Antibody-drug conjugate (ADC)-focused Callio Therapeutics debuted on March 3 with the closing of a $187 million series A financing round based on cancer drug technology and assets in-licensed from Hummingbird Bioscience Pte Ltd. Read More
Kyorin Pharmaceutical Co. Ltd. has out-licensed its preclinical candidate, KRP-M223, and its back-up compounds to Novartis Pharma AG in a deal worth up to $777.5 million. Under the terms, Novartis gains an exclusive worldwide license to develop, manufacture and commercialize Kyorin-discovered KRP-M223. Read More
HBM Alpha Therapeutics Inc. signed a potential $395 million licensing deal Feb. 26 with an unnamed “business partner” for its endocrine asset, HAT-001, adding another contender to the congenital adrenal hyperplasia space. Read More
Antibody-drug conjugate developer Duality Biotherapeutics Inc. is gearing up for a second IPO attempt this year, having filed on Feb. 27 a new prospectus on the Hong Kong Stock Exchange. Two other biotechs – Genuine Biotech Ltd. and Cloudbreak Pharma Inc. – also are having another go at a listing in Hong Kong in 2025. Read More
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course. Read More
Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia. Read More
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025. Read More
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria. Read More
Basel Medical Group Ltd. is the first Singapore-based med-tech to price an IPO on the Nasdaq this year, aggregating gross proceeds of $8.82 million on its debut. The funds will be used to power future M&As and business expansion plans in Singapore and Southeast Asia, the company said. Read More
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy. Read More
Billion-dollar M&As are commonplace now, but not too long ago they were a rarity. So many have occurred in the past few years, they’ve become the norm. But were all these multi-billion-dollar mega mergers worth the money? Karen Carey, BioWorld’s senior managing editor and chief analyst, crunched the numbers on 21 of the biggest M&As in a three-part BioWorld series and found very few have been, so far, good deals for the buyer. In this podcast, Carey sifts through the winners and losers and explains the analysis. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Biocity, Cstone, Delta-Fly, Innocare, Yoltech. Read More
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Biond Biologics, Carsgen, Eisai, Epimab, Hansoh, Holling Bio-Pharma, Infex, Idorsia, Ligand, Medigene, Nxera, Sanofi, Sciclone, Silence, Venus Remedies, Ucarsgen. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ardelyx, Astrazeneca, Bioarctic, Celltrion, Innovent, Sanofi, Takeda. Read More