Two major developments in China—the government’s shift to a U.S. FDA-style of drug approvals and its new membership in the global “harmonization” consortium ICH—have created a level of regulatory stability that promises to accelerate the already booming Chinese biotech industry.

For decades, the Chinese drug industry has been characterized by the production of raw ingredients and, occasionally, generic drugs. However, thanks to the Chinese government’s crackdown on corruption and sweeping changes to the research and approval system, newfound predictability of the regulatory process has led to an uptick of research and development at Chinese firms and research centers.

For the first time, Chinese companies are debuting new drugs candidates in the international arena, exemplified by Nanjing Legend Biotech’s headline-snatching data at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago last month. Although these new treatments are being developed in China, the companies behind them are still seeking the ultimate prize, U.S. FDA approval, and due to China’s updated regulatory process, it’s increasingly likely they’ll succeed. 

According to experts, China’s biotech boom will not be without growing pains. The country still lacks a sufficient number of highly skilled scientists, doctors and researchers to manage the growing biotech sector. Yet thanks to innovations in laboratory and manufacturing technology, Chinese firms are able to conduct clinical research inexpensively while still producing reliable data, said John Moller, chief executive officer of the CRO Novotech, based in Australia.

“In 2010, bioscience was listed as a strategic interest as part of the governing party’s five year plan, and from 2010 to 2014 there was 23% annualized revenue growth from the biopharma sector,” Moller said. In addition, Moller added, in its most recent strategic plan “the government wants to see the development of two to three newly marketed drugs by 2020 with U.S. FDA approval.”

Some government initiatives include expedited review for certain types of drugs, including brand new compounds, such as pediatric oncology and orphan drugs, as well as funding for certain innovative drugs and New Chemical Entities (NCEs) developed in China and included in the state development plan by the Chinese government, said Ping Xu, director regulatory affairs, China, ICON.

Among these government-led efforts to bolster biotech, perhaps the most significant was a recent proposal to fundamentally alter the way trial sites are approved. The proposed change, which outsources existing China Food and Drug Administration (CFDA) responsibilities to the Center for Drug Evaluation and Research (CDER), will “greatly improve delays in clinical trial approval,” said Moller.

Under the current system, companies must wait for CFDA approval before starting a clinical trial. However, under the new system, if companies do not hear back from the CDER within 60 days, it’s assumed the trial has been ‘cleared’ to move forward.

“The CDER can now approve the following on behalf of the CFDA—CTAs/IND approvals, supplementary applications for approved drugs and re-registration of imported drugs, said Xu, adding, “this has reduced the timeline for these approvals by approximately one month.”

In an effort to clear the backlog of submissions, the CDER hired 80 reviewers to bring the total number up to 200 in 2016, Moller said. By the end of 2017, CDER will likely have 600 reviewers.

Chinese authorities also implemented strict penalties for incomplete data packages, according to Moller. At present, applications with gaps can result in a banned company or CRO, he said. In, response to this new rule, Moller said that “80% of the companies withdrew their applications” in 2016.

“Finally,” added Xu, “changes to the clinical trial inspection system has meant that there is a lot more focus on the quality of how clinical trials are managed, which has led to sponsors upgrading their drug development methods.” 

The Chinese government has initiated a variety of programs and regulatory changes to bolster the globalization of biotech.

“Historically, only China-based drug manufacturers could apply for approval to market new drugs in China,” said Xu. But in 2015, the government launched a pilot program in 10 Chinese provinces which enabled research-based organizations and individuals to commercialize their new drugs while retaining the marketing rights to their products, Xu said. These research groups can outsource manufacturing to a CRO while retaining marketing authorization, Xu continued.

Chinese firms, in turn, “are looking for global approvals in terms of the ability of Western consumers to pay,” said Moller. The FDA has signaled its willingness to grant approvals based on data packages that contain entirely non-U.S. patient populations, particularly if the drug in question was a life-saving treatment, said Robert Califf, M.D., the Donald F. Fortin professor of cardiology, in the School of Medicine, Duke University and former FDA Commissioner.

Some Chinese companies are already enjoying international attention due to impressive data for novel oncology treatments. In 2015, Chipscreen landed China’s first “orphan drug” approval for the HDAC inhibitor Epidaza (Chidamide) for patients with peripheral T-cell lymphoma. In addition, Betta Pharmaceuticals won Chinese approval for Icotinib (Conmana), for patients with non small cell lung cancer in 2011, and U.S. FDA approval for further studies in 2014.

Chinese companies are trying to find innovative ways to bring drugs to the market in a way that will ensure they are still affordable in China, both by making use of the lower cost of development and manufacturing in China, as well as locally producing laboratory substrates and media that will substantially lower the cost of conducting clinical research, said Moller.
“The biggest challenges for Chinese biotech companies include the lack of global drug development experience and a lack of global commercial footprint,” said Mary Pan, vice president, Asia Pacific, ICON. “Bringing on board professionals with global experience is key to moving forward in this domain,” Pain said.

“I think there will inevitably be some growing pains, particularly around the skill base,” agreed Moller. In addition, “there have been issues around confidence in regard to China’s quality of data and IP protection, but I think those concerns are diminished quite rapidly.”

This article was reprinted from Volume 21, Issue 27, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »