HONG KONG – South Korean company Alteogen Inc. signed a nonexclusive global license agreement with a top 10 global pharmaceutical company for its recombinant human hyaluronidase enzyme, ALT-B4, in exchange for an up-front payment of $13 million. It is also eligible to receive additional payments of up to $1.37 billion tied to the achievement of development, regulatory approval and sales milestones. While the undisclosed big pharma will secure the global rights to develop and commercialize multiple products in combination with the Hybrozyme technology, Alteogen will be responsible for the clinical and commercial supply of ALT-B4 materials. Read More
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13. Read More
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home. Read More
HONG KONG – Seoul, South Korea-based GI Innovation Inc. has licensed to Nanjing, Jiangsu-based Simcere Pharmaceutical Co. Ltd. rights to its immunotherapy drug candidate, G1-101, a bispecific CD80/interleukin2 (IL-2) variant fusion protein. Read More
PERTH, Australia – On the heels of positive phase IIb data, Opthea Ltd. announced a private placement of AU$50 million (US$33.87 million) from institutional investors in Australia and the U.K. to advance lead candidate OPT-302 to phase III trials in wet AMD. Read More
NEW DELHI, India – While India is still an attractive prospect for investment in biotechnology, the country needs to learn from the successful examples of other countries, including its Asian biotech competitors, according to a new report. Read More
HYDERABAD – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its capacity to fight TB drug resistance and bolster susceptibility testing under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND). Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific. Read More