In recent years, the number of breakthrough therapeutic drugs selected has been steadily increasing. It is reported that many listed companies have recently announced that their related products have been included in the list of breakthrough therapeutic drugs.

 

 

 

On July 3rd, according to the website of the National Medical Products Administration, the antisense oligonucleotide (ASO) drug AHB-137 developed by Hangzhou Haobo Pharmaceutical is planned to be included in breakthrough therapy, with an indication for chronic hepatitis B.

 

 

 

According to the data, AHB-137 is based on the independent research and development platform Med-Oligo of Haobo Pharmaceutical ™ Developing innovative non coupled antisense oligonucleotide (ASO) drugs with the potential to become the cornerstone of functional cure for chronic hepatitis B. At the 2024 annual meeting of the European Society of Hepatology (2024 EASL), the company disclosed two latest clinical research progress of AHB-137, namely, the Phase I/IIa clinical study (AB-10-8002) for subjects in Chinese Mainland, and the international multi center Phase I clinical study (AB-10-8001).

 

 

 

In addition, according to the analysis, in June, several listed companies including Hengrui Pharmaceutical, Yifang Biotechnology, and Microchip Biotechnology also announced that their related products were included in the list of breakthrough therapeutic drugs.

 

 

 

Among them, Hengrui Pharmaceuticals announced on June 5th that its subsidiary drugs plan to be included in the list of breakthrough treatment varieties. The data shows that SHR-A1811 injection is used for HER2 positive unresectable or metastatic biliary tract cancer patients who have received one or more treatment regimens in the past. SHR-A1811 for injection can bind and internalize HER2 expressing tumor cells, release toxins through protease cleavage in the lysosome of tumor cells, induce cell cycle arrest, and induce tumor cell apoptosis.

 

 

 

According to the CDE website on June 8th, the drug "D-1553 tablets" jointly applied by Yifang Biotechnology has been approved for inclusion in the breakthrough treatment drug program after review. On June 11th, Microelectronics announced that its original anti-tumor drug, Xidabenzamide tablets, had been officially included in the list of "breakthrough therapeutic varieties" by the Drug Evaluation Center (CDE) of the National Medical Products Administration.

 

 

 

Industry insiders point out that breakthrough therapeutic drugs are suitable for innovative or improved new drugs that are used during drug clinical trials to prevent and treat diseases that seriously endanger life or seriously affect quality of life, and there is no effective prevention and treatment method, or there is sufficient evidence to demonstrate significant clinical advantages compared to existing treatment methods. The steady increase in the number of selected breakthrough therapeutic drugs also indicates China's sustained investment and achievements in the field of innovative drug research and development. According to data, as of June 27th, since the beginning of this year, 42 applications from pharmaceutical companies have been officially included in the list of breakthrough therapeutic drugs through public announcement.