虎嗅

mRNA is evolving from a technology to a fundamental platform that will reshape the pharmaceutical industry.

原文:mRNA正在从一种技术,变成重塑制药工业的底层平台

From Manufacturing Parts to Writing Code: How mRNA Is Reengineering the Fundamental Logic of the Pharmaceutical Industry

Hello everyone, I'm your financial journalist and economist. The in-depth article we're discussing today might be a bit technical, but I'll try my best to explain the complex biological terms in plain language, so you can understand the quiet yet profound revolution that's taking place in the pharmaceutical industry in 2026.

In simple terms, the main idea of this article is that mRNA (messenger ribonucleic acid) is no longer just a technology used for making vaccines; it's becoming a universal “biological operating system.” In the past, pharmaceuticals focused on “manufacturing functional entities” (such as antibodies to fight viruses), but now they're about “delivering information instructions” to cells. This shift is reshaping the speed, cost, form of drugs, and the competitive landscape of the industry.

Below, I'll break down the article into five key aspects to provide you with a detailed interpretation of this transformation.

---

1. The Reengineering of Speed: From Stockpiling to Building Factories

Core Logic: In the past, we would prepare specific drugs in advance for patients. Now, we build fast production lines that can produce new drugs whenever needed.

The pharmaceutical industry used to rely on stockpiling products. For example, with flu vaccines, manufacturers had to predict which strain would be prevalent each year and spend months cultivating the virus in chicken embryos before producing the vaccine. If they guessed wrong or the virus mutated, the entire production process had to start over, which was very passive.

mRNA changes this logic. Its key advantage lies in its modularity:

  • Traditional Model: Changing to treat a different disease meant starting from scratch with a completely new production line (e.g., switching from producing antibodies to enzymes).
  • mRNA Model: The underlying “factories” (in vitro transcription and lipid packaging equipment) remain the same. If the pathogen changes, we only need to modify the RNA sequence, and the rest of the production steps remain largely unchanged.

Evidence from the News:

  • National Strategic Shifts: After the pandemic, governments continued to invest in mRNA, viewing it as a strategic asset. For instance, Europe's HERA agency invested in German company Ethris, not just for treating respiratory diseases but also to build the capacity for rapid response to new pandemics.
  • GSK's Asset Replacement: In September 2026, while advancing mRNA flu vaccine trials, GSK announced the closure of its traditional chicken embryo vaccine factory in Germany. This signals that multinational pharmaceutical companies are actively phasing out old, slow, and inflexible production methods in favor of faster, lighter, and more flexible mRNA platforms.

Popular Metaphor: Traditional pharmaceuticals were like “custom-made suits” that required time and effort for each patient or disease. mRNA is more like “3D printing,” where the “printer” (the platform) is versatile, and by changing the digital model (the sequence), different “parts” (drugs) can be produced quickly. In the face of emergencies, we no longer need to stockpile specific “suits” but ensure that the “3D printing factory” is always ready.

---

2. The Economic Essence: From Scale Economies to Scope Economies

Core Logic: In the past, we saved money by producing large quantities. Now, we save money by being flexible and able to switch between different products easily.

In economics, there are two concepts:

  • Economies of Scale: The more of a product you produce, the lower the unit cost (e.g., insulin and antibodies).
  • Economies of Scope: Using the same infrastructure to produce different products at low marginal costs (e.g., mRNA).

Why This Matters: Developing new protein drugs (such as recombinant proteins and antibodies) often involves solving various engineering problems, such as selecting cell lines, culturing conditions, and purification processes. Each new drug requires a significant investment.

mRNA, however, is different. Whether it's encoding a flu antigen, a new tumor antigen, or a metabolic enzyme, the core of the drug is always an RNA sequence. The production line can be used for various products with little modification:

  • Factory Unchanged: It can produce flu vaccines today, cancer therapies tomorrow, and rare disease drugs later without major changes.
  • Cost Reduction: The real savings come from the lower cost of switching to the next product.

Two Key Technologies Supporting This:

1. In-Process Quality Control (PAT/RTRT): Instead of sending drugs to laboratories for slow offline testing, automated and real-time testing have reduced the approval cycle to within a week, making small-batch, multi-product production possible.

2. Regulatory Knowledge Reuse: The FDA and EMA are allowing the reuse of data from existing mRNA platforms. This means that if a platform is proven safe, the safety of a new drug doesn't need to be re-verified; only the effectiveness of the new sequence needs to be proven.

Popular Metaphor: Traditional pharmaceuticals are like opening new restaurants, which is costly and time-consuming. mRNA manufacturing is like a “chain restaurant central kitchen” where the central kitchen (the platform) is standardized. You can quickly produce different products by changing the recipe (the sequence), making it commercially viable to develop drugs for rare diseases, which were previously unattainable due to low production volumes.

---

3. The Evolution of Drug Form: From Delivering Proteins to Executing Programs

Core Logic: In the past, we gave patients pre-made “parts.” Now, we give them “instructions” that the cells can use to assemble the drug themselves.

