The Year of the Snake brings spring early, and good news arrives during the festive season. On January 22, 2025, the BTK inhibitor jointly declared by EMICRO Biomedicine and Henan Normal University for the treatment of "multiple sclerosis (MS)" was approved by the National Medical Products Administration (NMPA) for a Phase I clinical trial. This is another significant achievement following the approval of the company's "BTK inhibitor TM471 - 1 Capsule" for lymphoma drug clinical trials at the end of 2023. This achievement is the latest result of the school - enterprise cooperation, not only filling relevant gaps in Henan Province but also marking that EMICRO Biomedicine is aiming at the new track opened up by international pharmaceutical giants and demonstrating strong competitive advantages in the research and development of first - class innovative drugs.

This time, the approval notice number of the clinical trial of EMICRO Biomedicine's multiple sclerosis (MS) obtained from the NMPA is: 2025LP00212. Animal experiments have shown that the pre - clinical research of EMICRO Biomedicine's BTK inhibitor indicates that it exhibits extremely high safety in aspects such as the heart and liver, and can be comparable to similar products of a leading domestic company in the treatment of autoimmune diseases. The BTK brain occupancy rate of EMICRO Biomedicine's BTK inhibitor is the highest, indicating that TM471 - 1 is confident to be the best in this field.

Since its establishment eight years ago, EMICRO Biomedicine has been committed to the research and development of anti - tumor innovative drugs. It has developed multiple pipelines, including the BTK inhibitor project, TRK - ALK - ROS1 inhibitor, cMET - CSF1R inhibitor, and PROTAC/molecular glue projects, multi - dimensionally striving for the peak of international anti - tumor drug research and development and achieving remarkable results. At the end of 2023, the approved innovative drug project for clinical trials was for the treatment of lymphoma; the project approved this time is for the treatment of the autoimmune disease multiple sclerosis. In the same field, it is the first time in Xinxiang City and Henan Province that a company has had two innovative drug clinical trial projects approved within two years.

In the early stage of the Chinese Lunar New Year in 2025, EMICRO Biomedicine has received a series of good news from the scientific research front. First, the lymphoma project of the BTK inhibitor has smoothly carried out a Phase I clinical trial. Two groups of patients have been enrolled. As of now, the feedback is good. In particular, for the patients in the first group, after taking the medicine at the minimum dose (50mg) for two months, not only is the safety excellent, but the lymphoma lesions of the patients have decreased by 51%. Second, the international patent application for EMICRO Biomedicine's three - target TRK - ALK - ROS1 has been preliminarily successful. Its indicators are comparable to those of the globally recognized second - generation "cancer - agnostic" legendary targeted drug TPX - 0005, and some are even better. In this research field, EMICRO Biomedicine is expected to continue to create "legends". Third, the BTK inhibitor project has obtained a European Union patent certificate (covering 18 countries: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Slovenia, Sweden, Romania). Fourth, another approval was obtained before the 2025 Chinese Lunar New Year, truly a series of happy events.

At present, there is no targeted drug for the treatment of autoimmune diseases in the world. The market has huge potential, and once the drug is developed, it can bring substantial benefits to patients. The industry predicts that the Chinese market could reach $12.6 billion in 2025 and $32.3 billion in 2030. The BTK inhibitor for some autoimmune diseases is a hot track with intense competition in the international innovative drug field. The BTK inhibitor for the "multiple sclerosis (MS)" indication jointly declared by EMICRO Biomedicine and Henan Normal University has been approved by the NMPA for a Phase I clinical trial. This will enable the company to stand at the international high - point in this field and is expected to achieve transcendence.

The leadership team of EMICRO Biomedicine, along with the R & D team and all employees, is embarking on a dream - chasing journey that brings honor to the country in the field of research and development of innovative drugs for anti - tumor and autoimmune diseases. Although the dream is distant, it can be achieved through pursuit.