Shanghai anticancer drugs to treat breast cancer, gastric cancer and other tumor diseases will enter the Middle East market
Anticancer drugs developed by Shanghai companies will enter the Middle East market. Recently, "Hanquyou" developed and produced by Henlius was sent from the company's Xuhui base to Saudi Arabia, and is expected to become the first domestically produced monoclonal antibody biological drug to enter the Middle East market. In April this year, this monoclonal antibody biological drug was approved for marketing by the US Food and Drug Administration for the adjuvant treatment of breast cancer with overexpression of human epidermal growth factor receptor 2, metastatic breast cancer with overexpression of HER2, and metastatic gastric adenocarcinoma and gastroesophageal junction adenocarcinoma with overexpression of HER2.
Breast cancer is the second most common cancer in the world. According to data from the American Cancer Society, there are expected to be more than 370,000 new cases of breast cancer in the United States this year, ranking first in the country's cancer incidence rate and showing a trend of increasing year by year. Among them, HER2-overexpressing breast cancer accounts for approximately 15% to 20% of the total number of breast cancers. The proportion of HER2 overexpression in gastric cancer patients is approximately 12%-23%.
Trastuzumab is a cornerstone drug for the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab developed by Henlius is a "Chinese" biosimilar drug approved in China, the European Union and the United States. It has been launched in more than 40 countries and regions including the United States, the United Kingdom, France, Germany, Australia, Argentina, Saudi Arabia, Thailand, etc., and has been included in the medical insurance catalogues of many countries including China, the United Kingdom, France and Germany, benefiting more than 190,000 patients.
Zhu Jun, Executive Director and CEO of Henlius, said that since 2015, the company has conducted a series of head-to-head comparison studies on this trastuzumab, including quality comparison studies, Phase I clinical trials and international multicenter Phase III clinical trials. Relevant data showed that it was highly similar to the original trastuzumab in terms of quality, safety and efficacy.
In terms of production quality, this trastuzumab has also reached international advanced standards. Last year, the "Hanquyou" production site and facilities passed the US FDA's pre-approval inspection. This is the second time that Henlius has been recognized by an international authoritative organization after the Good Manufacturing Practice Certification in China and the EU, becoming a biopharmaceutical company that independently develops and produces antibody drugs that has passed GMP certification in China, the EU, and the United States.
The Xuhui base that shipped to Saudi Arabia this time is the first antibody biopharmaceutical production base in China to obtain the China-Europe dual GMP certification. Its quality management system has passed nearly 100 on-site inspections and audits by the China National Drug Administration, the European Medicines Agency, the Indonesian Food and Drug Administration, the Brazilian National Health Supervision and Administration Agency and other agencies.
The first commercial shipment of domestic monoclonal antibody biologics to the Middle East is the result of an exclusive commercial cooperation between a Shanghai company and an international partner. The cooperation between the two parties will cover Europe, North America, parts of the Middle East and North Africa, and some CIS countries.
It is reported that Fuhong Hanlin has made a lot of forward-looking arrangements around the overseas expansion of "Hanquyou" and has reached cooperation with a number of foreign biopharmaceutical companies. It plans to cover about 100 countries and regions around the world, realize the globalization of "Made in China" in the field of monoclonal antibody biological drugs, and benefit more cancer patients.
