China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
Akeso Pharmaceuticals Inc. raised $250 million via a public offering that will allow the company to accelerate clinical development of its internally developed drugs in both China and international markets. The offering consists of 31.7 million shares priced at HKD$61.28 (US$7.88) per share and marks the second successful placement in 2024 for Guangdong, China-based Akeso. Following the offering, the company's cash on hand is expected to be $1.064 billion.
Regenerative medicine company Orthocell Ltd.’s nerve repair product, Remplir, was approved by Singapore’s Health Sciences Authority, opening up the Asian market for the company’s biggest product.
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.
Immunotherapy company Cartherics Pty Ltd. raised AU$15 million (US$10.3 million) in an oversubscribed series B round that will support the first clinical trial for lead chimeric antigen receptor natural killer therapy CTH-401 for ovarian cancer, and to expand its pipeline to include other diseases.
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. raised NT$6.4 billion (US$206 million) in its IPO on the Taipei Stock Exchange, making it the largest IPO in Taiwan’s biotech industry history and valuing the company at nearly $3 billion following the listing.
Wuhan YZY Biopharma Co. Ltd. is out-licensing lead candidate M-701, a CD3/EpCAM bispecific antibody, to Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ) for China rights in a deal worth up to $143 million. Under the deal, Sino Biopharmaceutical Ltd. subsidiary CTTQ is granted an exclusive license to develop, register, manufacture and commercialize M-701 within mainland China.
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. raised NT$6.4 billion (US$206 million) in its IPO on the Taipei Stock Exchange, making it the largest IPO in Taiwan’s biotech industry history and valuing the company at nearly $3 billion following the listing.
Varian Medical Systems Inc. launched its Hypersight imaging solution for its Truebeam and Edge linear accelerators across the Asia Pacific region, providing clinicians with better image quality, enhancing their ability to deliver more precise radiation treatments.