Product approvals

Explore the landscape of product approvals in China’s pharmaceutical industry. Fineline Info & Tech delivers reliable data and insights on product approvals to help you navigate complexities with precision and clarity. Stay informed and enhance your decision-making at flcube.com.

Qyuns Therapeutics' Oturkibart Delivers Late‑Breaking Phase III Data in Prurigo Nodularis at EADV 2026 – IL‑4Rα Antibody Beats Placebo on Itch and Lesion Clearance
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Qyuns Therapeutics’ Oturkibart Delivers Late‑Breaking Phase III Data in Prurigo Nodularis at EADV 2026 – IL‑4Rα Antibody Beats Placebo on Itch and Lesion Clearance

Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that results of the China Phase III clinical study of Oturkibart (QX005N), its innovative IL‑4Rα monoclonal antibody, for the treatment of prurigo nodularis…

Abogen Biosciences Strikes Licensing and Option Deal with Novartis for ABO2203 – Up to $7.2 Billion to Advance the First mRNA‑Encoded T‑Cell Engager in Autoimmune Disease

Abogen Biosciences Strikes Licensing and Option Deal with Novartis for ABO2203 – Up to $7.2 Billion to Advance the First mRNA‑Encoded T‑Cell Engager in Autoimmune Disease

Shandong Lukang Wins NMPA Registration for Generic Cefuroxime Sodium for Injection – Entering a RMB 2.6 Billion Chinese Cephalosporin Market

Shandong Lukang Wins NMPA Registration for Generic Cefuroxime Sodium for Injection – Entering a RMB 2.6 Billion Chinese Cephalosporin Market

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NMPA Approves Lilly's Jaypirca (Pirtobrutinib) as First‑Line Monotherapy for CLL/SLL – Non‑Covalent BTK Inhibitor Completes Line‑of‑Therapy Progression in China
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NMPA Approves Lilly’s Jaypirca (Pirtobrutinib) as First‑Line Monotherapy for CLL/SLL – Non‑Covalent BTK Inhibitor Completes Line‑of‑Therapy Progression in China

FDA Approves Eli Lilly's Olumiant for Pediatric Patients Aged 12 and Older With Severe Alopecia Areata
CompanyDrug

FDA Approves Eli Lilly’s Olumiant for Pediatric Patients Aged 12 and Older With Severe Alopecia Areata

FDA Approves Eli Lilly's Onswik – Once‑Weekly Basal Insulin for Adults With Type 2 Diabetes
CompanyDrug

FDA Approves Eli Lilly’s Onswik – Once‑Weekly Basal Insulin for Adults With Type 2 Diabetes

Merck's Subcutaneous Pembrolizumab Approved by China's NMPA Across 19 Solid Tumor Indications – First and Only Subcutaneous PD‑1 Inhibitor in China
CompanyDrug

Merck’s Subcutaneous Pembrolizumab Approved by China’s NMPA Across 19 Solid Tumor Indications – First and Only Subcutaneous PD‑1 Inhibitor in China

FDA Approves AbbVie's Tavapadon as Juvmo for Parkinson's Disease – Once‑Daily Dopamine Mimetic Joins $8.7 Billion Cerevel Portfoli
CompanyDrug

FDA Approves AbbVie’s Tavapadon as Juvmo for Parkinson’s Disease – Once‑Daily Dopamine Mimetic Joins $8.7 Billion Cerevel Portfolio

European Commission Approves AbbVie's RINVOQ (Upadacitinib) for Juvenile Idiopathic Arthritis – Ninth EU Indication for the JAK Inhibitor
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European Commission Approves AbbVie’s RINVOQ (Upadacitinib) for Juvenile Idiopathic Arthritis – Ninth EU Indication for the JAK Inhibitor

Jenscare's JensClip Wins NMPA Registration Approval – Self‑Locking Transcatheter Mitral Valve Repair Clip Enters the Chinese Market
CompanyMedical Device

Jenscare’s JensClip Wins NMPA Registration Approval – Self‑Locking Transcatheter Mitral Valve Repair Clip Enters the Chinese Market

Merck's Subcutaneous Pembrolizumab KEYJECT Wins MHLW Approval Across All KEYTRUDA Indications in Japan – Phase III Shows Comparable Exposure and 45% ORR in First-Line Metastatic NSCLC
CompanyDrug

Merck’s Subcutaneous Pembrolizumab KEYJECT Wins MHLW Approval Across All KEYTRUDA Indications in Japan – Phase III Shows Comparable Exposure and 45% ORR in First-Line Metastatic NSCLC

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