To say something is "made in China" — in India, in our generation, in our markets — is to say something specific. Cheap. Mass-produced. Probably imitation. Likely to break within months. We grew up handling Chinese tube-light fittings, Chinese mobile batteries, Chinese-made everything that we eventually replaced with the Korean or Japanese or German version when we could afford to. The conditioning is so deep that most of us do not notice we have it.
For more than a decade in oncology, I have noticed the same reflex at international conferences. The data would be presented — often by a Chinese investigator whose English was good but not native — and the questions were skeptical. The result, even when it was excellent, was treated with not a pinch but a mountain of salt.
That was the world of around 2016.
Things have changed.
Toripalimab. A PD-1 inhibitor from Junshi Biosciences. FDA-approved in October 2023 for nasopharyngeal carcinoma. Approved by India's CDSCO in September 2024 and launched here as Zytorvi by Dr. Reddy's — the first and only immunotherapy approved in India for nasopharyngeal cancer. Tislelizumab. A PD-1 from BeiGene. FDA-approved in March 2024 for esophageal squamous-cell carcinoma, extended within twelve months to non-small-cell lung cancer and gastric cancer. Launched in India as Tevimbra by Glenmark, covering first-line NSCLC with chemotherapy, second-line NSCLC monotherapy, and esophageal squamous-cell carcinoma. Serplulimab. A PD-1 from Shanghai Henlius. Approved by India's CDSCO for extensive-stage small-cell lung cancer, marketed here at roughly one-third the price of the equivalent international PD-1. Camrelizumab. From Jiangsu Hengrui, used in China across hepatocellular carcinoma, lung, esophageal, lymphoma. Sintilimab. From Innovent. Penpulimab. From Akeso. Ivonescimab — also Akeso — the subject of one of the more talked-about trials at ASCO this year. Zanubrutinib, a BTK inhibitor from BeiGene, discovered in Beijing in 2012 and the first cancer drug developed in China to receive FDA approval. Disitamab vedotin, an antibody-drug conjugate from RemeGen.
What do they have in common? Almost all are immunotherapy or targeted-antibody molecules. They are not me-too chemotherapies. They are not cheap copies of Western drugs already on the market. Several belong to mechanisms the West has not yet matched. Most were developed by Chinese companies, with Chinese-led pivotal trials, and have arrived in the international regulatory conversation in the last forty months.
What the Indian patient notices, when they notice anything, is that the PD-1 their oncologist is recommending costs a fraction of the international brand, and the brand name is one they have not heard of.
The Trial That Asked the Question Out Loud
At ASCO 2026, in a special session on VEGF inhibition with immunotherapy, a Chinese investigator named Shun Lu presented HARMONi-6 — advanced squamous non-small-cell lung cancer. Control: tislelizumab plus chemotherapy. Experimental: ivonescimab, a bispecific antibody that binds both PD-1 and VEGF, plus the same chemotherapy. Both drugs Chinese-developed. Trial across forty-five Chinese sites.
Median overall survival was 27.89 months in the ivonescimab arm, 23.69 months in the tislelizumab arm. Hazard ratio for death, 0.66 (95% CI 0.50–0.86). Progression-free survival, 11.1 versus 6.9 months, HR 0.60, p less than 0.0001. The Kaplan-Meier curves separated early and stayed separated.
This is, in its specifics, a meaningful trial. It is also, in its design, an entirely Chinese trial — Chinese sites, Chinese patients, Chinese standard-of-care chemotherapy. The applause was sustained but not unbroken. People were waiting for the discussant.
What Julie Brahmer Asked
Julie Brahmer, professor of thoracic oncology at Johns Hopkins, was assigned to discuss HARMONi-6. She did not dismiss the result. She did not endorse it. She raised six specific questions.
Median age of patients was sixty-four. The protocol excluded anyone over seventy-five. Lung cancer in the US is diagnosed at a median age closer to seventy, with a substantial fraction above seventy-five. Whether the survival benefit holds in an older, more comorbid population is not addressed.
Median follow-up was about twenty-one months. The interim OS boundary was crossed appropriately, but the curves are early.
The control arm — tislelizumab plus chemotherapy — performed at a level not seen in equivalent Western trials of pembrolizumab plus chemotherapy. KEYNOTE-407, the closest Western analogue, had a median overall survival of around seventeen months in its experimental arm. The tislelizumab control arm in HARMONi-6 reached almost twenty-four. Is the difference because Chinese patients respond differently to chemotherapy? Because tislelizumab is a better drug than pembrolizumab? Because the trial population was younger and more carefully selected than the real-world patient most oncologists see?
Exclusion criteria included major blood-vessel invasion, tumour cavitation, significant haemoptysis. Reasonable exclusions, because ivonescimab carries a real bleeding risk. Real-world patients are not so easy to exclude. The safety profile showed higher grade-three adverse events on the ivonescimab arm and higher rates of VEGF-class toxicities — hypertension, proteinuria, bleeding.
