In March of this year, Tianjin Municipality released the second batch of specialized and innovative SMEs recognized in 2023, and Accendatech was on the list. Also in this month, its wholly-owned subsidiary, Accendatech (Tianjin) Biopharmaceutical Co., Ltd. was registered and established in Tianjin.

Founded by a group of high-caliber talents, including Chen Yue, a professor at the School of Chemistry, Nankai University and a recipient of the 'National Outstanding Youth' award, Accendatech is a high-tech enterprise focusing on the research and development of new drugs for diseases such as malignant brain tumors and brain metastases, interstitial pneumonia, and pulmonary fibrosis. Since its establishment, the company has rapidly assembled a complete R&D team encompassing pharmacy, pharmacology, pharmacokinetics, intellectual property, registration, clinical trials, and quality control. Driven by innovation, the company focuses on the most pressing clinical needs, conducting research, pilot production, and domestic and international clinical trials of original drugs worldwide. It has also built a technology platform that crosses the blood-brain barrier and a drug development platform targeting cancer stem cells.

The remarkable achievement of Accendatech can be traced back to the development of its small-molecule immunomodulator ACT001. Professor Chen Yue explained that immunomodulators (such as lenalidomide) often have broad application prospects in cancer, inflammation, and fibrosis. However, among the candidate drugs that are marketed and undergoing clinical trials globally, immunomodulators that can enter the brain are extremely rare due to the difficulty in overcoming the blood-brain barrier and the difference between the brain's immune microenvironment and the body's tumor microenvironment. Thus, brain tumors have become a 'forbidden zone' for targeted drugs. Professor Chen Yue and his team broke into this 'forbidden zone' and insisted on developing original drugs. Adhering to this philosophy, Accendatech has developed several candidate new drugs, among which the exclusively developed small-molecule immunomodulator ACT001 can effectively cross the blood-brain barrier and enter the brain in large quantities.

On December 20, 2023, Suntech Power announced exciting news: its innovative drug ACT001 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse midline gliomas in children, including but not limited to diffuse en bloc pontine glioma (DIPG). This marks another significant step forward for ACT001, following its three orphan drug designations in Europe and the U.S., and one rare disease designation for children (the first in China). This recognition not only underscores ACT001's potential in treating serious and life-threatening diseases but also represents a crucial milestone in Suntech Power's internationalization strategy.

Regarding the company's focus on originality and its goal of achieving disruptive breakthroughs in the biopharmaceutical field, Professor Chen Yue remarked, 'The mission of original drugs is to solve the dilemma of having no available treatments and bring real hope to patients. We have chosen a difficult but correct path because we believe that only originality can truly drive medical progress and benefit patients.'

Currently, the company has applied for nearly 100 invention patents, of which 48 have been authorized, and 3 international patents have been authorized in 20 countries and regions around the world. The new drug ACT001 for malignant brain tumors has obtained more than 10 clinical trial approvals worldwide, the first rare disease qualification for children in my country, and the rare fast track qualification nationwide. The drug has entered the pivotal clinical trial for use in children with brain tumors and brain metastases of lung cancer, and the product is expected to be launched in 2025.

Accendatech has not only made breakthroughs in scientific research, but also made great progress in industrialization. It has completed hundreds of millions of yuan in financing, and the Pre-IPO round of financing is also underway, laying a solid foundation for subsequent product launches and market promotion.

In addition, Accendatech has received numerous honors, including titles such as National Intellectual Property Advantage Enterprise, High-tech Enterprise, Specialized and Innovative Small and Medium-sized Enterprise, Gazelle Enterprise, and the First Prize of Tianjin Science and Technology Award for Technological Invention.

The story of Suntech Power is a microcosm of the rise of China's biopharmaceutical innovation power and a vivid embodiment of the indomitable spirit and pioneering spirit of researchers. Each international recognition is a testament to Suntech Power's innovative strength and another solid step forward for Chinese innovative drugs to go global. Today, Suntech Power is continuously increasing its R&D investment and deepening international cooperation, moving towards becoming a multinational pharmaceutical group integrating R&D, production, and sales. It is committed to translating more scientific research results into clinical applications, contributing Chinese wisdom and solutions to conquering intractable diseases such as brain tumors, and benefiting patients worldwide.