Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23. Read More
South Korea’s SK Biopharmaceuticals Co. Ltd. and Shanghai-based Ignis Therapeutic Co. Ltd. signed a ₩804 billion (US$58 million) licensing deal on April 18, granting the latter global rights to a non-narcotic pain treatment candidate dubbed SKL-22544. A sodium channel blocker, SKL-22544 is in late discovery. Read More
BNC Korea Inc. is picking up exclusive commercial rights to Kariya Pharmaceuticals ApS’ dual GLP-1/GIP agonists for Parkinson’s and Alzheimer’s disease in five countries – a move that comes shortly after BNC Korea dropped $1.5 million into the Danish pharma for a 4.5% stake. Read More
Immuneoncia Therapeutics Inc., a joint venture between South Korea’s Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., is looking to list on the Korea Exchange, having recently passed local technology evaluation. Read More
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering them exclusively to where patients need them most, BTB co-founder and CEO Chen Benkler told BioWorld. Read More
Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance. Read More
Suzhou, China-based Kintor Pharmaceutical Ltd. reported positive findings from a phase II study of GT-20029, a topical therapy for male androgenetic alopecia, on April 21 – boosting both the company’s stock and its chances of a late-stage clinical study in China and the U.S. Read More
China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors. Read More
In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals. Read More
In one of the biggest financings of the year so far, former Prometheus Biosciences Inc. CEO Mark McKenna helped raise $400 million to launch a new company, Mirador Therapeutics Inc. He didn’t sit on the sidelines for long after Merck & Co. Inc. bought Prometheus for $10.8 billion in 2023. He recruited key Prometheus executives to focus on Mirador’s genetic approach to drug discovery and precision medicine. McKenna said there was too much left undone to just hang back. In this BioWorld Insider episode, he talks about the new company and the multi-billion-dollar drugs that he believes provide sub-optimal efficacy compared to the tailor-made therapies he wants to develop. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Genfleet, Immutep, Takeda, Telix. Read More
