AstraZeneca’s Nirsevimab on Track for Priority Review for RSV Prevention in Infants
The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN)...
Pediatric drugs
Shanghai Ark Biopharmaceutical’s STAR Market IPO Filing Accepted, Aims to Raise $289.6 Million
Shanghai Ark Biopharmaceutical Co., Ltd’s Initial Public Offering (IPO) filing to the Shanghai Stock Exchange’s...
Fosun Pharmaceutical Gets NMPA Approval for FCN-159 Phase II Study in LCH
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has...
CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Development
The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on...
CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Clinical R&D
The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on...
Hainan Honz Partners with GPI for Pediatric and Maternity Medicine Expansion
China-based Hainan Honz Pharmaceutical Co., Ltd (SHE: 300086) has entered into a three-year partnership with...
SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017,...
China’s NHC Issues Guidelines to Improve Pediatric Medication Management
The National Health Commission (NHC) has released a notification aimed at refining management measures for...
Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai...
CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase...
Kexing Pharmaceutical Initiates Phase I Trial for IFN-Alpha-1b Inhalation Solution
China-based Kexing Pharmaceutical (SHA: 688136) has announced the enrollment of the first subject and dosing...
AstraZeneca’s Nexium Approved by NMPA for Adolescent GERD Treatment
UK-based pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving market approval from the National Medical...
Mabwell Bioscience Licenses Biosimilars to Russian Firm Binnopharm
China-based Mabwell Bioscience (SHA: 688062) has announced the establishment of a licensing agreement with the...
Pfizer Exercises Option for Sisunatovir Rights with LianBio
US major Pfizer Inc. (NYSE: PFE) has agreed with China-based LianBio (OTCMKTS: LIANY) to exercise...
NMPA Approves Viatris’ Symfi Lo for HIV-1 Treatment in China
The National Medical Products Administration (NMPA) website indicates that US-based Viatris Inc.’s (NASDAQ: VTRS) Symfi...
Pediatrix Therapeutics Licenses Tris Pharma’s ADHD Portfolio for Greater China
China-based Pediatrix Therapeutics announced a licensing agreement with US firm Tris Pharma, Inc., obtaining exclusive...
Aclaris Therapeutics Licenses JAK Inhibitor ATI-1777 to Pediatrix for Greater China
US-based Aclaris Therapeutics Inc. (NASDAQ: ACRS) and Shanghai firm Pediatrix Therapeutics Inc. entered into a...
AstraZeneca to Launch Soliris in Hangzhou After Regulatory Approval
UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has revealed plans to sell Soliris (eculizumab)...
CDE Releases Guidelines on Pediatric Anti-tumor Drug Development
The Center for Drug Evaluation (CDE) has released a Technical Guidelines document focused on “Clinical...
Sinovac’s Varicella Vaccine Receives WHO Pre-Qualification
China-based Sinovac has announced receiving pre-qualification (PQ) status from the World Health Organization (WHO) for...