The Quiet Rise of China’s Original Drugs

When an American doctor told the family of Debbie Dolpert—a lung cancer patient whose disease had spread to her brain—that she could not access the drug she needed, the comment that followed was a mixture of resignation and quiet frustration: “It’s a pity she isn’t Chinese. Otherwise, she could go to a pharmacy in China and buy it.”

That drug was sunvozertinib. It was developed by Dizal Pharma, a biotech company based in Wuxi, a city in eastern China’s Jiangsu province. It was approved in China in August 2023 and received accelerated approval from the U.S. Food and Drug Administration in July 2025. But at the time, it was not yet commercially available in the United States. For patients like Debbie, it existed in a bureaucratic gap: approved, but out of reach.

Her son, Max, did not accept that gap as final. He reached out to friends and relatives, asked them to buy the medication in China, and eventually flew to Shanghai himself to collect it and carry it back. “Getting on the plane and bringing the medicine home felt like my life’s mission,” he later said. According to his understanding, at least thirty other American patients have followed a similar path—traveling to China to obtain the drug that was not yet available at home.

That story, first reported by KFF Health News and subsequently widely shared on social media, ended with a welcome resolution: on October 23, Dizal announced that sunvozertinib had officially launched in the U.S. market. What began as an individual act of desperation became a tangible marker of something larger—the arrival of Chinese original drugs on the global stage.

Sunvozertinib is an oral, irreversible inhibitor of EGFR exon 20 insertion mutations. These mutations are a distinct subset of EGFR-driven non-small cell lung cancer (NSCLC), and they have historically been difficult to treat. Unlike the more common EGFR mutations—such as L858R or exon 19 deletions—exon 20 insertions confer resistance to most first- and second-generation EGFR tyrosine kinase inhibitors. For years, patients with this mutation had limited options: conventional chemotherapy, or off-label use of drugs that were not specifically designed for their disease.

Sunvozertinib was designed specifically for this target. It is a first-in-class molecule, meaning it is not a “me-too” drug that follows an established pathway; it represents a new chemical entity developed from the ground up to address a specific unmet need. In China, it received conditional approval in August 2023 for previously treated patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. In the United States, it received breakthrough therapy designation and, in July 2025, accelerated approval—making it the first Chinese-developed, globally innovative drug to be approved in the U.S. for this indication.

The clinical data behind the approval are meaningful. In the pivotal WU-KONG6 study, sunvozertinib demonstrated a confirmed objective response rate of 61% in patients with platinum-pretreated EGFR exon 20 insertion–positive NSCLC, as assessed by an independent review committee. The median duration of response was 11.1 months, and the median progression-free survival was 6.9 months. In a disease where historical response rates to chemotherapy are typically in the single digits to low teens, a 61% response rate is not incremental. It is a different order of magnitude.

The story of Max and his mother is not only about access; it is also about cost. In the United States, the annual cost of oncology drugs routinely exceeds $150,000, and patients are often responsible for a significant share through copayments and deductibles. In China, sunvozertinib is priced substantially lower. For patients without comprehensive insurance coverage—or for those whose insurers have not yet added the drug to their formularies—the difference can be the difference between treatment and no treatment.

This is not a uniquely American problem. Drug pricing is a global challenge, and the disparity between what a drug costs in one market and what it costs in another is a structural feature of the pharmaceutical landscape. But the willingness of patients to travel across the world to obtain a medication reveals something important: when a drug works, people will find a way to get it. The barrier is not demand. The barrier is access.

The significance of sunvozertinib’s U.S. launch is that it closes one gap—the gap between approval and availability—without erasing the others. It means that patients in the United States can now receive the drug through normal channels, rather than through the informal and uncertain route of cross-border purchasing. It also means that the drug has passed the scrutiny of the world’s most rigorous regulatory agency, which is not a small achievement for a company that was founded in China and developed its molecule in China.

Sunvozertinib is not an isolated success. In Wuxi, a broader ecosystem of innovative drug development is taking shape, and several companies are pursuing global markets through distinct pathways.

D3 Bio (De Sheng Ji Pharma) has chosen the path of synchronous global clinical development. Earlier this year, the U.S. FDA approved two of its investigational new drug applications. The company now has four self-developed candidates in global clinical trials, spanning the United States, China, and the European Union. Its lead asset, a KRAS G12C inhibitor designated D3S-001, has received breakthrough therapy designation from both the FDA and China’s NMPA. This approach—designing trials from the outset to meet international regulatory standards—creates a pathway for subsequent global registration.

Abogen Biosciences has taken a different route: technology licensing. In October, the company signed a licensing agreement with Novartis with an upfront payment of $575 million and a total potential value of approximately $7.775 billion—the largest outbound licensing deal by a Chinese mRNA company to date. The collaboration covers mRNA-TCE and multiple RNA-based therapies, with Novartis gaining exclusive options to develop additional programs based on Abogen’s RNA platform. The significance of this deal extends beyond its headline value: it signals that Chinese platform technologies are now capable of deep integration with global R&D systems.

Nuoyu Pharmaceuticals has carved out a niche in radiopharmaceuticals. Its lead candidate, NYM096, has received both breakthrough therapy designation and fast-track status from the U.S. FDA. Phase I trials are underway in both China and the United States, and the drug has the potential to fill a gap in the global market for small-molecule radiopharmaceuticals for kidney cancer. In parallel, the company’s self-developed radiopharmaceutical manufacturing equipment has been sold to an Indian company—an example of “drug plus device” dual-track export.

These three companies represent three different strategies: global clinical benchmarking, platform technology licensing, and niche-market equipment-plus-drug integration. What they share is a common origin—Wuxi—and a common direction: the global market.

Innovative drug development does not happen in a vacuum. It depends on clinical trial infrastructure, regulatory pathways, capital, and specialized services that can meet international standards. Wuxi has been building these foundations deliberately.

In March, LabConnect, a leading global central laboratory services company, established its China headquarters in Wuxi’s International Life Science Innovation Park. The presence of a central laboratory capable of generating data that meets international regulatory standards means that local biotech companies can conduct globally acceptable clinical testing without sending samples overseas. This shortens timelines and reduces the logistical burden of global development.

Capital is the other critical input. In May, the Vivo (Wuxi) Accelerator was launched, with a 2 billion RMB fund focused on importing globally competitive first-in-class pipelines and supporting local companies’ overseas expansion. Additional funds—including the Jiadao QFLP fund and a 15 billion RMB AstraZeneca biopharmaceutical industry fund—have also been established. Across the city, 64 biopharmaceutical industry funds are now under management, with 18.3 billion RMB invested across 183 projects, covering the full lifecycle from early discovery to global clinical development.

The results are visible in the aggregate numbers. Wuxi’s biopharmaceutical industry has surpassed 200 billion RMB in total scale, with nearly 2,500 enterprises. Five Class 1 innovative drugs have received marketing approval. And China as a whole has seen outbound licensing deals for innovative drugs exceed $140 billion in the first ten months of 2026, with the full-year figure expected to approach $200 billion. A decade ago, Chinese-origin assets accounted for less than 5% of global out-licensing transactions. Today, that figure exceeds 50%.