——A New Domestic Anti-tumor Drug for Advanced Metastatic Colorectal Cancer Will Be Put on the Market Soon, With the Affirmation of International Authoritative Medical Journals to Its Efficacy For the First Time.

On June 26, Journal of the American Medical Association (JAMA), an international top medical journal, published the full results of the critical phase III clinical study on the effect of fruquintinib, an oral vascular endothelial growth factor receptor(VEGFR) inhibitor, in metastatic colorectal cancer (FRESCO). This study was developed jointly by Professor Jin Li, director of the Department of Medical Oncology, Tongji University Shanghai East Hospital, and Professor Shukui Qin, vice president of Nanjing Chinese Medicine University-Affiliated Bayi Hospital. Results show that fruquintinib is effective for patients with metastatic colorectal cancer who have received at least two chemotherapy regimens but still have disease progression, and can significantly prolong the survival period of patients. The publication of this study realized a number of important breakthroughs in the field of anti-tumor drugs in China. For the first time, the clinical research of new anti-tumor drugs in China has been published in international authoritative journals.

As one of the top four medical journals widely recognized by the international medical community, JAMA has an impact factor of 47.6. The publication of FRESCO is the first time that China's clinical research of new anti-tumor drugs “landed in” JAMA. The prospective design, complete and reliable data, clinical value and research quality of this research are recognized for the first time on the international stage. Professor Jin Li and Professor Shukui Qin, as the co-authors, completed the writing and contribution of the article.

The First Research Achievement Independently Invented by Chinese People, Researched by Chinese Doctors and Developed by Chinese Enterprises

FRESCO is a randomized, double-blind, placebo-controlled, multi-center phase III clinical trial conducted in China. It was jointly led by Professor Jin Li, director of the Department of Medical Oncology, Tongji University Shanghai East Hospital, and Professor Shukui Qin, vice president of Nanjing Chinese Medicine University-Affiliated Bayi Hospital. 28 clinical medicine research institutions in China, including Fudan University Shanghai Cancer Center, Hutchison MediPharma Ltd., and Eli Lilly and Company, participated in the completion.

The Most Perfect Results In the Treatment of Stage III Metastatic Colon Cancer In the World So Far

Every year, there are 1,360,000 newly diagnosed colorectal cancer cases and 694,000 deaths in the world. 376,000 cases of newly diagnosed colorectal cancer are found in China every year, and most of them have been in the advanced stages the moment they got diagnosed. At present, the standard treatment of metastatic colorectal cancer is chemotherapy. For patients with advanced colorectal cancer undergoing chemotherapy failure, effective treatment options are very limited. After the failure of two-stage chemotherapy, many patients are still in good condition and have a strong desire for survival. These patients need the help of safe and effective follow-up treatment.

In response to this situation, FRESCO enrolled 416 patients with advanced colorectal cancer, aged 54.6 on average, with 161 females. These patients were divided into two groups, one being treated with fruquintinib, and the other being treated with placebos. The treatment was given once a day, 28 days as one course of treatment (21 days after treatment, 7 days after discontinuation). The study was followed up to January 17, 2017. The survival time of the patients in the fruquintinib group was prolonged to 9.3 months, significantly longer than that of the patients in the placebo group by 2.7 months; meanwhile fruquintinib also showed ideal safety features, especially with the lowest liver toxicity comparing with other analog medicines, and there was no significant difference compared with the placebo group. Through clinical trials, fruquintinib showed the advantages of strong effect, low toxicity and good tolerance to colorectal cancer. According to Professor Jin Li, the results harvested in the trail are the largest extension period data that can be achieved in this field in the world at present. Now, this clinical research has been supported by the National Major Scientific and Technological Special Project for “Significant New Drugs Development” during the Twelfth Five-year Plan Period, the Science and Technology Project of Ministry of Science and Technology of Shanghai, the Science and Technology Development Fund Project of Ministry of Science and Technology of Pudong New Area District and the corresponding supporting funds of Zhangjiang High Tech Park Management Committee.

It is understood that based on the data from FRESCO, Hutchison MediPharma has submitted the new drug application for fruquintinib in the treatment of advanced colorectal cancer to China Food and Drug Administration, and the application has been awarded the qualification of “priority review” due to its “obvious clinical value”.

Promoting the Transformation of Domestic Anti-Tumor Drugs From “Generic” to “Original”

The research and development of anti-tumor drugs have always been controlled in the hands of European and American countries just like chip technology. The quantity and quality of new anti-tumor drugs in China are still far behind those in developed countries at present. So, what is the present situation of the innovation and research of anti-tumor drugs in China? What are the development bottlenecks?

Statistics show that of the 49 new anti-tumor drugs launched in 2010-2014, only 6 were launched in China. By January 2018, about 33,407 cancer-related clinical trials have been carried out in China, while the number in the United States has exceeded 110,000, more than three times the number in China. The majority of new drugs on the market and under research in China are generic drugs, so we can say that the pharmaceutical industry in China is in the stage of imitations combined with innovations. The reason for the incapacity of the Chinese pharmaceutical industry in research and development and production of original drugs is that new drug research and development is a process of high investment, high risk and long cycle (10-15 years), which requires sufficient manpower, financial and equipment investment.

As an independent research and development of new anti-tumor drug fruquintinib, the whole research team has gone through a 12-year research and development process from the project establishment to the current marketing stage. It is expected that the near marketing authorization of fruquintinib will encourage the establishment of the innovation system of new anti-tumor drugs and accelerate the transformation from imitation to innovation in the research and development of anti-tumor drugs in Chinese pharmaceutical industry.

It is known that 20 clinical trials of anti-tumor drugs are being carried out in phase I clinical trial center of anti-tumor drugs on the sixth floor of South Hospital of Shanghai East Hospital. Professor Li Jin said that the center is planning to promote the research and development of new anti-tumor drugs at the rate of 30-35 projects per year.