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IFENG.COM: Chinese Prostate Cancer Patients Are Expected to Use Cellular Immunotherapy Medicine after a Successful Acquisition of the American Original Drug by Sanpower Group

Time Published:2017-07-03Source:Author:
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On the evening of 29th June, Sanpower Group officially announced its completion of acquisition of Dendreon, an American biomedical company. The Group has now possessed Dendreon and the full IP rights of its star product - the first and only FDA approved immunotherapy drug for prostate cancer - Provenge as well as its manufacturing and application technologies. The acquisition of Provenge, the up-to-date only cellular immunotherapy drug ever purchased overseas by Chinese businesses, sets a precedent for Chinese businesses to acquire American original biopharmaceuticals.


 


 “Cross-border finding” of cellular immunotherapy drugs provides Chinese with world-class anti-cancer drugs

 

At the beginning of this year, Chinese private business Sanpower Group singed an agreement on the 100% acquisition of Dendreon with Valeant, a world-renowned biopharmaceutical company, of which Provenge is the core product.

 


 

American biopharmaceutical company Dendreon

 

In 2010, Provenge was officially approved by FDA for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This is the first FDA approved autoimmune drug for prostate cancer and also the only one for the treatment of advanced prostate cancer at present. It is reported that not only the median survival time of Provenge-treated patients can be prolonged by some 4.1 months, but also most patients can survive at least 12 months longer with small side effects (flu-like symptoms, 1-2 days to ease). During the treatment, the quality of life of the patients was significantly improving and other drugs could also be used simultaneously.

 

Since Provenge was marketed in 2010, over 20,000prostate cancer patients have been treated with it, through which the safety and clinical efficacy are fully recognized. Provenge has been covered by most American insurance systems including Medicare, Medicaid and commercial insurance.

 

 “When the transaction is closed, Sanpower wishes to bring Provenge to China and SE Asia markets as soon as possible to benefit the patients there out of cutting-edge precision medical results while it will continue to expand in America and the EU market,” said Yang Huaizhen, President of Sanpower.

 

Cellular immunotherapy represents the latest development of tumor therapy and ushers in a global boom of related cutting-edge technology research, product development and application. “Although there are plenty of domestic cellular immunotherapy R&D institutions and businesses, most of them are in clinical trials or pre-trial study stage with no cellular immunotherapy technology formally put into clinical application.” said Ms. Yang, “the acquisition of Provenge is intended to let Chinese patients use the world-class cellular immunotherapy drug as soon as possible.”

 

Yuan Yafei, Chairman of Sanpower, has illustrated on many occasions the overseas M&A logic “Let Future Define Future”, which means “the best things in the world are our future directions, and we should buy them to build our own future.” In terms of new drugs, the R&D cycle is too long and with big risks, and Sanpower takes a direct path of “cross-border finding” to avoid risks as far as possible.

 

It’s said that through this transaction, Sanpower has acquired not only the full IP rights of the cellular immunotherapy medicine Provenge, but also Dendreon’s top talent team, world-class R&D platform for cellular immunotherapy drugs, production facilities, clinical application platform, logistics and distribution network, and more importantly, its quality control standards and quality assurance systems, known as the core of cellular immunotherapy drugs production. It also signals that, with the help of those Dendreon’s resources, Sanpower could be able to take more actions in cellular immunotherapy R&D and become a world-wide leading company in the cutting-edge precision medical care industry in the future.

 

Promoting the optimization and improvement of domestic cellular immunotherapy medicine review and assessment system

 

Professor Zhang Shuren, Vice Chairman of the Cancer Hospital of Chinese Academy of Medical Sciences and the Society of Cancer Biotherapy of Chinese Anti-Cancer Association, pointed out that in the basic research field of cellular immunotherapy, China is not inferior to countries in Europe and America, but in the way of industrialization, clinical application research and industry supervision, there’s still a gap.

 

As is known to all, FDA's review and assessment criteria for new drugs are very strict. It’s reported that Provenge has finished three Phase III clinical trails and finally becomes the only FDA-approved autoimmune drug. Now this mature cellular immunotherapy medicine, acquired by a Chinese business, can not only offer an effective and safe treatment option for prostate cancer patients, but also provide a scientific benchmark for China to improve and optimize its review and assessment system of this type of medicine, and earn an opportunity for China to lead in the global biomedical industry.

 

 

In view of the fact that it’s the first time for a Chinese business to acquire an American original biopharmaceutical and due to its unique properties of Provenge, can it succeed in landing in China, going to market, and being applied? In this regard, Ms. Yang stated that they have not only actively carried out the technology transfer and registration application work of Provenge in China, but also contacted the relevant competent authority many a time and received positive responses.

 

In fact, the CFDA has recently launched a series of policy reforms, which is favorable for Provenge’s domestic review and sales. The better news is that, on June 19th, CFDA announced its official participation in ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), meaning that China will gradually introduce and implement the highest international technical standards and guidelines to facilitate international innovative drugs’ early entry into China’s market.

 

News Link: http://finance.ifeng.com/a/20170629/15498197_0.shtml

 

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