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September 28, 2018

Novartis signs Chinese manufacturing deal with Cellular Biomedicines for Kymriah

Swiss pharmaceutical company Novartis has signed an exclusive marketing agreement with Cellular Biomedicines to manufacture its CAR-T therapy Kymriah in China.

By Allie Nawrat

Swiss pharmaceutical company Novartis has signed an exclusive marketing agreement with Cellular Biomedicines to manufacture its CAR-T therapy Kymriah in China.

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The agreement is part of Novartis’ effort to gain approval for Kymriah in China; the Chinese Government requires drugs sold to patients in China to be manufactured in the country.

Although immuno-oncology specialist company Cellular is based in the California, US, it has production facilities in three cities in China that meet both US and Chinese good manufacturing practices standards.

According the agreement, Cellular will only be responsible for manufacturing, while Novartis will solely control distribution, regulatory efforts and commercialisation.

Novartis will make a $40m equity investment in Cellular, meaning Novartis will gain a 9% stake in the company at $27.43 per share. Cellular will also receive payments on net product sales that will rise over time. In return, Novartis will receive rights to some of Cellular’s technology used to create CAR-T therapies.

Cellular CEO Tony Liu said in a statement: “Together with Novartis, we hope to bring the first CAR-T cell therapy to patients in China. In addition, we continue to focus on developing [Cellular’s] pipeline of immuno-oncology assets.”

Novartis’ expansion into China follows a move made by its CAR-T rival Gilead to manufacture its CAR-T therapy Yescarta in the country, which is indicated for certain types of non-Hodgkin lymphoma.

Novartis has faced previous issues regarding the manufacturing of Kymriah in Europe. Before receiving European Commission approval for the treatment in August, the company signed a licensing agreement with French contract manufacturer Cell for Cure to help with its capacity and supply challenges.

Earlier in September, the UK’s pricing regulator the National Institute of Health and Clinical Excellence (NICE) recommended Novartis’ Kymriah for use by the National Health Service (NHS) for patients under 25 years old with refractory acute lymphoblastic leukaemia. This made Kymriah the first CAR-T therapy to be available in patients in Europe.

However, NICE later rejected Kymriah for routine use by the NHS to treat patients with diffuse large B cell lymphoma, because it is not cost effective and of concerns about adverse events. NICE ruled the same way for Yescarta for the same indication in August.

A spokesperson for Novartis said: “While we are disappointed with this preliminary decision, we recognise that this one-time therapy is an innovative and radically different treatment approach with curative intent, and it may be challenging to adequately compare Kymriah to current treatments for patients with this type of blood cancer who have limited options.”

Related Companies

Free Whitepaper
img

What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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