After more than ten years of long-distance running, the world's first diabetes new drug, Hualing Pharmaceutical, has "crossed" the finish line! On October 8, the latest announcement on the official website of National Drug Administration showed that the first-class innovative drug Dogliasetin tablets (trade name: Huatanging) approved by Hualing Pharmaceutical Technology (Shanghai) Co., Ltd. to be launched. This drug is suitable for improving blood sugar control in adult patients with type 2 diabetes.
This category 1 new global innovative drug was developed and held by Hualing Pharmaceutical Technology (Shanghai) Co., Ltd. and entrusted by Shanghai DiSano Biopharmaceutical Co., Ltd. It is a typical representative of Zhangjiang's research and development and Shanghai production, and is also a successful case of Shanghai's pilot drug marketing authorization holder system (MAH) and promoting the rapid market launch of innovative R&D results. The approval of this time also means that the innovative drug has become the first global innovative drug to be launched in China. After more than ten years, Hualing Pharmaceutical finally achieved the "world's first and China's first launch."
is based in China and has developed the global original innovative drug
for ten years: data piled up three trucks
Biopharmaceuticals is an innovative process with long cycle, high risks and great investment. On the road of "global new", Hualing Pharmaceutical has been on the road for more than ten years. In 2010, Chen Li founded Hualing Pharmaceuticals with the goal of: based in China and developing global original innovative drugs.
This time, dozagliasetin is a glucose kinase (GK) activator independently developed by Hualing Pharmaceutical. It acts on glucose kinase targets in the storage and output organs of glucose in the islets, intestinal endocrine cells, and liver, improving blood sugar homeostasis disorder in patients with type 12 diabetes. The drug is available for new treatment options for patients with type 2 diabetes.
It is worth noting that from preclinical trials to phase I, phase II, phase III clinical trials to market launch, the entire process is led by Chinese scientists, clinical experts and Chinese companies.
"Since the establishment of Hualing Pharmaceutical, we have always adhered to the concept of based in China and developing global original innovative drugs. The research on dogliasen tablets has been promoted for ten years, and the data and data are piled up in three trucks. Why? Because it is the world's first, there is no precedent for reference." Dr. Chen Li, founder, CEO and Chief Scientific Officer of Hualing Pharmaceutical, said.
Hualing Pharmaceutical has also verified in the past decade that it can better and more effectively develop the world's first innovative drug in China. In the process of insisting on making global original innovative drugs, Chen Li adopted a "joint" R&D model: for example, using the laboratory of the Shanghai Institute of Pharmaceuticals to conduct technical research, and using the lab of the WuXi AppTec company to develop products. In the process of drug development, enterprises can be found to connect with the animal experiments, cell experiments, biological testing, and product production.
In May this year, the top international medical journal Nature-Medicine published two peer-reviewed papers on the results of Phase III research on the world's first new diabetes drug Dogliasetin, representing the results of China's large-scale registered clinical research began to enter the international stage, once again proving the international academic community's recognition and affirmation of China's new drug development capabilities.
Dare to think, dare to break, dare to fight
Pudong "innovative drugs" explore feasible paths for the development of new drugs in China
On the innovation path of the world's first and China's first launch, Hualing Pharmaceutical has always strived to stand at the high ground of reform and opening up and the forefront of pharmaceutical innovation. The world's first innovative drug developed has broken the foreign monopoly of the world's first innovative drug development.
"Hualing Pharmaceuticals better utilizes China's high-quality clinical resources and corporate business vitality in the process of industry, education, research and medicine, and benefit more patients." As a representative of Pudong's "innovative drug" enterprise, Dr. Chen Li said that Pudong's development and opening up has cultivated the spirit of Pudong people's daring to think, dare to break, and dare to fight, and has nurtured a new miracle and new look. As the vanguard of Pudong's biomedical industry, I feel a great responsibility.
This spirit has always been upheld by Hualing Pharmaceuticals. Over the past decade, Hualing Pharmaceutical has made breakthrough progress in clinical research and development, commercialization and capital markets. Both phase III registered clinical trials have achieved remarkable results, becoming the world's first company to successfully achieve clinical development of glucose kinase activators; it has set a precedent for the world's first innovative drug to apply for clinical research approval in China; it took only 8 months to obtain the clinical approval for the first trial of dogliaptin tablets in China, filling the gap in the first innovative drug research in China; it actively promoted the implementation of the drug marketing authorization holder (MAH) system and was selected as the first batch of domestic MAH system pilot enterprises, solving the technical problems entrusted by domestic biotechnology companies to produce third parties, and achieving the connection between China's biopharmaceutical industry and the global pharmaceutical industry chain.
Before 2010, China had no complete innovative drug industry, and the innovative drugs independently developed were almost blank; more than ten years later, innovative drugs have developed into the most active force in China's pharmaceutical industry and have begun to compete with multinational pharmaceutical companies. The progress of the industry also represents the gradual enhancement of the innovation capabilities of enterprises. Biopharmaceutical companies represented by Hualing Pharmaceuticals have flourished and gradually grown into domestic innovation entities. They not only have the preclinical and clinical research capabilities of new drugs that are in line with international standards, but also promote a new pattern of the drug innovation system.
Hualing Pharmaceutical's ten years of hard work not only explores a feasible path for the development of new drugs in China, but also breaks the foreign monopoly of the world's first innovative drugs; Hualing Pharmaceutical's 10 years of innovation have also brought rules that are in line with the international level, helping Pudong to build a vibrant "innovative drug" industrial ecosystem.
Source: Pudong release
