South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012. Read More
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration. Read More
Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 million). Read More
Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine. Read More
Nuevocor Pte. Ltd. has closed a $45 million series B, enabling it to move lead gene therapy NVC-001 into the clinic in the treatment of an inherited form of cardiomyopathy. Read More
Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma in patients with PD-L1 expression below 1. Read More
Among three Korean biotech companies slated to sell shares on the Korea Exchange this month, Immuneoncia Therapeutics Inc. is the latest to price a ₩33.9 billion (US$24 million) Kosdaq IPO for May 19. Regenerative cell therapy maker Organoid Sciences Ltd. and antibody-drug conjugate specialist Intocell Inc. are also gearing up for respective Kosdaq listings starting next week. Read More
Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research. Read More
First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. Read More
“We are prepared for every scenario, even though we don’t know what some of those are.” That sums up the message from executives of Astrazeneca plc, GSK plc and Sanofi SA, when quizzed during presentations of their first-quarter 2025 results this week, about the fallout if pharmaceuticals they import to the U.S. are subject to tariffs. Read More
Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies. Read More
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple. Read More
Total biopharma financings for the first four months of 2025 reached $15.48 billion, a 71% decline from $53.49 billion in 2024. Biopharma companies raised $2.4 billion in April 2025, reflecting a 37% drop from March's $3.82 billion. Read More
A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter. NMEs include compounds chosen for further pharmacological evaluation or as clinical candidates; new leads whose structural optimization could provide new therapeutic agents; new additions to the structural diversity of known mechanistic classes of drugs; and new pharmacological tools for investigating drug targets. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Akeso, Alterity, Chemomab, Yoltech. Read More
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Formosa, Galmed, Laboratorios Saval. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Innocare, Innorna, Innovent, Junshi, Telix. Read More
