BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.
When the time was right to make a powerful Western biotech welcome in China, Beigene Ltd. was ready when Amgen Inc. came calling. Its massive $2.7 billion cash equity investment in Beigene buys Amgen an oncology footprint in China.
HONG KONG – I-Mab Biopharma (Shanghai) Co. Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for its CD73 antibody, getting the go-ahead for a phase I/II trial of TJD-5 in patients with advanced solid tumors.
HONG KONG – Singapore's Aslan Pharmaceuticals Ltd. and South Korea's Bukwang Pharmaceutical Co. Ltd. have jointly established a new company dedicated to the development of aryl hydrocarbon receptor (AhR) drug candidates. Named Jaguahr Therapeutics Pte. Ltd. – the unusual spelling a clear reference to "AhR" – it will be based in Singapore and will focus on developing immuno-oncology therapeutics for global markets based on the preclinical AhR antagonists in Aslan's early stage pipeline.
HONG KONG – Hutchison China Meditech Ltd.'s (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.
HONG KONG – South Korean biotech Bioleaders Co. Ltd., headquartered in Yong-in city, Gyeonggi-do, and Israel's Weizmann Institute of Science, based in Rehovot, recently founded a joint venture in Israel. With the new entity, they will accelerate the R&D of a Weizmann-developed approach targeting p53, a strong tumor suppressor that has proved difficult to drug.
PERTH, Australia – Australia is at risk of falling behind the U.S. and Europe in preventing recurrence of melanoma, the Melanoma Institute Australia warns. It is urging the Australian government to undertake a timely review of immunotherapy treatments effective in preventing the spread of melanoma and to fast track listings on the government-subsidized Pharmaceutical Benefits Scheme (PBS).
Ten targeted cancer drugs currently being tested in clinical trials involving 1,000 patients do not reach the targets at which they are aimed, according to recently published research.
HONG KONG – In one of the latest combination efforts against cancer, Kahr Medical Ltd. is teaming up with Switzerland's Basel-based Roche Holding AG to study the use of the former's lead program, DSP-10, in combination with the latter's PD-L1-blocking checkpoint inhibitor, Tecentriq (atezolizumab), in patients with advanced non-small-cell lung carcinoma refractory to checkpoint inhibitors.
BEIJING – Despite tensions between the U.S. and China, especially in the tech sector, Oncologie Inc. maintains its plans to pursue drug development in both markets. The clinical-stage startup, led by U.S. scientists and funded with Chinese capital, has stationed itself in both Boston and Shanghai to focus on developing innovative cancer therapies simultaneously in China and the U.S.
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