In the last few years, China has seen a major boom in innovative drug development, and the pharmaceutical industry in China has been rapidly transitioning from a generic drug-focused industry to an innovative drug development industry. This is partly fueled by a wave of "returnees” – Chinese-born scientists who were trained in the West and then migrated back to China to help jump start the life science industry in China. It is also attributed to the fundamental cultural change at the China FDA (CFDA), which has implemented a series of policies to improve drug development data quality and drug quality and reward innovation. As a result, several China-based biotech companies have discovered a number of world-class innovative drug candidates that have been licensed by several global companies – one example is Nanjing Legand’s CAR-T therapy that was licensed by Johnson & Johnson for $350 million upfront.
The new policies of CFDA have also made the global pharmaceutical companies more welcome in China, both for market access and patient access. Now global companies can bring their ex-China trial data to regulatory filing with CFDA, saving years of time for marketing approval in China. The improving IP protection in China has also been an important factor in innovative drug development.
The above observations were made by Shichang Miao, President, Pharmaceutical & BioScience Society (PBSS), and also a panelist during a recent WuXi IND (WIND) workshop. The panel, moderated by Ed Amat, Vice President of International Sales and Marketing, Laboratory Testing Division at WuXi AppTec, also included Vincent Xiang, Partner of 6 Dimensions Capital; and David Lau, Senior Vice President of NCE Preclinical and Clinical Development, Foresee Pharmaceuticals. These thought leaders discussed current and future trends on bridging the Pacific gap to accelerate preclinical drug development.
In terms of the current state of the industry and its support of cross-border collaboration in innovative drug R&D, Miao noted that within the last 10 years, small biotechs have become the growth engine for the pharmaceutical industry, supplying the majority of the drug candidates to the big pharma companies.
“This trend will continue to accelerate,” he said. “This business model is very similar to what Hollywood has done for many decades: more nimble and creative smaller studios produce a large number of movies for the major studios, which have mostly become marketing and distribution partners. With a new wave of biotechs growing in China, these promising biotechs will contribute to the global pharmas' pipelines or bring their drugs to the world stage on their own.”
David Lau of Foresee Pharmaceuticals, noted that since most companies are thinking about global development, this trend will encourage China and other emerging markets to open up more. This growing focus on global drug development, he said, may shift companies’ IND filing strategies.
“The locations of filing the first-in-man studies are important, and that affects the strategy,” Lau said. “Also, the use of PK/PD and biomarkers in phase 1 studies are becoming more common, and in creating an IND package, one has to take that into consideration.”
As far as advice for start-ups, he said, “Do the planning as early as possible. Think globally. Also think about not just getting into humans as quickly as possible, but think about getting through a proof-of-concept study in humans as quickly as possible. Engage regulatory consultants as early as possible, and that helps in setting a strategy on how to interact with various regulatory agencies. Find a CRO that will fit your needs and will pay attention to your needs, and not necessarily the largest and the most well-known. For example, the WIND program is ideal for smaller biotechs who want a one-stop shop with an experienced CRO.”
In terms of filing, Miao said for First-in-Human (FIH) studies, there's not much benefit at this point for global companies to file in China, since IND filing and approval in the US is still a lot faster. However, after completion of Phase 1 in the US, he said global companies should proactively consider planning for their development pathway in China, so that they can get ready to include China as part of their global Phase 3 development program, in order to take advantage of the vast patient pool there for Phase 3 and get a head start for the regulatory approval process in China.
“A lot of the China-based biotech companies do have the incentive to file IND with both the CFDA and US FDA,” Miao said. “Getting the US IND status and conducting the FIH in the US will help them elevate the quality and valuation of their clinical asset when it comes to partnering discussions with global companies. Getting the IND approval in China will also boost their strength in China in terms of government support and VC investment valuation.”
On the investment side, the whole China industry is still learning to spot the mega trends in investing in therapeutic areas and medical devices as companies and investors alike strive to improve drug R&D efficiency and productivity while reducing redundancy, according to Vincent Xiang of 6 Dimensions Capital.
“Companies are striving for some differentiation in their platform for target disease areas and for a best-in-class exercises,” Xiang said. “Also, I think in terms of the post-deal alliance management, there is a lot to be improved, and I think the Chinese companies are getting there. It’s not just about sourcing, negotiating and closing a deal; there is a lot of communications and post deal follow-up needed to ensure the partnership is getting to the right track and for future success. As investors, we do as much as we can, not only negotiating, but also discussing with the licensees how to manage their relationships.”
While drug development innovation is increasing in China, Xiang still sees first-in-class and best-in-class innovation mainly coming from the US and Europe.
“In China, we see an abundance of local capital, but not a lot of high-quality assets. So, by default, a lot of strategic financial investors are looking at North America for most opportunities to get an innovative asset and then to improve the industrial pipeline quality,” he said.
Xiang did say, however, that “returnees” in China are upping the drug development innovation ante. “Those returnees are students of the western way of drug development. So, they are duplicating what they learned and practiced in China. They are implementing a more efficient way to cut the time and capital to develop drugs in China,” he said.
While the industry and regulatory agencies work to bridge the Pacific gap to accelerate preclinical drug development, some challenges are still ahead, Xiang said. For example, “Clinical trials will become more complex due regional differences, but CFDA is trying to make this process smoother, and more globalized and harmonized.”
Looking at a global perspective, Lau added, “In the clinical testing area, differences in standard of care treatment in other countries may open up opportunities for clinical trials that cannot be conducted in the US and the western world.”
Although some regional differences remain, cross-border collaboration for innovative drug R&D will continue to be at the center stage as the industry as a whole works toward better treatments for patients.
“Disease has no border, so I think that cross border collaboration is necessary to leverage each other’s unique resources and domain expertise,” Xiang said. “We will see more of this kind of collaboration surface. There are a lot of lessons to be learned, but I think it is necessary for all the stakeholders to keep doing it for the benefit of the patient, national health and wellness, and the for future of our society. It’s beneficial for all stakeholders if we can provide better care in general.”
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