The US Food and Drug Administration (FDA) has approved a generic drug developed by Taiwan-based TTY Biopharm Co Ltd (台灣東洋藥品) to treat acute promyelocytic leukemia (APL), the company said on Sunday.
The drug, arsenic trioxide, sold under the brand name Asadin, was first approved for medical use in the US last year, and is listed by the WHO as an essential medicine for treating APL.
APL, a rare form of acute myeloid leukemia (AML), is distinguished by there being too many immature blood-forming cells in the blood and bone marrow, which leads to a shortage of normal white and red blood cells in the body.
Photo: Chang Chia-ming, Taipei Times
It needs to be treated differently from other types of AML, and arsenic trioxide combined with all-trans retinoic acid has become the standard treatment for the cancer.
When APL was first identified in 1957, APL patients had a median survival rate of less than a week, but now 10-year survival rates are plausible thanks to improvements in diagnosis and medication.
TTY Biopharm said in a statement that it hoped the approval of its generic drug could help patients in the US.
The company first received a license to make the drug from the Taiwanese FDA in 2002. It was the first APL treatment license issued in Taiwan.
From 2018, the company developed the drug further under a milestone payment contract with another partner, which it did not identify.
The partner is responsible for the sale, licensing and approval of the TTY Biopharm’s generic drug in international markets, such as Malaysia, the Philippines, Thailand, the US and Vietnam.
The US FDA approval was the first received by TTY Biopharm for any of its drugs, and recognizes the company’s research and development capabilities and manufacturing strength, the company said.
As the materials used to make the drug are highly toxic, the company has partnered with National Central University to create a recycling technique for arsenic ions that makes wastewater from the drug production process safe to release.
In related news, TTY Biopharm’s board of directors yesterday approved the dismissal of general manager Shih Chun-liang (施俊良), after Shih admitted to being involved in an insider-trading scandal involving the company’s shares.
TTY Biopharm chairman Lin Chuan (林全) is also to act as general manager, the company said in a regulatory filing.
Additional reporting by Kao Shih-ching
TECH BOOST: New TSMC wafer fabs in Arizona are to dramatically improve US advanced chip production, a report by market research firm TrendForce said With Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) pouring large funds into Arizona, the US is expected to see an improvement in its status to become the second-largest maker of advanced semiconductors in 2027, Taipei-based market researcher TrendForce Corp (集邦科技) said in a report last week. TrendForce estimates the US would account for a 21 percent share in the global advanced integrated circuit (IC) production market by 2027, sharply up from the current 9 percent, as TSMC is investing US$65 billion to build three wafer fabs in Arizona, the report said. TrendForce defined the advanced chipmaking processes as the 7-nanometer process or more
Who would not want a social media audience that grows without new content? During the three years she paused production of her short do-it-yourself (DIY) farmer’s lifestyle videos, Chinese vlogger Li Ziqi (李子柒), 34, has seen her YouTube subscribers increase to 20.2 million from about 14 million. While YouTube is banned in China, her fan base there — although not the size of YouTube’s MrBeast, who has 330 million subscribers — is close to 100 million across the country’s social media platforms Douyin (抖音), Sina Weibo (新浪微博) and Xiaohongshu (小紅書). When Li finally released new videos last week — ending what has
OPEN SCIENCE: International collaboration on math and science will persevere even if the incoming Trump administration imposes strict controls, Nvidia’s CEO said Nvidia Corp CEO Jensen Huang (黃仁勳) said on Saturday that global cooperation in technology would continue even if the incoming US administration imposes stricter export controls on advanced computing products. US president-elect Donald Trump, in his first term in office, imposed restrictions on the sale of US technology to China citing national security — a policy continued under US President Joe Biden. The curbs forced Nvidia, the world’s leading maker of chips used for artificial intelligence (AI) applications, to change its product lineup in China. The US chipmaking giant last week reported record-high quarterly revenue on the back of strong AI chip
Qualcomm Inc’s interest in pursuing an acquisition of Intel Corp has cooled, people familiar with the matter said, upending what would have likely been one of the largest technology deals of all time. The complexities associated with acquiring all of Intel has made a deal less attractive to Qualcomm, said some of the people, asking not to be identified discussing confidential matters. It is always possible Qualcomm looks at pieces of Intel instead or rekindles its interest later, they added. Representatives for Qualcomm and Intel declined to comment. Qualcomm made a preliminary approach to Intel on a possible takeover, Bloomberg News and other media
RSS