Juns Bioscience's 'Roktorji' Partially Approved
"Turning Overseas Due to US Drug Shortage Crisis"
An immuno-oncology drug developed by a Chinese pharmaceutical company has received its first approval from the U.S. Food and Drug Administration (FDA).
On the 4th, according to Bloomberg and the Hong Kong South China Morning Post (SCMP), Shanghai Junshi Biosciences announced on the 27th of last month that its immuno-oncology drug 'Loqtorzi' has been approved by the U.S. FDA.
Anticancer drug Loktorzi developed by a Chinese pharmaceutical company Photo by South China Morning Post
Loqtorzi is a cancer treatment similar to global pharmaceutical companies Merck's 'Keytruda' and Bristol Myers Squibb (BMS)'s 'Opdivo'. It belongs to the class of immune checkpoint inhibitors that block human programmed cell death protein 1 (PD-1), which acts as a brake on the immune system. Its generic name is Toripalimab.
It was approved in China at the end of 2018 and is used as a more affordable alternative to Keytruda or Opdivo. While it has been approved in China for the treatment of common cancers, in the U.S. it received limited approval for the treatment of rare tumors such as nasopharyngeal carcinoma, which affects tissues at the back of the nose and mouth.
Bloomberg described this as "an unprecedented success among Chinese pharmaceutical companies seeking entry into the world's most profitable U.S. market," and called it "a groundbreaking event for Chinese pharmaceutical companies that have long faced questions about the quality of their clinical trials."
It also noted, "Last year, the FDA rejected approvals for cancer treatments from two other Chinese pharmaceutical companies," adding, "Although these drugs were already approved for use in China, the FDA pointed out that their clinical data did not sufficiently represent non-Chinese patients."
SCMP commented on Loqtorzi's FDA approval, stating, "The U.S. has led the global pharmaceutical industry but has recently experienced drug shortages," and "In September, the White House announced that it was facing shortages of 15 types of cancer treatments due to manufacturing and supply chain issues."
It continued, "Many did not expect that as the U.S. struggles with domestic drug production, it would instead turn its attention to China," and evaluated that "Amid the U.S. drug crisis, China's innovative cancer drug has made a historic entry into the U.S. market."
In February last year, the U.S. placed Wuxi Biologics, China's largest biopharmaceutical contract manufacturing organization (CMO), on the export control 'unverified list.' This led to forecasts that U.S. export controls on China would expand to the pharmaceutical industry.
However, in October of the same year, Wuxi Biologics announced that after on-site inspections by U.S. Department of Commerce officials at its subsidiary in Jiangsu Province, it was removed from the 'unverified list.'
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