Fosun Pharma and Kite unveil plans for JV
Shanghai Fosun Pharmaceutical (HK: 02196) and the USA’s Kite Pharma (Nasdaq: KITE) unveiled their plan for the joint venture they are about to establish at a press meeting on Monday in Shanghai, where the JV will be located.
The priority for the JV will be bringing China KTE-C19, a CAR T cell therapy targeting the antigen CD19 that aims to curenon-Hodgkin lymphoma (NHL)through just one injection, reports The Pharma Letter’s local correspondent Wang Fangqing.
“We will start to apply for clinical studies in China as soon as the technologies are transferred. It shouldn’t take too much time,” Wu Yifang, Fosun Pharma’s president, told The Pharma Letter. He said the facility is already in place as it will be located in Fosun’s existing innovation incubator in Zhangjiang high tech zone, which is home to many multinationals’ China operations, including Roche and AstraZeneca.
The facility will supply KTE-C19 product for mainland China, Hong Kong and Macau. As one last resort for NHL treatment, KTE-C19 was selected strategically.
“We have an antibody to treat NHL, and if it does not work we will have KTE-C19. It’s a combo we can offer to patients,” Mr Wu said, referring to CD20, a biosimilar of Roche’s MabThera (rituximab) that is under Phase III studies in China.
“It will also be a lot easier for us to conduct studies for KTE-C19 as the two therapies share the same patients,” Mr Wu added.
Unlike many other JVs which receive actual investments from each party, Kite offered the JV exclusive rights to use its products and technologies valued at $20 million. Kite will nominate the chief technology and financial officers in the JV, while the chief executive will be nominated by Fosun.
Option to license additional Kite products
After KTE-C19, the JV plans to move on to Kite’s two other TCR-T products - KITE439 and KITE718 for solid tumors. The JV has an option to license the two products, according to an agreement.
The JV is more than a vehicle to bring Kite’s products to China. It will also be turned into a platform dedicated to developing Fosun’s own T cell therapies, open to many other opportunities including contract manufacturing and work with other parties to co-develop new treatments, said Mr Wu.
Kite and Fosun have been in touch for some time, but the idea of the JV came about six months ago, when Guo Guangchang, chairman of Fosun Group, was on a business trip in the USA.
“We had many Chinese companies come to us asking for a licensing deal, and I said absolutely no,” said Kite CEO Arie Belldegrun. The reason, he added, is that cell engineering is highly complex to deliver and any negligence could lead to serious consequences.
In November, Kite’s rival Juno halted Phase II studies of JCAR015, an immunotherapy also targeting CD19, after three patients died from cerebral edemas. In April last year, Juno also formed a JV in Shanghai - JW Biotechnology – with the major Chinese CRO WuXi AppTec, to develop cell therapies.
“Cell engineering is not for a small company which is interested in developing some new technologies, but a company which has a commitment to cell immunotherapy engineering technologies, is capable of doing the complex manufacturing and has the distribution network in the entire China. And we are extremely pleased to have Fosun as our partner,” Dr Belldegrun said.
Just before the JV deal, Kite licensed KTEC19 to Daiichi Sankyo in Japan. Dr Belldegrun said there is a reason that he insisted building a JV in China.
“China is a large market but cell therapies are not regulated here. With the JV we can have a say in manufacturing, and we want to make sure the quality is at its highest level,” he said.
Chinese regulatory environment
Currently, there are no regulations in China for cell therapies, many small companies and even hospitals are claiming they can offer the advanced treatments. Because of this, a tragedy occurred last year when a young patient named Wei Zexi died from the DC-CIK therapy conducted by a private hospital in Beijing. The therapy, which uses cytokine induced killer cells to attack cancer cells, is only for clinical studies in the USA.
The China’s Food and Drug Administration (CFDA) was alerted and already took actions. In December the CFDA drafted a regulation for cell therapy studies in the China. It is currently open for public opinion until January 25.
An innovative therapy, KTE-C19 was granted breakthrough therapy designation by the FDA in the USA and priority medicines status by the European Medicines Agency to enjoy shortened approval processes.
In China, officials are equally interested. At the press meeting, Chen Yaoshui, deputy director of CFDA Shanghai office, said the Chinese authorities are “very pleased “that such an advanced technology will be brought to China.
“We are confident about the future of the JV and we hope our novel therapies will meet the unmet demand in China,” said Fosun president Wu YiFang.
19-01-2017
Source: http://www.thepharmaletter.com/
