Tamra Sami

Gan & Lee Pharmaceuticals Co. Ltd. has signed its largest ex-China licensing agreement for obesity candidate bofanglutide (GZR-18), granting Menarini

China's National Medical Products Administration has approved two differentiated therapies aimed at reducing the burden of acute and seasonal disease: Everest Medicines Ltd.'s Cardamyst, a self-administered nasal spray for paroxysmal supraventricular tachycardia, and Simcere Pharmaceutical Group Ltd.'s Yingmule, a long-acting monoclonal antibody to prevent respiratory syncytial virus (RSV)-related lower respiratory tract infections in newborns and infants.

China's National Medical Products Administration has approved two differentiated therapies aimed at reducing the burden of acute and seasonal disease: Everest Medicines Ltd.'s Cardamyst, a self-administered nasal spray for paroxysmal supraventricular tachycardia (PSVT), and Simcere Pharmaceutical Group Ltd.'s Yingmule, a long-acting monoclonal antibody to prevent respiratory syncytial virus (RSV)-related lower respiratory tract infections in newborns and infants.

Asian-generated clinical and preclinical data are becoming a bigger part of global biotech development, but panelists at the Asia Bio Partnering Forum in Singapore said credibility alone is no longer enough. Companies need to design data packages from the outset so they can withstand partner due diligence, regulatory review and cross-border transfer requirements.

Gan & Lee Pharmaceuticals Co. Ltd. has signed its largest ex-China licensing agreement for obesity candidate bofanglutide (GZR-18), granting Menarini Group rights across 39 European countries in a deal worth up to €726 million (US$844 million).

Asia-Pacific biotechs that want to compete globally need to make decisions about corporate structure, intellectual property, financing and clinical development from the outset, panelists said during the recent Asia Bio Partnering Forum in Singapore.

Kyowa Kirin Co. Ltd. reported mixed phase II results for KHK-4951, a nanocrystal tivozanib eye drop being developed as a maintenance therapy for neovascular age-related macular degeneration (nAMD), also known as wet AMD. The study missed its primary endpoint, but many patients maintained stable vision over roughly one year after initial anti-VEGF treatment.

Echo IQ Ltd. disclosed that the U.S. FDA issued a not substantially equivalent determination for the company's initial 510(k) application for Echosolv HF, its AI-based heart failure clinical decision support software, delaying U.S. commercial clearance for now.

Fresh off a multibillion-dollar licensing deal with China's Harbour Biomed, Solstice Oncology has emerged from stealth mode with a $225 million series A round to advance porustobart, a next-generation CTLA4 antibody designed to expand immunotherapy's reach into microsatellite-stable colon cancer.

The U.S. FDA has issued a second complete response letter (CRL) to Seikagaku Corp. for the company's resubmitted BLA for condoliase (SI-6603), a treatment for radicular leg pain associated with lumbar disc herniation.