Home to a booming clinical trials market, China presents a huge opportunity for clinical innovation. Since 2015, the country has undergone a significant shift in clinical research regulatory frameworks and processes, and this radical reform is opening the door to Western biotechnology companies to operate clinical development in China.
For overseas companies, the advantages of China’s new framework include faster review timelines, easier market access and powerful government backing. Biotechs that are flexible enough to take advantage of alternative approaches in this highly promising market will be able to navigate challenges and make the most of the region’s opportunities.
1. Leverage overseas data
Regulatory reform has massively cut down review timelines by creating a more systematic and efficient review process, with the IND/CTA review timeline now set at 60 days.
As well as this, Western biotechs have the opportunity leverage data from other countries which have a fast and simple approval process, like the US and Australia, for drug development in China. Products approved in other markets can directly file an NDA in China, and overseas Phase 3 data is also accepted.1,2,3
Western biotechs can therefore take advantage of the quickest timeframes to reduce the overall clinical development timeline by conducting early-phase trials overseas and leveraging this clinical data for late-stage trials and CTA and NDA approval in China.
Swiss pharmaceutical company Roche recently implemented this strategy, using results from a global Phase 3 HELP trial4 to gain NMPA approval for Takhzyro in December 2020.
2. Conduct trials in parallel with Western geographies
Another key strategy is to include China as part of a multi-regional clinical trial for first-in-human drugs,1,2,5,6 operating clinical trials in China alongside other countries. The big plus of this approach is that it unlocks a large patient pool for the trial phase, which speeds up trial progress and means there is a large market available when the drug is commercialised.
For example, in 2017, a global Phase 1 study of retifanlimab for advanced tumours was initiated in multiple locations, including China. Since then, biotechs Incyte and Sai Lab have announced a licence agreement for the drug’s commercialisation in Greater China.7
3. Recognise the power of partnership
Western biotechs operating in China might come up against linguistic or cultural barriers. Communication and documentation is often required to be in the local language, and operators may have to adapt to differences in project management and businesses methods.
Partnering with a local CRO can help overcome this. Partial or full outsourcing of clinical trial management to the CRO through co-development, co-marketing rights or out-licensing is a powerful strategy to simplify the development process and ease execution. The partner organisation can help conduct clinical development and navigate the regulatory process.
The challenge is to identify the correct partner: one with a strong local presence and an international mindset,8,9 as well as a good track record and global experience.
For example, in September 2020, AbbVie collaborated with China’s I-Mab to develop lemzoparlimab to treat multiple types of cancers. The drug is now in early-stage studies by the Chinese biotech.10
4. Make the most of fast-track opportunities
Following its recent regulatory reform, China offers accelerated approval channels that biotechs can leverage.
Accelerated approval is available through four pathways: breakthrough therapy designation, conditional approval, priority review and special approval.1,3,6,11,12
In April 2019, NMPA included Dupixent for adults with moderate-to-severe atopic dermatitis in the “urgently needed overseas drugs” list, leading to expedited review and approval. It was approved for use in June 2020.13
One therapeutic area that should be of particular focus in China is cancer. According to GlobalData, China saw 4.5m new cases in 2020, the highest incidence in the world, making cancer a major health concern in the country, representing a high unmet treatment need. Western biotechs have an opportunity to play a significant role in these developments.
Challenge to opportunity
Whilst China is certainly a highly attractive market, Western biotechs should remain conscious of the remaining challenges.
For example, investigator-initiated trials remain complex and cannot be used for NDA filing. They are regulated by the National Health and Family Planning Commission, which has different regulatory requirements and can lead to delays. This means that China is best suited to trials initiated through pharmaceutical companies and CROs.
Challenges also remain around IP protection and resourcing for regulatory review. Biotechs importing overseas drugs should be conscious of stringent regulatory requirements imposed by the Chinese regulator, such as requiring approval from the Human Genetic Resource Administration, and the additional time required to obtain an import licence.
By understanding the challenges that come with operating clinical trials in China, biotechs can develop effective strategies to address them. For those that do, China represents an outstanding opportunity to drive clinical innovation forward.
1. ClinRegs – Aggregating clinical research regulations from around the globe – China
2. Covington – China Promulgates Revised Drug Registration Regulation
3. Lexology – China Accepts Overseas Clinical Trial Data to Expedite Drugs Registration in China
4. Takeda Announces Approval of TAKHZYRO® (lanadelumab) subcutaneous injection in China for the Treatment of Hereditary Angioedema
5. Applied Clinical Trials – The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in China
6. Medical Trend – Nature: China has approved 52 new anti-tumor drugs in 2016-2020
7. Zai Lab Announces First Patient Dosed in China in a Potentially Registrational Study of Retifanlimab in Patients with Endometrial Cancer
8. BioMed Central, Yun-Zhen Shi et al, 2014, Contract Research Organizations (CROs) in China: integrating Chinese research and development capabilities for global drug innovation
9. Clinical CRO Tigermed: The ‘Small and Beautiful’ – Equal Ocean
10. AbbVie and I-Mab Enter Into Global Strategic Partnership for Differentiated Immuno-oncology Therapy
11. Austrade – Insight – Fast-track approvals in China’s drugs market to unlock pharma prospects
12. China’s National Reimbursement Drug List (NRDL) 2020: What Reward for Innovation?
13. Dupixent® (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitis