Tian Hui Technology Oral Insulin Is Expected To Come Out In 2 Years.

"I started acting as an insulin injecting product from novo Nord in 1994, and founded Hefei life science and technology park investment and Development Co., Ltd. in 2005, focusing on the development and production of insulin. In 2010, we invested in Hefei Tian Mai Biotechnology Development Co., Ltd., specializing in the production of insulin injection products. In 2012, we invested in Hefei Tian Hui hatching Technology Co., Ltd., specializing in the development of oral insulin delivery technology. Over the years, nearly 3 billion yuan has been invested in the insulin project. " In recent days, Gao Xiaoming, chairman of Tian Hui technology, received a deep "insulin complex" during his interview with the economic news reporters in twenty-first Century.

In fact, Gao Xiaoming has been following up oral insulin for many years, finalizing the cooperation with Oramed and signing the "technology licensing agreement" to introduce the technology of oral insulin production into China. At present, the Hefei production base of Tian Hui science and technology has complete production technology and production line of oral insulin capsule.

In November 12, 2019, Oramed released the preliminary results of the IIb study. It was the first time that the glycosylated hemoglobin has been dropped for 3 months after oral administration for the first time in nearly 100 years. After successful completion of the IIb clinical trial, Oramed is about to apply for pre launch III phase clinical trials, which will be launched in the United States, Europe and China respectively. Gao Xiaoming disclosed that the production of oral insulin in China is expected to be available 2 years later. According to the current progress, it is the first oral insulin product in the world.

"Insulin complex"

"Insulin technology, production barriers are high, Denmark, the United States, France (Germany), Israel and other countries occupy a leading position, over the years, the market has been monopolized by Novo Nord, Lilly and Sanofi." Gao Xiaoming told reporters on twenty-first Century economic report.

In the 60s of last century, the insulin products of Danish company novo Nord were introduced into China in the form of imports. In 90s, Gao Xiaoming, general manager of Shenzhen health care products import and Export Co., Ltd. was the agent of Norfolk nordnow insulin products. In the 2005-2009 year, another import insulin heavy and forest registration in China was completed, and the import drug registration certificate was obtained.

"Over the years, we have done the injection of insulin, the world's finest Japanese nuns 34G needle general agent in China, as well as GLP-1 and other whole series of insulin products. In 2005, we began investing heavily in the development of insulin, including oral buccal mucosa and nasal spray insulin. Although the project has not been successful, we have not given up the search for better insulin delivery." Gao Xiaoming said.

In 2015, Gao Xiaoming finally chose Israel Oramed company, and its cooperation with Tian Hui technology. Israel is also one of the four big powers in the world in the world of insulin.

Oramed is an Israeli company that developed oral protein delivery platform, including oral insulin and oral GLP-1. It was founded in 2006 and listed on NASDAQ the following year.

Although Israel is a small country, Israel has advanced technology, medical and other aspects. They have "thought" and "positive innovation". Although the whole Oramed company in Israel has only 5 people, the family business has studied the technology of oral protein delivery for more than thirty years, and has designed and tested 34 drug formulations, and finally developed a safe and effective platform for oral administration of protein. Gao Xiaoming told reporters on twenty-first Century economic report.

Oramed pharmaceutical company has patents and technology, but it is very weak in production and commercialization, and needs external force. Since October 2006, the clinical study of oral insulin capsules has been carried out. As of November 2019, Oramed has completed 22 clinical studies in the United States, South Africa and Israel respectively.

In the development of oral insulin capsules, Oramed has been looking for suitable suppliers and production plants worldwide. In view of the special characteristics of raw and auxiliary materials and preparation processes, Oramed has collaborated with 6 countries and 7 companies to complete the production and testing of oral insulin capsules in preclinical and clinical samples.

"In November 12, 2019, Oramed announced the results of IIb clinical research, indicating that the oral insulin capsule ORMD-0801 has a definite effect on reducing glycosylated hemoglobin, and also shows its reliable safety." Gao Xiaoming said.

China's production or global debut

As the academician of the Chinese Academy of engineering and vice president of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Ning Guang said, oral insulin is our dream.

The industry reached a consensus that type 1 diabetes is diagnosed immediately after insulin treatment. Type 2 diabetes is based on the development of the patient's condition, first of all, lifestyle intervention, followed by a single oral hypoglycemic treatment. If a single oral hypoglycemic agent is still unable to control blood sugar well, it is necessary to use combined medication, including insulin, and most of the diabetics need insulin in the clinic.

At present, insulin is injected through acupuncture, and many times daily acupuncture and injections have caused great pain and inconvenience to the patients, resulting in their blood sugar failing to achieve the control goal and causing various complications. Jiang Lixin, chief technology officer of Tian Hui technology, points out that many scientists are trying to change the way insulin is administered, and the injection is changed to oral administration.

"Oral insulin in addition to bringing good patient compliance, its intestinal absorption pathway is closer to the physiological process of human natural insulin secretion, so it can reduce or avoid hypoglycemia and avoid weight gain." Jiang Lixin pointed out.

Oral administration of oral insulin as a protein, the technical difficulties to overcome are not only the digestive system's degradation of protein and polypeptide, but also the problem of how protein can reach the target of action through the digestive system, and the individual differences in drug absorption. Scientists have been exploring for nearly 100 years.

In September 20th, good news came from Novo Nordisk. FDA (US Food and Drug Administration) officially approved Norfolk Rybelsus (oral application of sumarurin 1 times daily).

According to Jiang Lixin, the mechanism of Novo Norde's oral insulin I338 is through changing individual amino acids and combining a short fatty acid insulin analogue. The Tian Hui technology oral insulin capsule ORMD-0801 is natural insulin, which uses its enteric coating and enzyme inhibitors to protect insulin from degradation of gastric acid and protease in the intestine, and no side effects such as hypoglycemia and body weight after oral administration.

Norman Norde's oral sumarurin is an agonist of GLP-1 receptor and promotes insulin production in vivo. In theory, there is no competitive relationship between oral sumarurin and oral insulin capsule ORMD-0801, and they can be combined. Jiang Lixin pointed out.

In January 2019, the oral insulin capsule of Tian Hui science and technology has obtained the "clinical trial notice" issued by the State Administration of drug administration and has carried out clinical trials in China.

All along, the global insulin market is dominated by European and American enterprises, and the Chinese insulin market is also dominated by imported drugs. Gao Xiaoming hopes that when China imports insulin products, it will also have more high-quality Chinese innovative medicines. "We hope that oral insulin will be made in China, and more patients will be given insulin by innovative technology."

"In the future, we hope that oral insulin can enter health insurance, reduce the burden of patients, and benefit more patients." Gao Xiaoming briefed reporters on twenty-first Century economic report.

The industry expects that in China, the number of oral insulin capsules ORMD-0801 will be over 100 million in the future. Oral insulin can partially replace the injection of insulin, including type 1 diabetes patients who reduce the number of insulin injections and make blood sugar more stable. Type two diabetes can partially replace insulin injection. From the point of view of pharmacoeconomics, if the above population use insulin earlier, the diabetes process will be controlled, which will greatly reduce the economic burden for the country and the patients' families.