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.

CompanyDeals

GeneScience Acquires Global Rights to Megestrol Acetate Oral Suspension from TWi Pharmaceuticals – $100M Deal Transforms Distributor into MAH for Cachexia Therapy

Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its controlled subsidiary Changchun GeneScience Pharmaceutical Co., Ltd. — through its wholly‑owned subsidiary GENSCI Singapore Pte. Ltd. —…

ApicHope's Oral Small‑Molecule GLP‑1R Agonist APH04935 Wins FDA IND Approval – Once‑Daily Pill Targets Obesity in Competitive Weight Loss Market

ApicHope’s Oral Small‑Molecule GLP‑1R Agonist APH04935 Wins FDA IND Approval – Once‑Daily Pill Targets Obesity in Competitive Weight Loss Market

Biocause Heilen Wins NMPA Approval for Ibuprofen Arginine Granules – Enhanced‑Solubility NSAID Enters China's OTC Analgesic Market

Biocause Heilen Wins NMPA Approval for Ibuprofen Arginine Granules – Enhanced‑Solubility NSAID Enters China’s OTC Analgesic Market

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MicroPort CardioFlow's VitaFlow Liberty Receives Marketing Approval in Turkey
CompanyMedical Device

MicroPort CardioFlow’s VitaFlow Liberty Receives Marketing Approval in Turkey

Roche's cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry
CompanyMedical Device

Roche’s cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry

Novo Nordisk's Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication
CompanyDrug

Novo Nordisk’s Ozempic Receives Positive CHMP Opinion for Kidney Disease Indication

Johnson & Johnson MedTech's Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
CompanyMedical Device

Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure

Grand Pharmaceutical Group Receives NMPA Approval for NOVASYNC HYBRID SYSTM
CompanyMedical Device

Grand Pharmaceutical Group Receives NMPA Approval for NOVASYNC HYBRID SYSTM

Huadong Medicine's Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
CompanyDrug

Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment

Sperogenix Therapeutics' Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
CompanyDrug

Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment

Merck's PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
CompanyDrug

Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China

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