Lepu Biopharma Co. Ltd. has been given conditional approval by China’s NMPA for its anti-PD-1 monoclonal antibody, Puyouheng (pucotenlimab injection), based on data from a phase II study. The drug was conditionally greenlighted for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors. Read More
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. Read More
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. Read More
Inventisbio Co. Ltd. has raised ¥2.084 billion (US$296 million) in an IPO on Shanghai’s STAR Market priced at ¥18.12 per share, though its stock saw a disappointing debut, opening at ¥14 per share on the first trading day July 25 and closing at $15.29, for a drop of 15.6%. The stock closed Aug. 1 at ¥14.42. Read More
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. Read More
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. Read More
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. Read More
Since the very beginning of the COVID-19 pandemic, in addition to the attempts to rapidly develop a vaccine that was effective against current strains, researchers have been looking for a vaccine that could protect more broadly against multiple coronaviruses. Read More
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. Read More
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: ACM Biolabs, Adamis, Ashvattha, Astellas, Biontech, Enanta, Lynk, Pfizer, Revive, Seagen. Read More
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. Read More
