Astellas Pharma Inc. and 4D Molecular Therapeutics Inc. (4DMT) inked a deal worth up to $942 million under which Astellas will license 4DMT's intravitreal R100 gene therapy vector for rare ophthalmic targets. Read More
Kelun-Biotech Biopharmaceutical Co. Ltd. raised HK$1.36 billion (US$174 million) in an IPO in Hong Kong to support its push into the increasingly competitive antibody-drug conjugate (ADC) market in China. Read More
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma. Read More
Worg Pharmaceuticals (Zhejiang) Co. Ltd. raised ¥1.1 billion (US$152 million) in a series C round to develop its therapies for allergy and autoimmune diseases, as well as to expand into the global market. Read More
Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutic interventions. Read More
Extending its efforts in the booming antibody-drug conjugate (ADC) space, Beigene Co. Ltd. tapped Duality Biologics Co. Ltd. in a deal that could be worth a potential $1.3 billion, picking up an option for rights to a preclinical-stage ADC candidate targeting select solid tumors. It marks the seventh $1 billion-plus ADC-focused deal so far in 2023 and the second for Dualitybio, which inked a potential $1.7 billion deal in April. Read More
Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market. Read More
In a move to address both prevention and treatment of hepatitis B virus (HBV), Brii Biosciences Ltd. has acquired from VBI Vaccines Inc. a global exclusive license to HBV therapeutic vaccine BRII-179 (VBI-2601) and an exclusive license for HBV prophylactic vaccine Prehevbri in the Asia Pacific region, excluding Japan. Read More
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older. Read More
Lotte Biologics Co. Ltd. said it partnered with domestic bioventure Kanaph Therapeutics Inc. to develop an antibody-drug conjugate (ADC) technology platform in hopes of rounding out a full, in-house ADC value-chain. Read More
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer. Read More
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments. Read More
Microba Life Sciences Ltd. has started dosing patients in a phase I trial of its gut microbiome-derived therapeutic, MAP-315, for ulcerative colitis, the major form of inflammatory bowel disease (IBD). Read More
In June 2023, biopharmas collectively raised $6.82 billion through 109 financing transactions. The amount raised is 32.95% more than last June’s $5.13 billion, and the number of transactions is up 26.74%, compared to 86 in June 2022. This echoes the 23.34% increase seen in financings in the first half of 2023 compared to last year. Read More
The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space. Read More
Privately held F-star Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. have completed their third license agreement, one that could bring F-star about $1 billion. The new collaboration is focused on R&D against undisclosed cancer targets. Read More
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer. Read More
The trophoblast cell surface antigen 2 (TROP2) class chalked mix news by way of Astrazeneca plc and Daiichi Sankyo Co. Ltd. as the pair disclosed phase III data from the closely watched Tropion-Lung 1 trial with datopotamab deruxtecan (dato-dxd) against non-small-cell lung cancer. Read More
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC). Read More
New and updated clinical data presented by biopharma firms at the European Association for the Study of the Liver Congress, including: Arrowhead, Takeda. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aimed, Alvotech, Amgen, Beigene, Biocon, Biocytogen, Boehringer Ingelheim, Celltrion, Chime, Coherus, Edirna, Fresenius Kabi, Fresenius SE, Genequantum, Hong-Kong King Friend Industry, Huadong Medicine, Innovent, Leaderna, Leads, Lipigon, Meitheal, Organon, Pheon, Remegen, Samsung Bioepis, Sandoz, Sanyou, Shionogi, Sirnaomics, SK Bioscience, Xentria, Zymedi. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Argenx, Ascentage, Astellas, Astrazeneca, Ausper, Ausperbio, Drug Farm, Harbour, Iaso, Innovent, Invivyd, Kazia, Moderna, Recce, Sihuan, Skyline, Specialised, Transcenta, Xuanzhu, Zai Lab. Read More
