Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
In July, Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd.) became the first amyloid-targeting drug to win traditional approval from the U.S. FDA, after getting accelerated approval in January based on the surrogate endpoint of plaque removal.
Asia continues its push to be the global leader with precision health and artificial intelligence/machine learning (AI/ML) models for diagnosing disease. Most health care systems in Asia’s major markets include universal health care coverage and are leaning toward electronic health records, paving the way for seamless use of data. At the same time, AI/ML is making its way across the entire health care spectrum, including applications to diagnose breast cancer, kidney disease, cognitive decline, depression and even retinal imaging to detect cardiac disease.
In 2023, Japan has faced mounting criticism from the pharma industry for its annual price reductions. Ahead of the G7 summit hosted in Japan in May 2023, a delegation of 24 CEOs from the Biopharmaceutical CEO Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan. Meanwhile, in 2023, China agreed to add 126 drugs to its National Reimbursement Drug List, in a negotiation process that has become more transparent and predictable than ever before. South Korea faces drug pricing reform, while Australia’s government has started an overhaul of its health technology assessment process.
If the COVID-19 pandemic shocked countries to build self-reliance in biomedical ecosystems, the re-opening of borders in 2023 kickstarted international collaborations to grow major biohubs in Asia. Countries in the Asia Pacific region – including Singapore, China, Japan, Korea and Australia – increasingly drew overseas investors and collaborators, helping each country grow national biotech capabilities and expertise.
If the COVID-19 pandemic shocked countries to build self-reliance in biomedical ecosystems, the re-opening of borders in 2023 kickstarted international collaborations to grow major biohubs in Asia. Countries in the Asia Pacific region – including Singapore, China, Japan, Korea and Australia – increasingly drew overseas investors and collaborators, helping each country grow national biotech capabilities and expertise.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.
South Korean researchers from the Gwangju Institute of Science and Technology (GIST) have penned a “groundbreaking” adversarial task adaptive pretraining (A-TAPT) model that could improve the accuracy of analyzing vocal cord vibrations for medical conditions.
Medical Microinstruments Inc. (MMI) is expanding its Symani surgical system into the Asia Pacific – a region with “clear demand for the technology” – through two local partners, Device Technologies Australia Pty Ltd. and Seoul-based TRM Korea Corp.
