Rare / orphan disease drugs

Discover the landscape of Rare / orphan disease drugs in China’s pharmaceutical industry. Fineline Info & Tech provides reliable data, news, and intelligence on Rare / orphan disease drugs, helping you navigate complexities with precision and clarity. Stay informed and enhance your decision-making at flcube.com.

Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption
Policy / Regulatory

Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption

The Hainan Boao Lecheng International Medical Tourism Pilot Zone has released the "Implementation Rules for the Exit Mechanism of Clinical Translation and Application of New Biomedical Technologies" (the "Rules"), aiming…

BRL Medicine’s Allogeneic CD19 CAR‑T Included in CDE’s “Care Program‑Extension” – Rare Disease Fast Track for Relapsed/Refractory Systemic Sclerosis

Walvax’s Third‑Generation COVID‑19 mRNA Vaccine Wins NMPA Approval – JN.1‑Based Shot Clears Regulatory Bar for Adults in China

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Roche's Enspryng Granted FDA Priority Review for MOGAD – First IL‑6 Inhibitor Poised to Expand Beyond NMOSD
CompanyDrug

Roche’s Enspryng Granted FDA Priority Review for MOGAD – First IL‑6 Inhibitor Poised to Expand Beyond NMOSD

Novo Nordisk's Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China's Broadest‑Label Long‑Acting Growth Hormone
CompanyDrug

Novo Nordisk’s Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China’s Broadest‑Label Long‑Acting Growth Hormone

CompanyDrug

Novartis Remibrutinib Beats Teriflunomide in Phase III REMODEL Trials for Relapsing Multiple Sclerosis

CompanyPolicy / Regulatory

Shanghai RAAS’s SR604 Enters NMPA CDE Rare Disease Encouragement Program for Hemophilia and Factor VII Deficiency Treatment

Policy / Regulatory

GluBio’s GLB‑005 WIZ Degrader Enters NMPA Rare Disease Pilot for β‑Thalassemia

Roivant's Lisraya Wins FDA Approval as First Targeted Therapy for Dermatomyositis
CompanyDrug

Roivant’s Lisraya Wins FDA Approval as First Targeted Therapy for Dermatomyositis

FDA Approves J&J's IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab
CompanyDrug

FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab

Ultomiris Wins NMPA Approval for PNH in China, Bringing Long‑Acting Ravulizumab C5 Inhibitor to Adult and Pediatric Patients
CompanyDrug

Ultomiris Wins NMPA Approval for PNH in China, Bringing Long‑Acting Ravulizumab C5 Inhibitor to Adult and Pediatric Patients

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