Despite strong efficacy data, the drug DV-Toripalimab scored lower than a competitor (2.5 vs 3.0). Experts attribute this confidence gap to its Phase 3 trial being conducted only in China, which raises generalizability concerns and reflects a lack of hands-on experience for Western physicians.
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US biotechs increasingly use sites like Australia to accelerate development, as Create Medicines did by moving from concept to clinic in under 12 months. What was once viewed with suspicion is now a key strategy to generate data faster and more cheaply, competing with the speed of China's ecosystem.
When prioritizing pipelines, biotechs must consider commercial viability, not just science. With China's ecosystem specializing in fast-follow "Me Too" drugs, such assets are becoming commoditized. To secure funding and premium exits, companies must focus on truly differentiated "first-in-class" or "best-in-class" programs.
China is no longer just a low-cost manufacturing hub for biotech. It has become an innovation leader, leveraging regulatory advantages like investigator-initiated trials to gain a significant speed advantage in cutting-edge areas like cell and gene therapy. This shifts the competitive landscape from cost to a race for speed and novel science.
The FDA is predicted to approve new PARP inhibitors from trials like AMPLITUDE only for BRCA-mutated patients, restricting use to where data is strongest. This contrasts with the EMA's potential for broader approvals or denials. This highlights the diverging regulatory philosophies that create different drug access landscapes in the US and Europe.
An expert argues forcefully that the PD-L1 biomarker should be "ditched" in bladder cancer. Citing its repeated failure to predict overall survival benefit across multiple major trials, it is deemed an oversimplified and unreliable tool that leads to both over- and under-treatment of patients.
A significant criticism of the pivotal KEYNOTE-564 trial is that only half the patients in the control arm received standard-of-care immunotherapy upon relapse. This lack of subsequent optimal treatment complicates the interpretation of the overall survival benefit, raising questions about its true magnitude.
In high-risk non-muscle invasive bladder cancer (NMIBC), trials like CREST and POTOMAC show adding a systemic immune checkpoint inhibitor to BCG therapy introduces significant toxicity. The benefit is primarily in local control, which may not justify the risk, especially with other effective intravesical options available.
China is poised to become the next leader in biotechnology due to a combination of structural advantages. Their regulatory environment is moving faster, they have a deep talent pool, and they can conduct clinical trials at a greater speed and volume than the U.S., giving them a significant edge.
The next decade in biotech will prioritize speed and cost, areas where Chinese companies excel. They rapidly and cheaply advance molecules to early clinical trials, attracting major pharma companies to acquire assets that they historically would have sourced from US biotechs. This is reshaping the global competitive landscape.
The ultimate validation for a new medical treatment is when physicians themselves start using it. The high rate of GLP-1 drug use among neuroscientists and other doctors, who have the deepest understanding of the risks and benefits, is a powerful signal of the drug's effectiveness.
