Tokyo-based Takeda Pharmaceutical Co. Ltd. plans to release at least four cancer drugs in China in the next five years through an accelerated launch process, an executive told S&P Global Market Intelligence.
These oncology therapies will be among a bucket of at least 15 drugs that Takeda plans to roll out in China, Phil Rowlands, head of the company's oncology unit, said in an interview.
Rowlands said the four drugs will include blood cancer therapy Adcetris and lung cancer treatments Alunbrig and TAK-788. He did not name other drugs that may be included.
"We are definitely committed to seeking China registration for these three," Rowlands said, adding that Adcetris will likely be approved by Chinese regulators in the next few months.
He said the company is also in talks with the Chinese government to have Alunbrig approved using global trial data, without study on local patients. Chinese regulators in 2017 began accepting global study data for approval of certain drugs amid efforts to accelerate drug approvals in the country.
TAK-788, however, enrolled Chinese patients in its clinical study, Rowlands said. Chinese patients are one of the first groups outside of the U.S. that joined the study, he noted. Takeda aims to release the drug in China at almost the same time as in the U.S. and Europe.
In the future, Takeda will narrow the gap in drug development and launches among countries worldwide.
"We expect TAK-788 to be the first example in our pipeline for parallel development and hope to use that as a base case moving forward," he said.
Adcetris was first approved in Europe in October 2012, and Alunbrig received approval from the U.S. Food and Drug Administration in 2017. TAK-788 is under clinical study, and the company is aiming to have the drug approved in 2021.
Takeda is selling one cancer therapy in China: multiple myeloma drug Ninlaro, according to Rowlands. Myeloma is a cancer of the plasma cells that prevents the normal production of antibodies and weakens the immune system. Ninlaro was approved in China in April 2018, and Rowlands said 5,000 patients have been treated by the drug there so far.
Takeda is among many overseas drugmakers that aim to see more drugs approved in China at a faster pace.
AstraZeneca PLC plans to release 55 innovative drugs there in the next five years, the company's general manager of China, Mike Lai, told Market Intelligence in November.
Pfizer Inc. is also aiming to narrow the gap between releases in China and the U.S. and Europe, according to Chris Ariyan, emerging markets group lead for the oncology business at Pfizer Biopharmaceuticals Group. The company's five cancer drugs available in China were all launched after priority reviews.
Pfizer Biopharmaceuticals Group is Pfizer's innovative drug unit.