By Cao Shulin in Beijing, PEOPLE.CN, June 30^th

It’s learned from Sanpower Group that the company completed its equity delivery with the American biomedical company, Dendreon, on June 29^th, making this shocking transnational acquisition a complete success.

Provenge, Dendreon's core product, is the first and only FDA-approved cellular immunotherapy drug for prostate cancer treatment. The completion of the transaction, marking the first-time acquisition of American original biopharmaceuticals by China’s businesses, signals that the full IP rights, production technologies, R&D platform and competent talent team of Provenge now belong to Sanpower, a China’s business, thus Chinese patients are hopefully to use the world's advanced cellular immunotherapy drug as soon as possible.

 

Provenge, American first cellular immunotherapy drug for prostate cancer, is now in the hands of a China’s business

Obvious advantages over prostate cancer treatment

In April 2010, Provenge was officially approved by the all-the-time stringent U.S. Food and Drug Administration (FDA) for the treatment of metastatic castrate-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. Industry experts point out that FDA is very strict in assessing new drugs. According to statistics, no more than 10% of new drugs can be approved to go to market, even if they enter Phrase III clinical trial. Provenge has finished three Phase III clinical trails and finally becomes the only FDA-approved autoimmune drug.

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

First-time “cross-border finding” of cellular immunotherapy original drugs by China’s businesses

Sanpower’s takeover of Provenge is the first acquisition of cellular immunotherapy original drugs by China’s businesses. At present, there are no same type drugs listed in china, while the registration review and assessment system for cellular immunotherapy drugs, and the management and regulatory systems such as GMP, GCP and GSP are still in the course of improvement. Sanpower acquired its substantive, innovative and high-tech target by “cross-border inding”, achieving corner overtaking in precision medical care.

Yuan Yafei, Chairman of Sanpower, has illustrated on many occasions the group’s overseas investment logic “Let Future Define Future”, which means the best things in the world represent future directions. Sanpower should conform to the trend of supply-side structural reform and consumption upgrading by introducing advanced product technologies, services, business models and management systems via overseas M&A. Precision medical care is one of the key links in the group’s comprehensive health industry landscaping, while the acquisition of Provenge is the open sesame for Sanpower to enter precision medical field.

At present, Sanpower has the world’s largest umbilical cord blood stem cell (UCBSC) storage capacity in China and SE Asia and it also enters the gene test business. The big data of gene brought forth by USBSC and gene test is the basis for the development of cutting-edge precision medical care industry. Its pension business covers more than 6 million elder men and Provenge is exactly aimed at prostate cancer which is highly prevalent among them. Mr. Yuan pointed out that Provenge will join Sanpower’s other health business areas concerning pension service, rehabilitation therapy, UCBSC storage, gene test, and etc. to create a synergy effect. Later, 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.

Expecting to offer a scientific benchmark for domestic related medicine review and assessment system

Statistics show that in recent years as China steps into the aging society, the incidence of prostate cancer in China records an upward trend, ranking the sixth in tumors among males with the average annual growth rate at 12.07%. Experts predict that within ten years, prostate cancer will rise to the top three malignancies among Chinese males. “In China, the effective treatment in metastatic castration-resistant prostate cancer (mCRPC) is limited and we face severe challenges. Usually the prostate cancer patients can only live for less than 2 years.” said Professor Xie Liping, Vice Chairman of the Urology Branch of the Chinese Medical Association and Chief of Urology at the First Affiliated Hospital of Zhejiang University. Provenge is exactly aimed at these mCRPC patients who receive no effective treatment and it is the only cellular immunotherapy drug for the treatment of advanced prostate cancer.

In the 21^st century, cellular immunotherapy is expected to be an effective method to conquer tumor, and China's cellular immunotherapy industry can be described as "the road is long, but we will arrive at the destination." 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. Cellular immunotherapy is one of the few opportunities for China to seize so as to lead the world's counterparts.

It is gratifying that recently CFDA launched a series of policy reforms in order to let the people use better drugs as soon as possible. In December 2016, CFDA issued the "Technical Guiding Principles for Research and Evaluation of Cell Products" (draft), for the first time to clarify the drug property of cellular immunotherapy products and ends up the controversy for many years over whether cellular immunotherapy is technique or drug. On June 19, 2017, 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.