Provenge To Drive Sanpower Growth And Wider China Cell Therapy Market?

China will provide a rising market potential for Sanpower’s newly acquired Dendreon and its Provenge product for prostate cancer, as part of the Chinese firm’s broader strategy, and the deal could also have an impact on the regulatory climate for cellular immunotherapies in China.

After completing the acquisition of Dendreon Corp., Sanpower hopes the first ever cross-border deal by a Chinese company to buy an innovative product will not only boost its own prospects but could also promote the wider development of China’s immunotherapy standards and regulations.

At the heart of the deal is Provenge (sipuleucel-T), the first and only US FDA-approved cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). The product could help set a benchmark to perfect and optimize the drug review system for other cellular immunotherapies in China, Sanpower’s spokesperson Guikan Hua said.

Through this transaction, Sanpower acquired not only Provenge but also Dendreon’s world-class cellular R&D platform, production facilities, logistics and distribution, and also its quality control standards and quality assurance system, which address precisely the challenges and risks that China’s immunotherapy developers have been struggling to solve.

Furthermore, “The acquisition will effectively promote establishment and improvement of China's cellular immunotherapy in terms of quality control and the regulatory system, which will also provide a reference for other immunotherapy drugs such as CAR-T and TCR-T,” predicted Shuren Zhang, the vice president of the China Anti-Cancer Association (CACA).

Sanpower’s Synergy, M&A Strategy

The acquisition of Provenge is an important step in the area of precision medical treatment for Sanpower, which will allow the group to expand its umbilical cord blood banking resources in China and elsewhere in Asia from the basics to practical application, together with the company’s senior care services and genetic testing.

Currently Sanpower has six million elderly users of its AnKangTong healthcare services arm, providing a large potential patient base for Provenge in the future. And the genetic big data from its umbilical cord blood banking with a storage capability of one million units will also provide the basis for developing precision medicine.

In a recent interview with Scrip, Dendreon’s CEO James Caggiano noted that through the first step of acquiring Dendreon, Sanpower sees immunotherapy and stem cell therapies as the wave of the future and plans to build a portfolio of those products, which it expects to bring to China and Southeast Asia. (Also see "Under Sanpower, Can Provenge Finally Have A Happy Ending?" - Scrip, 3 Jul, 2017.)

In the future, Sanpower will leverage its expertise in senior care, hospitals, umbilical cord blood banking, and stem cell storage, together with further development in precision medicine, “to create a new healthcare platform covering whole industry chain,” Sanpower’s chairman Yafei Yuan commented.

The firm also has an internal investment team of 50 to 60 members to screen overseas acquisition opportunities, and is seeking targets that can synergize with Sanpower’s existing healthcare businesses.

In 2014, Sanpower acquired Israel's largest home healthcare provider Natali Seculife Holding Ltd. for $70m. And later in 2016, its China A-share listed subsidiary, Nanjing Cenbest, set foot into the biopharmaceutical business by acquiring a 20% equity stake in Singapore’s Cordlife Group Limited and 76% of Sinocord, as well as setting up a buyout fund to acquire NYSE-listed China Cord Blood Corporation for CNY5.7bn ($840m).

In January this year, Sanpower signed a strategic collaboration agreement with China CITIC Bank to establish a global healthcare M&A fund of $2.9bn in a bid to boost Sanpower’s healthcare and biotechnology investment strategies. The fund will focus on investing and acquiring overseas projects, importing advanced technologies, and improving industry supply chains.

As for the Dendreon deal, Caggiano said that there will be no disruption or changes to the company’s technology, manufacturing, operations, or distribution process and that product for the US will continue to be made in the USA.

But for Chinese patients, Yang Wang, senior vice president for cross-border investment at Sanpower, expressed the possibility of building a local manufacturing facility to save costs, aiming to provide products at a cheaper price.

Wang noted that the company will learn from the practical experience of marketing Provenge in the US, and discuss with authorities to create an innovative insurance system to provide better access to the new immunotherapy for patients with fewer financial power.

Regulatory Climate Improving?

The Dendreon deal may also have other implications in the policy field in China, where currently there is no approved cellular immunotherapy. The registration review pathway for such products and the related regulatory system including Good Manufacture Practice, Good Clinical Practice and Good Supply Practice are still under development, which could possibly challenge and impact the technology transfer and launch of Provenge in China. Chinese industry experts have showed their concerns.

“China is not far behind the US and Europe in the field of basic research in cellular immunotherapy, but there is still a gap between China and the developed countries regarding the industrialization of research results, clinical application and regulations,” CACA’s Zhang noted.

After the death last year of Zexi Wei, who received experimental immunotherapy treatments for synovial sarcoma after reading about these in a promoted result on the Chinese search engine Baidu, China has tightened supervision of immunotherapies. Currently the China FDA is in the process of drafting technical guidance for clinical evaluation and clinical studies for cellular immunotherapy, and the industry expects the authority to improve the regulations to accelerate approvals, Zhang said.

Sanpower Group’s president Huaizhen Yang said in an interview with local media that Sanpower has already started to prepare the technology transfer and for the filing of a new drug registration application with the China FDA, while the company is proactively communicating with relevant authorities. Yang noted that Sanpower had received positive feedback from the authorities.

Regulatory reforms in China since last year have been sending positive signals to cellular therapy developers. In December 2016, the CFDA published a technical guideline for research and evaluation of cell-based products, which for the first time clarified cellular immunotherapy as a pharmaceutical product instead of a therapeutic technology.

In May this year, the CFDA issued three promoting policies to accelerate approvals for drugs that address unmet medical needs, and to support clinical use of innovative drugs by accepting overseas clinical trial data and global multicenter studies.

Most recently in June, the CFDA became a member of the International Council for Harmonization (ICH), which would benefit international companies and innovation-driven firms to speed up the entries of their new drugs in China.

Prostate Cancer Market In China

The incidence of prostate cancer in China and Asia was lower than in Europe and the US in the past, but in the last 10 years, it has risen rapidly in China with an annual growth rate of 12%, ranking the sixth most common cancer in Chinese males, according to data from Urological and Male Reproductive System Tumors Committee under the CACA.

As the end of 2015, there were more than 220 million people aged over 60 in China, and more than 18% of the population will be over the age of 60 in 2020. Given the huge population base of the aged, it is expected that prostate cancer will continue to grow accordingly.

Currently, androgen deprivation therapy is the main treatment of advanced prostate cancer in China. Major products include leuprorelin from Takeda Pharmaceutical Co. Ltd., Beijing Biote Pharmaceutical and Livzon Pharmaceutical Group Inc., goserelin from AstraZeneca PLC, and triptorelin from Ipsen and Ferring Pharmaceuticals Inc.

The latest approved treatment for metastatic castration-resistant disease was Janssen Pharmaceuticals Inc.’s Zytiga (abiraterone acetate), which was cleared for use in combination with prednisone in May 2015 and was launched in January 2016. Zytiga has been included into the reimbursement drug list in some cities.

Other drugs for mCRPC undergoing clinical trials in China include Jevtana (cabazitaxel) from Sanofi, Xtandi (enzalutamide) of Astellas Pharma Inc., and Xofigo (radium Ra 223 dichloride) from Bayer AG.

From the editors of PharmAsia News.