In late May, ChinaBio® Group and EBD Group convened the ninth iteration of the ChinaBio® Partnering Forum. This year's event took place against a very positive industry backdrop of rapidly accelerating change -- 34 new funds focused on China life-science funds raised over $15 billion last year and $5.4 billion was invested, three times the previous year's $1.8 billion. In addition, China has taken numerous steps to bring its drug development regulations in line with global practices, a "sea change" that will speed up approvals of novel drugs. The ninth CBPF, which took place in Zhuhai, China, hosted 858 attendees representing 460 companies from 30 countries. It featured over 50 company presentations, and the attendees scheduled a record-breaking 1,682 meetings from over 6,800 requests.

“Innovation is coming from within China, and new CFDA rules have relieved the concerns of many Western companies and investors," said Greg B. Scott, Chairman of ChinaBio® Group. "The landscape has transformed significantly from just a few years ago resulting in an increase in cross-border in-licensing deals with Western companies.”

Matthieu Merlin, VP, Business Development, Sanofi Asia, speaking at one of the several Forum panel discussions, reinforced the positive outlook: "We are now seeing Chinese companies that are very good and are challenging the ways we proceed with innovation because they are faster, more focused and cheaper," he added.

In addition, Merlin believes China's regulatory changes will alter the way a multinational company such as Sanofi, operates in China. "From a partnering point of view, the MAH pilot program [the program allows a company to outsource manufacturing to a CMO] creates different ways of looking at partnering. Maybe we can get into real licensing models for example, maybe we can get into tech transfer and manufacturing partnerships a bit differently," he said.

For Zhengqing Li, PhD, VP and Head of China Development, Merck/MSD, the improvement in CFDA response times will be a major step forward for China, significantly shortening drug approval timelines. "Look at clinical trial approval," he said. "Two or three years ago, it could take two years, sometime eighteen months for approval to start a clinical trial. It changed from time to time and was hard to predict. But it will now be accelerated [tacit approval is granted if the CFDA does not issue a ruling in two months]."

Under the new regulations, a multinational can include China in a global clinical trial. Li said. Previously, a company would get approval ex-China and then apply in China. The upshot? It took an additional eight years or so for novel drugs to be reach China patients as the candidate made its way through a second set of regulatory hurdles.

For Roche, the importance of China may be its innovation in data management and AI, said Mark Noguchi, MBA, VP and Global Head, Alliance and Asset Management, Roche Partnering. Roche is dependent on data, he pointed out, as it moves deeper into personalized medicine. In fact, Roche considers one of its major competitors/collaborators in the future will be Google. "Google has $2.4 billion under management in young companies, both data management and bio," he said, "and Google has large amounts of data. Roche also invests in small AI/data companies, sometimes alongside Google Ventures."

Roche believes pharmas will become increasingly dependent on patient data. "China, with Alibaba, Baidu and Tencent as Google-like companies, is also developing a sophisticated data management capability that will become increasingly important to drug development and China pharma companies in the future," the company believes.

For Pfizer, it will continue to seek innovative molecules in China to in-license, just as it does in the US, Europe and Japan. "Three years ago, we launched a project called iChina," said Xianghong Shao, MD, Director, Business Development and Head, Alliance Management and GEP Business Planning, Pfizer China. "Our strategy is to work together with local partners to accelerate the Pfizer pipeline and launch at the same time in China as the rest of the world." 

Drug pricing, however, remains a problem, according to Shao. In China, Pfizer is working to extend its market its reach into lower tier hospitals and rural clinics, but given the provincial bidding system, profit margins are very slim. She believes that China needs to address drug reimbursement, that the reform in China R&D needs to be extended to the commercial side of the business. 

In addition to panels, over 50 companies, some China-based, others involved with China, presented their stories at the Ninth CBPF. Showing increasing sophistication, they can also claim growing external validation. For example, HitGen, a Chengdu mAb discovery company, has announced a steady stream of partnerships so far this year -- Merck (MSD), Pfizer, the Scripps Institution of La Jolla -- though the company revealed there's more: it has about 20 partnerships underway. With deals that include upfront payments now and milestones/royalties in the future, HitGen seems to have developed a solid financial basis for its own drug development efforts.

In sum, China continues to be the world’s fastest growing healthcare market. By 2020, it is expected to be the largest in the world. For the members of the CBPF Panel, the future is positive, the changes accelerating as China's life science sector comes of age. Sanofi's Merlin summed up by saying, "We now see really big changes in the next four years, whether how we do our business or changes in the regulatory environment, or in other dimensions of innovation like big data and high tech. I think the growth will put China at the center of our company's strategy."

Disclosure: none.