Research & Development

Multikine, a novel immunotherapy drug for the head and neck cancer, is currently in a Phase III pivotal clinical study for US FDA approval. Participating countries include the United States, Taiwan, Canada, Poland, Hungary, Russia, Israel and India. 

The study plans to recruit 880 patients as subjects worldwide. The study will be the first clinical trial to enhance patient's immunity and weaken the tumor activity before the standard of treatment (surgery plus radiotherapy or concurrent chemoradiotherapy). The study was designed to compare the efficacy of "immunotherapy before standard treatment plus standard of treatment" and "standard of treatment" in patients with late stage of primary oral squamous cell carcinoma or soft palate cancer.

In Taiwan, the study was presided by Professor Hao Sheng-Po, who is also the founder of the Asian Society of Head and Neck Oncology and the chief of the ENT Department at the Shin-Kong Memorial Hospital. The clinical study was conducted in 9 medical centers. Enrollment was completed and 40 qualified patients were included in the study.

NC-6004 is a new platinum-based micelle chemotherapeutic drug. Pre-clinical studies proved NC-6004 could be quickly distributed to tumor site, while it significantly enhanced the anti-tumor activity and reduced Platin induced toxicity. Currently, NC-6004 has completed the Phase I and Phase II clinical development and has entered a Phase III study in Asian region. Expected participants include subjects from China, Korea, Hong Kong, Singapore and Taiwan. NC-6004 retained the Platin activity for therapeutic effect, while it reduced nephrotoxicity and neurotoxicity incurred from the maximum plasma concentration (Cmax).

The study is presided by Professor Chen Li-Tzong, who is the director of Division of Cancer Research, National Health Research Institutions. A total of 290 qualified patients to be randomized in the study conducted in 12 medical centers in Taiwan. 

ASC-J9 is a small molecular new chemical entity drug with new mechanism which can effectively and selectively increase androgen receptor degradation. It reduces the physiological activity of androgen and the production by sebaceous glands, and thus, showing high potential for treating acnes. Taiwan and United States have completed a Phase IIb clinical study. The study was designed to evaluate the safety and efficacy of 0.1% and 0.025% ASC‑J9 Cream applied topically twice daily for 12 weeks for the treatment of facial acne vulgaris.

In Taiwan, the project is headed by Dr. Huang Chieh-Chen of the Shin Kong Wu Ho-Su Memorial Hospital. A total of 181 patients from Taiwan and the United States were recruited and had completed the treatment. Our company is working with partners to plan future Phase III clinical study. 

2ccPA is a natural derivative of phospholipid (cyclic phosphatidic acid). Previous animal studies show that 2ccPA can inhibit inflammation and alleviate the pain caused by osteoarthritis.

The phase one clinical trial of 2ccPA is currently ongoing. The purpose of the trial is to evaluate the safety, tolerance, pharmacokinetics, and maximum tolerance dose (MTD) in administering a single dose of 2ccPA to patients with symptomatic osteoarthritis of the knee, and to collect scientific data as reference for subsequent trial designs and execution. Patient subjects are still being recruited.