Chinese health authority erects new gold standard in oncology R&D, spooking investors in booming field
The US has long been the leader in research and development in oncology, but homegrown Chinese drugmakers have jumped one hurdle after another in making a name for themselves. Now, the Chinese government is erecting new hurdles for its native industry to leap, and — at least for now — it’s putting a slight chill on the field.
The Chinese health authority NMPA’s Center for Drug Evaluation released new guidance on oncology R&D late last week, offering a new gold standard for how homegrown drugmakers should determine clinical efficacy amid a booming field for drug innovation, according to draft documents.
The guidance broadly calls on Chinese drugmakers to focus on a patient-centric R&D approach, folding changing standards of care into clinical trials and sharpening research around areas of unmet need. The newest roadmap comes amid a wave of Chinese investment in drug development, particularly oncology, which has scored some massive valuations on the Hong Kong Exchange and earned big-name partners in some of the largest multinational pharmas.
As biotech investor Brad Loncar noted in a tweet, the draft documents are most notable for their insistence on using best standard of care as control in late-stage clinical trials, raising the bar higher for oncology drugs to show clinical benefit.
China today put out cancer drug development guidance essentially saying if you run a phase 3 trial, it needs to be against best standard of care. That’s good for patients, overall quality of medicines, and leading companies…and not so great for also rans.
— Brad Loncar (@bradloncar) July 6, 2021
“When planning to choose a placebo or BSC as the control drug, you should ensure that there is no standard treatment for this indication in clinical practice; when BSC is available, BSC should be preferred [as] a control, not a placebo,” according to a translation of the documents.
As Loncar notes, the guidance could go a long way toward raising the quality of Chinese oncology R&D but could also have a stifling effect on smaller players looking for a market to approval for their own drugs. In the meanwhile, Chinese investors appear to have taken the guidance as a general negative on the field as a whole.
On Monday, major oncology players such as BeiGene (-1.93%), Hutchmed (-5.21%), Zai Lab (-3.49%) and Junshi Biosciences (-4.79%) were all down, potentially underscoring some concern over how the new guidance could make late-stage development more difficult.
Where that effect could be most apparent is in the PD-1 class, an area where China has shown a deep pipeline as late-stage entrants into the global and US markets. All four drugmakers listed above have at least one PD-1 candidate in the pipeline, with BeiGene — which has headquarters in both Beijing and Cambridge, MA — partnering with pharma giant Novartis on a global licensing deal.
Chinese players have not only looked to get the eighth PD-1 across the finish line in the US but are also looking to take an inside track on the Chinese market as well. Junshi, which is partnered globally with Coherus on PD-1 toripalimab, recently released winning Phase III data for its drug in nasopharyngeal cancer, a condition that affects Southeast Asian patients at a disproportionate rate. Data from that pivotal study could undergird an approval in the US, which would be a first for the FDA and a sign of the growing influence of Chinese R&D on the global drug market.