(Yicai Global) Dec. 18 -- China's first home-grown chimeric antigen receptor T-cell immunotherapy may get the go-ahead from national regulators in three years, and the price of CAR-T products will drop, perhaps below CNY100,000 (USD15,130), a market insider told Yicai Global.
"Many Chinese companies have obtained CAR-T treatment data on more than 100 patients," said Qian Qijun, head of the Shanghai Engineering Cell Therapy Research Center.
"As the government relaxed relevant policies, at least 20 Chinese enterprises and organizations have applied for cellular immunotherapy clinical experiments, and a growing amount of capital has been, or is being, invested in cellular immunotherapy projects," Qian said. "Chinese therapies can be as effective as their American counterparts, and we're on track to overtake the US [as the global leader in this field]."
Cellular immunotherapy, represented by CAR-T, forms one of the frontiers of medical science and is widely noted for its enormous commercial potential. It is ushering in a new era in medicine following the invention of chemical drugs and biopharmaceuticals, and will help us find a solution to cancer, Qian said.
"CAR-T therapy will grow into a USD1 trillion market by 2030," he said. The Shanghai Engineering Cell Therapy Research Center specializes in cellular immunotherapy, and has carried out clinical experiments on 117 patients as of October, with a disease control rate of 71.2 percent.
Fosun Pharma Kite Biotechnology Co., a joint venture Kite Pharma Inc. and Shanghai Fosun Pharmaceutical Group Co. [SHA:600196] established, opened a cellular immunotherapy laboratory in Zhangjiang, Shanghai on Dec. 5. The lab is capable of producing cells for the clinical treatment of five million cancer patients.
Fosun Pharma Kite Biotechnology is working on technology conversion, preparation and certification for KTE-C19 (with the product name 'Yescarta'), Kite Pharma's first product that has been approved by the US Food and Drug Administration, meaning that the firm may get the first cellular immunotherapy product license in China.
"We hope that the CFDA [China Food and Drug Administration] will draw up legislation on cellular immunotherapy assessment and approval, and that the CFDA, the Ministry of Human Resources and Social Security and the National Development and Reform Commission can issue medical insurance and pricing policies for cellular immunotherapy products to facilitate commercial release, so that quality CAR-T drugs will be accessible to patients soon," Fosun Kite Assistant President Sun Minmin said.
The release of CAR-T products will accelerate in China, Qian opined. Safe and effective cellular immunotherapy ones producing standardized operating procedures will stand out in market competition, he said.
"CAR-T is one of the few medical research areas in which Chinese companies are running toe-to-toe with their Western counterparts, and we are ahead of them in some cases," Qian said. "Chinese manufacturers can get pricing power only if they can acquire strong research and development capabilities, otherwise they won't be able to challenge foreign competitors' oligopoly."
About one third of the world's cellular immunotherapy have taken place in China, and the country has become the second largest clinical research market after the US, undertaking more than 130 CAR-T exploratory clinical studies.
Chinese biotechnology companies are still behind American firms in initial innovation capability, but they have outpaced the latter in terms of driving technology integration, innovation and development, said Qian.
"Through capital investment, our products may become more effective than their US counterparts," he said. "The user-friendliness of home-grown technologies coupled with the massive amounts of patient data available in China will enable Chinese companies to come to the forefront of cellular immunotherapy research once the government abolishes restrictive policies."