Traditional protein drugs have a challenge: it's difficult for them to accurately enter cells or target specific cell membranes. For example, CAR-T cell therapies require CAR proteins to be on the T cell membrane, and gene editing requires Cas9 proteins to enter the nucleus. If the protein is made in a factory, how do you ensure it reaches the right location?

mRNA solves this by delivering the manufacturing instructions, allowing the target cells to translate, fold, and position the protein themselves. The article highlights three ways this can be done:

1. In-Situ Persistent Expression (for cystic fibrosis): Inhaling mRNA allows lung cells to produce the missing CFTR protein.

2. Temporary Expression for Permanent Editing (for genetic diseases): mRNA carries the “gene scissors” (Cas9) into liver cells, and after editing the DNA, the mRNA degrades and disappears. This “temporariness” is actually an advantage, as it prevents long-term damage.

3. In-Situ Temporary Reprogramming (for autoimmune diseases): CAR instructions are delivered directly to T cells, turning them into “killer T cells” temporarily, which then revert back to normal after the task is completed. This avoids the need to retrieve and modify cells.

Key Insight: The temporary nature of mRNA can be a natural mechanism for controlling the duration of its effects. For diseases that require long-term function, this can be a challenge; for tasks that need precise timing, it ensures safety.

Popular Metaphor: Traditional protein drugs are like “takeout” where the ingredients (proteins) are delivered, but it's hard to ensure they reach the right place. mRNA is like a “recipe” that you provide to the cells, allowing you to control the amount, duration, and timing of the protein production. Moreover, since the cells produce the protein themselves, it can be precisely targeted.

---

4. The Industrialization of Personalized Medicine: From One-Drug Per Patient to Batch Production on a Platform

Core Logic: In the past, personalized medicine was expensive and unattainable. Now, mRNA platforms make it possible to produce drugs in large quantities.

A major challenge in cancer treatment is that each patient's tumor mutations are unique. Traditional methods were costly and time-consuming for developing personalized drugs.

Moderna's V940 therapy (intismeran autogene) achieved Phase III success in August 2026, marking the entry of “individualized new antigen therapies” into the mainstream. The process involves sequencing the patient, identifying unique tumor mutations, designing an mRNA to encode the corresponding protein, producing the drug, and administering it. This isn't about being more advanced because of individual differences but about using the same platform for different products.

Industrial Value: This makes personalized treatments for rare diseases more feasible, as the platform handles the manufacturing and quality control, significantly reducing the cost of developing small-batch drugs. The FDA has also issued new guidelines that allow the approval of drugs for very small patient groups (e.g., N=1) based on mechanism evidence and non-clinical data, eliminating the need for large-scale randomized trials.

Popular Metaphor: Personalized medicine used to be like “handcrafted jewelry,” expensive and time-consuming. mRNA platforms are like automated assembly lines for “high-end custom clothing.” Although each drug has a unique sequence, the processes (cutting, sewing, and quality control) are standardized, making personalized treatments more accessible.

---

5. The Reshaping of the Competitive Landscape: From Drug-to-Drug Competition to Platform-to-Platform Competition

Core Logic: The future winners won't be companies with a single excellent drug but those with the strongest “data ecosystems” and delivery technologies.

The biggest bottleneck with mRNA isn't sequence design but delivery—the process of getting the code to the right cells. LNP (lipid nanoparticles) are best for gene editing and protein replacement, while inhalable mRNA is being used for respiratory diseases, and targeted LNP approaches are entering the T cell space.

The “delivery map” corresponds to the range of diseases that can be treated. Each new delivery technology opens up new therapeutic possibilities.

AI and Data Circuits: mRNA is digital, making it ideal for AI. The value of AI lies in data iteration:

  • Sequence Design → Human Expression → Pharmacological Results → Feedback Optimization: AI helps optimize the sequence based on real-world data.
  • Barriers: Companies like Moderna and BioNTech have extensive real-world data, which tells them which lipids work best for which tissues and which UTR sequences are most effective. This knowledge is invaluable and cannot be replicated from public databases.

Changing Competitors: In the past, competition focused on the efficacy of drugs. In the future, it will be about the strength of the platforms:

  • Who can switch payloads faster?
  • Who can deliver the code to more cell types safely?
  • Who remains effective after multiple doses?
  • Who has the most real-world data?

Popular Metaphor: Pharmaceutical competition used to be like car races, about who has the fastest and most fuel-efficient cars. In the future, it will be like operating system competitions (e.g., iOS vs Android). The platform determines how well the “drugs” (applications) work and how stable and updatable they are. Companies with the most user data (clinical data) will have a significant advantage.

---

Conclusion

This article reveals a profound industry trend: the pharmaceutical industry is transitioning from an era of chemical synthesis to one of biological programming.

  • Speed: From stockpiling specific products to having platforms that can respond quickly.
  • Cost: From scale economies to scope economies, making personalized and small-batch production feasible.
  • Form: From delivering static proteins to delivering dynamic instructions, turning cells into drug factories.
  • Personalization: From being unindustrializable to producing personalized drugs in large quantities.
  • Competition: From competing on individual drugs to competing on platforms and their data ecosystems.

For consumers, this means more precise treatments for rare diseases, cancer, and autoimmune diseases at potentially lower costs. For investors and industry observers, the focus should shift from individual mRNA vaccines or therapies to companies with strong delivery technologies, automated manufacturing capabilities, and extensive clinical data.

This is not just a technological advancement but a fundamental reengineering of the pharmaceutical industry's logic.