MSD’s Clesrovimab (MK-1654) has been approved in China today for the prevention of lower respiratory tract infections caused by respiratory syncytial virus (RSV) in neonates and infants who are about to enter or are born during their first RSV season.…
Today, PAH treatment in China has reached a historic breakthrough! On June 8, it was officially announced that the world’s first fully human biologic targeting the core pathological mechanism of PAH — Sotatercept for Injection (brand name: Winrevair®) — has…
On June 17, the CDE official website showed that the New Drug Application (NDA) for CSPC Pharmaceutical Group’s Secukinumab Injection has been accepted, with a registration classification of Category 3.3. Secukinumab, originally developed by Novartis, specifically binds to IL-17A and…
On June 18, the CDE official website showed that the Category 1 new drug Galvokimig Injection, filed by UCB, has been approved for clinical trial for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD). Galvokimig is a global first-in-class…
On June 18 local time, Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab), a subcutaneous formulation, in combination with Polivy® (polatuzumab vedotin) for the treatment of…
On June 18 local time, Nicox SA announced that its exclusive license partner in China, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the CDE for NCX 470 . Ocumension considers the feedback sufficient to support the filing of a…
On June 17, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Kerui Pharmaceutical, a subsidiary of Qingfeng Pharmaceutical, has registered a Phase III study of DN022150 monotherapy versus chemotherapy in advanced pancreatic cancer carrying the KRAS G12D…
On June 17, the CDE official website announced that Henlius’ HLX3902 Injection has been approved for clinical trial in China, intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors. According to the Insight database, HLX3902…
On June 16, the Hong Kong Stock Exchange website showed that the IPO application submitted by Junsai Bio has been accepted. The exclusive sponsor for this IPO is CITIC Securities. Founded in 2019, Junsai Bio focuses on the research, development,…
On June 16, Henlius announced that HLX04-O, its recombinant anti-VEGF humanized monoclonal antibody injection, has met the primary endpoint in an international multicenter Phase III clinical study in patients with wet age-related macular degeneration (wAMD). This study was an international…