BEIJING – Antibody developer Akeso Biopharma Inc., from China's Guangdong province, closed a $150 million series D financing round to advance its pipeline, especially the two PD-1-based bispecific antibodies, AK-104 and AK-112, aimed to help it stand out in the fierce PD-1 space in China. "A significant portion of the proceeds will go to AK-104 and AK-112, which are both first-in-class drug candidates," Akeso CEO Michelle Xia told BioWorld. This year is a big one for Akeso, as AK-104 and AK-112 received IND approvals from the FDA in March and July, respectively. Read More
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." Read More
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, said its BAT-1406 became the first biosimilar referencing Abbvie Inc.'s blockbuster TNF-blocker, Humira (adalimumab), to win a marketing nod in China. It is Bio-Thera's first biosimilar and China's second homegrown biosimilar approved by the National Medical Products Administration (NMPA). Read More
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. Read More
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. Read More
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. Read More
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. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific. Read More
