Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Agios, Celltrion Dizal, Everest, Junshi, Sumitomo, Teva.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Astria, Coherus, Fresenius, Intas, Kaken, Kashiv, MS Pharma, Nxera, Neuren, Polpharma, Takea.
Lepu Biopharma Co. Ltd. has out-licensed two preclinical T-cell engagers to Shanghai-based newco Excalipoint in a deal worth $857.5 million plus equity interest. Under the deal terms, Excalipoint gains an exclusive global license to CTM-012 and CTM-013, developed by Lepu’s Topabody T-cell engager platform. In exchange, Lepu will receive $10 million up front and up to $847.5 million in development and commercial-based milestones, plus tiered royalties on sales.
Chinese vaccine company Ab&B Bio-tech announced an IPO listing on the Hong Kong Stock Exchange (HKEX:2627) under which it hopes to raise up to HK$518.36 million (US$66 million) to commercialize its influenza and human rabies vaccines in China and internationally.
Alterity Therapeutics Ltd. helped develop a new neuroimaging biomarker called the multiple system atrophy index (MSA-AI), which looks to be a more reliable biomarker for tracking disease progression of MSA.
Chinese scientists have discovered a common mechanism by which structurally distinct proteins elicit an allergic reaction, showing they cause the formation of pores in epithelial airway cells.
While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.