Novartis expands radiotherapy manufacturing network with $85M plant in China

When it comes to expanding radiotherapy manufacturing capacity for Lutathera and Pluvicto, Novartis is putting its money where its mouth is.

The Swiss pharma is building a new radiotherapy production facility in China with an investment of more than 600 million Chinese yuan ($84.6 million), the company said (Chinese) Friday.

The new plant is located in Haiyan in the Zhejiang province about 60 miles from Shanghai. Pending regulatory approvals, the plant is expected to be operational for local production in 2026, Novartis told Fierce Pharma. The company declined to comment on the volume of capacity at the site.

Radioligand therapy requires sophisticated technology to ensure that the medication can reach patients within hours of production, Novartis’ operations president Steffen Lang, Ph.D., said in a Chinese statement. The Haiyan facility will make sure that patients in need of these therapies receive a consistent and reliable treatment experience, he added.

The Chinese project adds to Novartis’ existing radioligand therapy manufacturing facilities in Ivrea, Italy; Zaragoza, Spain; Millburn, New Jersey; and Indianapolis, Indiana, which is pending FDA approval to supply commercial doses. Novartis is aiming to have a combined annual capacity of at least 250,000 doses from existing facilities by around 2024.

Further, the company is evaluating the possibility of establishing more production base in other key markets.

The expansion comes as Novartis grapples with surging demand for its PSMA-targeted radiotherapy Pluvicto in prostate cancer. In fact, demand was so high that the drug earlier this year went into a temporary shortage, which was resolved in fall.

Meanwhile, the company is preparing to move Pluvicto into earlier lines of treatment, which would significantly increase the therapy’s patient base. But Novartis recently postponed a potential FDA filing for Pluvicto as a pre-chemo treatment as it awaits a longer-term overall survival readout from the phase 3 PSMAfore trial.

In China, Novartis in May kicked off a phase 2 trial for Pluvicto in Chinese patients with progressive PSMA-positive metastatic castration-resistant prostate cancer. The global phase 3 PSMAdditioin trial that’s testing Pluvicto in metastatic hormone-sensitive disease includes multiple sites in China.

In its Friday press release, Novartis highlighted recent guidance on reviewing radiotherapies from China’s National Medical Products Administration. The agency encourages innovative radiotherapies that are already approved abroad to seek registration in China and offers expedited reviews for those therapies that meet urgent medical need. Novartis hopes the new facility will accelerate the introduction of its radioligand therapy into the country.

China is an important market for Novartis, and the new Haiyan facility will further expand the reach of Novartis’ innovative medicines, Lang said in his statement.

China, alongside the U.S., Germany and Japan, is a priority geography for Novartis. Back in September 2022, Novartis laid out a goal to be a top-three pharma player in China, up from fifth. And the radioligand field is one of three novel technology platforms that the company is focused on besides the traditional chemistry and biologics. The other two platforms are xRNA and cell & gene therapy.

After a pandemic-related lull, China has lately been delivering double-digit sales growth for Novartis. In the third quarter, the Swiss pharma booked a 14% revenue growth in the country at constant currencies to $848 million.

Besides the new radiotherapy plant, Novartis owns a large facility in Beijing. That oral drug production plant occupies 6.9 acres of land and can make up to 3 billion tablets per year. Back in 2019, Novartis sold a drug ingredient plant in the Shanghai-neighboring city of Suzhou to local firm Zhejiang Jiuzhou for about $110.5 million.