With
money pouring into biopharma in China, and regulatory reforms favoring market
growth and R&D speed, western firms should watch their backs, warns Viren
Mehta, founding partner of Mehta Partners LLC.
The dollars and renminbi are adding up, as are structural and regulatory changes in China. With the modified IPO listing rules in Hong Kong, China’s momentum as a biopharma leader is accelerating. Even the Trump trade tirade seems to bypass many bold biopharma initiatives in China that have brought this nation into a leadership position in two short decades. (Also see “Can Pharmas Come Out Unscathed As China-US Trade War Escalates?” – Scrip, 11 Apr, 2018.)
Money
talks. And China knows that it has more than most other countries. Biopharma
being one of the top 10 focus areas for more sustainable growth, China has
turned open the spigot. Let us consider the numbers.
Chinese
venture capital investments in Chinese biopharma were in the millions until
2016, but 2017 was a turning point when $4bn of the total $10bn VC investments
came from Chinese investors. 2018 is only half over, and China has already
exceeded $5bn, according to Pitchbook. ChinaBio notes that Chinese VC firms
raised $40bn in 2017, but invested only $12bn. The reserve of dry power
continues to be fortified by both existing and newly emerging Chinese VC
groups. Valuation of Chinese biopharma companies is rocketing up.
It
is hardly surprising that lofty Chinese biotech valuations are driving Chinese
investors to greener pastures. Having invested tiny sums in western biopharma
until 2013, and less than $2bn a year in 2014 and 2015, Chinese VCs pumped in
$5.3bn into western biotechs in 2016, and doubled down again in 2017 with
$11.7bn.
This
rapid growth in biopharma investing by China calls for a robust IPO listing
platform. The Hong Kong Stock Exchange has obliged, creating a special category
for money-losing, non-revenue-generating biotech companies, requiring the
underwriting bankers to take responsibility for the quality of disclosures and
scientific analysis. The resulting talent gap has caused a feeding frenzy among
the major banks keen to capitalize on this new biopharma financial frontier.
Hong Kong may be the most attractive base today for biopharma investment
analysts, as biotechs from mainland China choose Hong Kong over other bourses
for its proximity to home, comparatively less strict reporting rules, and the
linkage between HKEX and domestic Shanghai stock market. (Also see “Hong
Kong Ushers in ‘New Era’ For Bioventures As Listing Rules Eased” –
Scrip, 1 May, 2018.)
Talent Flowing Back To China
A
parallel talent flow into Chinese biopharma companies is reinforcing this
eastward march. A growing number of Chinese expats are returning home, leaving
safe, secure and often lucrative positions with western pharma majors.
Wuxi,
BeiGene, Zai Labs, to name just three, are among several dozen Chinese
companies thriving at various biotech parks across China, enticing western
talent to look east. These companies are not only flush with VC cash, but also
supported by generous local and central government incentives – from
multi-year, fully equipped, highly subsidized laboratories at these biotech
parks, to an increasingly robust ecosystem that can meet most infrastructure
and process needs, not to mention a wide range of cross-fertilization
opportunities. (Also see “BeiGene Bags $750m, Sees China Reforms
Creating New Opportunities” – Scrip, 24 Jan, 2018.)
A
core catalyst behind this explosive progress is the regulatory change to
harmonize preclinical and clinical development requirements with those in the
west. Chinese FDA is nearly ready with these harmonized regulatory frameworks,
and is rapidly recruiting staff to implement the regulations. (Also see “Bigger,
Bolder, SMAR: Decoding China’s All-In-One Regulatory Agency” –
Pink Sheet, 12 Apr, 2018.)
R&D Freedom
In
parallel, basic research and human studies of new technologies are much less
regulated, and are often left to the researchers, ostensibly to unshackle the
industry of the barriers that have thwarted such R&D with the new tools,
especially those that can fundamentally change gene function. That many new
cancer drugs are not yet approved in China, or are highly priced and thus
inaccessible to many, only makes it easier for Ethics Review Boards to be much
less strict about the potential life-saving pathways. Yes, transitional hiccups
are inevitable, but the power of centralized government is such that the
lessons of any hiccups can be implemented with a swift decree – something that
most western nations can only watch with envy – a striking case study of
populism aimed at a specific industry.
This
centralized authority enables courageous actions that are fraught with
catastrophic risk if the experiments were to go terribly wrong. Some may argue
that such cutting edge research could harm many, but China is focusing on the
glass half-full benefits of such experiments succeeding.
Dr.
Wu Shixiu is an oncologist who heads Hangzhou Cancer Hospital in China. He has
been using CRISPR-Cas9 to treat cancer patients by deleting a gene that may
inhibit the immune system’s ability to fight the disease since at least March
of 2016.
Wu
did not need approval from national regulators for the trial, and his hospital
review board reportedly took one afternoon to okay the trial. “China
shouldn’t have been the first one to do it,” Wu told The Wall Street
Journal. “But there are fewer restrictions.” CRISPR makes
irreversible changes in the human genome, leading many researchers in the west
to focus on ethical considerations when it comes to such fundamental gene
editing. Wu selects and treats cancer patients facing terminal diseases with
the belief that “If we don’t try, we will never know,” while
acknowledging the risks of the technology.
While
most US researchers and institutional review boards do not advocate relaxing
the US regulatory requirements, they are searching for an international
consensus on ethical issues triggered by such emerging technologies, especially
those that change human DNA, at least while researchers grasp the potential
unintended consequences.
The
challenge is to find this international consensus so that “everyone is under
the same tent,” as Dr. Jeffrey Kahn, director of the Berman Institute of
Bioethics at Johns Hopkins University, put it.
Such
an international dialog seems to be receding while regulators await direction
from a rapidly polarizing global political landscape. In the meantime, a team
of researchers from University of Pennsylvania have waited for well over two
years for regulatory approvals to start the first CRISPR trial to treat US
cancer patients, even as China expands its application of such cutting-edge
biopharma tools. As of early 2018, the US National Library of Medicine database
listed nine human CRISPR studies ongoing in China. Just as China has become a
leader in solar and wind energy, IT and AI, and many other frontiers, biopharma
leadership does not seem to be far behind.
The
Chinese marketplace also leaves the global biopharma industry on an unequal
footing. A range of barriers, from the requirement of a Chinese partner for
many foreign companies to enter China, to unpredictable pricing and regulatory
changes, often leave non-Chinese companies on the sidelines, while the
centralized, populist actions widen the gap.
If
biopharma is to remain among the top 10 critical industries for the US, Europe,
Japan and most of the world, just as it is for China, all the pharma-political
stakeholders need to recalibrate their priorities to be prepared for the
rapidly emerging populist pharma power – China.
This column originally appeared on Scrip Biopharma
Intelligence, July 20th, 2018