1:17 PM
Sep 07, 2018
 |  BioCentury  |  Strategy

Thinking beyond Bi

What’s next for regulatory, IP reform in China after Bi’s departure

Following the resignation of Jingquan Bi, early signs for continued biopharma regulatory reform in China remain positive. But the IP reforms spearheaded by Bi look to have fallen off the government’s priority list, and there is rising uncertainty about whether biotechnology will be dragged into the discord embroiling the U.S. and China.

China lost a champion of innovative biopharma products when the Politburo Standing Committee announced on Aug. 16 that Bi would resign as secretary at the State Administration of Market and Supervision amid a vaccines manufacturing scandal.

From 2015 until March this year, Bi had served as head of China’s State Drug Administration (SDA, now National Medical Products Administration (NMPA)), where he led the government’s march to bring innovative new drugs to China via a slew of regulatory reforms (see “Opening the Gates in China”).

The result has been an increase in new drug approvals, including six new HCV drugs and the first two checkpoint inhibitors -- Keytruda pembrolizumab from Merck & Co. Inc. and Opdivo nivolumab from Bristol-Myers Squibb Co. and Ono Pharmaceuticals Co. Ltd.

Bi also proposed a patent linkage system, akin to the Hatch-Waxman Act and other laws in the West, and the establishment of six years of data exclusivity for most innovative drugs, with innovative biologics and drugs for rare and pediatric diseases receiving 10 years of exclusivity.

In March, Bi took over the top job at the State Administration of Market and Supervision, where it was expected he would implement these IP reforms. The agency oversees NMPA, the State Intellectual Property Office and other pricing, quality and antitrust functions.

There is already evidence that Hong Jiao, who is now head of NMPA, will continue Bi’s regulatory mission. However, stakeholders in China who spoke with BioCentury anticipate the implementation of Bi’s initiatives will slow as regulators focus more on the quality control issues that led to the vaccines fallout in the first place.

“We must continue to deepen the reform of product review and approval.”

Hong Jiao, NMPA

It’s less clear what direction the new secretary at the State Administration of Market and Supervision will take, but a State Council memo published on Aug. 28 signals that patent reform will be on hold at least until the end of the year.

Following Bi

Bi’s successor at NMPA is picking up where he left off.

Jiao, who was named head of NMPA in late March, is a physician who was vice minister at China FDA where she presided over the medical devices division and implemented changes to smooth the path to approval for these products.

“She has very similar views as Bi,” said Haishan Xiong, head of BD for Chinese CRO Fountain Medical Development Ltd.

In her keynote address at the Drug Information Association (DIA) China meeting in July, Jiao committed to implementing the reforms started under Bi.

“We must continue to deepen the reform of product review and approval. We must conscientiously implement the requirements of the documents endorsed by the Central Party office and the State Council to ensure that all reform tasks can be implemented according to the time limit,” Jiao said.

She also suggested more reforms could be in the offing.

“Further optimizing and simplifying the relevant review and approval process will improve our review quality and efficiency. By...

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