Bristol-Myers’ Opdivo ushers in a new era as the first I-O therapy approved in China

In a historic moment for China’s medical world, China’s Drug Administration on Friday approved Opdivo, the country’s first immuno-oncology—and the first PD-1—therapy. For developer Bristol-Myers Squibb, though, the time for celebration won’t last long, as there’re many more to come, including its archnemesis Keytruda.

Different from its world-first and U.S.-first indication of melanoma, Opdivo goes directly to the larger and more lucrative lung cancer market with this Chinese approval, for patients with previously chemo-treated advanced non-small cell lung cancer to be exact.

In the phase 3 Checkmate-078 trial done predominantly on Chinese people, Opdivo reduced the risk of death in those patients by 32% compared to chemo, regardless of PD-L1 expression status.

Since Opdivo is the first immuno-oncology product approved in China, many eyes are on its price tag as a potential benchmark for their own pricing strategy. Priyanka Shah, a company spokeswoman, told FiercePharma that BMS is in the process of submitting the pricing material to authorities. Without providing an exact number, she said the price of Opdivo “will take the value of the medicine, affordability of Chinese patient and the high unmet medical needs into consideration.”

Lung cancer is the most common tumor type in China, with about 781,000 new diagnoses each year, based on official data from 2014. In comparison, the U.S. has less than one-third of that, or 234,000, according to the American Cancer Society’s estimate for 2018.

RELATED: How different are I-O stars from Merck, Roche and Bristol-Myers? Depends who you ask

The Chinese nod falls behind over 60 countries, but it comes as Opdivo faces increasing competition from Merck’s Ketyruda. Though Opdivo still leads the PD-1/L1 market with $1.51 billion in first-quarter worldwide sales, Keytruda is closing up the gap, with $1.46 billion in the same period.

Keytruda has recently been building its case with glamorous data one after another, especially in the much-heated lung cancer realm. Earlier this year, Merck rolled out data showing a Keytruda-chemo combo could cut the risk of death among previously untreated lung cancer patients by 51%. A few days ago at this year’s American Society of Clinical Oncology annual meeting, it provided Keyturda monotherapy data, showing the drug’s ability at cutting the risk of death by 19%, compared with chemo, in all PD-L1-positive patients.

In China, Merck’s Keytruda filing was accepted by the Chinese authority in February, and there’s a high chance it’ll also be approved this year. To complicate the market landscape, several local firms have PD1/L1s not far behind.

RELATED: ASCO: Bristol-Myers racks up Opdivo combo data to sell its new biomarker, but will doctors buy it?

After voluntarily withdrawing its application, Innovent Biologics in April resubmitted its Eli Lilly-partnered PD-1, sintilimab (IBI308), for Chinese approval and was immediately granted priority review. Its current target is relapsed and refractory Hodgkin lymphoma. The company is also eyeing NSCLC.

Shanghai Junshi Biosciences’ NDA for JS001 and Jiangsu Hengrui’s camrelizumab (SHR-1210), which was until recently under a co-development deal with Incyte, have also been accepted by the drug regulator. BeiGene’s Celgene-partnered tislelizumab (BGB-A317) is in phase 3.

BMS’ Shah told FiercePharma that the company has ongoing Phase 3 immuno-oncology studies across multiple tumor types prevalent in China, including liver, gastric, and esophageal cancer, and pleural mesothelioma, some of which the candidates above are also going after.

Editor's Note: The story has been updated to reflect that Junshi's and Hengrui's NDAs were accepted by the Chinese drug regulator.