals Blow to Sanofi’s Aubagio, Confirms Patent Cancellation
BEIJING—In a recent development for the pharmaceutical industry, Sanofi’s multiple sclerosis therapy Aubagio (teriflunomide) has...
Gene Cradle Initiates First Regulatory Gene Therapy Study in China for Late-Onset Pompe Disease
Gene Cradle, a Beijing-based gene therapy specialist, has achieved a milestone by administering its GC301...
AstraZeneca’s Strensiq Approved for Rare Disease Therapy under Greater Bay Area’s Drug Access Policy
AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK pharmaceutical company, has received approval for...
AstraZeneca’s Strensiq Gains Approval for Rare Disease Therapy in Guangdong Under “Hong Kong-Macau Drug and Device Access”
LONDON—AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK-based pharmaceutical company, has announced that its...
Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma...
Zelgen Biopharmaceuticals’ ZG006 Earns Orphan Drug Designation from FDA for Small-Cell Lung Cancer
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced...
Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has...
BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination...
Organon’s Liptruzet Launches in China for Hypercholesterolemia Treatment
US pharmaceutical company Organon (NYSE: OGN) has announced the official market launch of its single-tablet...
Alphamab’s KN057 Earns FDA Orphan Drug Designation for Hemophilia B Treatment
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has received another orphan drug...
Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
The Center for Drug Evaluation (CDE) has indicated on its website that the market application...
Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
Shenyang Sinqi Pharmaceutical Co., Ltd (SHE: 300573), a pharmaceutical company based in China, has received...
Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the...
IASO Biotherapeutics’ CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
China-based IASO Biotherapeutics has announced that it has received Investigational New Drug (IND) approval from...
China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted...
AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China,...
Bain Capital-Backed Tenacia Wins NMPA Approval for Ganaxolone Oral Suspension for CDKL5 Deficiency
Tenacia, a central nervous system (CNS) specialist company incubated by Bain Capital, has announced that...
Mabwell Bioscience Lands Orphan Drug Status for B7-H3 Targeting ADC in Small Cell Lung Cancer
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by...
Johnson & Johnson’s Opsumit Faces Generic Competition with Qilu Pharmaceutical’s Entry
Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter...