It has been over 50 years since China created a drug for the international global market when Tu Youyou discovered artemisinin, a vital component for curing malaria. This drug went on to save millions of lives and led to Tu being awarded the Nobel Prize. It has been a long time since a market changing drug innovation like artemisinin was created in China, but it looks like those times are about to change significantly.
For example, there are currently more than 140 companies in China developing immuno-therapy assets. There are an eye-popping 80 CAR-T drug candidates in the clinic, placing China at the number two position behind the US in this important cutting-edge therapeutic area. As China continues to invest heavily in developing its biotechnology industry, it is only a matter of time before China becomes a leading source of innovations for consumption by the global healthcare industry.
With ChinaBio® Partnering Forum, April 25–26 in Suzhou, China, many of the most exciting homegrown projects will be looking for partners. In preparation for the event, let’s review some of the most significant trends shaping the China market and the partnering landscape.
China venture capital activity explodes in 2017
The long-held belief was that investment dollars were typically siphoned to US cities such as Boston and the Silicon Valley region. However, the new sentiment that it is easier to get a new biotech company funded in China proved to be true based on 2017’s activity alone.
According to ChinaBio’s report, last year was an incredibly fruitful year in venture capital and private equity activity with USD 40 billion raised (doubled from 2016) and USD 12 billion were invested in life science. In addition, the government backed their thirst for innovation by providing more than USD 100 to state, provincial and local sectors.
China is loaded with vast pools of investment capital and 2018 already started another record year, with over USD 1.2 billion invested in just the first few weeks. Investors are eager to help Chinese companies access foreign markets, which will help facilitate the industry’s growth.
To learn more, join the panel, “China VC explodes in 2017: How to get your share” and see what the experts have forecasted for the future.
With all signs indicating only an upward trend from here, China drug developers continue to flex their muscles and will hopefully join the ranks of Tu Youyou in revolutionary pharma breakthroughs.
China now at a tipping point from generics to homegrown pharmaceuticals
According to Linda Pullan, President of Pullan Consulting, “The transition from generics to true innovation is exploding, because once the Chinese decide to do something, they do it fast."
China’s reputation as a generics market packed with non-patented copiers may be a thing of the past as it continues to invest in new ideas and implement tighter regulatory standards. The new ‘two invoices’ distribution model was imposed to stop corruption by cutting down the number of intermediaries and will now only allow two transactions between the producer and distributors, forcing many middle men to close shop. In return, it will improve the industry, increase competition and allows for high-quality drug developers to rise to the top of the market. As a result, smaller players with inferior products will fall by the wayside or become acquired by the top companies.
Modernization and standardization to global norms of regulation
With the Chinese government working on the regulatory access of clinical trials, they are also making giant strides in developing drug pricing guidelines that allow for the standardization in commercial approval of pharma drugs that will conform to global industry norms. According to L.E.K. Consulting in Shanghai, the China Food & Drug Administration is working to achieve global alignment through the following initiatives: international multi-center trial (IMCT) reform, increasing acceptance of global data, and the adoption of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human (ICH) guideline.
Helen Chen, Managing Director and Partner at L.E.K. Consulting, weighed in on the government encouraging innovation and creating a new consistent pathway.
“Their overall objective is to have the China approval to be as close to the international first approval as possible. In the short term, we will undoubtedly have some teething pains,” said Chen.
The CFDA is also quickly trying to improve efficiency through centralized CDE review, timely communications and clinical trial site expansion.
Stay tuned for the upcoming China Showcase at Biotech Showcase, January 6, 2019, in San Fransisco, CA. The program will feature keynotes, specialized sessions and networking opportunities. Tap into cross-border investment opportunities at China Showcase.