A New Space Race: Reclaiming Efficiency In The mRNA Industry

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Over the past few weeks, I’ve written a handful of 2026 Outlook articles showcasing the “highs” of 2025 and what we have to look forward to and work on in 2026, thanks to the perspectives of several RNA C-Suite executives. (You can check this series out here: Part 1; Part 2; and Part 3).

I also waxed poetic on the handful of reasons why, despite its low-lows, I thought 2025 was a notable year for mRNA & oligos.

But when it comes to the mRNA side of the industry, there is no mincing words; 2025 was a disheartening year, with the U.S. political landscape upending the FDA and inspiring regulatory uncertainty. These upheavals went on to augment what is already a stressful development environment with many mRNA companies at an early stage of development attempting to enter the clinic while facing funding challenges.

These realities were a central focus of my conversation with Allan Shaw, CFO, CREATE Medicines (formerly Myeloid Therapeutics). It goes without saying that efficiency in drug development is tantamount — especially when it comes to getting much-needed clinical data. So, when I asked Shaw about the ongoing trends he anticipates seeing more of in 2026, he immediately pointed to the increasing prominence of overseas development, particularly in nations like Australia and China.

Of course, offshoring development is hardly novel; as Shaw clarified, 60 percent of first-in-human studies are offshore. CREATE itself has been working in Australia, where the company has been able to tackle preclinical development and enter the clinic in less than a year. To Shaw, offshoring is an important means of answering key development questions: “How do we do more with less?” and “How do we compress timelines?” But he also pointed to another benefit of getting into the clinic sooner, rather than later: If a product is going to fail, we need it to fail fast.

“The goal isn’t always keeping a product alive; sometimes you have to kill a development program quickly, too,” he clarified. “I’ve said it before and I’ll say it again: In God we trust, in data we believe. So, if you really want to de-risk your programs, it’s almost essential to develop an offshore strategy today — especially given the ongoing regulatory uncertainty in the U.S.”

Naturally, this brought us to the topic of China. Over the past few years, we’ve been increasingly noticing the growth of China’s prowess in the biotech field. Not only does IP play a less prominent (or nonexistent) role in the nation, but the nation’s regulatory infrastructure promotes much quicker access to the clinic and, in turn, a less resource-intensive means of pressure testing drug candidates. These two factors alone increase the nation’s intimidation factor.

But beyond these efficiencies, the high percentage of licensing deals being struck indicates the credibility of the nation’s science, as well. Look no farther than this article outlining the jump in licensing and acquisition agreements with Chinese biotechs. In 2025, the aggregate value of deals hit $92.2 billion by the end of November — a massive jump from the $51.9 billion amassed in 2024.  

“To me, the high percentage of in-licensed products [across all modalities] originating from Chinese entities speaks to the fact that the value is not the asset; the value is in the clinical data and how you develop it,” Shaw added.

There have been many articles and opinion pieces written on how the U.S. should be considering/approaching the swift growth of China’s biotech industry — especially during this day and age when the U.S.’s own relationship with science has become unnecessarily fraught. Though we didn’t editorialize on this topic, I appreciated Shaw’s callback to the space race in the 60s as an example of what we as a nation should be doing today as the Chinese biopharma sector becomes increasingly prominent.

“If you go back to the 60s when the Soviet Union had rockets in space, JFK saw this as a threat,” he shared. “He stood up in front of the world and rallied the Western world to embark on the Great Space Race. It was an incredible industrial effort. Today, the Chinese are throwing similar shots across our bow. Our response should not be to dismantle the FDA.”

If you’re reading this publication, there’s a high probability you agree with Shaw’s take — and not just because of the innovations we stand to miss out on should the credibility of our/the U.S.  regulatory system be called into question. Such dismantling also stands in the way of bringing safe and effective drugs — especially mRNA vaccines and therapeutics — to the market as quickly as possible. And as Shaw nicely concluded:

“To me, the biggest issues the mRNA industry is facing are evergreen — the issues of time and money. We need to be running like our hair is on fire.”