None of these are dismissals. They are the questions any senior thoracic oncologist would ask of any phase-three trial, regardless of geography. The fact that they were asked of a Chinese trial — and asked, in the moment, on the largest oncology stage in the world — is the actual change.
The Decade Behind the Question
The reservations against Chinese-trial data, as a class, did not arise from xenophobia alone. They arose from specific events.
In 2015 and 2016, China's National Medical Products Administration launched a sweeping audit of clinical trials submitted for drug registration. The audit found data-integrity problems — fabricated case report forms, missing source documentation, altered laboratory values. By some agency reports, more than eighty per cent of submitted applications were withdrawn. The aftermath was the most aggressive housecleaning in modern Chinese pharmaceutical regulation, followed by adoption of ICH guidelines, full GCP compliance, and joinder to the ICH as a regulatory member in 2017. The pre-2018 reputation problem was real. It was also being addressed.
The second event was the sintilimab decision. In February 2022, the FDA's Oncologic Drugs Advisory Committee voted fourteen-to-one against approval of sintilimab — Innovent Biologics' PD-1, partnered with Eli Lilly — for first-line non-small-cell lung cancer in the US. The pivotal trial, ORIENT-11, had been conducted entirely in China. The FDA's argument, articulated by Richard Pazdur, then director of the Oncology Center of Excellence, was that a drug intended for the American market should be tested in a population resembling the American patients who would receive it.
The sintilimab rejection became, for several years, the canonical reference cited by Western reviewers when discussing Chinese-only trial data. It was also the high-water mark of that posture. By October 2023, the FDA had approved toripalimab on the basis of a primarily Chinese trial. By March 2024, tislelizumab. Within twelve months, tislelizumab's approval extended to NSCLC and gastric cancer. Each of these trials had enrolment that was disproportionately Asian. Each was approved anyway.
What changed was not, principally, the trials. What changed was the recognition that the original objection — the trial population is not American — was starting to look like a moving goalpost when applied selectively only to drugs from China.
The Scale
In 2015, China filed seven oncology drug applications with its own regulator. In 2024, the number was over three hundred. In 2025, the number of phase-three oncology trials initiated in China exceeded the number initiated in any single European country.
BeiGene, Innovent, Akeso, Junshi, Jiangsu Hengrui, Shanghai Henlius, RemeGen — companies not on the average Western oncologist's radar a decade ago. Today several are listed on multiple international exchanges, have global commercial footprints, and are running phase-three trials in the United States. BeiGene, ten years ago, was a small Chinese biotech with a single asset. Today it has multiple FDA-approved drugs and a market capitalisation in the tens of billions.
At ASCO 2026, more than a dozen randomised phase-three trials of Chinese-developed drugs were presented across plenary, oral, and special sessions. HARMONi-6 was one.
What This Means in India
The Chinese-developed PD-1 and PD-L1 inhibitors are no longer hypothetical for Indian oncology. Three are already on the market. Toripalimab — Zytorvi, Dr. Reddy's — is the only approved immunotherapy in India for nasopharyngeal carcinoma. Tislelizumab — Tevimbra, Glenmark — covers first-line and second-line non-small-cell lung cancer and esophageal squamous-cell carcinoma. Serplulimab is approved for extensive-stage small-cell lung cancer at roughly one-third the price of the equivalent international PD-1. Bispecific antibodies, including ivonescimab, are in licensing negotiation for early access.
For Indian oncologists, this creates a practical set of questions in clinic. Is the data quality sufficient to recommend the drug? Are the trial populations relevant enough to Indian patients? Is the price difference enough to make the drug accessible in a way the international PD-1 is not? Are there toxicity signals to specifically watch for? Are there indications where the Chinese drug is, on the available evidence, the better choice?
The answer is increasingly: it depends, but it is not unreasonable. The data, in many of these cases, are real. The pricing, for Indian middle-class families, is transformative. The drugs are not what they were five years ago.
The conditioning runs deep, and it does not disappear because a regulatory body has changed its position. Made in China still carries a particular weight in the Indian middle-class imagination. Patients still hesitate when they read the manufacturer name on the pharmacy bill. The reflex to assume cheap means inferior is not entirely unhealthy in a market where counterfeits exist and the regulatory floor is sometimes lower than we would like. But that reflex, applied to oncology drugs in 2026, is increasingly out of step with the molecules themselves.
The drugs are already on Indian prescription pads. The question is no longer whether to use them. It is which one, for which patient, in which indication, with what monitoring, against which alternative. Those are clinical questions, not ideological ones, and they get harder to dodge with every new trial that lands.
That, by itself, is worth naming.