SUZHOU, China – Under the "Healthy China" campaign, China has introduced a three-year action plan for preventing and treating cancer. The plan vows to speed up the marketing of cancer drugs in the country, even aiming for simultaneous marketing with other countries.
The action plan lays out a few goals: a 3% increase in five-year survival rate for cancer patients over 2015; no fewer than 850 cancer types be recorded in the national oncology annual report by 2022; and access to early diagnosis for more than 55% of patients with major cancer types by 2022.
Part of that effort includes a commitment to making cancer drugs more accessible. "Speed up NDA reviews for domestic and foreign new cancer drugs, promote simultaneous marketing of foreign new drugs in China, open a temporary pathway for importing urgently needed cancer drugs, and replace cancer drugs that are urgently needed, necessary and expensive with generics," article 22 reads.
Most of those initiatives have already made their way into the drug administration law that was revised last month and will take effect on Dec. 1. This latest document is an action plan that is made specifically to address cancer.
To expedite new drug reviews, Chinese health care regulators had already put in place, in 2016, a priority review pathway for drugs that treat life-threatening and rare diseases. Overseas clinical data are also accepted.
"The package of reforms is designed to encourage manufacturers to bring their best products to the market in China before or simultaneously with their launch in other markets," Nick Beckett, co-head of the CMS Life Sciences & Healthcare Group, told BioWorld.
"For example, in order to benefit fully from the new data protection regime, an applicant must file an application for market registration and data protection within one year of the date the drug obtained overseas market approval, in the EU, the U.S. or Japan," he added.
It has yielded some success in recent years. As of 2018, 117 imported drugs received priority review status in China.
New drug approvals increased by 75% in 2018 from two years ago, said Pei Liu, director-general of department of policies and regulations of NMPA.
"We approved 48 innovative drugs last year, of which 38 were imported drugs; 18 cancer drugs were approved, up 157% from 2017," she said.
Eventually, China hopes to market the new drugs at the same time as other markets. The time gap is getting narrower.
Lynparza (olaparib, AstraZeneca plc.) is China's first approved drug to be used as a maintenance therapy for treating platinum-sensitive recurrent ovarian cancer. It took the drugmaker just nine months from marketing application to approval.
China approved the drug in August last year, three months after the EU, seven months after Japan, and a year behind the U.S.
Other foreign cancer drugs that received marketing clearance in China were PD-1 inhibitors Opdivo (nivolumab, Bristol-Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co.), as well as ALK inhibitor Alecensa (alectinib, Roche Holding AG).
Keytruda got its approval in five months. Alecensa also got its nod just eight and nine months after EMA and FDA approvals, respectively.
Early signs of progress
While China is yet to approve a cancer drug simultaneously with other markets, it was the first in the world to approve Fibrogen Inc.'s roxadustat, which was developed with Astrazeneca plc in the country, to treat anemia caused by chronic kidney disease in patients who are dialysis-dependent and use either hemodialysis or peritoneal dialysis.
Many see that as a milestone in China's drug approval history.
Beckett said in the short term, drugs for critical and rare diseases, pediatric medications and therapeutic areas for which the market currently lacks an effective treatment will be able to enter China faster.
A temporary pathway for importing urgently needed cancer drugs and replacing cancer drugs that could be heavy burden for patients with generics are already in the drug administration law.
Local authorities can approve a one-time importation of drugs not approved in China. Small amounts of those drugs are also allowed in for personal use.
The situation is beginning to show flexibility when the country is not fast enough to approve drugs that are needed by patients. It is also a direct response to the long-term plight faced by Chinese cancer patients who cannot afford medication.
Those patients had been bringing home generics from India that are much cheaper, to alleviate their financial burden, but Chinese officials cracked down on that practice, declaring those drugs as "fake medicine" since they were unapproved within the country.
Now, officials have decided to stop calling those drugs that are sold legally overseas "fake medicine" and are allowing them to be imported into China in small amounts. But it remains to be seen what regulators define as "small."
The India-based Council for Healthcare and Pharma, meanwhile, has welcomed that move. "We hope the initial reforms to open up the Chinese market by Dec. 1 for generics in small batches will be further deepened to allow for larger imports," president of the council, Gurpreet Sandhu, said.
Other measures to achieve the goals stipulated in the action plan include leveraging AI to enable telemedicine to reach more people, promoting data sharing to enhance cancer research, emphasizing basic research, as well as including qualified cancer drugs in the national drug reimbursement list.