Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs.

In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan.

Radiopharmaceuticals refer to a special class of drugs containing radionuclides for medical diagnosis or treatment, and have unique advantages and huge market potential in diagnosis and treatment.

64Cu is an important accelerator-produced medical isotope with a half-life of 12.7h, which can emit β+ rays for PET imaging diagnosis, as well as β-particles and electrons for nuclide-targeted therapy, which has the potential for diagnosis and therapy integration and has a broad application prospect, and it is mainly used in PET diagnosis of nuclear medicine department at present. Currently, the 64Cu-labeled drug 64Cu-DOTATATE has been approved by the FDA for use in neuroendocrine tumors (NETs) that are found to have positive Somatostatin (SST) receptors in adults by positron emission tomography (PET). A clinical study published in the Journal of Nuclear Medicine showed that the use of 64Cu-DOTATATE to assist PET imaging achieved a sensitivity of 90.9% and specificity of 96.6% in the detection of NETs [1]. Currently, there are no 64Cu-related products available in China. Compared with PET nuclides such as 18F (T1/2=109.6 min) and 68Ga (T1/2= 68 min), 64Cu has a relatively long half-life, which allows for long-time imaging studies, and facilitates longer-distance transportation and supply of nuclides and labeled drugs.

Hengrui Medicine's innovation in the field of nuclear drugs has been outstanding.2023 Since then, Hengrui Medicine has had four nuclear drug products approved for clinical trials, lutetium [177Lu] oxytetracycline injection is Hengrui Medicine's first nuclear drug product, and the nuclide diagnostic drug gallium [68Ga] ixotetracycline injection is the company's first pair of radiological precision diagnostic products in the field of nuclear drugs, HRS-4357 injection and HRS-9815 injection are respectively the company's first pair of nuclear drug products approved for clinical trial, and the company's first pair of radioactive precise diagnosis products in the field of nuclear drugs, HRS-4357 injection and HRS-9815 injection. HRS-4357 Injection and HRS-9815 Injection are the first innovative drug in the field of nuclide therapy and the first innovative drug in the field of radio-diagnostics, respectively, approved for clinical use by the Company. Among them, lutetium [177Lu] oxytetracycline injection, HRS-4357 injection and HRS-9815 injection have completed the enrollment of their first subjects last year.

Tianjin Hengrui, a wholly-owned subsidiary of Hengrui Medicine, was established in 2020 and is committed to building a research and development and transformation platform for integrated nuclide drugs for tumor diagnosis and treatment. The company has been awarded a series of honors and recognitions such as national high-tech enterprise certification, radioactive drug production license, Tianjin Radiopharmaceutical Innovation Consortium, Tianjin Nuclide Precision Diagnostic Drugs Key Laboratory, executive director unit of Tianjin Nuclear Society, etc., and appeared on CCTV's News Feed as a typical case of accelerating scientific and technological achievements transformation in Tianjin.

As an innovative and internationalized pharmaceutical enterprise, Hengrui Medicine has continued to step up its R&D in recent years. Since the first innovative drug was approved for marketing in 2011, the company has invested more than 33 billion yuan in R&D, ranking the forefront of the national pharmaceutical industry. The company has set up 14 R&D centers in Lianyungang, Shanghai, the U.S. and Europe, with a global R&D team of more than 5,000 people, and established a number of international leading new technology platforms such as protein hydrolysis-targeted chimeras (PROTAC), molecular gels, antibody-coupled drugs (ADCs), and b/multi-specific antibodies, etc., and focuses on innovation in a number of areas such as antitumor, metabolic diseases, autoimmune diseases, respiratory diseases, neurological diseases and so on, Neurological diseases and other areas of innovative research and development. At present, the Company has approved and listed 16 Class 1 innovative drugs and 4 self-developed Class 2 new drugs in China, and has more than 80 self-developed innovative products under clinical development, with more than 270 clinical trials conducted at home and abroad, and its R&D achievements have steadily ranked the leading position in the industry.

https://mp.weixin.qq.com/s/OvSpPG0vYk89pRfE3vm9kw