Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Daiichi Sankyo, Genuine, Inflarx, Lepu, Novartis, Novavax, Qbiotics, Sirnaomics, Veru.
Big pharma is increasingly turning to Taiwan to leverage the power of the country’s data and computing power as precision medicine takes center stage in drug development, speakers said during the recent BIO Asia-Taiwan conference in Taipei.
Keeping innovation growing at a fast clip while retaining new global supply chain capacity built up during the pandemic were the main topics of discussion at the Bio Asia-Taiwan conference July 27 in Taipei. With the theme of the conference, “Connecting the Asia Value Chain,” Taiwan Vice President Ching-Te Lai said the pandemic has demonstrated Taiwan’s resilience as well as the strength of the global biopharma industry.
Elevation Oncology Inc. has picked up the global rights to SYSA-1801, an anti-Claudin 18.2 antibody-drug conjugate (ADC) candidate, from CSPC Megalith Biopharmaceutical Co. Ltd. in a deal worth up to $1.195 billion. Under the terms, Elevation gets rights to develop and commercialize SYSA-1801 outside of mainland China, Hong Kong, Macau and Taiwan.
The controversy about the origins of the SARS-CoV-2 virus and the accusations that it escaped from the Wuhan Institute of Virology, or even that it was deliberately engineered there, could – possibly – be brought to a close by two papers published July 26, 2022.
Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine approved to treat COVID-19 in China and was approved just 10 days after its application was submitted on July 15.
Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. out-licensed an investigational antibody-drug conjugate (ADC) for the treatment of solid tumors to Merck & Co. Inc. in a deal worth up to $936 million. Sichuan, China-based Kelun-Biotech will receive $35 million up front in the deal and is eligible to receive up to $901 million in future development, approval and commercial milestone payments, as well as tiered royalties on net sales.
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