Hundreds of scientists, regulators, and investors from China and the US gathered in Gaithersburg, Maryland, on June 11, 2016 to attend the 21st Annual Conference of the Chinese Biopharmaceutical Association (known as CBA), a Maryland-based non-profit organization striving to serve as “the bridge of US-China biopharmaceuticals.”
From the advances in immune-oncology and precision medicine, to regulatory challenges in global drug development, the one-day conference covered a wide range of topics.
Here are a few highlights pertinent to drug development in China.
Policy changes from the CFDA
The Chinese Food and Drug Administration issued a number of new policies that have a huge impact on the Chinese as well as global drug developers, according to Yi Feng, a senior vice president for Regulatory and Medical Affairs at Fountain Medical Development who worked at the CFDA for 17 years before joining the industry.
Some of most significant changes include:
The definition of “New Drug.” According to Feng and other conference attendees, the CFDA has changed the definition from “not yet approved in China” to “not yet approved anywhere in the world.”
Classification of investigational products. Coming along with the new definition of “New Drug” is the change in classification of investigational products. Many products that would have been considered new drugs a few years ago are now deemed as generics.
According to Feng, these are just parts of many considered “a series of changes.” Many more policy changes are expected to come.
The new changes pose many challenges to biopharmaceutical companies that strive to achieve global approvals by conducting simultaneous clinical trials in multiple regions. On top of the new changes, currently available guidance on how to interpret CFDA’s new policies is limited. Early and effective communication with the agency is critical, says Feng and others who have experience in working the agency.
Trends of new drug development in China
The drug development model in China has gradually evolved from in-licensing mature technology and products to co-developing new therapeutic products between Chinese biopharmaceutical companies and global companies and universities, says Guozhong Rui, Director of China Pharmaceutical Technology Transfer Center and Executive Secretary-general of China Association for Pharmaceutical Enterprises Development.
In addition, providing innovative platforms and funding is becoming a new trend, observes Rui. Rui’s observation is echoed by others. In his Award acceptance speech, Li Ge, Chairman and CEO of WuXi AppTec says, “WuXi’s is building and strengthening an open-access capability and technology platform to enable anyone and any company to discover and develop pharmaceuticals and healthcare products to benefit patients.”
Collaboration opportunities
Chinese biopharmaceutical companies and high-tech parks have been actively recruiting talents from oversees for a long time. Big companies such as WuXi in recent years have increased their efforts in collaborating with global companies and universities.
Interestingly, small startup companies, many of which founded by overseas returnees, are actively seeking collaboration opportunities from global companies outside of China as well. These small companies often have unique technology or promising drug candidates but not the resources to bring the products all the way to the market. Some of these companies are interested in co-developing their products, and others are open to transfer their technology or even sell their companies.