Recently, Dendreon HK Limited, a subsidiary of Sanpower Group, has announced the successful acquisition of GMP Lab under China Life Health Industry Group (CLHIG) in Wong Chuk Hang, Hong Kong. This means that Dendreon's core product -- Provenge, the only FDA-approved autologous competent cell immune product for advanced prostate cancer, is expected to enter the Hong Kong market and bring the world's most advanced cellular immunotherapy for prostate cancer patients to Hong Kong and Asia.

Provenge collects leukocytes from the peripheral blood of patients and fuses the leukocytes with prostate cancer-specific antigen in-vitro to create active antigen presenting cells, which are then transported back to the patients for activation and expansion of T cells, using their specificity to recognize and attack prostate cancer cells. Products used on each patient have undergone individualized production and processing, therefore they are considered medical products with precision. Median survival time in patients treated with Provenge is 25.8 months, which is approximately 4.1 months longer than those who are not administered with the drug. However, for most patients, the duration could be 12 months or longer. Provenge uses autologous cells with low immunogenicity and weak side effects. Its safety has been unanimously acknowledged by FDA review experts. In 2015, Provenge was recommended as a first-line treatment for patients with mCRPC (metastatic Castration Resistant Prostate Cancer) by the NCCN (Clinical Practice Guidelines for Various Malignancies published by the National Comprehensive Cancer Network).

In June 2017, Sanpower Group acquired a 100% stake in Dendreon and formally took over the complete intellectual property, production technology, R&D platform and talent team of Provenge, the world's advanced prostate cancer cell-based immunotherapy drug. After the acquisition, Dendreon expanded its business worldwide and established Dendreon HK Limited in Hong Kong, with the strong support of Sanpower Group.

The acquisition of CLHIG’s Wong Chuk Hang Lab has shown that Dendreon is taking a significant step in the internationalization of its business after being acquired by Sanpower Group. Dendreon HK Limited will use the GMP Laboratory in Wong Chuk Hang as a production platform to register the listing of Provenge products in Hong Kong.

With a total area of nearly 1,000 square meters, Hong Kong Wong Chuk Hang laboratory was constructed according to the GMP standard of WHO and has been certificated by NEBB (National Environmental Balance Bureau). Dendreon's US technological and quality control team will adhere strictly to the standards of the U.S. laboratories to create a completely identical laboratory in the Wong Chuk Hang Laboratory for cell-immune products. Through this laboratory, Dendreon HK Limited may submit an application for approvals of new drugs to the Pharmacy and Poisons Board of Hong Kong.

Above: GMP Lab in Wong Chuk Hang, Hong Kong

It is understood that Hong Kong has a rigorous approval system for new drugs to ensure that all medicines taken by Hong Kong residents conform to the established standards. During the new drug approval process, Hong Kong recognizes new drug certification documents which have been approved by certain developed countries, including clinical data and drug testing certificates, and accept them as application information which do not require additional clinical trials. Therefore, as a prostate cancer cell immunotherapy product approved by the U.S. FDA, Provenge products are expected to appear on the Hong Kong market in no time.

The rate of prostate cancer is high in developed countries in Europe and America, and it is rising rapidly in developing countries. This is related to unhealthy habits, including high-fat diet, smoking, excessive drinking etc. Early prostate cancer can be diagnosed and controlled effectively. While non-metastatic prostate cancer patients are known to survive longer, metastatic cancer is not curable. Data indicates that the incidence rate of prostate cancer in the Asia-Pacific region has increased by more than 10 times in the last 20 years. Patients currently diagnosed with or who have progressed to Castrated Resistant Prostate Cancer (CRPC) have limited options for clinically effective and safe treatments. Therefore, there are serious unmet medical needs in this area.

        The arrival of Dendreon and the listing of Provenge in Hong Kong will quickly benefit prostate cancer patients in Hong Kong, mainland China and Southeast Asia, who will receive the most advanced cellular immunotherapy in the world. In addition, the promotion in Hong Kong also helps to accumulate commercial operation experience of cell-based products in markets outside the United States and accumulate application cases of Asians, providing the data support that Provenge will need to be listed in mainland China