Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific.
SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.
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MELBOURNE, Australia – Although Australia was one of the first movers in the regenerative medicine space, until now a cohesive plan for investing in regenerative medicine was holding the sector back.
BEIJING – Chinese clinical-stage cancer drug developer Tot Biopharm International Co. Ltd. went public on Hong Kong's stock exchange under the stock code of 1875 on Friday, raising HK$511.4 million (US$61.3 million) by issuing shares at HK$6.55 apiece. But its debut met with an unexpected setback, with share prices down nearly 7% in mid-morning. Prior to the listing, the company said its shares were oversubscribed by around 11.95 times and it "was well received by the capital market."
PERTH, Australia – Melbourne-based Cartherics Pty Ltd. plans on taking its pluripotent stem cell technology into the clinic next year. It is employing advanced gene editing techniques for the next generation of CAR T therapy.
HONG KONG – South Korea's Samsung Bioepis Co. Ltd. will get $100 million in up-front payments in a commercialization deal for two of its biosimilar candidates with U.S. company Biogen Inc. Under the deal, Samsung Bioepis will also be eligible for up to $270 million in milestone and option payments, as well as a share of sales revenue.
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