The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients. Read More
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples. Read More
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11. Read More
South Korea’s Eubiologics Co. Ltd. said it gained the World Health Organization’s (WHO) prequalification designation on April 16 for its simplified oral cholera vaccine, approved as Euvichol-S. Read More
On the heels of a $4.6 million series A round in December 2023, cell therapy company Rxcell Inc. is planning to raise another $15 million in 2024 to take its iPSC-derived photoreceptors to the clinic for retinitis pigmentosa and other degenerative diseases of the retina. Read More
The U.S. FDA granted fast track designation to Telix Pharmaceutical Ltd.’s TLX101-CDx for glioma imaging as the firm prepares to file its NDA in the first half of 2024, a Telix spokesperson told BioWorld. Read More
Nxera Pharma Co. Ltd. announced that its partner, Neurocrine Biosciences Inc., is advancing NBI-1117568 to phase II trials for treatment of schizophrenia and other neuropsychiatric disorders. Read More
Prior to this year’s Annual Meeting of the American Association for Cancer Research (AACR), it had been 14 years since metastasis had been the subject of a plenary session. So, the Tuesday session on “Evolution of the genome, microenvironment, and host through metastasis” had plenty of new insights to share. Read More
In March, biopharma deals reached $8.29 billion, slightly higher than February’s $7.76 billion. Meanwhile, biopharma M&As amounted to $22 billion for the month. In terms of volume, March saw 104 biopharma deals, up from the 100 recorded in February, yet lower than January’s 158 and the 2023 monthly average of 115 deals. Read More
Research in the Alzheimer’s disease and dementia space has advanced in recent years, but it still has a long way to go. In a recent three-part series, BioWorld’s Anette Breindl delves into some of the biggest questions, such as the hallmarks of aging and the role of amyloid in Alzheimer’s disease, and reports on the latest efforts by researchers and industry players to accelerate R&D efforts. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Abbisko, Akeso, Henlius, Imugene, Kexing, Transthera. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Biocity, Delta-Fly, Junshi, Mabwell. Read More
