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Dongfang Baitai long-acting diabetes biological class I new drug obtained clinical approval
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Dongfang Baitai long-acting diabetes biological class I new drug obtained clinical approval

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-20
  • Views:469

(Summary description)In April this year, the clinical approval document of the State Food and Drug Administration (CFDA) was obtained for the application of JY09 Exendin-4 fusion protein, a diabetes treatment drug, by Beijing Dongfang Baitai Biotechnology Co., Ltd. (hereinafter referred to as "Dongfang Baitai"). At present, the voucher preparation is completed. The breakthrough of this technology will break the monopoly of imported antibody drugs in China for a long time. This marks another important milestone in the field of Dongfang Baitai anti diabetes series drugs.

Dongfang Baitai long-acting diabetes biological class I new drug obtained clinical approval

(Summary description)In April this year, the clinical approval document of the State Food and Drug Administration (CFDA) was obtained for the application of JY09 Exendin-4 fusion protein, a diabetes treatment drug, by Beijing Dongfang Baitai Biotechnology Co., Ltd. (hereinafter referred to as "Dongfang Baitai"). At present, the voucher preparation is completed. The breakthrough of this technology will break the monopoly of imported antibody drugs in China for a long time. This marks another important milestone in the field of Dongfang Baitai anti diabetes series drugs.

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-20
  • Views:469
Information

In April this year, the clinical approval document of the State Food and Drug Administration (CFDA) was obtained for the application of JY09 Exendin-4 fusion protein, a diabetes treatment drug, by Beijing Dongfang Baitai Biotechnology Co., Ltd. (hereinafter referred to as "Dongfang Baitai"). At present, the voucher preparation is completed. The breakthrough of this technology will break the monopoly of imported antibody drugs in China for a long time. This marks another important milestone in the field of Dongfang Baitai anti diabetes series drugs.

 

JY09

JY09 is a new class of biological products independently developed by the R&D team of Dongfang Baitai, which gathers the technical strength of many antibody R&D personnel. It is used to treat type II diabetes. The 7-10 day injection of the drug broke through the technical bottleneck of frequent injection of traditional GLP-1 receptor agonists. From three injections a day to one administration every 7-10 days, the pain and inconvenience of patients were greatly relieved. It can steadily control the blood sugar level of patients, reduce the risk of hypoglycemia, and improve the safety of drug use. JY09 is bound to become a "blockbuster" in the field of biomedicine in China, with an immeasurable market prospect.

 

 

Seven years to sharpen a sword

As is known to all, independent R&D and innovation of biopharmaceuticals have long cycle, high risk and large investment. Few domestic pharmaceutical enterprises can afford such a large amount of capital and long-term time investment. For a long time, it has been monopolized by foreign well-known large pharmaceutical enterprises. Since the development of Dongfang Baitai JY09 project was launched in 2009, the company team has experienced a full seven years of hard and long years. We have also experienced many ups and downs, which were unexpected by the founders. The blood and tears made the project grow. In the past seven years, hundreds of expert researchers, technicians and relevant staff have presided over or participated in the development of new drugs. A large amount of scientific research funds and social resources have been collected. It takes a long time, has a huge investment, has a hard time to pay, and has superb technology comparable to that of large foreign pharmaceutical enterprises.

Seven years is a long journey for all companies. In the era of national entrepreneurship, one year of product research and development, two years of financing, and three years of listing to create considerable income and "honor" seems to have become the normal development of entrepreneurial enterprises. But that is not what Dongfang Baitai pursues. Because the team understands that new drug research and development can not be quick and quick, but should be responsible for patients. We cannot neglect the quality of drugs for the sake of interests. The goal of Dongfang Baitai is to provide the majority of patients with internationally leading, safer, more effective and more economical biological new drugs!

Dongfang Baitai not only has the interests pursued by the enterprise, but also has the responsibilities and responsibilities on its shoulders. The successful development of JY09 has realized the historical mission that a pharmaceutical enterprise should follow. In the past seven years, Dongfang Baitai has made the most comprehensive, thorough and in-depth interpretation of the core values of "responsibility, quality, innovation and health" to the world. It took us seven years to prove to the society our professional attitude, rigorous style and the spirit of daring to explore in the unknown biological field. We have really condensed the great power of biomedicine in seven years to help people enjoy a healthy life! This is the future of biomedicine! It is the future of Chinese medicine!!

During the seven years of cold and hot weather, the sun and the moon alternated and the stars changed. The passion of the team was not dissipated. We have been down-to-earth in our research and innovation. We are determined not to take shortcuts or play tricks. We do a solid job in every experiment and carefully record every data, which is reasonable and well documented. This is also the key for JY09 project to obtain a number of biological innovative drugs with independent intellectual property rights in China, the United States, Europe, Japan, South Korea and other countries.

 

 

Choose firmly

Looking back on the seven years of exploration is full of our blood and tears. After seven years of cold and hot weather, the team has gone through too many twists and tribulations from the initiation of JY09 project at the beginning of research and development to the step by step clinical trial. These difficulties include the continuous improvement of early laboratory equipment, the departure of some team members, the lack of research and development funds, the tedious and repetitive experiments, the huge and complex data volume, and so on. But we were not knocked down by many difficulties. Under the correct choice and leadership of the company's leaders, the road of R&D has always been moving forward unswervingly. We have persevered, patiently explored and improved the innovative R&D system platform, worked hard without arrogance and impatience, and finally completed all the work before JY09 clinical research.

What a long long road!

Of course, the smooth approval of JY09 clinical application is only the first step in the extremely long process of new drug development. There is still a long way to go before drugs are successfully marketed. The task behind is still arduous and arduous! The clinical research in the next few years needs all the company members to guard against arrogance and rashness, and work with professional attitude and full passion. The team needs to create an atmosphere of tolerance for failure, abandon impetuosity and devote themselves to research. At present, the company plans to accelerate the clinical research of JY09. We look forward to the successful listing of JY09 as soon as possible!

 

 

Special thanks

In the past seven years, not only the company team has paid unimaginable hard work and sweat. At the same time, we would like to thank Yizhuang Development Zone, Beijing Municipality and national departments and leaders at all levels for their great attention and support. It is the care and encouragement of leaders that directly promote the smooth progress of JY09 new drug research and development process.

We would also like to thank the investors who have been quietly supporting us. In today's social atmosphere, which requires a short investment cycle and a high rate of return, your trust and support over the years have enabled our R&D team to pioneer and devote themselves to research in a professional platform. It is your years of understanding and patient company that can make JY09 project achieve such impressive results! All colleagues of the company will make unremitting efforts, never fail to live up to the support of investors, and return the trust and investment of investors with better results!

 

Concluding remarks

The road of Dongfang Baitai will be wider and farther in the future! All members of the company will work together to complete the clinical research as soon as possible under the premise of ensuring the drug quality, so that JY09 can be successfully listed as soon as possible. We will enable Chinese patients with diabetes to enjoy the benefits of new cutting-edge drugs that are in line with international standards as soon as possible!

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